21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...
21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...
21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was in...
21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...
21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...
21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...
21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was in...
21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...
21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... substantially equivalent to an ankle joint metal/polymer non-constrained cemented prosthesis that was in... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non...
21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... substantially equivalent to an ankle joint metal/polymer non-constrained cemented prosthesis that was in... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non...
21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... substantially equivalent to an ankle joint metal/polymer non-constrained cemented prosthesis that was in... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an...
21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part...
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an...
21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...
21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...
21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...
21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...
21 CFR 888.3340 - Hip joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/composite semi-constrained... Hip joint metal/composite semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a...
21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...
21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...
21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...
21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...
21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...
21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...
21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...
21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...
21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
21 CFR 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal constrained cemented or uncemented... metal constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal constrained... Administration on or before December 26, 1996 for any hip joint metal constrained cemented or uncemented...
21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...
21 CFR 888.3340 - Hip joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/composite semi-constrained cemented prosthesis. 888.3340 Section 888.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Hip joint metal/composite semi-constrained cemented prosthesis. (a) Identification. A hip joint metal...
21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ankle joint metal/polymer semi-constrained cemented prosthesis. 888.3110 Section 888.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal...
21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Elbow joint metal/polymer semi-constrained cemented prosthesis. 888.3160 Section 888.3160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal...
21 CFR 888.3640 - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...
21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...
21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...
21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...
21 CFR 888.3640 - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...
21 CFR 888.3640 - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...
21 CFR 888.3640 - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...
21 CFR 888.3640 - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...
21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...
21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...
21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...
21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...
21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...
21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...
21 CFR 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal constrained cemented or uncemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3300 Hip joint metal constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal constrained...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/metal semi-constrained, with a... Devices § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. (a) Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/metal semi-constrained, with a... Devices § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. (a) Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. 888.3560 Section 888.3560 Food and Drugs FOOD AND DRUG... Devices § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. 888.3560 Section 888.3560 Food and Drugs FOOD AND DRUG... Devices § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. 888.3560 Section 888.3560 Food and Drugs FOOD AND DRUG... Devices § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. 888.3560 Section 888.3560 Food and Drugs FOOD AND DRUG... Devices § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. 888.3560 Section 888.3560 Food and Drugs FOOD AND DRUG... Devices § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented...
21 CFR 888.3480 - Knee joint femorotibial metallic constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metallic constrained... Knee joint femorotibial metallic constrained cemented prosthesis. (a) Identification. A knee joint... knee joint. The device prevents dislocation in more than one anatomic plane and has components that are...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint... shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint... shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint... shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or...
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint... shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its...
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint... shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its...
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint... shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its...
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3660... device are: (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical... metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3650... are: (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices... metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint metal constrained cemented prosthesis. 888.3790 Section 888.3790 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal...
21 CFR 888.3480 - Knee joint femorotibial metallic constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metallic constrained cemented prosthesis. 888.3480 Section 888.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3480...
21 CFR 888.3480 - Knee joint femorotibial metallic constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metallic constrained cemented prosthesis. 888.3480 Section 888.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3480...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite non-constrained cemented prosthesis. 888.3490 Section 888.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. 888.3500 Section 888.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. 888.3500 Section 888.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/composite non-constrained cemented prosthesis. 888.3490 Section 888.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/composite non-constrained cemented prosthesis. 888.3490 Section 888.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
21 CFR 888.3480 - Knee joint femorotibial metallic constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metallic constrained cemented prosthesis. 888.3480 Section 888.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3480...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. 888.3500 Section 888.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
21 CFR 888.3480 - Knee joint femorotibial metallic constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metallic constrained cemented prosthesis. 888.3480 Section 888.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3480...
21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint metal constrained cemented prosthesis. 888.3790 Section 888.3790 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal...
21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal constrained cemented prosthesis. 888.3790 Section 888.3790 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/metal constrained cemented prosthesis. 888.3210 Section 888.3210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3210 Finger joint...
21 CFR 888.3340 - Hip joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/composite semi-constrained cemented prosthesis. 888.3340 Section 888.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3340...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/metal constrained cemented prosthesis. 888.3210 Section 888.3210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3210 Finger joint...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/composite semi-constrained cemented prosthesis. 888.3100 Section 888.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3100...
21 CFR 888.3340 - Hip joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/composite semi-constrained cemented prosthesis. 888.3340 Section 888.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3340...
21 CFR 888.3340 - Hip joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal/composite semi-constrained cemented prosthesis. 888.3340 Section 888.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3340...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/metal constrained cemented prosthesis. 888.3210 Section 888.3210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3210 Finger joint...
21 CFR 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal constrained cemented or uncemented prosthesis. 888.3300 Section 888.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3300 Hip joint...
21 CFR 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal constrained cemented or uncemented prosthesis. 888.3300 Section 888.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3300 Hip joint...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/composite semi-constrained cemented prosthesis. 888.3100 Section 888.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3100...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/composite semi-constrained cemented prosthesis. 888.3100 Section 888.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3100...
21 CFR 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal constrained cemented or uncemented prosthesis. 888.3300 Section 888.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3300 Hip joint...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 888.3320 Section 888.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 888.3320 Section 888.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 888.3320 Section 888.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/polymer or ceramic/polymer... Devices § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. (a) Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/polymer or ceramic/polymer... Devices § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. (a) Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/polymer or ceramic/polymer... Devices § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. (a) Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/polymer or ceramic/polymer... Devices § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. (a) Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal/polymer or ceramic/polymer... Devices § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. (a) Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing...
Code of Federal Regulations, 2011 CFR
2011-04-01
... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...
Code of Federal Regulations, 2013 CFR
2013-04-01
... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...
Code of Federal Regulations, 2014 CFR
2014-04-01
... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...
Code of Federal Regulations, 2012 CFR
2012-04-01
... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...
Code of Federal Regulations, 2010 CFR
2010-04-01
... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...
Code of Federal Regulations, 2010 CFR
2010-04-01
... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...
Code of Federal Regulations, 2011 CFR
2011-04-01
... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...
Code of Federal Regulations, 2012 CFR
2012-04-01
... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...
Code of Federal Regulations, 2013 CFR
2013-04-01
... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...
Code of Federal Regulations, 2014 CFR
2014-04-01
... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...
Cooke, Christopher C; Hozack, William; Lavernia, Carlos; Sharkey, Peter; Shastri, Shani; Rothman, Richard H
2003-10-01
Fifty-eight patients received an Osteonics constrained acetabular implant for recurrent instability (46), girdlestone reimplant (8), correction of leg lengthening (3), and periprosthetic fracture (1). The constrained liner was inserted into a cementless shell (49), cemented into a pre-existing cementless shell (6), cemented into a cage (2), and cemented directly into the acetabular bone (1). Eight patients (13.8%) required reoperation for failure of the constrained implant. Type I failure (bone-prosthesis interface) occurred in 3 cases. Two cementless shells became loose, and in 1 patient, the constrained liner was cemented into an acetabular cage, which then failed by pivoting laterally about the superior fixation screws. Type II failure (liner locking mechanism) occurred in 2 cases. Type III failure (femoral head locking mechanism) occurred in 3 patients. Seven of the 8 failures occurred in patients with recurrent instability. Constrained liners are an effective method for treatment during revision total hip arthroplasty but should be used in select cases only.
21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...
21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...
21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...
21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...
21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices... Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90... device intended to be implanted to replace part of a knee joint in the treatment of primary...
21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...
21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...
21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...
21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...
Kim, Seok-Gyu; Son, Mee-Kyoung
2015-01-01
PURPOSE The purpose of this study was to examine the abutment screw stability of screw- and cement-retained implant-supported dental prosthesis (SCP) after simulated cement washout as well as the stability of SCP cements after complete loosening of abutment screws. MATERIALS AND METHODS Thirty-six titanium CAD/CAM-made implant prostheses were fabricated on two implants placed in the resin models. Each prosthesis is a two-unit SCP: one screw-retained and the other cemented. After evaluating the passive fit of each prosthesis, all implant prostheses were randomly divided into 3 groups: screwed and cemented SCP (Control), screwed and noncemented SCP (Group 1), unscrewed and cemented SCP (Group 2). Each prosthesis in Control and Group 1 was screwed and/or cemented, and the preloading reverse torque value (RTV) was evaluated. SCP in Group 2 was screwed and cemented, and then unscrewed (RTV=0) after the cement was set. After cyclic loading was applied, the postloading RTV was measured. RTV loss and decementation ratios were calculated for statistical analysis. RESULTS There was no significant difference in RTV loss ratio between Control and Group 1 (P=.16). No decemented prosthesis was found among Control and Group 2. CONCLUSION Within the limits of this in vitro study, the stabilities of SCP abutment screws and cement were not significantly changed after simulated cement washout or screw loosening. PMID:26140172
21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint (hemi-hip) acetabular metal cemented... (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint...
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
...: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems... of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94...
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
...: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems... of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94...
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
...: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems... of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
Allograft-prosthesis composites after bone tumor resection at the proximal tibia.
Biau, David Jean; Dumaine, Valérie; Babinet, Antoine; Tomeno, Bernard; Anract, Philippe
2007-03-01
The survival of irradiated allograft-prosthesis composites at the proximal tibia is mostly unknown. However, allograft-prosthesis composites have proved beneficial at other reconstruction sites. We presumed allograft-prosthesis composites at the proximal tibia would improve survival and facilitate reattachment of the extensor mechanism compared with that of conventional (megaprostheses) reconstructions. We retrospectively reviewed 26 patients who underwent resection of proximal tibia tumors followed by reconstruction with allo-graft-prosthesis composites. Patients received Guepar massive custom-made fully constrained prostheses. Allografts were sterilized with gamma radiation, and the stems were cemented into the allograft and host bone. The minimum followup was 6 months (median, 128 months; range, 6-195 months). Fourteen patients had one or more components removed. The median allograft-prosthesis composite survival was 102 months (95% confidence interval, 64.2-infinity). Of the 26 allografts, seven fractured, six showed signs of partial resorption, and six had infections develop. Seven allografts showed signs of fusion with the host bone. Six extensor mechanism reconstructions failed. Allograft-prosthesis composites sterilized by gamma radiation yielded poor results for proximal tibial reconstruction as complications and failures were common. We do not recommend irradiated allograft-prosthesis composites for proximal tibia reconstruction.
21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint femoral (hemi-hip) metal/polymer... § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part...
Li, Chaodi; Kotha, Shiva; Mason, James
2003-01-01
The exothermic polymerization of bone cement may induce thermal necrosis of bone in cemented hip arthroplasty. A finite element formulation was developed to predict the evolution of the temperature with time in the cemented hip replacement system. The developed method is capable of taking into account both the chemical reaction that generates heat during bone cement polymerization (through a kinetic model) and the physical process of heat conduction (with an energy balance equation). The possibility of thermal necrosis of bone was then evaluated based on the temperature history in the bone and an appropriate damage criterion. Specifically, we evaluate the role of implant materials and designs on the thermal response of the system. Results indicated that the peak temperature at the bone/cement interface with a metal prosthesis was lower than that with a polymer or a composite prosthesis in hip replacement systems. Necrosis of bone was predicted to occur with a polymer or a composite prosthesis while no necrosis was predicted with a metal prosthesis in the simulated conditions. When reinforcing osteoporotic hips with injected bone cement in the cancellous core of the femur, the volume of bone cement implanted is increased which may increase the risk of thermal necrosis of bone. We evaluate whether this risk can be decreased through the use of an insulator to contain the bone cement. No thermal necrosis of bone was predicted with a 3 mm thick polyurethane insulator while more damage is predicted for the use of bone cement without the insulator. This method provides a numerical tool for the quantitative simulation of the thermal behavior of bone-cement-prosthesis designs and for examining and refining new designs computationally.
21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint (hemi-hip) acetabular metal cemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. A hip joint (hemi-hip) acetabular...
Piemjai, Morakot; Nakabayashi, Nobuo
2015-01-01
A dentin-cement-prosthesis complex restored with either all-porcelain, cured resin-composite, or cast base metal alloy and cemented with either of the different resin cements was trimmed into a mini-dumbbell shape for tensile testing. The fractured surfaces and characterization of the dentin-cement interface of bonded specimens were investigated using a Scanning Electron Microscope. A significantly higher tensile strength of all-porcelain (12.5 ± 2.2 MPa) than that of cast metal (9.2 ± 3.5 MPa) restorations was revealed with cohesive failure in the cement and failure at the prosthesis-cement interface in Super-Bond C&B group. No significant difference in tensile strength was found among the types of restorations using the other three cements with adhesive failure on the dentin side and cohesive failure in the cured resin. SEM micrographs demonstrated the consistent hybridized dentin in Super-Bond C&B specimens that could resist degradation when immersed in hydrochloric acid followed by NaOCl solutions whereas a detached and degraded interfacial layer was found for the other cements. The results suggest that when complete hybridization of resin into dentin occurs tensile strength at the dentin-cement is higher than at the cement-prosthesis interfaces. The impermeable hybridized dentin can protect the underlying dentin and pulp from acid demineralization, even if detachment of the prosthesis has occurred. PMID:26539520
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained uncemented... metal/metal constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal... Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained uncemented... metal/metal constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal... Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis...
Lee, Ju-Hyoung; Park, In-Sook; Sohn, Dong-Seok
2016-07-01
If a cement-retained implant prosthesis is placed on an abutment, excess cement should be minimized or removed to prevent periimplant inflammation. Various methods for fabricating an abutment replica have been introduced to maintain tissue health and reduce clean-up time. The purpose of this article is to present an alternative technique for fabricating an abutment replica with computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint (hemi-hip) acetabular metal cemented prosthesis. 888.3370 Section 888.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint...
21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint (hemi-hip) acetabular metal cemented prosthesis. 888.3370 Section 888.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint...
21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint (hemi-hip) acetabular metal cemented prosthesis. 888.3370 Section 888.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint...
21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. 888.3390 Section 888.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/polymer/metal semi-constrained... Devices § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (a) Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device...
Periprosthetic Fractures Following Total Knee Arthroplasty
Kim, Nam Ki
2015-01-01
Periprosthetic fractures after total knee arthroplasty may occur in any part of the femur, tibia and patella, and the most common pattern involves the supracondylar area of the distal femur. Supracondylar periprosthetic fractures frequently occur above a well-fixed prosthesis, and risk factors include anterior femoral cortical notching and use of the rotational constrained implant. Periprosthetic tibial fractures are frequently associated with loose components and malalignment or malposition of implants. Fractures of the patella are much less common and associated with rheumatoid arthritis, use of steroid, osteonecrosis and malalignment of implants. Most patients with periprosthetic fractures around the knee are the elderly with poor bone quality. There are many difficulties and increased risk of nonunion after treatment because reduction and internal fixation is interfered with by preexisting prosthesis and bone cement. Additionally, previous soft tissue injury is another disadvantageous condition for bone healing. Many authors reported good clinical outcomes after non-operative treatment of undisplaced or minimally displaced periprosthetic fractures; however, open reduction or revision arthroplasty was required in displaced fractures or fractures with unstable prosthesis. Periprosthetic fractures around the knee should be prevented by appropriate technique during total knee arthroplasty. Nevertheless, if a periprosthetic fracture occurs, an appropriate treatment method should be selected considering the stability of the prosthesis, displacement of fracture and bone quality. PMID:25750888
Code of Federal Regulations, 2010 CFR
2010-04-01
... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...
Code of Federal Regulations, 2014 CFR
2014-04-01
... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...
Code of Federal Regulations, 2011 CFR
2011-04-01
... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...
Code of Federal Regulations, 2012 CFR
2012-04-01
... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...
Code of Federal Regulations, 2013 CFR
2013-04-01
... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...
2014-01-01
Background In total knee arthroplasty (TKA), cement penetration between 3 and 5 mm beneath the tibial tray is required to prevent loosening of the tibia component. The objective of this study was to develop and validate a reliable in vivo measuring technique using CT imaging to assess cement distribution and penetration depth in the total area underneath a tibia prosthesis. Methods We defined the radiodensity ranges for trabecular tibia bone, polymethylmethacrylate (PMMA) cement and cement-penetrated trabecular bone and measured the percentages of cement penetration at various depths after cementing two tibia prostheses onto redundant femoral heads. One prosthesis was subsequently removed to examine the influence of the metal tibia prostheses on the quality of the CT images. The percentages of cement penetration in the CT slices were compared with percentages measured with photographs of the corresponding transversal slices. Results Trabecular bone and cement-penetrated trabecular bone had no overlap in quantitative scale of radio-density. There was no significant difference in mean HU values when measuring with or without the tibia prosthesis. The percentages of measured cement-penetrated trabecular bone in the CT slices of the specimen were within the range of percentages that could be expected based on the measurements with the photographs (p = 0.04). Conclusions CT scan images provide valid results in measuring the penetration and distribution of cement into trabecular bone underneath the tibia component of a TKA. Since the proposed method does not turn metal elements into artefacts, it enables clinicians to assess the width and density of the cement mantle in vivo and to compare the results of different cementing methods in TKA. PMID:25158996
Mobile-bearing total knee arthroplasty: a full traumatic rotation of 180°.
Sudanese, Alessandra; Castiello, Emanuela; Affatato, Saverio
2013-06-25
From February 2008 to September 2012 we implanted 204 mobile-bearing knee prostheses in 192 patients. All the prostheses were cemented (both femoral and tibial components), and the patella was not replaced. Only one early complication of the implants (1/204 = 0.004%) occurred after a traumatic event as a full 180° rotation of the mobile-bearing polyethylene insert. A 78-year-old woman presented with swelling and severe pain at her right knee. This traumatic event was the only case among our mobile-bearing insert patients. The failed polyethylene inserts were retrieved and studied using a scanning electron microscope (SEM, ZEISS EVO 50 EP, Cambridge, UK) operating at 20 kV. Scratching and pitting were found on the UHMWPE insert perpendicular to the machining tracks for the concave surface. SEM micrographs of the insert showed burnishing on the concave surfaces and longitudinal scratches were clearly detectable and well-marked on the analyzed surfaces. A traumatic, fully rotating, polyethylene insert is rare and our case is the first report describing a traumatic event with a complete 180 degree rotation mobile-bearing in a total knee prosthesis. In the literature few reports discuss clinical outcomes after total knee arthroplasty in patients with Parkinson's disease and they cite mixed results. However, some authors suggest that posterior-stabilized and cruciate-retaining TKA should work well while others prefer cruciate-retaining, condylar constrained kinetics, or hinged devices. Although we did not implant a posterior-stabilized mobile-bearing total knee prosthesis or a constrained prosthesis, we obtained good clinical and radiological results at the 2-year followup.
Neut, Daniëlle; Kluin, Otto S; Thompson, Jonathan; van der Mei, Henny C; Busscher, Henk J
2010-11-10
Around about 1970, a gentamicin-loaded poly (methylmethacrylate) (PMMA) bone cement brand (Refobacin Palacos R) was introduced to control infection in joint arthroplasties. In 2005, this brand was replaced by two gentamicin-loaded follow-up brands, Refobacin Bone Cement R and Palacos R + G. In addition, another gentamicin-loaded cement brand, SmartSet GHV, was introduced in Europe in 2003. In the present study, we investigated differences in gentamicin release and the antibacterial efficacy of the eluent between these four cement brands. 200 μm-wide gaps were made in samples of each cement and filled with buffer in order to measure the gentamicin release. Release kinetics were related to bone cement powder particle characteristics and wettabilities of the cement surfaces. Gaps were also inoculated with bacteria isolated from infected prostheses for 24 h and their survival determined. Gentamicin release and bacterial survival were statistically analysed using the Student's t-test. All three Palacos variants showed equal burst releases but each of the successor Palacos cements showed significantly higher sustained releases. SmartSet GHV showed a significantly higher burst release, while its sustained release was comparable with original Palacos. A gentamicin-sensitive bacterium did not survive in the high gentamicin concentrations in the interfacial gaps, while a gentamicin-resistant strain did, regardless of the type of cement used. Survival was independent of the level of burst release by the bone cement. Although marketed as the original gentamicin-loaded Palacos cement, orthopaedic surgeons should be aware that the successor cements do not appear to have the same release characteristics as the original one. Overall, high gentamicin concentrations were reached inside our prosthesis-related interfacial gap model. These concentrations may be expected to effectively decontaminate the prosthesis-related interfacial gap directly after implantation, provided that these bacteria are sensitive for gentamicin.
Gallart, X; Gomez, J C; Fernández-Valencia, J A; Combalía, A; Bori, G; García, S; Rios, J; Riba, J
2014-01-01
To evaluate the short-term results of an ultra high molecular weight polyethylene retentive cup in patients at high risk of dislocation, either primary or revision surgery. Retrospective review of 38 cases in order to determine the rate of survival and failure analysis of a constrained cemented cup, with a mean follow-up of 27 months. We studied demographic data, complications, especially re-dislocations of the prosthesis and, also the likely causes of system failure analyzed. In 21.05% (8 cases) were primary surgery and 78.95% were revision surgery (30 cases). The overall survival rate by Kaplan-Meier method was 70.7 months. During follow-up 3 patients died due to causes unrelated to surgery and 2 infections occurred. 12 hips had at least two previous surgeries done. It wasn't any case of aseptic loosening. Four patients presented dislocation, all with a 22 mm head (P=.008). Our statistical analysis didn't found relationship between the abduction cup angle and implant failure (P=.22). The ultra high molecular weight polyethylene retentive cup evaluated in this series has provided satisfactory short-term results in hip arthroplasty patients at high risk of dislocation. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.
Effects of Prosthesis Stem Tapers on Stress Distribution of Cemented Hip Arthroplasty
NASA Astrophysics Data System (ADS)
Abdullah, Abdul Halim; Nor, Mohd Asri Mohd; Saman, Alias Mohd; Tamin, Mohd Nasir; Kadir, Mohammed Rafiq Abdul
2010-10-01
Aseptic loosening effects are critical issues in encouraging long term stability of cemented hip arthroplasty. Stress shielding is believed to be an important factor that contributes to the aseptic loosening problems. The numerous changes in the prosthesis stem design are intended to minimize the stress shielding and aseptic loosening problems and to improve the long term performance of the implants. In this study, the stress distribution in cemented hip arthroplasty is established using finite element method. The taper of the prosthesis is designed to be 3° at anterior/posterior, 3° at medial/lateral and 10° from wide lateral to narrow medial. Major muscle loads and contact forces are simulated for walking (toe-off phase) and stair climbing load cases. Effects of prosthesis stem tapers on the resulting stress distribution are investigated. Results show that compressive stress dominates in the medial plane while tensile stress in the lateral plane of the femur. The corresponding stress levels of intact femur for walking and stair-climbing load cases are 22 and 29 MPa, respectively. The magnitude of Tresca stress for the THA femur in stair-climbing load case remains higher in the region of 85 MPa while the walking load case induces around 40 MPa. The stress range in the straight and single taper stem prosthesis is lower than 260 MPa, while localized Tresca stress is in the order of the yield strength of Ti-6Al-4V alloy for double and triple taper stem design.
Management of long span partially edentulous maxilla with fixed removable denture prosthesis
Jeyavalan, Mahilan I.; Narasimman, M.; Venkatakrishnan, C. J.; Philip, Jacob M.
2012-01-01
Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis. PMID:23293488
Management of long span partially edentulous maxilla with fixed removable denture prosthesis.
Jeyavalan, Mahilan I; Narasimman, M; Venkatakrishnan, C J; Philip, Jacob M
2012-07-01
Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis.
Loza-Herrero, María A; Rivas-Tumanyan, Sona; Morou-Bermudez, Evangelia
2015-11-01
The success rate of implant-retained prostheses in a postdoctoral prosthodontics program was unknown and could not be related to any set of potential clinical issues or patient characteristics. The purpose of this study was to determine the success rate of implant-retained prostheses placed by prosthodontic residents between 1997 and 2012 and to evaluate the associations between patient classifications and specific restoration characteristics as related to prosthesis success or failure. A total of 272 prostheses in 119 patients were clinically evaluated. Success was defined as the absence of prosthetic complications or any implant-related complication that affected prosthesis survival. Logistic regression was used to evaluate associations between prosthesis success/failure and a wide array of study variables, adjusting for patient age, sex, and prosthesis longevity. The overall success rate was 71%, with a mean prosthesis age of 4.5 years (range: 4 months to 16.8 years). Implant single crowns were the most successful prosthesis type (81% success). The most common complications observed were porcelain fractures in fixed dental prostheses (15%) and lack of stability (31%) and retention (29%) in removable dental prostheses. Having a removable prosthesis (versus natural dentition) in the opposing occlusion significantly decreased the odds of success (OR=0.26, 95% CI: 0.11-0.64). Definitively cemented fixed prostheses were more successful than those cemented with an interim cement (OR=4.56, 95% CI: 1.37-15.22). The overall success rate of the implant-retained prostheses placed in the program was low compared with previously published studies. This study revealed the need for an efficient, comprehensive recall system for patients receiving implant-retained prostheses, either fixed or removable. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Tang, Fan; Zhou, Yong; Zhang, Wenli; Min, Li; Shi, Rui; Luo, Yi; Duan, Hong; Tu, Chongqi
2017-04-04
Whether all-polyethylene tibial (APT) components are beneficial to patients who received distal femur limb-salvage surgery lacks high-quality clinical follow-up and mechanical evidence. This study aimed to investigate the biomechanics of the distal femur reconstructed with APT tumor knee prostheses using finite element (FE) analysis based on our previous, promising clinical outcome. Three-dimensional FE models that use APT and metal-backed tibial (MBT) prostheses to reconstruct distal femoral bone defects were developed and input into the Abaqus FEA software version 6.10.1. Mesh refinement tests and gait simulation with a single foot both in the upright and 15°-flexion positions with mechanical loading were conducted. Stress distribution analysis was compared between APT and MBT at the two static positions. For both prosthesis types, the stress was concentrated on the junction of the stem and shaft, and the maximum stress in the femoral axis base was more than 100 Mpa. The stress on the tibial surface was relatively distributed, which was 1-19 MPa. The stress on the tibial bone-cement layer of the APT prosthesis was approximately 20 times higher than that on the MBT prosthesis in the same region. The stress on the proximal tibial cancellous bone and cortical bone of the APT prosthesis was 3-5 times greater than that of the MBT prosthesis, and it was more distributed. Although the stress of bone-cement around the APT component is relatively high, the stress was better distributed at the polyethylene-cement-bone interface in APT than in MBT prosthesis, which effectively protects the proximal tibia in distal femur tumor knee prosthesis replacement. These results should be considered when selecting the appropriate tibial component for a patient, especially under the foreseeable conditions of osteoporosis.
Kim, Seok-Gyu; Park, Jae-Uk; Jeong, Jae-Heon; Bae, Chang; Bae, Tae-Soo; Chee, Winston
2009-01-01
The purpose of this study was to evaluate the clinical efficacy of implant prostheses retained by screws and cement (SCPs) by examining the reverse torque values (RTVs) of the abutment screws and the marginal openings of the implant prostheses. Two implants (3.8 x 13 mm; Camlog Biotechnologies) were embedded in an acrylic resin block 5 mm apart. Eighteen copies of this resin specimen were fabricated and randomly divided into two groups. Two-unit implant prostheses with two different designs-purely cement-retained implant prostheses (group 1) and SCPs (group 2)-were made out of type IV gold alloy and placed on the implants. After tightening to about 30 Ncm, the preloading RTVs of the abutment screws were measured. After retightening the abutment screws or cementing the prostheses, followed by cyclic loading, the postloading RTVs of the abutment screws were examined. Also, the marginal openings of the prostheses in the two groups were measured under a stereomicroscope. These measurements were compared statistically. The postloading RTVs and their differences from the preloading RTVs of the abutment screws demonstrated no significant differences between groups (P > .05). Group 2 prostheses showed significantly smaller marginal openings than group 1 prostheses (P < .05). The forces generated when torquing the abutment screw of the SCP did not cause more loosening of the abutment screws than the purely cement-retained implant prosthesis. The SCP showed better marginal adaptation of the cement-retained part than the purely cement-retained implant prosthesis, possibly as a result of the screw-retained abutment seating the restoration. Within the limitations of this in vitro test, the SCP showed no significant difference in RTV of the abutment screw and a smaller marginal gap compared to a purely cement-retained implant prosthesis.
The effect of total knee arthroplasty on body weight.
Lee, Gwo-Chin; Cushner, Fred D; Cannella, Laura Y; Scott, W Norman
2005-03-01
This prospective study quantified the weight change in 20 consecutive patients undergoing total knee arthroplasty. Resected bone, soft tissues, and bone reamings were collected during surgery and weighed using a digital scale at the end of the procedure. Results were compared to the cumulative weights of the prosthesis, bone cement, patellar component, and polyethylene liner. Average weight of the resected bone and soft tissues was 167.71 g for men and 130.13 g for women. Mean weight of the implanted prosthesis and cement used was 509.92 g for men and 422.56 g for women. Men tended to receive a larger-sized prosthesis than women. Overall, the average weight gain as a result of knee arthroplasty was 345.54 g for men and 292.44 g for women. This translates to an insignificant increase in body weight.
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/metal constrained uncemented prosthesis. 888.3200 Section 888.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3200 Finger joint...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/metal constrained uncemented prosthesis. 888.3200 Section 888.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3200 Finger joint...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/metal constrained uncemented prosthesis. 888.3200 Section 888.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3200 Finger joint...
The "caviar" madreporic knee prosthesis.
Kenesi, C
1979-01-01
The madreporic ("caviar") prosthesis is a hinged knee prosthesis that can be inserted without the use of cement. The surfaces of the intramedullary stems are constructed with contiguous spheres one mm in diameter. These spaces are filled by bone trabeculae and haversian bone, providing permanent biologic fixation. Experimental madreporic knee arthroplasties in dogs show that bone probes these surfaces and produces solid attachments. Histologically, the trabeculae remain separated from the metal by a fine layer of fibrous tissue. The method of insertion of the prosthesis is simple. Preparing the epiphyses before any bone resection avoids the possibility of rotational positioning errors. The form of the intramedullary stems offers good positioning in the frontal plane. The analysis of an initial series of 15 cases shows results that are far from outstanding. The 2 deaths, the 2 cases of sepsis, and the recuperation of only mediocre motion can be explained, at least in part, by the advanced age of the patients and the poor bone quality of the rheumatoid patients. Nevertheless, this type of prosthesis has 2 important advantages. It avoids the complications from the use of acrylic cement and allows for a revision operation for cases of failed surface replacement designs. Obviously further experimentation with noncemented designs will continue and definitive studies will be reported later.
Hearing Outcome With the Use of Glass Ionomer Cement as an Alternative to Crimping in Stapedotomy.
Elzayat, Saad; Younes, Ahmed; Fouad, Ayman; Erfan, Fatthe; Mahrous, Ali
2017-10-01
To evaluate early hearing outcomes using glass ionomer cement to fix the Teflon piston prosthesis onto the long process of incus to minimize residual conductive hearing loss after stapedotomy. Original report of prospective randomized control study. Tertiary referral center. A total of 80 consecutive patients with otosclerosis were randomized into two groups. Group A is a control group in which 40 patients underwent small fenestra stapedotomy using the classic technique. Group B included 40 patients who were subjected to small fenestra stapedotomy with fixation of the incus-prosthesis junction with glass ionomer bone cement. Stapedotomy with the classical technique in group A and the alternative technique in group B. The audiometric results before and after surgery. Analysis of the results was performed using the paired t test to compare between pre and postoperative results. χ test was used to compare the results of the two groups. A p value less than 0.05 was considered significant from the statistical standpoint. Significant postoperative improvement of both pure-tone air conduction thresholds and air-bone gaps were reported in the two studied groups. The postoperative average residual air-bone gap and hearing gain were statistically significant in group B (p < 0.05) compared with group A. The use of glass ionomer bone cement in primary otosclerosis surgery using the aforementioned prosthesis and the surgical technique is of significant value in producing maximal closure of the air-bone gap and better audiological outcomes.
Wakitani, S; Imoto, K; Saito, M; Yamamoto, T; Kawabata, H
2002-05-01
Reconstruction of a knee damaged by cement packed to cure a giant-cell tumor is sometimes difficult. We reconstructed such a knee by removal of the cement, autologous bone transplantation and distraction osteogenesis using the Ilizarov apparatus. In this paper the results 29 months after the salvage surgery are given. We saw a 31-year-old woman's knee joint that showed osteoarthritic change after curettage, cryosurgery and cementation performed 4 years previously for a giant-cell tumor of the proximal tibia. We reconstructed the knee joint. This procedure included cement removal, alignment correction by tibial osteotomy, subchondral bone reconstruction by autologous bone transplantation, and filling the defect after removing the bone cement by elongating the diaphysis using the Ilizarov apparatus. Distraction was terminated 4 months later when 54 mm of elongation was performed. All devices were removed 12 months after the surgery. Seventeen months after the removal of the apparatus, the range of motion of the right knee was 0 degrees extension and 110 degrees flexion, and the patient was able to walk without pain. Although the treatment period is long and there may be some complications of Ilizarov lengthening and distraction osteogenesis, this procedure has numerous benefits. Bony defects can be soundly reconstructed and, at the same time, the alignment of the knee can be corrected. Also it is not necessary to reconstruct the ligaments because the insertions are intact. If osteoarthritis progresses, a surface type total knee replacement can be performed, not constrained type prosthesis, which would be used if the bony structure had not been reconstructed. This procedure may be one of the candidates for reconstructing such knee joints destroyed by bone cement. Copyright 2002 OsteoArthritis Research Society International. Published by Elsevier Science Ltd. All rights reserved.
Rosenberg, Nahum; Neumann, Lars; Modi, Amit; Mersich, Istvan J; Wallace, Angus W
2007-01-01
Background The uncemented Nottingham Total Shoulder Replacement prosthesis system (Nottingham TSR) was developed from the previous BioModular® shoulder prosthesis taking into consideration the causes of the initial implant's failure. We investigated the impact of changes in the design of Nottingham TSR prosthesis on its survivorship rate. Methods Survivorship analyses of three types of uncemented total shoulder arthroplasty prostheses (BioModular®, initial Nottingham TSR and current Nottingham TSR systems with 11, 8 and 4 year survivorship data respectively) were compared. All these prostheses were implanted for the treatment of disabling pain in the shoulder due to primary and secondary osteoarthritis or rheumatoid arthritis. Each type of the prosthesis studied was implanted in consecutive group of patients – 90 patients with BioModular® system, 103 with the initial Nottingham TSR and 34 patients with the current Nottingham TSR system. The comparison of the annual cumulative survivorship values in the compatible time range between the three groups was done according to the paired t test. Results The 8-year and 11-year survivorship rates for the initially used modified BioModular® uncemented prosthesis were relatively low (75.6% and 71.7% respectively) comparing to the reported survivorship of the conventional cemented implants. The 8-year survivorship for the uncemented Nottingham TSR prosthesis was significantly higher (81.8%), but still not in the desired range of above 90%, that is found in other cemented designs. Glenoid component loosening was the main factor of prosthesis failure in both prostheses and mainly occurred in the first 4 postoperative years. The 4-year survivorship of the currently re-designed Nottingham TSR prosthesis, with hydroxylapatite coating of the glenoid baseplate, was significantly higher, 93.1% as compared to 85.1% of the previous Nottingham TSR. Conclusion The initial Nottingham shoulder prosthesis showed significantly higher survivorship than the BioModular® uncemented prosthesis, but lower than expected. Subsequently re-designed Nottingham TSR system presented a high short term survivorship rate that encourages its ongoing use PMID:17683577
Molt, Mats; Toksvig-Larsen, Sören
2014-10-01
The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.
Ahmed, Ayman; Maroulakos, Georgios; Garaicoa, Jorge
2016-05-01
Abutment screw loosening represents a common and challenging technical complication of cement-retained implant prostheses. This article describes the fabrication of a simple and accurate poly(methyl methacrylate) guide for identifying the location and angulation of the abutment screw access channel of a cement-retained implant prosthesis with a loosened abutment screw. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Ensing, Geert T; Neut, Daniëlle; van Horn, Jim R; van der Mei, Henny C; Busscher, Henk J
2006-12-01
Antibiotic-loaded bone cements are used for the permanent fixation of joint prostheses. Antibiotic-loaded cements significantly decrease the incidence of infection. The objective of this study was to investigate whether the viability of bacteria derived from patients with a prosthesis-related infection could be further decreased when antibiotic release from bone cements was combined with application of pulsed ultrasound. Escherichia coli ATCC 10798, Staphylococcus aureus 7323, coagulase-negative staphylococci (CoNS 7368 and CoNS 7391) and Pseudomonas aeruginosa 5148 were grown planktonically in suspension and as a biofilm on three different bone cements: Palacos R without gentamicin as control, gentamicin-loaded Palacos R-G and gentamicin/clindamycin-loaded Copal. The viability of planktonic and biofilm bacteria was measured in the absence and presence of pulsed ultrasound for 40 h. Ultrasound itself did not affect bacterial viability. However, application of pulsed ultrasound in combination with antibiotic release by antibiotic-loaded bone cements yielded a reduction of both planktonic and biofilm bacterial viability compared with antibiotic release without application of ultrasound. This study shows that antibiotic release in combination with ultrasound increases the antimicrobial efficacy further than antibiotic release alone against a variety of clinical isolates. Application of ultrasound in combination with antibiotic release in clinical practice could therefore lead to better prevention or treatment of prosthesis-related infections.
Cement-in-cement acetabular revision with a constrained tripolar component.
Leonidou, Andreas; Pagkalos, Joseph; Luscombe, Jonathan
2012-02-17
Dislocation of a total hip replacement (THR) is common following total hip arthroplasty (THA). When nonoperative management fails to maintain reduction, revision surgery is considered. The use of constrained acetabular liners has been extensively described. Complete removal of the old cement mantle during revision THA can be challenging and is associated with significant complications. Cement-in-cement revision is an established technique. However, the available clinical and experimental studies focus on femoral stem revision. The purpose of this study was to present a case of cement-in-cement acetabular revision with a constrained component for recurrent dislocations and to investigate the current best evidence for this technique. This article describes the case of a 74-year-old woman who underwent revision of a Charnley THR for recurrent low-energy dislocations. A tripolar constrained acetabular component was cemented over the primary cement mantle following removal of the original liner by reaming, roughening the surface, and thoroughly irrigating and drying the primary cement. Clinical and radiological results were good, with the Oxford Hip Score improving from 11 preoperatively to 24 at 6 months postoperatively. The good short-term results of this case and the current clinical and biomechanical data encourage the use of the cement-in-cement technique for acetabular revision. Careful irrigation, drying, and roughening of the primary surface are necessary. Copyright 2012, SLACK Incorporated.
Key Parameters Evaluation for Hip Prosthesis with Finite Element Analysis
NASA Astrophysics Data System (ADS)
Guo, Hongqiang; Li, Dichen; Lian, Qin; Li, Xiang; Jin, Zhongmin
2007-09-01
Stem length and cross section are two key parameters that influence the stability and longevity of metallic hip prosthesis in the total hip arthroplasty (THA). In order to assess their influence to the stress and fatigue behavior of hip prosthesis, a series model of hip prosthesis with round-shaped or drum-shaped cross section, and with different stem lengths were created. These models were analyzed under both static and dynamic loading conditions with finite element analysis, and dynamic loading represents normal walking was used in the dynamic analysis. The stress on the metallic stem, cement, and adjacent bone were got, micromotion on the cement-metal interface were got too. Safety factors for fatigue life of the hip prothesis were calculated based on data obtained from dynamic analysis. Static analysis shows that drum-shaped cross section can decrease the displacement of the stem, that stress on drum-shaped stem focus on the corner of the femoral neck and the distal part of hip prosthesis, whereas the stress on the round-shaped stem distributes evenly over most part of the stem, and maximum stress on stem prosthesis fluctuates with stem length bottoming out at stem length range from 80 mm to 110 mm, that drum-shaped stems with drum height 8 mm generate more stress at the distal part of stem than drum-shaped stems with drum height 10 mm and round stems do. Dynamic and fatigue analysis shows that drum-shaped stem with drum height 10 mm and stem length 90 mm has the greatest safety factor therefore long fatigue life.
Method of adhering bone to a rigid substrate using a graphite fiber reinforced bone cement
NASA Technical Reports Server (NTRS)
Knoell, A. C.; Maxwell, H. G. (Inventor)
1977-01-01
A method is described for adhering bone to the surface of a rigid substrate such as a metal or resin prosthesis using an improved surgical bone cement. The bone cement has mechanical properties more nearly matched to those of animal bone and thermal curing characteristics which result in less traumatization of body tissues and comprises a dispersion of short high modulus graphite fibers within a bonder composition including polymer dissolved in reactive monomer such as polymethylmethacrylate dissolved in methylmethacrylate monomer.
Parameswari, B. Devi; Rajakumar, M.; Lambodaran, G.; Sundar, Shyam
2016-01-01
Introduction: Several commercially available luting agents are used to cement the dental restorations such as intra-coronal, extra-coronal, and fixed partial dentures. Tensile bond strength (TBS) and accurate marginal fit are the essential factors to determine the good clinical results in fixed prosthesis. The retentivity of the luting cements is assessed by their adhesive capacity over the tooth surface and metal surface. Generally, the adhesive ability has been evaluated with in vitro testing, with tensile bond tests. The failure of fixed prosthesis may be happened as a result of incomplete seating during cementation. Most research on cementation of crowns relates seating failure to the thickness of the cement film. Materials and Methods: The study is divided into four groups with 10 samples for each of the luting cement taken up for testing TBS and four groups with 5 samples for each luting agent chosen for assessing marginal fit. The results were tabulated and statistically analyzed. Results: In this in vitro study, the TBS of luting cements, and marginal fit in relation to luting cements were tested by using appropriate testing devices. The TBS of cement is measured using universal testing machine, and the results are tabulated. The marginal gap that exists between the margin of the cast metal crown, and the finish line is measured using travelling microscope before and after cementation. The difference between these two values gives the discrepancy that is due to the film thickness of cement used for luting the restoration. Summary and Conclusion: The TBS value of zinc phosphate cement and glass ionomer cement were found to be almost same. The chemical adhesiveness of the glass ionomer with calcium ions of enamel and dentin may be the attributed reason (ionic bonding). In this study, the polycarboxylate is the one that showed low TBS, and it may be attributed to the weakness of the cement due to reduced film thickness, though this cement has a chemical bonding nature. The observation of results of marginal fit in this study is the increased gap found in zinc phosphate cement followed by resin cement, zinc polycarboxylate, and glass ionomer cement. It is agreeable to estimate the marginal fit of the restoration, which could be affected by the film thickness of the luting cement along with other factors. PMID:27829765
Parameswari, B Devi; Rajakumar, M; Lambodaran, G; Sundar, Shyam
2016-10-01
Several commercially available luting agents are used to cement the dental restorations such as intra-coronal, extra-coronal, and fixed partial dentures. Tensile bond strength (TBS) and accurate marginal fit are the essential factors to determine the good clinical results in fixed prosthesis. The retentivity of the luting cements is assessed by their adhesive capacity over the tooth surface and metal surface. Generally, the adhesive ability has been evaluated with in vitro testing, with tensile bond tests. The failure of fixed prosthesis may be happened as a result of incomplete seating during cementation. Most research on cementation of crowns relates seating failure to the thickness of the cement film. The study is divided into four groups with 10 samples for each of the luting cement taken up for testing TBS and four groups with 5 samples for each luting agent chosen for assessing marginal fit. The results were tabulated and statistically analyzed. In this in vitro study, the TBS of luting cements, and marginal fit in relation to luting cements were tested by using appropriate testing devices. The TBS of cement is measured using universal testing machine, and the results are tabulated. The marginal gap that exists between the margin of the cast metal crown, and the finish line is measured using travelling microscope before and after cementation. The difference between these two values gives the discrepancy that is due to the film thickness of cement used for luting the restoration. The TBS value of zinc phosphate cement and glass ionomer cement were found to be almost same. The chemical adhesiveness of the glass ionomer with calcium ions of enamel and dentin may be the attributed reason (ionic bonding). In this study, the polycarboxylate is the one that showed low TBS, and it may be attributed to the weakness of the cement due to reduced film thickness, though this cement has a chemical bonding nature. The observation of results of marginal fit in this study is the increased gap found in zinc phosphate cement followed by resin cement, zinc polycarboxylate, and glass ionomer cement. It is agreeable to estimate the marginal fit of the restoration, which could be affected by the film thickness of the luting cement along with other factors.
Cai, Pengde; Hu, Yihe; Xie, Lie; Wang, Long
2012-10-01
To investigate the effectiveness of two-stage revision of infected total knee arthroplasty (TKA) using an antibiotic-impregnated articulating cement spacer. The clinical data were analyzed from 23 patients (23 knees) undergoing two-stage revision for late infection after primary TKA between January 2007 and December 2009. There were 15 males and 8 females, aged from 43 to 75 years (mean, 65.2 years). Infection occurred at 13-52 months (mean, 17.3 months) after TKA. The time interval between infection and admission ranged from 15 days to 7 months (mean, 2.1 months). One-stage operation included surgical debridement and removal of all knee prosthesis and cement, then an antibiotic-impregnated articulating cement spacer was implanted. The re-implantation of prosthesis was performed after 8-10 weeks when infections were controlled. The American Hospital for Special Surgery (HSS) score and Knee Society Score (KSS) were used to compare the function of the knee between pre- and post-revision. The rate of infection control and complication were analyzed. All incisions healed primarily. Re-infection occurred in 2 cases after two-stage revision, and infection was controlled in the other 21 cases, with an infection control rate of 91.3%. The patients were followed up 2-5 years (mean, 3.6 years). The HSS score was increased from 60.6 +/- 9.8 at pre-revision to 82.3 +/- 7.4 at last follow-up, the KSS score was increased from 110.7 +/- 9.6 at pre-revision to 134.0 +/- 10.5 at last follow-up, all showing significant differences (P < 0.01). Radiographs showed that prosthesis had good position with no loosening, fracture, or periprosthetic radiolucent. Two-stage revision using an antibiotic-impregnated articulating cement spacer is an effective method to control infected TKA and to restore the function of affected knee.
Fink, Bernd; Rechtenbach, Annett; Büchner, Hubert; Vogt, Sebastian; Hahn, Michael
2011-04-01
Articulating spacers used in two-stage revision surgery of infected prostheses have the potential to abrade and subsequently induce third-body wear of the new prosthesis. We asked whether particulate material abraded from spacers could be detected in the synovial membrane 6 weeks after implantation when the spacers were removed for the second stage of the revision. Sixteen hip spacers (cemented prosthesis stem articulating with a cement cup) and four knee spacers (customized mobile cement spacers) were explanted 6 weeks after implantation and the synovial membranes were removed at the same time. The membranes were examined by xray fluorescence spectroscopy, xray diffraction for the presence of abraded particles originating from the spacer material, and analyzed in a semiquantitative manner by inductively coupled plasma mass spectrometry. Histologic analyses also were performed. We found zirconium dioxide in substantial amounts in all samples, and in the specimens of the hip synovial lining, we detected particles that originated from the metal heads of the spacers. Histologically, zirconium oxide particles were seen in the synovial membrane of every spacer and bone cement particles in one knee and two hip spacers. The observations suggest cement spacers do abrade within 6 weeks. Given the presence of abrasion debris, we recommend total synovectomy and extensive lavage during the second-stage reimplantation surgery to minimize the number of abraded particles and any retained bacteria.
von Schewelov, Thord; Besjakov, Jack; Sanzén, Lennart; Carlsson, Ake
2009-07-01
The press-fit condylar (PFC) cruciate-retaining total knee prosthesis is well documented in the literature. In 1997, a modification of the femoral component was introduced, and the prosthesis was renamed PFC-Sigma. The alteration may influence the migratory and rotational pattern of the tibial component and thus long-time survival rate. In this radiostereometric analysis, we found that the micromotion of the PFC-Sigma prosthesis differs slightly from the original PFC design, an advantage of the PFC-Sigma prosthesis. The median maximum total point motion at 5 years was 0.64 mm for the PFC-Sigma design and 0.79 mm for the previous version of PFC (P = .9). However, the PFC-Sigma rotated less around the transverse (x) axis than did the PFC (medians, 0.22 mm and 0.48 mm, respectively; P = .04). From the radiostereometric, radiographic, and clinical data, we conclude that the PFC-Sigma knee prosthesis can be used with confidence.
Swamy, Girish N.; Quah, Conal; Bagouri, Elmunzar; Badhe, Nitin P.
2014-01-01
This paper reports a case of fatigue fracture of the femoral component in a cruciate-retaining cemented total knee arthroplasty (TKA). A 64-year-old man had undergone a primary TKA for osteoarthritis 10 years previously at another institution using the PFC-Sigma prosthesis. The patient recovered fully and was back to his regular activities. He presented with a history of sudden onset pain and locking of the left knee since the preceding three months. There was no history of trauma, and the patient was mobilizing with difficulty using crutches. Radiographs revealed fracture of the posterior condyle of the femoral prosthesis. Revision surgery was performed as an elective procedure revealing the broken prosthesis. The TC3RP-PFC revision prosthesis was used with a medial parapatellar approach. The patient recovered fully without any squeal. Mechanical failure of the knee arthroplasty prosthesis is rare, and nontraumatic fracture of the femoral metallic component has not been reported before. PMID:24587928
Swamy, Girish N; Quah, Conal; Bagouri, Elmunzar; Badhe, Nitin P
2014-01-01
This paper reports a case of fatigue fracture of the femoral component in a cruciate-retaining cemented total knee arthroplasty (TKA). A 64-year-old man had undergone a primary TKA for osteoarthritis 10 years previously at another institution using the PFC-Sigma prosthesis. The patient recovered fully and was back to his regular activities. He presented with a history of sudden onset pain and locking of the left knee since the preceding three months. There was no history of trauma, and the patient was mobilizing with difficulty using crutches. Radiographs revealed fracture of the posterior condyle of the femoral prosthesis. Revision surgery was performed as an elective procedure revealing the broken prosthesis. The TC3RP-PFC revision prosthesis was used with a medial parapatellar approach. The patient recovered fully without any squeal. Mechanical failure of the knee arthroplasty prosthesis is rare, and nontraumatic fracture of the femoral metallic component has not been reported before.
A Review of Periprosthetic Femoral Fractures Associated With Total Hip Arthroplasty
Marsland, Daniel; Mears, Simon C.
2012-01-01
Periprosthetic fractures of the femur in association with total hip arthroplasty are increasingly common and often difficult to treat. Patients with periprosthetic fractures are typically elderly and frail and have osteoporosis. No clear consensus exists regarding the optimal management strategy because there is limited high-quality research. The Vancouver classification facilitates treatment decisions. In the presence of a stable prosthesis (type-B1 and -C fractures), most authors recommend surgical stabilization of the fracture with plates, strut grafts, or a combination thereof. In up to 20% of apparent Vancouver type-B1 fractures, the femoral stem is loose, which may explain the high failure rates associated with open reduction and internal fixation. Some authors recommend routine opening and dislocation of the hip to perform an intraoperative stem stability test to rule out a loose component. Advances in plating techniques and technology are improving the outcomes for these fractures. For fractures around a loose femoral prosthesis (types B2 and 3), revision using an extensively porous-coated uncemented long stem, with or without additional fracture fixation, appears to offer the most reliable outcome. Cement-in-cement revision using a long-stem prosthesis is feasible in elderly patients with a well-fixed cement mantle. It is essential to treat the osteoporosis to help fracture healing and to prevent further fractures. We provide an overview of the causes, classification, and management of periprosthetic femoral fractures around a total hip arthroplasty based on the current best available evidence. PMID:23569704
Lee, Mi-Young; Heo, Seong-Joo; Park, Eun-Jin; Park, Ji-Man
2013-08-01
The aim of this study was to compare the passivity of implant superstructures by assessing the strain development around the internal tapered connection implants with strain gauges. A polyurethane resin block in which two implants were embedded served as a measurement model. Two groups of implant restorations utilized cement-retained design and internal surface of the first group was adjusted until premature contact between the restoration and the abutment completely disappeared. In the second group, only nodules detectable to the naked eye were removed. The third group employed screw-retained design and specimens were generated by computer-aided design/computer-aided manufacturing system (n=10). Four strain gauges were fixed on the measurement model mesially and distally to the implants. The strains developed in each strain gauge were recorded during fixation of specimens. To compare the difference among groups, repeated measures 2-factor analysis was performed at a level of significance of α=.05. The absolute strain values were measured to analyze the magnitude of strain. The mean absolute strain value ranged from 29.53 to 412.94 µm/m at the different strain gauge locations. According to the result of overall comparison, the cement-retained prosthesis groups exhibited significant difference. No significant difference was detected between milled screw-retained prostheses group and cement-retained prosthesis groups. Within the limitations of the study, it was concluded that the cement-retained designs do not always exhibit lower levels of stress than screw-retained designs. The internal adjustment of a cement-retained implant restoration is essential to achieve passive fit.
Szalay, G; Meyer, C; Mika, J; Schnettler, R; Thormann, U
2014-12-01
Treatment of periprosthetic fractures by implantation of a specially constructed, retrograde hollow nail which fits over the tip of the prosthesis and becomes locked on it. Periprosthetic femoral fractures with firmly anchored prosthesis shaft after total hip arthroplasty of types B1 and C according to the Vancouver classification. Loosened prosthesis (type B2/B3) and trochanteric fractures (type A). Broken or damaged prosthesis, florid inflammation and soft tissue injuries in the operation field, contracted knee joint, advanced deformation in the knee joint and distal femur, enclosed prosthesis and general contraindications. In a supine position the periprosthetic fracture is exposed via a lateral access. For cemented prostheses the cement is removed around the tip of the prosthesis (at least 2-3 cm) and medullary cavity. Arthrotomy with flexion of the knee joint and marking of the nail entry point. Drill the medullary cavity, retrograde introduction of the nail, visually fit the nail over the tip of the prosthesis and lock the nail with the prosthesis. If necessary use additional spongiosaplasty or also placement of additional cerclages depending on fracture type and size of the defect zone. Lock the nail distally. Use intraoperative radiological imaging to control correct positioning and length of the nail. Close the wound layer by layer with placement of suction drainage devices and dressing. Partial loading for 6 weeks with a subsequent pain-adapted loading gradient until full loading is possible. If selective partial loading is not possible, a decision must be made in individual cases as to whether the intraoperative findings allow immediate full loading. From 2004 to 2011 a total of 25 periprosthetic femoral fractures in 25 patients were treated in 2 locations using specially constructed slotted hollow nails. Within the framework of a retrospective study 20 of these patients (16 female and 4 male; average age 77.2 [72-84] years) were clinically and radiologically re-examined on average 19.3 (7-31) months postoperatively. No postoperative bleeding, wound healing disorders and infections. In all patients there was a loading stable consolidation of the fracture in the correct femoral axis, length and rotation with no evidence for radiological signs of loosening of the prosthesis or dislocation of the nails. In one case there was loosening of the prosthesis which had obviously occurred during the operative procedure. After consolidation of the fracture it was necessary to exchange the prosthesis for a long shafted prosthesis. A comparable situation to the preoperative degree of mobility was found in 12 out of the 20 patients, a moderate deterioration in 5 patients, a substantial residual impairment in 2 patients and an improvement of the situation in 1 patient.
NASA Astrophysics Data System (ADS)
Yang, Jinkyu; Silvestro, Claudio; Sangiorgio, Sophia N.; Borkowski, Sean L.; Ebramzadeh, Edward; De Nardo, Luigi; Daraio, Chiara
2012-01-01
We propose a new biomedical sensing technique based on highly nonlinear solitary waves to assess orthopaedic implant stability in a nondestructive and efficient manner. We assemble a granular crystal actuator consisting of a one-dimensional tightly packed array of spherical particles, to generate acoustic solitary waves. Via direct contact with the specimen, we inject acoustic solitary waves into a biomedical prosthesis, and we nondestructively evaluate the mechanical integrity of the bone-prosthesis interface, studying the properties of the waves reflected from the contact zone between the granular crystal and the implant. The granular crystal contains a piezoelectric sensor to measure the travelling solitary waves, which allows it to function also as a sensor. We perform a feasibility study using total hip arthroplasty (THA) samples made of metallic stems implanted in artificial composite femurs using polymethylmethacrylate for fixation. We first evaluate the sensitivity of the proposed granular crystal sensor to various levels of prosthesis insertion into the composite femur. Then, we impose a sequence of harsh mechanical loading on the THA samples to degrade the mechanical integrity at the stem-cement interfaces, using a femoral load simulator that simulates aggressive, accelerated physiological loading. We investigate the implant stability via the granular crystal sensor-actuator during testing. Preliminary results suggest that the reflected waves respond sensitively to the degree of implant fixation. In particular, the granular crystal sensor-actuator successfully detects implant loosening at the stem-cement interface following violent cyclic loading. This study suggests that the granular crystal sensor and actuator has the potential to detect metal-cement defects in a nondestructive manner for orthopaedic applications.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Abdullah, Abdul Halim; Nor, Mohd Asri Mohd; Saman, Alias Mohd
Aseptic loosening effects are critical issues in encouraging long term stability of cemented hip arthroplasty. Stress shielding is believed to be an important factor that contributes to the aseptic loosening problems. The numerous changes in the prosthesis stem design are intended to minimize the stress shielding and aseptic loosening problems and to improve the long term performance of the implants. In this study, the stress distribution in cemented hip arthroplasty is established using finite element method. The taper of the prosthesis is designed to be 3 deg. at anterior/posterior, 3 deg. at medial/lateral and 10 deg. from wide lateral tomore » narrow medial. Major muscle loads and contact forces are simulated for walking (toe-off phase) and stair climbing load cases. Effects of prosthesis stem tapers on the resulting stress distribution are investigated. Results show that compressive stress dominates in the medial plane while tensile stress in the lateral plane of the femur. The corresponding stress levels of intact femur for walking and stair-climbing load cases are 22 and 29 MPa, respectively. The magnitude of Tresca stress for the THA femur in stair-climbing load case remains higher in the region of 85 MPa while the walking load case induces around 40 MPa. The stress range in the straight and single taper stem prosthesis is lower than 260 MPa, while localized Tresca stress is in the order of the yield strength of Ti-6Al-4V alloy for double and triple taper stem design.« less
Code of Federal Regulations, 2014 CFR
2014-04-01
... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...
Code of Federal Regulations, 2013 CFR
2013-04-01
... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...
Code of Federal Regulations, 2012 CFR
2012-04-01
... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...
Code of Federal Regulations, 2011 CFR
2011-04-01
... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...
Code of Federal Regulations, 2010 CFR
2010-04-01
... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...
Lemos, Cleidiel Aparecido Araujo; Verri, Fellippo Ramos; Santiago, Joel Ferreira; Almeida, Daniel Augusto de Faria; Batista, Victor Eduardo de Souza; Noritomi, Pedro Yoshito; Pellizzer, Duardo Piza
2018-01-01
The purpose of this study was to evaluate different retention systems (cement- or screw-retained) and crown designs (non-splinted or splinted) of fixed implant-supported restorations, in terms of stress distributions in implants/components and bone tissue, by 3-dimensional (3D) finite element analysis. Four 3D models were simulated with the InVesalius, Rhinoceros 3D, and SolidWorks programs. Models were made of type III bone from the posterior maxillary area. Models included three 4.0-mm-diameter Morse taper (MT) implants with different lengths, which supported metal-ceramic crowns. Models were processed by the Femap and NeiNastran programs, using an axial force of 400 N and oblique force of 200 N. Results were visualized as the von Mises stress and maximum principal stress (σmax). Under axial loading, there was no difference in the distribution of stress in implants/components between retention systems and splinted crowns; however, in oblique loading, cemented prostheses showed better stress distribution than screwed prostheses, whereas splinted crowns tended to reduce stress in the implant of the first molar. In the bone tissue cemented prostheses showed better stress distribution in bone tissue than screwed prostheses under axial and oblique loading. The splinted design only had an effect in the screwed prosthesis, with no influence in the cemented prosthesis. Cemented prostheses on MT implants showed more favorable stress distributions in implants/components and bone tissue. Splinting was favorable for stress distribution only for screwed prostheses under oblique loading.
21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...
21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...
21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...
Polymethylmethacrylate bone cements and additives: A review of the literature
Arora, Manit; Chan, Edward KS; Gupta, Sunil; Diwan, Ashish D
2013-01-01
Polymethylmethacrylate (PMMA) bone cement technology has progressed from industrial Plexiglass administration in the 1950s to the recent advent of nanoparticle additives. Additives have been trialed to address problems with modern bone cements such as the loosening of prosthesis, high post-operative infection rates, and inflammatory reduction in interface integrity. This review aims to assess current additives used in PMMA bone cements and offer an insight regarding future directions for this biomaterial. Low index (< 15%) vitamin E and low index (< 5 g) antibiotic impregnated additives significantly address infection and inflammatory problems, with only modest reductions in mechanical strength. Chitosan (15% w/w PMMA) and silver (1% w/w PMMA) nanoparticles have strong antibacterial activity with no significant reduction in mechanical strength. Future work on PMMA bone cements should focus on trialing combinations of these additives as this may enhance favourable properties. PMID:23610754
The cost analysis of cemented versus cementless total hip replacement operations on the NHS.
Kallala, R; Anderson, P; Morris, S; Haddad, F S
2013-07-01
In a time of limited resources, the debate continues over which types of hip prosthesis are clinically superior and more cost-effective. Orthopaedic surgeons increasingly need robust economic evidence to understand the full value of the operation, and to aid decision making on the 'package' of procedures that are available and to justify their practice beyond traditional clinical preference. In this paper we explore the current economic debate about the merits of cemented and cementless total hip replacement, an issue that continues to divide the orthopaedic community.
Rezaei, Farshid; Hassani, Kamran; Solhjoei, Nosratollah; Karimi, Alireza
2015-12-01
Total hip replacement (THR) has been ranked within the most typical surgical processes in the world. The durability of the prosthesis and loosening of prosthesis are the main concerns that mostly reported after THR surgeries. In THR, the femoral prosthesis can be fixed by either cement or cementless methods in the patient's bones. In both procedures, the stability of the prosthesis in the hosted bone has a key asset in its long-term durability and performance. This study aimed to execute a comparative finite element simulation to assess the load transfer between the prosthesis, which is made of carbon/PEEK composite and stainless steel/titanium, and the femur bone. The mechanical behavior of the cortical bone was assumed as a linear transverse isotropic while the spongy bone was modeled like a linear isotropic material. The implants were made of stainless steel (316L) and titanium alloy as they are common materials for implants. The results showed that the carbon/PEEK composites provide a flatter load transfer from the upper body to the leg compared to the stainless steel/titanium prosthesis. Furthermore, the results showed that the von Mises stress, principal stress, and the strain in the carbon/PEEK composites prosthesis were significantly lower than that made of the stainless steel/titanium. The results also imply that the carbon/PEEK composites can be applied to introduce a new optimum design for femoral prosthesis with adjustable stiffness, which can decrease the stress shielding and interface stress. These findings will help clinicians and biomedical experts to increase their knowledge about the hip replacement.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Oswald, S.G.; Van Nostrand, D.; Savory, C.G.
1989-08-01
Although few reports address the use of three-phase bone scanning (TPBS) and {sup 111}In-labeled white blood cell (In-WBC) scintigraphy in hip arthroplasty utilizing a porous coated prosthesis, the literature suggests that scintigraphic patterns in the uncomplicated patient may differ from that seen in the cemented prosthesis. In an attempt to determine the scintigraphic natural history, 25 uncomplicated porous coated hip arthroplasties in 21 patients were prospectively studied with serial TPBS and In-WBC at approximately 7 days, and at 3, 6, 12, 18, and 24 mo postoperatively. This report deals with findings related to the prosthetic tip. Only one of 136more » flow studies were abnormal and only two of 136 blood-pool images demonstrated focally increased activity. All 25 prostheses (120 of 143 scans) demonstrated increased uptake on the bone phase images. The area about the tip was divided into three segments; increased uptake at 24 mo was noted in the medial, distal, and lateral segments in 16%, 72%, and 56% of prostheses, respectively. Twenty of 25 prostheses (82 of 142 scans) showed uptake on In-WBC scintigraphy, being noted in 48% of prostheses at 24 mo. We conclude that scintigraphic patterns in the uncomplicated patient with a porous coated prosthesis appear to differ from patterns described in cemented prostheses.« less
Evaluation of metal-polymeric fixed partial prosthesis using optical coherence tomography
NASA Astrophysics Data System (ADS)
Sinescu, C.; Negrutiu, M. L.; Duma, V. F.; Marcauteanu, C.; Topala, F. I.; Rominu, M.; Bradu, A.; Podoleanu, A. Gh.
2013-11-01
Metal-Polymeric fixed partial prosthesis is the usual prosthetic treatment for many dental patients. However, during the mastication the polymeric component of the prosthesis is fractured and will be lost. This fracture is caused by the material defects or by the fracture lines trapped inside the esthetic components of the prosthesis. This will finally lead to the failure of the prosthetic treatment. Nowadays, there is no method of identification and forecast for the materials defects of the polymeric materials. The aim of this paper is to demonstrate the capability of Optical Coherence Tomography (OCT) as a non-invasive clinical method that can be used for the evaluation of metal-polymeric fixed partial prostheses. Twenty metal-polymeric fixed partial prostheses were used for this study. The esthetic component of the prostheses has been Adoro (Ivoclar). Optical investigations of the metal prostheses have revealed no material defects or fracture lines. All the prostheses were temporary cemented in the oral cavities of the patients for six month. The non-invasive method used for the investigations was OCT working in Time Domain mode at 1300 nm. The evaluations of the prostheses were performed before and after their cementation in the patient mouths. All the imagistic results were performed in 2D and than in 3D, after the reconstruction. The results obtained after the OCT evaluation allowed for the identification of 4 metal-polymeric fixed partial prostheses with material defects immediately after finishing the technological procedures. After 6 month in the oral environment other 3 fixed partial prostheses revealed fracture lines. In conclusion, OCT proved to be a valuable tool for the noninvasive evaluation of the metal-polymeric fixed partial prostheses.
von Schewelov, T; Carlsson, A; Sanzén, L; Besjakov, J
2014-05-01
In 2005, we demonstrated that the polished triple-tapered C-stem at two years had migrated distally and rotated internally. From that series, 33 patients have now been followed radiologically, clinically and by radiostereometric analysis (RSA) for up to ten years. The distal migration within the cement mantle had continued and reached a mean of 2 mm (0.5 to 4.0) at ten years. Internal rotation, also within the cement mantle, was a mean 3.8° (external 1.6° to internal 6.6°) The cement mantle did not show any sign of migration or loosening in relation to the femoral bone. There were no clinical or radiological signs indicating that the migration or rotation within the cement mantle had had any adverse effects for the patients.
Migration of cemented femoral components after THR. Roentgen stereophotogrammetric analysis.
Kiss, J; Murray, D W; Turner-Smith, A R; Bithell, J; Bulstrode, C J
1996-09-01
We studied the migration of 58 cemented Hinek femoral components for total hip replacement, using roentgen stereophotogrammetric analysis over four years. The implants migrated faster during the first year than subsequently, and the pattern of migration in the second period was very different. During the first year they subsided, tilted into varus and internally rotated. After this there was slow distal migration with no change in orientation. None of the prostheses has yet failed. The early migration is probably caused by resorption of bone damaged by surgical trauma or the heat generated by the polymerisation of bone cement. Later migration may be due to creep in the bone cement or the surrounding fibrous membrane. The prosthesis which we studied allows the preservation of some of the femoral neck, and comparison with published migration studies of the Charnley stem suggests that this decreases rotation and may help to prevent loosening.
Wiater, Brett P; Moravek, James E; Kurdziel, Michael D; Baker, Kevin C; Wiater, J Michael
2016-01-01
Newer glenoid components that allow for hybrid cement fixation via traditional cementation of peripheral pegs and bony ingrowth into an interference-fit central peg introduce the possibility of long-term biological fixation. However, little biomechanical work has been done on the initial stability of these components and the various fixation options. We conducted a study in which all-polyethylene glenoid components with a centrally fluted peg were implanted in polyurethane blocks with interference-fit, hybrid cement, and fully cemented fixation (5 per fixation group). Biomechanical evaluation of glenoid loosening, according to ASTM Standard F-2028-12, subjected the glenoids to 50,000 cycles of rim loading, and glenoid component motion was recorded with 2 differential variable reluctance transducers fixed to each glenoid prosthesis. Fully cemented fixation exhibited significantly less mean distraction in comparison with interference-fit fixation (P < .001) and hybrid cement fixation (P < .001). Hybrid cement fixation exhibited significantly less distraction (P < .001), more compression (P < .001), and no significant difference in glenoid translation (P = .793) in comparison with interference-fit fixation. Fully cemented fixation exhibited the most resistance to glenoid motion in comparison with hybrid cement fixation and interference-fit fixation. However, hybrid cement fixation and interference-fit fixation exhibited equivocal motion. Given these results, cementation of peripheral pegs may confer no additional initial stability over that provided by uncemented interference-fit fixation.
Cicciu, Marco; Bramanti, Ennio; Matacena, Giada; Guglielmino, Eugenio; Risitano, Giacomo
2014-01-01
Prosthetic rehabilitation of partial or total edentulous patients is today a challenge for clinicians and dental practitioners. The application of dental implants in order to recover areas of missing teeth is going to be a predictable technique, however some important points about the implant angulation, the stress distribution over the bone tissue and prosthetic components should be well investigated for having final long term clinical results. Two different system of the prosthesis fixation are commonly used. The screw retained crown and the cemented retained one. All of the two restoration techniques give to the clinicians several advantages and some disadvantages. Aim of this work is to evaluate all the mechanical features of each system, through engineering systems of investigations like FEM and Von Mises analyses. The FEM is today a useful tool for the prediction of stress effect upon material and biomaterial under load or strengths. Specifically three different area has been evaluated through this study: the dental crown with the bone interface; the passant screw connection area; the occlusal surface of the two different type of crown. The elastic features of the materials used in the study have been taken from recent literature data. Results revealed an adequate response for both type of prostheses, although cemented retained one showed better results over the occlusal area. PMID:24955150
2008-01-01
Hip resurfacing is an attractive concept because it preserves rather than removes the femoral head and neck. Most early designs had high failure rates, but one unique design had a femoral stem. Because that particular device appeared to have better implant survival, this study assessed the clinical outcome and long-term survivorship of a hip resurfacing prosthesis. Four hundred forty-five patients (561 hips) were retrospectively reviewed after a minimum of 20 years’ followup or until death; 23 additional patients were lost to followup. Patients received a metal femoral prosthesis with a small curved stem. Three types of acetabular reconstructions were used: (1) cemented polyurethane; (2) metal-on-metal; and (3) polyethylene secured with cement or used as the liner of a two-piece porous-coated implant. Long-term results were favorable with the metal-on-metal combination only. The mean overall Harris hip score was 92 at 2 years of followup. None of the 121 patients (133 hips) who received metal-on-metal articulation experienced failure. The failure rate with polyurethane was 100%, and the failure rate with cemented polyethylene was 41%. Hip resurfacing with a curved-stem femoral component had a durable clinical outcome when a metal-on-metal articulation was used. Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18338217
Survival of various implant-supported prosthesis designs following 36 months of clinical function.
Rodriguez, A M; Orenstein, I H; Morris, H F; Ochi, S
2000-12-01
The use of endosseous dental implants to replace natural teeth lost to trauma, dental caries, or periodontal disease has become a predictable form of prosthetic treatment since gaining popularity in the early 1980s. While numerous clinical studies have focused on the survival of implants, few address the survival of different prosthesis designs. Beginning in 1991, 882 prostheses supported by more than 2,900 implants (687 patients) were placed by the Department of Veterans Affairs Dental Implant Clinical Research Group (DICRG). These prostheses were divided into five research strata based on arch location. The recommended design for each stratum was: bar-supported overdenture (maxillary completely edentulous); screw-retained hybrid denture (mandibular completely edentulous); screw-retained fixed partial denture (mandibular and maxillary posterior partially edentulous); and cemented single crown (maxillary anterior single tooth). Alternative overdenture designs were utilized in the edentulous arches when the recommended prosthesis could not be fabricated. Prosthesis success rates for the research strata were calculated for an observation time of up to 36 months following prosthesis placement. Success rates for the maxillary edentulous stratum ranged from 94.6% for the bar-retained overdenture supported by five to six fixtures to 81.8% for the cap-retained overdenture. The mandibular edentulous strata produced success rates of 98.1% for the fixed hybrid prosthesis to 91.7% for the cap-retained prosthesis. Success rates for maxillary and mandibular posterior fixed partial dentures were 94.3% and 92.6%, respectively, while the maxillary anterior single-tooth prosthesis yielded a success rate of 98.1% for the 36-month observation period. The recommended prosthesis designs investigated in this study proved to be reliable, with encouraging success rates for an observation period of 36 months following placement.
Talsnes, Ove; Vinje, Tarjei; Gjertsen, Jan Erik; Dahl, Ola E; Engesæter, Lars B; Baste, Valborg; Pripp, Are Hugo; Reikerås, Olav
2013-06-01
Adverse events associated with the use of bone cement for fixation of prostheses is a known complication. Due to inconclusive results in studies of hip fracture patients treated with cemented and uncemented hemiprostheses, this study was initiated. Our study is based on data reported to the Norwegian Hip Fracture Register on 11,210 cervical hip fractures treated with hemiprostheses (8,674 cemented and 2,536 uncemented). Significantly increased mortality within the first day of surgery was found in the cemented group (relative risk 2.9, 95 % confidence interval 1.6-5.1, p=0.001). The finding was robust giving the same results after adjusting for independent risk factors such as age, sex, cognitive impairment and comorbidity [American Society of Anesthesiologists (ASA) score]. For the first post-operative day the number needed to harm was 116 (one death for every 116 cemented prosthesis). However, in the most comorbid group (ASA worse than 3), the number needed to harm was only 33. We found increased mortality for the cemented hemiprosthesis the first post-operative day compared to uncemented procedures. This increased risk is closely related to patient comorbidity estimated by the patient's ASA score.
El-Warrak, Alexander O; Olmstead, Marvin; Schneider, Rebecca; Meinel, Lorenz; Bettschart-Wolfisberger, Regula; Akens, Margarete K; Auer, Joerg; von Rechenberg, Brigitte
2004-01-01
Background Aseptic loosening of hip prosthesis as it occurs in clinical cases in human patients was attributed to wear particles of the implants, the response of the tissue dominated by macrophages and the production of inflammatory mediators and matrix degrading enzymes; however, the cascade of events initiating the process and their interaction regarding the time course is still open and discussed controversially. Therefore, the goal of this study was to establish an experimental animal model in sheep allowing to follow the cascade of early mechanical and biochemical events within the interface membrane and study the sequence of how they contribute to the pathological bone resorption necessary for aseptic loosening of the implant. Methods A cemented modular system (Biomedtrix) was used as a hip replacement in 24 adult Swiss Alpine sheep, with one group receiving a complete cement mantle as controls (n = 12), and the other group a cement mantle with a standardized, lateral, primary defect in the cement mantle (n = 12). Animals were followed over time for 2 and 8.5 months (n = 6 each). After sacrifice, samples from the interface membranes were harvested from five different regions of the femur and joint capsule. Explant cell cultures were performed and supernatant of cultures were tested and assayed for nitric oxide, prostaglandin E2, caseinolytic and collagenolytic activity. RNA extraction and quantification were performed for inducible nitric oxide synthase, cyclooxygenase-2, interleukin 1, and interleukin 6. Overall differences between groups and time periods and interactions thereof were calculated using a factorial analysis of variance (ANOVA). Results The development of an interface membrane was noticed in both groups at both time points. However, in the controls the interface membrane regressed in thickness and biological activity, while both variables increased in the experimental group with the primary cement mantle defect over time. Nitric oxide (NO) and PGE2 concentrations were higher in the 8.5 months group (P < 0.0001) compared to the 2 months group with a tendency for the unstable group to have higher concentrations. The same was true for collagenolytic activity (P = 0.05), but not for caseinolytic activity that decreased over time (P < 0.0001). Conclusion In this study, a primary cement mantle defect of the femoral shaft elicited biomechanical instability and biochemical changes over time in an experimental animal study in sheep, that resembled the changes described at the bone cement-interface in aseptic loosening of total hip prosthesis in humans. The early biochemical changes may well explain the pathologic bone resorption and formation of an interface membrane as is observed in clinical cases. This animal model may aid in future studies aiming at prevention of aseptic loosening of hip prosthesis and reflect some aspects of the pathogenesis involved. PMID:15113432
21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... type of device is designed to achieve biological fixation to bone without the use of bone cement. This... bearing is rigidly secured to the metal tibial base plate. (b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint...
Retention Strength of Conical Welding Caps for Fixed Implant-Supported Prostheses.
Nardi, Diego; Degidi, Marco; Sighinolfi, Gianluca; Tebbel, Florian; Marchetti, Claudio
This study evaluated the retention strength of welding caps for Ankylos standard abutments using a pull-out test. Each sample consisted of an implant abutment and its welding cap. The tests were performed with a Zwick Roell testing machine with a 1-kN load cell. The retention strength of the welding caps increased with higher abutment diameters and higher head heights and was comparable or superior to the values reported in the literature for the temporary cements used in implant dentistry. Welding caps provide a reliable connection between an abutment and a fixed prosthesis without the use of cement.
[Comparative study of retention of a Zn phosphate cement and 4-META].
Maroto Garcia, J
1990-12-01
The recent appearance, in the market of the supercements, suggest to us, news concepts of retention-adhesion, of our preparations, that they are going to put in to the mouth. Between his applications, we have the cementation of crowns, post or dowels, adhesive-prosthesis, and inlays. According to the manufactures, the long duration of the bond power, his great physiques properties, and his easy management, gives to this products a good conditions, to use in the mouth. The present report to prove in vitro, the retentive capacity on the dentine without treatment, and metal.
Cement-retained versus screw-retained implant restorations: a critical review.
Michalakis, Konstantinos X; Hirayama, Hiroshi; Garefis, Pavlos D
2003-01-01
This article presents a comparison of screw-retained and cement-retained implant prostheses based on the literature. The advantages, disadvantages, and limitations of the 2 different types of restorations are discussed, because it is important to understand the influence of the attachment mechanism on many clinical aspects of implant dentistry. Several factors essential to the long-term success of any implant prosthesis were reviewed with regard to both methods of fixation. These factors include: (1) ease of fabrication and cost, (2) passivity of the framework, (3) retention, (4) occlusion, (5) esthetics, (6) delivery, and (7) retrievability. (More than 50 references).
Sebastian, Sujeesh; Malhotra, Rajesh; Pande, Ashish; Gautam, Deepak; Xess, Immaculata; Dhawan, Benu
2018-06-01
Fungal prosthetic joint infection is a rare complication in total joint arthroplasty. There are no established guidelines for management of these infections. We present a case of a 53-year-old male with a hip joint prosthesis co-infected with Candida tropicalis and Staphylococcus haemolyticus. A two-stage exchange arthroplasty was performed. The patient underwent implant removal, debridement, irrigation with saline solution and application of cement spacer impregnated with vancomycin followed by aggressive antimicrobial treatment in first stage. Complete eradication of infection was demonstrated by negative culture of sonicated cement spacer fluid and negative 16S rRNA and 18S rRNA gene PCR of sonicate fluid, synovial fluid and periprosthetic tissue samples. He underwent second-stage revision hip arthroplasty after 9 months of the first stage. At the latest follow-up, there was no evidence of recurrence of infection. This case illustrates the utility of sonication of biomaterials and molecular techniques for microbiological confirmation of absence of infection in staged surgeries which is required for a successful outcome.
Aparicio, C
1994-10-01
To maintain osseointegration, it is essential that the prosthesis fit with total passivity because the absence of a periodontal ligament makes the implant unable to adapt its position to a nonpassive framework. The traditional system of building a metal framework by melting over mechanized pieces--called gold cylinders in the Brånemark system--has been modified so these pieces are joined to the metal framework by means of physicochemical bonding. This bond is achieved by treating the metallic surfaces with a Silicoater system and a composite resin cement that sets in the mouth using an improved cementing protocol. In this paper, the clinical viability of this new philosophy, shown over 2 years, is presented. A total of 64 prostheses (39 maxillary and 25 mandibular) supported by 214 abutments, with an average observation period of 9 months, were evaluated. The results show that it is possible to routinely obtain a ceramometal prosthesis with a totally passive circular fitting while maintaining the possibility of retrieval, thus making postceramic soldering unnecessary.
Rohit, Raghavan; Prathith, Uthappa; Regish, K M; Rupesh, P L; Basavaraj, Salagundi; Padmanabhan, T V
2014-09-01
Success of the prosthesis after mandibular resection is related directly to the amount of the remaining bone and soft tissue present. The prognosis for mandibulectomy patients becomes less favorable as the size of the resection increases. Prosthetic rehabilitation for such patients is a challenge for clinicians. Without preprosthetic reconstructive surgery, denture fabrication for mandibulectomy patients becomes extremely difficult. Telescopic dentures is a modality of treatment consisting of an inner or primary telescopic coping which is permanently cemented to an abutment and an outer or secondary telescopic coping which is attached to the prosthesis. These copings protect the abutment from dental caries and thermal irritations and also provide retention and stabilization of the secondary coping. The secondary coping engages the primary copings to form a telescopic unit and it provides retention and stability to the prosthesis. This clinical report aims at utilizing the remaining natural teeth for a mandibular overdenture with telescopic coping.
[Possibilities of follow-up imaging after implantation of a carbon fiber-reinforced hip prosthesis].
Krüger, T; Alter, C; Reichel, H; Birke, A; Hein, W; Spielmann, R P
1998-03-01
There are many problems in the radiological diagnosis of aseptic loosening in total hip arthroplasty. Computed tomography (CT) and magnetic resonance tomography (MRT) are not usable for metallic implants (stainless steel, cobalt alloy, titanium alloy). From April 1993 to December 1993 15 CFRP non-cemented hip prostheses have been implanted. In a prospective clinical study plane radiographs, CT and MRT have been analysed. Three stems were revised (1 femoral fracture, 1 severe thigh pain, 1 aseptic loosening). CFRP are not visible in plane radiographs. There was a complete (two-third of the cases) or nearly complete (one-third of the cases) small sclerotic interface between the prosthesis and the bone, these were apparent in CT and MRT in stable implant cases and did not have any clinical correlations. The small sclerotic interface is quite different in comparison to so called "Reactive Lines". In one case of aseptic loosening there was an interposition of soft tissue between prosthesis and bone in MRT and CT. CFRP inaugurates new diagnostic possibilities in aseptic loosening of hip prosthesis and in tumour surgery too.
Improving the fit of implant prosthetics: an in vitro study.
Yannikakis, Stavros; Prombonas, Anthony
2013-01-01
Accurate and passive fit between a prosthesis and its supporting implants has been considered a prerequisite for successful long-term osseointegration. The objective of this in vitro study was to evaluate the strain development during tightening of a five-unit screw-retained superstructure constructed using five different methods. Five-unit screw-retained fixed partial prostheses (n = 25) were fabricated on three implants embedded in an epoxy resin block using five different methods: (1) cobalt-chromium (Co-Cr), plastic cylinders, one-piece cast; (2) Co-Cr, plastic cylinders, framework sectioned, preceramic laser-welding soldering; (3) gold-platinum (Au-Pt), gold cylinders, one-piece cast; (4) Au-Pt, gold cylinders, framework sectioned, preceramic laser-welding soldering; (5) Co-Cr, one-piece cast, and cementation to "passive abutments" (Southern Implants) after final finishing and polishing. Strain gauges (SG) were attached to the fixed partial prosthesis (FPP) and to the resin block to measure the stress created during screw tightening. The combination of Co-Cr alloy and plastic cylinders in a one-piece cast showed such an inadequate fit among the fabricated methods that this group was excluded from the remainder of the experiment. Specimens of Au-Pt cast on gold cylinders in one piece showed higher strain development than the other groups used in this study, with strains ranging from 223.1 to 2,198.1 Μm/m. Sectioning and soldering significantly improved the overall fit. FPPs of Co-Cr in a one-piece cast cemented to "passive abutments" produced the best level of fit, with the least strain development in the prosthesis and the resin block (59 to 204.6 Μm/m). Absolute fit of superstructures on implants is not possible using conventional laboratory procedures. Cementing FPPs onto prefabricated cylinders directly onto the implants significantly reduces strain development compared to the other fabrication methods.
Fracture analysis of randomized implant-supported fixed dental prostheses
Esquivel-Upshaw, Josephine F.; Mehler, Alex; Clark, Arthur E.; Neal, Dan; Anusavice, Kenneth J.
2014-01-01
Objective Fractures of posterior fixed dental all-ceramic prostheses can be caused by one or more factors including prosthesis design, flaw distribution, direction and magnitude of occlusal loading, and nature of supporting infrastructure (tooth root/implant), and presence of adjacent teeth. This clinical study of implant-supported, all-ceramic fixed dental prostheses, determined the effects of (1) presence of a tooth distal to the most distal retainer; (2) prosthesis loading either along the non-load bearing or load bearing areas; (3) presence of excursive contacts or maximum intercuspation contacts in the prosthesis; and (4) magnitude of bite force on the occurrence of veneer ceramic fracture. Methods 89 implant-supported FDPs were randomized as either a three-unit posterior metal-ceramic (Au-Pd-Ag alloy and InLine POM, Ivoclar, Vivadent) FDP or a ceramic-ceramic (ZirCAD and ZirPress, Ivoclar, Vivadent) FDP. Two implants (Osseospeed, Dentsply) and custom abutments (Atlantis, Dentsply) supported these FDPs, which were cemented with resin cement (RelyX Universal Cement). Baseline photographs were made with markings of teeth from maximum intercuspation (MI) and excursive function. Patients were recalled at 6 months and 1 to 3 years. Fractures were observed, their locations recorded, and images compared with baseline photographs of occlusal contacts. Conclusion No significant relationship exists between the occurrence of fracture and: (1) the magnitude of bite force; (2) a tooth distal to the most distal retainer; and (3) contacts in load-bearing or non-load-bearing areas. However, there was a significantly higher likelihood of fracture in areas with MI contacts only. Clinical Significance This clinical study demonstrates that there is a need to evaluate occlusion differently with implant-supported prostheses than with natural tooth supported prostheses because of the absence of a periodontal ligament. Implant supported prostheses should have minimal occlusion and lighter contacts than ones supported by natural dentition. PMID:25016139
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer/metal nonconstrained... ORTHOPEDIC DEVICES Prosthetic Devices § 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. (a) Identification. A shoulder joint metal/polymer/metal...
Total Hip Arthroplasty Using a Polished Tapered Cemented Stem in Hereditary Multiple Exostosis
Kanda, Akio; Kaneko, Kazuo; Obayashi, Osamu; Mogami, Atsuhiko
2016-01-01
A 61-year-old Japanese man underwent right total hip arthroplasty for hereditary multiple exostosis. At first presentation, he had suffered from coxalgia for a long time. On radiographic images, there was a gigantic femoral head, increased shaft angle, and large diameter of the femoral neck. He had also developed coxarthrosis and severe pain of the hip joint. The transformation of the proximal femur bone causes difficulty in setting a cementless total hip prosthesis. Therefore, total hip arthroplasty using a cemented polished tapered stem was performed via a direct lateral approach. Using a cemented polished tapered stem allowed us to deal with the femoral bone transformation and bone substance defectiveness due to exostosis and also minimized the invasiveness of the operation. PMID:27127668
Keum, Eun-Cheol
2013-01-01
PURPOSE This study evaluated the effectiveness of various methods for removing provisional cement from implant abutments, and what effect these methods have on the retention of prosthesis during the definitive cementation. MATERIALS AND METHODS Forty implant fixture analogues and abutments were embedded in resin blocks. Forty cast crowns were fabricated and divided into 4 groups each containing 10 implants. Group A was cemented directly with the definitive cement (Cem-Implant). The remainder were cemented with provisional cement (Temp-Bond NE), and classified according to the method for cleaning the abutments. Group B used a plastic curette and wet gauze, Group C used a rubber cup and pumice, and Group D used an airborne particle abrasion technique. The abutments were observed using a stereomicroscope after removing the provisional cement. The tensile bond strength was measured after the definitive cementation. Statistical analysis was performed using one-way analysis of variance test (α=.05). RESULTS Group B clearly showed provisional cement remaining, whereas the other groups showed almost no cement. Groups A and B showed a relatively smooth surface. More roughness was observed in Group C, and apparent roughness was noted in Group D. The tensile bond strength tests revealed Group D to have significantly the highest tensile bond strength followed in order by Groups C, A and B. CONCLUSION A plastic curette and wet gauze alone cannot effectively remove the residual provisional cement on the abutment. The definitive retention increased when the abutments were treated with rubber cup/pumice or airborne particle abraded to remove the provisional cement. PMID:24049563
Marx, R; Faramarzi, R; Jungwirth, F; Kleffner, B V; Mumme, T; Weber, M; Wirtz, D C
2009-01-01
For cemented hip prostheses, all requirements can be fulfilled by using forged Co/Cr/Mo stems. Co/Cr/Mo alloys, however, are contraindicated for allergy sufferers. For these patients, a cemented prosthesis made of titanium (alloy) would be indicated. Cemented stems from titanium (alloy), depending on the geometry of the prosthesis and its specific surface texture, however, may have loosening rates which are clinically not tolerable. In comparison to Co/Cr/Mo alloys, the greater roughness in conjunction with lesser abrasion resistance of titanium-based alloys leads to high loosening rates caused by abrasion. On the other hand, the greater surface roughness permits good mechanical retention of bone cement to the surface. Good mechanical retention enhances migration behaviour and reduces micromotions. However, there is no stable hydrolytic bond between bone cement and metallic surface; intermediate-term debonding between metal and bone cement is predictable. This debonding results in relative movements, consequently in wear particles which have their origin both from the rough metallic surface and from the PMMA cement. The roughness of the metallic surface operates as emery and with that, a rubbing wear from the PMMA. For the above reasons, a low or moderate roughness is essential for easily abradable implants such as shafts made of titanium (alloy) because low roughness provides a fail-safe running function in case of debonding. Thus, one must allow for inappropriate migration behaviour accompanied by greater micromotions due to insufficient mechanical retention in the case of low roughness. This can be accomplished by a silicate layer coating applied to the metal shaft surface via electrochemical "ECD" or physical vapour deposition "PVD". For analysis, specimens (screws for pull-out, cones for push-out tests) were sand-blasted, so that roughnesses between Ra = 0.8 microm (Rz = 4 microm) and Ra = 2.0 microm (Rz = 9 microm) were generated. The bond strengths observed in tensile tests for roughnesses of Ra = 1.7 mm were always well above 25 MPa for all periods of hydrolytic load. Therefore, the investigation shows that surfaces of moderate roughness (Ra = 1.7 microm), however coated, provide a steady retention. Cave-in and micromotions should widely be prevented. The abrasion, which is a consequence of and reason for debonding and loosening at the same time, should be avoidable if the bonding of cement on the metallic shaft is stabilised with the help of a suitable chemical bond system.
Yang, Li-qing; Li, Xi; Fu, Qin; Wang, Cheng
2013-07-01
To retrospectively study early therapeutic effects of the ceramics to ceramics prosthesis design in treating hip disease. From October 2007 to September 2010, 42 patients (44 hips) with hip disease underwent replacement of total hip. Hip prosthesis designs included the Pinnacle ceramics to ceramics and the Duraloc metal to polyethylene,produced by DePuy Company, all were non-bone cement type of artificial hip joint. Twenty patients (22 hips) were performed with ceramics to ceramics total hip prosthesis (CoC group, there were 12 males and 8 females, aged from 21 to 49 years) and 22 patients (22 hips) were performed with metal to polyethylene total hip prosthesis (MoP group, there were 13 males and 9 females, aged from 42 to 55 years). All the surgical approachs were posterolateral, and the routine anticoagulation and the corresponding functional exercise were performed after operation. The follow-up time was 6 months at least including clinical and radiographic observation. Measured the motion of joint and evaluated the function of hip joint according to Harris classification. All clinical effects were satisfactory and no dislocation ,loosening,infection, deep venous thrombosis and other complications occurred. There was no statistical significance in Harris scoring and the motion of joint between two groups before and after operation (P>0.05). The clinical effect of ceramics to ceramics prosthesis design in improving clinical symptoms and the motion of joint is coordinate with metal to polyethylene total hip prosthesis, however, its advantages and long-term efficacy need further observing. The ceramics to ceramics prosthesis design may be a good choice for the young patients with hip disease because of its good wear resistance.
Faye, M B; Martin, C; Schmerber, S
2013-01-01
We report two surgical techniques devised to restore a disrupted incudostapedial joint. Thirty patients underwent rebridging of distal portion of incus long process in the ENT Department of University of Grenoble and Saint-Etienne, between October 1998 and September 2002. Two types of ossicular prostheses were used: A titanium-gold angle prosthesis according to Plester Winkel Kurz (n = 16 patients), and a hydroxylapatite prosthesis as Martin Incudo Prosthesis (n = 14 patients). The average hearing gain in short term is of 8.30 dB for the Martin-Incudo group. It is of 5.23 dB in the Winkel group. Seven and three cases of failures (Residual Rinne > 20 dB) were noticed respectively in the groups Martin-Incudo and Winkel. Seven and four cases of labyrinthisation were observed respectively in the groups Martin-Incudo and Winkel. The average hearing gain in long term is 3.43 dB in the Martin-Incudo group; and 2.85 dB among patients with Winkel Kurz prosthesis. Average residual Rinne is higher than 20 dB in the Winkel group. The hearing gain is not statistically significant between the two groups (p > 0.05). The titanium partial prosthesis did not give good functional results. In the case of a limited lysis (< 2 mm) of the distal portion of incus, we use the cement or cartilage interposition. When ossicular chain cannot be preserved entirely, we privilege incus transposition or a titanium PORP. The Martin-Incudo prosthesis seems interesting in the event of lysis of 2 mm of the long process of incus, nevertheless engineering changes are necessary in order to make rigid the incudostapedial joint.
Automated estimation of hip prosthesis migration: a feasibility study
NASA Astrophysics Data System (ADS)
Vandemeulebroucke, Jef; Deklerck, Rudi; Temmermans, Frederik; Van Gompel, Gert; Buls, Nico; Scheerlinck, Thierry; de Mey, Johan
2013-09-01
A common complication associated with hip arthoplasty is prosthesis migration, and for most cemented components a migration greater than 0.85 mm within the first six months after surgery, are an indicator for prosthesis failure. Currently, prosthesis migration is evaluated using X-ray images, which can only reliably estimate migrations larger than 5 mm. We propose an automated method for estimating prosthesis migration more accurately, using CT images and image registration techniques. We report on the results obtained using an experimental set-up, in which a metal prosthesis can be translated and rotated with respect to a cadaver femur, over distances and angles applied using a combination of positioning stages. Images are first preprocessed to reduce artefacts. Bone and prosthesis are extracted using consecutive thresholding and morphological operations. Two registrations are performed, one aligning the bones and the other aligning the prostheses. The migration is estimated as the difference between the found transformations. We use a robust, multi-resolution, stochastic optimization approach, and compare the mean squared intensity differences (MS) to mutual information (MI). 30 high-resolution helical CT scans were acquired for prosthesis translations ranging from 0.05 mm to 4 mm, and rotations ranging from 0.3° to 3° . For the translations, the mean 3D registration error was found to be 0.22 mm for MS, and 0.15 mm for MI. For the rotations, the standard deviation of the estimation error was 0.18° for MS, and 0.08° for MI. The results show that the proposed approach is feasible and that clinically acceptable accuracies can be obtained. Clinical validation studies on patient images will now be undertaken.
Chen, Hongwei; Wang, Ziyang; Shang, Yongjun
2018-06-01
To compare clinical outcomes of unipolar and bipolar radial head prosthesis in the treatment of patients with radial head fracture. Medline, Cochrane, EMBASE, Google Scholar databases were searched until April 18, 2016 using the following search terms: radial head fracture, elbow fracture, radial head arthroplasty, implants, prosthesis, unipolar, bipolar, cemented, and press-fit. Randomized controlled trials, retrospective, and cohort studies were included. The Mayo elbow performance score (MEPS), disabilities of the arm, shoulder, and hand (DASH) score, radiologic assessment, ROM, and grip strength following elbow replacement were similar between prosthetic devices. The pooled mean excellent/good ranking of MEPS was 0.78 for unipolar and 0.73 for bipolar radial head arthroplasty, and the pooled mean MEPS was 86.9 and 79.9, respectively. DASH scores for unipolar and bipolar prosthesis were 19.0 and 16.3, respectively. Range of motion outcomes were similar between groups, with both groups have comparable risk of flexion arc, flexion, extension deficit, rotation arc, pronation, and supination (p values <0.001 for both unipolar and bipolar prosthesis). However, bipolar radial head prosthesis was associated with an increased chance of heterotopic ossification and lucency (p values ≤0.049) while unipolar prosthesis was not (p values ≥0.088). Both groups had risk for development of capitellar osteopenia or erosion/wear (p values ≤0.039). Unipolar and bipolar radial head prostheses were similar with respect to clinical outcomes. Additional comparative studies are necessary to further compare different radial head prostheses used to treat radial head fracture.
In vitro Characteristics of a Glass Ionomer Cement.
Driscoll, C L; Green, J D; Beatty, C W; McCaffrey, T V; Marrs, C D
1998-01-01
Glass ionomer cements were first described by Wilson and Kent and have been used in dentistry since 1969. It has been recommended for bridging ossicular chain defects, fixation of ossicular chain prosthesis, anchoring of cochlear implants, mastoid obliteration, and repair of tegmen and posterior canal wall defects. The biocompatability and stability of this material over time is vital to its usefulness in neurotologic surgery. The purpose of this study was to assess the stability of a glass ionomer cement in the presence of bacteria and in different pH environments. We demonstrated that bacteria readily adhere to the surface and their presence is associated with accelerated loss of matrix. We found the cement to be susceptible to low pH and to release a visible cloud of debris upon contact with fluid. Calcium concentration in the solution was elevated at all pH levels. Although we are able to demonstrate these findings in vitro the clinical relevance is unclear. There have been several cases of aseptic meningitis possibly due to intracranial release of components of the cement. Until further studies are done use of the cement in contact with cerebral spinal fluid should be avoided. This cement, or a similar material, would be useful in neurotologic surgery but prior to widespread use further testing should be done to assess safety.
Brand, Stephan; Klotz, Johannes; Hassel, Thomas; Petri, Maximilian; Ettinger, Max; Krettek, Christian; Goesling, Thomas; Bach, Friedrich-Wilhelm
2013-10-01
The purpose of this study was to evaluate the different temperature levels whilst drilling cemented and cementless hip prostheses implanted in bovine femora, and to evaluate the insulating function of the cement layer. Standard hip prostheses were implanted in bovine donor diaphyses, with or without a cement layer. Drilling was then performed using high-performance-cutting drills with a reinforced core, a drilling diameter of 5.5 mm and cooling channels through the tip of the drill for constantly applied internal cooling solution. An open type cooling model was used in this setup. Temperature was continuously measured by seven thermocouples placed around the borehole. Thermographic scans were also performed during drilling. At the cemented implant surface, the temperature never surpassed 24.7 °C when constantly applied internal cooling was used. Without the insulating cement layer (i.e. during drilling of the cementless bone-prosthesis construct), the temperature increased to 47 °C. Constantly applied internal cooling can avoid structural bone and soft tissue damage during drilling procedures. With a cement layer, the temperatures only increased to non-damaging levels. The results could be useful in the treatment of periprosthetic fractures with intraprosthetic implant fixation.
Molt, Mats; Toksvig-Larsen, Sören
2015-01-01
A shortened tibial stem could influence the early prosthetic fixation. We therefore compared the short stem to the standard-length stem using radiostereometric analysis (RSA) as primary outcome measure. 60 patients were randomized to receive a cemented Triathlon total knee arthroplasty (TKA) with a tibial tray of either standard or short stem length. The patients were blinded regarding treatment allocation. The micromotion of the tibial component was measured by RSA postoperatively, at 3 months, and after 1 and 2 years; clinical outcome was measured with the American Knee Society score (AKSS) and the knee osteoarthritis and injury outcome score (KOOS). The maximum total point motion (MTPM) for the standard stem was 0.36 (SD 0.16) mm at 3 months, 0.51 (SD 0.27) mm at 1 year, and 0.54 (SD 0.28) mm at 2 years. For the short stem, it was 0.42 (0.24) mm, 0.59 (0.43) mm, and 0.61 (0.39) mm. 4 short-stemmed components and 2 standard-stemmed components had more than 0.2 mm of migration between the first- and second-year follow-up, and were classified as continuously migrating. The short-stemmed cemented tibial prosthesis showed an early prosthetic migratory pattern similar to that of the standard-stemmed cemented Triathlon knee prosthesis. The number of continuously migrating tibial plates in each group is predictive of a lower revision rate than 5% at 10 years.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Oswald, S.G.; Van Nostrand, D.; Savory, C.G.
1990-03-01
Although few studies address the use of three-phase bone scanning (TPBS) and indium-111-labeled white blood cell scintigraphy ({sup 111}In-WBC) in hip arthroplasty utilizing a porous-coated prosthesis, the literature suggests that scintigraphic patterns in the uncomplicated patient may differ from that seen with the cemented prosthesis. In an attempt to determine the scintigraphic natural history, 25 uncomplicated porous-coated hip arthroplasties in 21 patients were prospectively studied with serial TPBS and {sup 111I}n-WBC at approximately 7 days, and 3, 6, 12, 18, and 24 mo postoperatively. This report deals with findings related to the acetabulum. All 25 prostheses (144 of 144 scans)more » demonstrated increased uptake on the bone-phase images. Although this activity decreased with time, 76% had persistent uptake at 24 mo. Twenty-three of 25 prostheses (126 of 140 scans) showed increased uptake on {sup 111}In-WBC scintigraphy, invariably decreasing with time, but with 37% having significant uptake at 24 mo. Scintigraphic patterns in the uncomplicated porous-coated hip arthroplasty patient appear to differ from patterns described in cemented prostheses.« less
Difazio, F A; Incavo, S J; Howe, J D
1993-09-01
This study examined the effect of single versus triple-wrap cerclage fixation techniques in preventing propagation of a longitudinal fracture around a cementless femoral prosthesis. A proximal filling femoral component was implanted in 14 matched pairs of fresh-frozen bovine femora, following placement of a 45-mm longitudinal crack in the anteromedial cortical wall of the proximal femur. In one group of seven pairs, a single cerclage wire was applied to one specimen of each pair. A triple-wrap of a single cerclage wire was similarly placed in one specimen of each of the other seven pairs. All specimens were axially loaded on a materials testing system machine and the force required to propagate the fracture of the proximal femur was recorded. A triple-wrap cerclage technique required a significant increase in the force to propagate a proximal femur fracture around a non-cemented prosthesis when compared to a single cerclage wire. Copyright © 1993. Published by Elsevier Ltd.
Liquid-solid phase transition alloy as reversible and rapid molding bone cement.
Yi, Liting; Jin, Chao; Wang, Lei; Liu, Jing
2014-12-01
Acrylic bone cement has been an essential non-metallic implant used as fixing agent in the cemented total joint arthroplasty (THA). However, the currently available materials based mainly on polymethylmethacrylate (PMMA) still encounter certain limitations, such as time-consuming polymerization, thermal and chemical necrosis and troublesome revision procedure. Here from an alternative way, we proposed for the first time to adopt the injectable alloy cement to address such tough issues through introducing its unique liquid-solid phase transition mechanism. A typical cement along this way is thus made of an alloy Bi/In/Sn/Zn with a specifically designed low melting point 57.5 °C, which enables its rapid molding into various desired shapes with high plasticity and ultimate metallic behaviors. The fundamental characteristics including the mechanical strength, biocompatibility and phase transition-induced thermal effects have been clarified to demonstrate the importance of such alloy as unconventional cement with favorable merits. In addition, we also disclosed its advantage as an excellent contrast agent for radiation imaging on the bone interior structure which is highly beneficial for guiding the surgery and monitoring the therapeutic effects. Particularly, the proposed alloy cement with reversible phase transition feature significantly simplifies the revision of the cement and prosthesis. This study opens the way for employing the injectable alloy materials as reversible bone cement to fulfill diverse clinical needs in the coming time. Copyright © 2014 Elsevier Ltd. All rights reserved.
Cementless fixation of "isoelastic" hip endoprostheses manufactured from plastic materials.
Morscher, E W; Dick, W
1983-06-01
Nine years of clinical experience with an "isoelastic" shaft prosthesis manufactured using polyacetal resin reveal that for the transmission of forces from the pelvis through the femoral head and neck into the femoral shaft, some rigidity of the proximal part of the prosthesis is necessary. The object is to eliminate micromovements, which lead to bone resorption and implant loosening. However, elasticity greater than that present in metallic implants prevents stress concentrations and disuse stress protection atrophy of the bone. Greater elasticity of the prosthesis, which can be achieved by plastic materials, makes possible a more even, harmonious distribution of the forces transmitted from the implant to the bone and vice versa. A more elastic implant can also act as a better shock absorber than a rigid one. The results in 627 cementless polyethylene cups after a maximum observation period of 5.5 years reveal good incorporation and no aseptic loosening. Especially favorable results occurred in 61 cases by replacing loosened cemented cups with bone grafts and cementless polyethylene cups. On the femoral shaft side too high an elasticity in the proximal part of the prosthesis led to bone resorption and loosening with the first model of the prosthesis. By reinforcing the proximal part of the femoral component, much better results were obtained. The isoelastic femoral shaft, however, is in an early stage of experimentation.
[Tripolar arthroplasty for recurrent total hip prosthesis dislocation].
Beaulé, P-E; Roussignol, X; Schmalzried, T-P; Udomkiat, P; Amstutz, H-C; Dujardin, F-H
2003-05-01
The purpose of this study was to assess the results of revision surgery for recurrent total hip prosthesis dislocation using a tripolar prosthesis composed of a conventional stem with a mobile head of an intermediary prosthesis measuring more than 40 mm and a modified cup. This technique was used in two centers in Rouen France and Los Angeles USA. Twenty-one hips in 21 patients were operated on. The mobile heads measured 40 to 47 mm. Mean patient age was 70 years (range 29-92). The indication for the tripolar prosthesis was reserved for extremely unstable hips in patients with major risk factors for recurrent dislocation. These 21 patients had experienced 95 dislocations. The acetabular cup was custom-made for the large-diameter heads. A cemented polyethylene cup was used in 14 cases and a press-fit metal-backed around a polyethylene insert in 7. The polyethylene thickness varied from 6.5 to 16 mm for the cemented cups and 4 to 5 mm for the press-fit cups. Fourteen femoral stems were left in place as were two press-fit cups where only the inserts were changed. Mean follow-up was 5.4 years (range 3-11.8). There has been no recurrent dislocation for 20 hips. One patient experienced a dislocation one week after surgery which required a second revision procedure to reposition the acetabular implant. Final outcome was good at 7.6 years for this hip. One patient who had not had any recurrent dislocation died 4 years after the revision surgery due to a cause unrelated to the prosthesis. Two patients were lost to follow-up at 3.7 and 6 years, both were pain free and had no radiological anomalies. Infection occurred in one patient undergoing chemotherapy for a myeloma; the head and neck had to be resected. For the 20 other patients, functional outcome, assessed with the UCLA score, showed improvement in pain (5.8 preoperatively, 9.2 at last follow-up), walking (4.8 and 8 respectively), function (4 and 6 respectively), and daily activities (3.3 and 5.2 respectively). A revision procedure was necessary for one patient during the 4(th) year because of a fracture of the polyethylene insert on a metal-back cup; the insert alone was changed. Excepting the patient with infection, there were no cases of certain or probable loosening during the follow-up. The tripolar prosthesis with a mobile cup and a large-diameter head appears to be a reliable solution for these severely unstable hips. The procedure can often be limited to the acetabular component, reducing morbidity. The thickness of the polyethylene cup is a limitation which may affect long-term survival. Search for a highly wear-resistant couple continues.
DiResta, Gene R; Brown, Holly; Aiken, Sean; Doty, Steven; Schneider, Robert; Wright, Timothy; Healey, John H
2006-01-01
A device is presented that positions ultrahigh molecular weight polyethylene (UHMWPE) debris against periprosthetic bone surfaces. This can facilitate the study of aseptic loosening associated with cemented joint prostheses by speeding the appearance of this debris within the periprosthetic space. The device, composed of a 100 microm thick bioabsorbable membrane impregnated with 1.4 x 10(9) sub-micron particles of UHMWPE debris, is positioned on the endosteum of the bone prior to the insertion of the cemented orthopedic implant. An in vitro pullout study and an in vivo canine pilot study were performed to investigate its potential to accelerate "time to aseptic loosening" of cemented prosthetic joints. Pullout studies characterized the influence of the membrane on initial implant fixation. The tensile stresses (mean+/-std.dev.) required to withdraw a prosthesis cemented into canine femurs with and without the membrane were 1.15+/-0.3 and 1.54+/-0.01 MPa, respectively; these findings were not significantly different (p > 0.4). The in vivo pilot study, involving five dogs, was performed to evaluate the efficacy of the debris to accelerate loosening in a canine cemented hip arthroplasty. Aseptic loosening and lameness occurred within 12 months, quicker than the 30 months reported in a retrospective clinical review of canine hip arthroplasty.
Sharma, Rakesh; Kapusetti, Govinda; Bhong, Sayali Yashwant; Roy, Partha; Singh, Santosh Kumar; Singh, Shikha; Balavigneswaran, Chelladurai Karthikeyan; Mahato, Kaushal Kumar; Ray, Biswajit; Maiti, Pralay; Misra, Nira
2017-09-20
Bone cement has found extensive usage in joint arthroplasty over the last 50 years; still, the development of bone cement with essential properties such as high fatigue resistance, lower exothermic temperature, and bioactivity has been an unsolved problem. In our present work, we have addressed all of the mentioned shortcomings of bone cement by reinforcing it with graphene (GR), graphene oxide (GO), and surface-modified amino graphene (AG) fillers. These nanocomposites have shown hypsochromic shifts, suggesting strong interactions between the filler material and the polymer matrix. AG-based nanohybrids have shown greater osteointegration and lower cytotoxicity compared to other nanohybrids as well as pristine bone cement. They have also reduced oxidative stress on cells, resulting in calcification within 20 days of the implantation of nanohybrids into the rabbits. They have significantly reduced the exothermic curing temperature to body temperature and increased the setting time to facilitate practitioners, suggesting that reaction temperature and settling time can be dynamically controlled by varying the concentration of the filler. Thermal stability and enhanced mechanical properties have been achieved in nanohybrids vis-à-vis pure bone cement. Thus, this newly developed nanocomposite can create natural bonding with bone tissues for improved bioactivity, longer sustainability, and better strength in the prosthesis.
In vitro Characteristics of a Glass Ionomer Cement
Driscoll, Colin L. W.; Green, J. Douglas; Beatty, Charles W.; McCaffrey, Thomas V.; Marrs, Christopher D.
1998-01-01
Glass ionomer cements were first described by Wilson and Kent and have been used in dentistry since 1969. It has been recommended for bridging ossicular chain defects, fixation of ossicular chain prosthesis, anchoring of cochlear implants, mastoid obliteration, and repair of tegmen and posterior canal wall defects. The biocompatability and stability of this material over time is vital to its usefulness in neurotologic surgery. The purpose of this study was to assess the stability of a glass ionomer cement in the presence of bacteria and in different pH environments. We demonstrated that bacteria readily adhere to the surface and their presence is associated with accelerated loss of matrix. We found the cement to be susceptible to low pH and to release a visible cloud of debris upon contact with fluid. Calcium concentration in the solution was elevated at all pH levels. Although we are able to demonstrate these findings in vitro the clinical relevance is unclear. There have been several cases of aseptic meningitis possibly due to intracranial release of components of the cement. Until further studies are done use of the cement in contact with cerebral spinal fluid should be avoided. This cement, or a similar material, would be useful in neurotologic surgery but prior to widespread use further testing should be done to assess safety. ImagesFigure 1Figure 2Figure 3Figure 4Figure 5Figure 9Figure 10Figure 11 PMID:17171062
Tensile strength of cementing agents on the CeraOne system of dental prosthesis on implants.
Montenegro, Alexandre Campos; Machado, Aldir Nascimento; Depes Gouvêa, Cresus Vinicius
2008-12-01
The aim of this in vitro study was to evaluate the tensile strength of titanium cylinders cemented on stainless steel abutment mock-ups by the Cerazone system. Four types of cements were used: glass ionomer, Fuji I (GC); zinc phosphate, Cimento LS (Vigodent); zinc oxide without eugenol, Rely x Temp NE (3M ESPE); and resin cement, Rely x ARC (3M ESPE). Four experimental groups were formed, each composed of 5 test specimens. Each test specimen consisted of a set of 1 cylinder and 1 stainless steel abutment mock-up. All cements tested were manipulated in accordance with manufacturers' instructions. A static load of 5 Newtons (N) for 2 minutes was used to standardize the procedure. The tensile tests were performed by a mechanical universal testing machine (EMIC DL500MF) at a crosshead speed of 0.5 mm/min. The highest bonding values resulting from the experiment were obtained by Cimento LS (21.86 MPa mean), followed by the resin cement Rely x ARC (12.95 MPa mean), Fuji I (6.89 MPa mean), and Rely x Temp NE (4.71 MPa mean). The results were subjected to analysis of variance (ANOVA) and the Student's t test. The cements differed amongst them as regards tensile strength, with the highest bonding levels recorded with zinc phosphate (Cimento LS) and the lowest with the zinc oxide without eugenol (Rely x Temp NE).
Revision shoulder arthroplasty from resurfacing to non-cemented short-stem reverse prosthesis.
Natera, L; Bruguera, J; Atoun, E; Levy, O
2016-01-01
To assess the surgical parameters and the clinical and radiological outcomes of revisions of resurfacing shoulder arthroplasty to non-cemented short-stem reverse total shoulder arthroplasty. A total of 23 revisions from resurfacing shoulder arthroplasty to reverse total shoulder arthroplasty were performed. The mean age was 70.3±11.95 years. The patients included 82.6% (19/23) revised for cuff failure; 13.04% (3/23) cuff failure and aseptic loosening, and 4.35% (1/23) peri-prosthetic fracture. The need for humeral osteotomy or structural allograft, operation length, blood loss, blood transfusions and intraoperative fractures were recorded. Minimum follow-up 25 months. No humeral osteotomy or humeral structural allograft was required, and 2/23 (8.69%) required allograft for glenoid reconstruction. The mean operation time was 113.35±21.30minutes. Intra-operative blood loss was 374±245.09 mls. Blood transfusion was required in one case. Intra-operative fracture occurred in 1 case. The Constant score improved from 17.32 to 59.78 (age/sex adjusted, 84). Overall satisfaction improved from 1.37 to 8.04. The range of motion increased 79.57° in forward elevation; 72.88° in abduction; 38.06° in internal rotation; and 13.57° in external rotation. There was no evidence of radiolucency, subsidence, or bone resorption. Revisions of resurfacing implants to non-cemented short-stem reverse prosthesis show good clinical and radiological outcomes, with minimal intra-operative complexities. IV, case series. Copyright © 2016 SECOT. Published by Elsevier Espana. All rights reserved.
Silicone Disclosing Material used after Ceramic Surface Treatment Reduces Bond Strength.
Fraga, Sara; Oliveira, Sara Cioccari; Pereira, Gabriel Kalil Rocha; Beekman, Pieter; Rippe, Marília Pivetta; Kleverlaan, Cornelis J
To evaluate the effect of a silicone disclosing procedure performed at different timepoints on the shear bond strength (SBS) of cements (self-adhesive composite cement, self-etch composite cement, resin-reinforced glass-ionomer cement) to different substrates (zirconia, lithium disilicate, bovine dentin). The substrate/cement combinations were assigned to two groups (n = 15) according to the timepoint, at which the vinyl polyether silicone disclosing agent was applied: after (experimental groups, EXP) or before (control groups, CTRL) specific micromechanical treatments of the substrate surface. To increase standardization, the cements were applied into rubber rings (2.2 mm diameter x 1.0 mm thickness) positioned on the substrate surface. After luting procedures, all specimens were stored in 37°C distilled water for 24 h, then subjected to SBS testing using a wire loop of 0.2 mm diameter at a crosshead speed of 1 mm/min until failure. Failure analysis was performed for all tested specimens. SBS data were submitted to Weibull analysis. The silicone disclosing procedure performed after micromechanical surface treatment reduced the characteristic shear bond strength to zirconia and lithium disilicate when compared to CTRL. However, for dentin specimens, there was no significant difference between CTRL and EXP for any of the cements investigated. Failure analysis showed a predominance of interfacial failures. The silicone disclosing procedure performed after the micromechanical treatment of ceramic surfaces negatively affected the cement bond strength. Therefore, after using it to check the fit of a prosthesis, clinicians should carefully clean the ceramic surface.
Diagenesis of the Lisburne Group, northeastern Brooks Range, Alaska
DOE Office of Scientific and Technical Information (OSTI.GOV)
Carlson, R.C.; Goldstein, R.H.; Enos, P.
1995-05-01
Petrographic cathodoluminescence studies of the cement stratigraphy of the Lisburne Group yield insights on its diagenetic history. Crosscutting relationships between features of subaerial exposure and calcite cements show that early generations of nonferroan, nonluminescent and multibanded-luminescent calcites are synchronous with or postdated by subaerial exposure surfaces within the Lisburne. Surfaces of subaerial exposure occur at 18 horizons within the Lisburne and are distinguished by features as laminated crusts, rhizoliths, autoclastic breccia, fissure fills, mud cracks, and erosional surfaces. Crosscutting relationships also occur between calcite cements and clasts in karst breccias and conglomerates that formed along the sub-Permian unconformity at themore » top of the Lisburne. The sub-Permian unconformity postdates later generations of calcite cement. These cements formed in the following sequence: nonferroan to low-ferroan, dully luminescent calcite; ferroan, very-dully luminescent calcite; and second generation of nonferroan, multibanded calcite. The crosscutting relationships not only constrain the timing of cement precipitation, but also suggest that the cements probably were precipitated from meteoric groundwaters introduced during subaerial exposure of the Lisburne platform. Late cements in the Lisburne postdate the Permian Echooka Formation. These cements are low-ferroan, moderately-bright to dully luminescent calcite, followed by a second generation of ferroan, very-dully luminescent calcite. Features of compaction and pressure solution are coincident with the precipitation of the late ferroan calcite and further constrain its timing to deep burial of the Lisburne. The youngest phase of calcite cement precipitated in the Lisburne Group is nonferroan, very-dully luminescent calcite. It commonly fills tectonically-induced shear fractures, indicating precipitation after the onset of Cretaceous (and/or Cenozoic) tectonism in the northeastern Brooks Range.« less
Comparative study of the marginal microleakage of six cements in fixed provisional crowns.
Baldissara, P; Comin, G; Martone, F; Scotti, R
1998-10-01
In many situations, provisional restorations require a long-term permanence in the oral cavity. During this period, the abutments need the best possible biologic and mechanical protection. In this way, the vitality of the pulp and the integrity of mineralized tissues can be preserved. The luting cement used to fix interim restorations should have good mechanical properties, low solubility, and good adhesion to resist bacterial and molecular penetration. However, because of its provisional nature, the prosthesis should be easy to remove from the abutments. These contrasting requirements may lead to a compromise in cement behavior, particularly in its mechanical properties. This in vitro study evaluated the marginal microleakage of 4 provisional cements, a cavity base compound and a zinc-phosphate luting cement in provisional acrylic resin crowns fixed on extracted human teeth. Thirty acrylic resin crowns were made and fitted on intact human premolars with the 6 cements. All restorations were applied in a standardized manner by means of an axial load of 10 kg. Specimens were thermocycled then submerged in a 5% basic fuchsin solution, then sectioned and observed under a light stereomicroscope. A 5-level scale was used to score dye penetration in the tooth/cement interface. A high dye penetration in the tooth/cement interface was present in all 4 provisional cements. Microleakage existed in specimens where zinc-phosphate and cavity base compounds were used; however, it was lower than the other materials. A significant difference (P < .05) was found between zinc-phosphate and one eugenol-free cement and between cavity base and the same eugenol-free cement. All materials tested demonstrated different degrees of microleakage. Zinc-phosphate and cavity base compound cements had the best sealing properties. This latter, even if conceived as a cavity base, may be considered a good provisional cement as far as microleakage is concerned.
Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören
2014-03-01
A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.
Using "Rebar" to Stabilize Rigid Chest Wall Reconstruction.
Robinson, Lary A; Grubbs, Deanna M
2016-04-01
After major chest wall resection, reconstruction of the bony defect with a rigid prosthesis is mandatory to protect the underlying thoracic organs, and to prevent flail chest physiology. Although many methods have been described for chest wall reconstruction, a commonly used technique employs a composite Marlex (polypropylene) mesh with methyl-methacrylate cement sandwiched between two layers of mesh (MMS), which is tailored to the defect size and shape. In building construction, steel "rebar" is used to strengthen and reinforce masonry structures. To avoid the initial residual motion of the rigid prosthesis used to reconstruct very large defects, particularly the sternum, we devised a simple technique of adding one or more Steinmann steel pins as "rebar" to strengthen and immediately stabilize the prosthesis to the surrounding ribs and sternum. For the very large defects, particularly over the heart and great vessels, titanium mesh may also be readily added into the sandwich construction for increased strength and to prevent late prosthetic fractures. Short- and long-term results of this inexpensive modification of the MMS reconstruction technique are excellent. This modified MMS tailor-made prosthesis is only one-third the cost of the recently popular prosthetic titanium systems, takes much less operative time to create and implant, and avoids the well-described complications of late titanium bar fracture and erosion/infection as well as loosening of screws and/or titanium bars. Georg Thieme Verlag KG Stuttgart · New York.
Hua, Xijin; Li, Junyan; Wang, Ling; Wilcox, Ruth; Fisher, John; Jin, Zhongmin
2015-10-01
One important loosening mechanism of the cemented total hip arthroplasty is the mechanical overload at the bone-cement interface and consequent failure of the cement fixation. Clinical studies have revealed that the outer diameter of the acetabular component is a key factor in influencing aseptic loosening of the hip arthroplasty. The aim of the present study was to investigate the influence of the cup outer diameter on the contact mechanics and cement fixation of a cemented total hip replacement (THR) with different wear penetration depths and under different cup inclination angles using finite element (FE) method. A three-dimensional FE model was developed based on a typical Charnley hip prosthesis. Two acetabular cup designs with outer diameters of 40 and 43 mm were modelled and the effect of cup outer diameter, penetration depth and cup inclination angle on the contact mechanics and cement fixation stresses in the cemented THR were studied. The results showed that for all penetration depths and cup inclination angles considered, the contact mechanics in terms of peak von Mises stress in the acetabular cup and peak contact pressure at the bearing surface for the two cup designs were similar (within 5%). However, the peak von Mises stress, the peak maximum principal stress and peak shear stress in the cement mantle at the bone-cement interface for the 43 mm diameter cup design were predicted to be lower compared to those for the 40 mm diameter cup design. The differences were predicted to be 15-19%, 15-22% and 18-20% respectively for different cup penetration depths and inclination angles, which compares to the clinical difference of aseptic loosening incidence of about 20% between the two cup designs. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.
Kendal, Adrian R; Prieto-Alhambra, Daniel; Arden, Nigel K; Judge, Andrew
2013-01-01
Objectives To compare 10 year mortality rates among patients undergoing metal-on-metal hip resurfacing and total hip replacement in England. Design Retrospective cohort study. Setting English hospital episode statistics database linked to mortality records from the Office for National Statistics. Population All adults who underwent primary elective hip replacement for osteoarthritis from April 1999 to March 2012. The exposure of interest was prosthesis type: cemented total hip replacement, uncemented total hip replacement, and metal-on-metal hip resurfacing. Confounding variables included age, sex, Charlson comorbidity index, rurality, area deprivation, surgical volume, and year of operation. Main outcome measures All cause mortality. Propensity score matching was used to minimise confounding by indication. Kaplan-Meier plots estimated the probability of survival up to 10 years after surgery. Multilevel Cox regression modelling, stratified on matched sets, described the association between prosthesis type and time to death, accounting for variation across hospital trusts. Results 7437 patients undergoing metal-on-metal hip resurfacing were matched to 22 311 undergoing cemented total hip replacement; 8101 patients undergoing metal-on-metal hip resurfacing were matched to 24 303 undergoing uncemented total hip replacement. 10 year rates of cumulative mortality were 271 (3.6%) for metal-on-metal hip resurfacing versus 1363 (6.1%) for cemented total hip replacement, and 239 (3.0%) for metal-on-metal hip resurfacing versus 999 (4.1%) for uncemented total hip replacement. Patients undergoing metal-on-metal hip resurfacing had an increased survival probability (hazard ratio 0.51 (95% confidence interval 0.45 to 0.59) for cemented hip replacement; 0.55 (0.47 to 0.65) for uncemented hip replacement). There was no evidence for an interaction with age or sex. Conclusions Patients with hip osteoarthritis undergoing metal-on-metal hip resurfacing have reduced mortality in the long term compared with those undergoing cemented or uncemented total hip replacement. This difference persisted after extensive adjustment for confounding factors available in our data. The study results can be applied to matched populations, which exclude patients who are very old and have had complex total hip replacements. Although residual confounding is possible, the observed effect size is large. These findings require validation in external cohorts and randomised clinical trials. PMID:24284336
Fousek, J; Indráková, P
2007-02-01
The aim of the study was a retrospective evaluation of our patients with post-dysplastic hips treated by cemented or non-cemented total hip arthroplasty (THA) in order to ascertain which type and position of the acetabular component was most effective. In the years 1999-2002, 111 THA procedures were performed in 93 patients, 76 women and 17 men, with post-dysplastic hip arthritis. The average age of the patients at the time of implantation was 52.6 years. On the basis of pre-operative radiographic findings, the patients' conditions were evaluated using the Hartofilakidis classification into three disease categories: dysplasia, low dislocation and high dislocation, and the patients were placed in two groups. Group 1 included 78 patients, and group 2 comprised 26 patients. None of our patients was classified as having high dislocation. Thirty-nine of these patients had previously undergone surgery for dysplastic hips. A total of 104 THAs were evaluated, because radiographic data was incomplete in seven cases. In addition to X-ray findings, the prosthesis type (cemented, hybrid, non-cemented), post-operative complications and signs of loosening were included in the evaluation. Clinical outcomes were assessed by the Harris score. The follow-up terminating on 31st December 2005 was 67 months on the average. In group 1 patients, the average Harris score increased from 38.6 to 80.3 points and in group 2 patients from 35.5 to 84.9 points, mostly with excellent and good results. In 72.1 % of the hips, a press-fit acetabular component was implanted. In 55.8 % of the cases, the acetabular component was implanted off the anatomical center of rotation, into the high hip center, with the range from 9 to 20 mm and an average of 15 mm. The average limb lengthening was 2.5 cm, ranging from 1.0 to 3.5 cm. Our results show that it is more effective to use non-cemented THA for post-dysplastic hips. The implantation of a noncemented acetabular component into the high center provides better covering of the cup with solid bone, without the necessity of cotyloplasty or structural graft use. Also, it does not markedly affect hip function or patients' subjective feelings.
Effect of fabrication pressure on the fatigue performance of Cemex XL acrylic bone cement.
Lewis, Gladius; Janna, S I
2004-01-01
During a cemented arthroplasty, the prepared polymerizing dough of acrylic bone cement is subjected to pressurization in a number of ways; first, during delivery into the freshly prepared bone bed, second, during packing in that bed (either digitally or with the aid of a mechanical device), and, third, during the insertion of the prosthesis. Only a few studies have reported on the influence of the level of pressurization experienced during these events (which, depending on the cementing technique used, has been put at between 8 and 273 kPa) on various properties of the cement. That was the focus of the present study, in which the fully reversed tension-compression (+/-15 MPa; 5 Hz) fatigue lives (expressed as number of cycles to fracture, N(f)) of rectangular cross-sectioned "dog-bone" specimens (Type V, per ASTM D 638) fabricated from Cemex XL cement, at pressure applied continuously to the cement dough during curing in the specimen mold, p=75,150, and 300 kPa, were determined. The N(f) results were analyzed using the linearized transformation of the three-parameter Weibull relationship to obtain estimates of the Weibull mean, N(WM), which was taken to be the index of fatigue performance of the specimen set. Over the range of p studied, N(WM) increased as p increased (for example, from 329,118 cycles when p was 75 kPa to 388,496 cycles when p was 300 kPa); however, the increase was not significant over any pair of p increment steps (Mann-Whitney U-test; alpha<0.05).
Salesky, Madeleine A; Grace, Trevor R; Feeley, Brian T; Ma, C Benjamin; Zhang, Alan L
2018-05-01
The influence of primary humeral stem fixation method (cemented or press fit) on intraoperative or postoperative outcomes in the setting of revision shoulder arthroplasty is unknown. A retrospective analysis of a prospectively collected cohort of revision shoulder arthroplasty patients from a single tertiary center was performed. Demographic variables, intraoperative data, and 90-day complication rates were compared between cemented and press-fit primary stem fixation cohorts. Follow-up radiographs were graded and compared using a modified Gruen system for humeral lucencies. Eighty-six primary shoulder replacements (34 hemiarthroplasties, 39 anatomic total shoulder arthroplasties, 13 reverse total shoulder arthroplasties) underwent revision arthroplasty with humeral stem removal between 2004 and 2017. Forty-five patients had cemented primary humeral fixation and 41 had press-fit fixation. The cemented cohort was older than the cementless cohort (66.6 vs. 61.4 years; P = .03) but otherwise demonstrated no difference in gender, body mass index, type of primary prosthesis (hemi, total, or reverse), or time between primary and revision operations. The cemented and cementless cohorts showed similar rates of humeral osteotomy (28.9% vs. 29.3%; P = .97), operative time (133.5 vs. 121.3 minutes; P = .16), and 90-day complication rates (13.3% vs. 9.8%; P = .61). Cemented vs. press-fit primary stems also had similar rates of humeral lucencies seen on follow-up radiographs after revision (77.1% vs. 60.6%; P = .14). Humeral stem fixation with or without cement during primary shoulder arthroplasty demonstrated similar operative time, need for intraoperative humeral osteotomy, and postoperative complication rates in the setting of revision arthroplasty. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.
Kopinski, Judith E; Aggarwal, Ajay; Nunley, Ryan M; Barrack, Robert L; Nam, Denis
2016-11-01
Recent literature has shown debonding of the tibial implant-cement interface as a potential cause for implant loosening. The purpose of this case series is to report this phenomenon in a historically well-performing implant when used with high-viscosity cement (HVC). Thirteen primary cemented Biomet Vanguard total knee arthroplasties were referred to 1 of 2 institutions with complaints of persistent pain after their index procedure. A radiographic and infectious work-up was completed for each patient. All 13 patients underwent a revision of the index surgery with intraoperative diagnosis of tibial component debonding at the implant-cement interface. HVC (Cobalt, DJO Surgical, Vista, CA and Depuy HVC; Depuy Inc, Warsaw, IN) was used in all index cases. The average time to revision surgery for the 13 patients was 2.7 ± 1.9 years from the index surgery. Laboratory infectious markers were within normal in most cases, and all intra-articular aspirations showed no bacterial, fungal, or anaerobic growth. Eleven of 13 patients showed no radiographic evidence of loosening; however, all cases demonstrated tibial component debonding intraoperatively. Given our institution's experience and previously reported data demonstrating excellent survivorship with this total knee arthroplasty prosthesis, we propose that the early failures seen in this case series may be associated with the use of HVC cement. In the setting of a negative infectious work-up and no radiographic evidence to suggest loosening, the surgeon should consider debonding of the tibial component as a potential cause for persistent pain if HVC cement was used with this prosthetic design. Copyright © 2016 Elsevier Inc. All rights reserved.
Arikupurathu, Oommen Mathew; Johnston, Linda; MacInnes, Alasdair; Nicol, Graeme; Nassif, Manhal
2018-06-20
The NexGen legacy posterior stabilized (LPS) prosthesis was introduced in 1997 after many design changes to its predecessor, the Insall-Burstein II prosthesis. However, there have been no reported long-term studies on the performance of this implant. Prospectively, collected data from a local database comprising primary total knee replacements (TKRs) with LPS between 1997 and 2002 was analyzed. All implants were fixed with cement. Patients were followed up at 1, 3, 5, 7, and 10 years, with patient satisfaction, range of movement, and Knee Society score (KSS) assessed. A total of 621 primary TKRs were analyzed with an average follow-up of 11.25 years (9.15-14.55). The mean age was 69.53 years. The mean KSS was 88.97 and mean flexion increased from 88.3 to 103.5 degrees at 10 years. Kaplan-Meier's analysis revealed a survivorship of 96.5% with revision for any reason as the end point and 98.9% if aseptic loosening was the reason for revision at 14 years. This study revealed excellent mid- to long-term results with the NexGen LPS prosthesis. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Agins, H J; Alcock, N W; Bansal, M; Salvati, E A; Wilson, P D; Pellicci, P M; Bullough, P G
1988-03-01
We conducted extensive histological examination of the tissues that were adjacent to the prosthesis in nine hips that had a failed total arthroplasty. The prostheses were composed of titanium alloy (Ti-6Al-4V) and ultra-high molecular weight polyethylene. The average time that the prosthesis had been in place in the tissue was 33.5 months (range, eleven to fifty-seven months). Seven arthroplasties were revised because of aseptic loosening and two, for infection. In eight hips cement had been used and in one (that had a porous-coated implant for fifty-two months) no cement had been utilized. Intense histiocytic and plasma-cell reaction was noted in the pseudocapsular tissue. There was copious metallic staining of the lining cells. Polyethylene debris and particles of cement with concomitant giant-cell reaction were present in five hips. Atomic absorption spectrophotometry revealed values for titanium of fifty-sic to 3700 micrograms per gram of dry tissue (average, 1047 micrograms per gram; normal, zero microgram per gram), for aluminum of 2.1 to 396 micrograms per gram (average, 115 micrograms per gram; normal, zero micrograms per gram), and for vanadium of 2.9 to 220 micrograms per gram (average, sixty-seven micrograms per gram; normal, 1.2 micrograms per gram). The highest values were found in the hip in which surgical revision was performed at fifty-seven months. The concentrations of the three elements in the soft tissues were similar to those in the metal of the prostheses. The factors to which failure was attributed were: vertical orientation of the acetabular component (five hips), poor cementing technique on the femoral side (three hips), infection (two hips), and separation of a sintered pad made of pure titanium (one hip). A femoral component that is made of titanium alloy can undergo severe wear of the surface and on the stem, where it is loose, with liberation of potentially toxic local concentrations of metal debris into the surrounding tissues. It may contribute to infection and loosening.
CKS knee prosthesis: biomechanics and clinical results in 42 cases.
Martucci, E; Verni, E; Del Prete, G; Stulberg, S D
1996-01-01
From 1991 to 1993 a total of 42 CKS prostheses were implanted for the following reasons: osteoarthrosis (34 cases), rheumatoid arthritis (7 cases) tibial necrosis (1 case). At follow-up obtained after 17 to 41 months the results were: excellent or good: 41; the only poor result was probably related to excessive tension of the posterior cruciate ligament. 94% of the patients reported complete regression of pain, 85% was capable of going up and down stairs without support. Mean joint flexion was 105 degrees. Radiologically the anatomical axis of the knee had a mean valgus of anatomical axis of the knee had a mean valgus of 6 degrees. The prosthetic components were always cemented. The posterior cruciate ligament was removed in 7 knees, so that the prosthesis with "posterior stability" was used. The patella was never prosthetized. One patient complained of peri-patellar pain two months after surgery which then regressed completely.
Nishida, Keiichiro; Hashizume, Kenzo; Nasu, Yoshihisa; Kishimoto, Makoto; Ozaki, Toshifumi; Inoue, Hajime
2014-01-01
We determined mid to long-term results of total elbow arthroplasty (TEA) by use of unlinked elbow prostheses with solid alumina ceramic trochleae, and ceramic ulnar stems (stemmed Kyocera type I; SKC-I) for patients with rheumatoid arthritis. Fifty-four elbows of 39 patients were available for detailed clinical and radiographic review after a follow-up period of at least 5 years. The mean follow-up period was 12.6 years (range 5-22 years). Clinical condition before and after surgery was assessed by use of a modified version of the Mayo Elbow Performance Score (MEPS; 0-100 points) and a Japan Orthopaedic Association Elbow score (JOA score; 0-100 points). The radiographs were reviewed and loosening was defined as a progressive radiolucent line >1 mm wide that was completely circumferential around the prosthesis. Clinical records of post-operative events affecting the elbows were used for survival analysis of the prostheses using the Kaplan-Meier method. The average modified MEPS and JOA scores improved significantly from 39.7 ± 14.3 to 44.7 ± 9.4, respectively, pre-operatively, to 89.7 ± 15.4 and 83.1 ± 12.8, respectively, post-operatively (P < 0.0001). The functional assessment score also improved from 4.9 ± 2.8 to 8.5 ± 3.3 points (P < 0.0001). With loosening or implant revision defined as end points, the likelihood of survival of the prosthesis for up to 20 years was 92.6% (95% confidence interval (CI), 85.6-100.0) or 86.3 % (95 % CI 75.0-97.6), respectively. Satisfactory clinical results were obtained after TEA using SKC-I prostheses, which provided excellent pain relief and functional range of motion. The results of our study reveal the high reliability over a long period of the cemented SKC-I prosthesis with an alumina ceramic component.
Candida periprosthetic joint infection: A rare and difficult-to-treat infection.
Escolà-Vergé, Laura; Rodríguez-Pardo, Dolors; Lora-Tamayo, Jaime; Morata, Laura; Murillo, Oscar; Vilchez, Helem; Sorli, Luisa; Carrión, Laura Guío; Barbero, José Mª; Palomino-Nicás, Julián; Bahamonde, Alberto; Jover-Sáenz, Alfredo; Benito, Natividad; Escudero, Rosa; Sampedro, Marta Fernandez; Vidal, Rafael Pérez; Gómez, Lucía; Corona, Pablo S; Almirante, Benito; Ariza, Javier; Pigrau, Carles
2018-05-08
Candida periprosthetic joint infection (CPJI) is a rare, difficult-to-treat disease. The purpose of this study was to evaluate the clinical characteristics and outcomes of CPJI treated with various surgical and antifungal strategies. We conducted a multicenter retrospective study of all CPJI diagnosed between 2003 and 2015 in 16 Spanish hospitals. Forty-three patients included: median age, 75 years, and median Charlson Comorbidity Index score, 4. Thirty-four (79.1%) patients had ≥1 risk factor for Candida infection. Most common causative species were C. albicans and C. parapsilosis. Thirty-five patients were evaluable for outcome: overall, treatment succeeded in 17 (48.6%) and failed in 18 (51.4%). Success was 13/20 (67%) in patients with prosthesis removal and 4/15 (27%) with debridement and prosthesis retention (p = 0.041). All 3 patients who received an amphotericin B-impregnated cement spacer cured. In the prosthesis removal group, success was 5/6 (83%) with an antibiofilm regimen and 8/13 (62%) with azoles (p = 0.605). In the debridement and prosthesis retention group, success was 3/10 (30%) with azoles and 1/5 (20%) with antibiofilm agents. Therapeutic failure was due to relapse in 9 patients, need for suppressive treatment in 5, persistent infection in 2, and CPJI-related death in 2; overall attributable mortality was 6%. CPJI is usually a chronic disease in patients with comorbidities and risk factors for Candida infection. Treatment success is low, and prosthesis removal improves outcome. Although there is insufficient evidence that use of antifungals with antibiofilm activity has additional benefits, our experience indicates it may be recommendable. Copyright © 2018 Elsevier Ltd. All rights reserved.
Sadoghi, Patrick; Leithner, Andreas; Labek, Gerold
2013-09-01
Worldwide joint arthroplasty registers are instrumental to screen for complications or implant failures. In order to achieve comparable results a similar classification dataset is essential. The authors therefore present the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) European Arthroplasty Register (EAR) minimal dataset for primary and revision joint arthroplasty. Main parameters include the following: date of operation, country, hospital ID-code, patient's name and prename, birthday, identification code of the implant, gender, diagnosis, preoperations, type of prosthesis (partial, total), side, cementation technique, use of antibiotics in the cement, surgical approach, and others specifically related to the affected joint. The authors believe that using this minimal dataset will improve the chance for a worldwide comparison of arthroplasty registers and ask future countries for implementation. Copyright © 2013 Elsevier Inc. All rights reserved.
The Use of Structural Allograft in Primary and Revision Knee Arthroplasty with Bone Loss
Kuchinad, Raul A.; Garbedian, Shawn; Rogers, Benedict A.; Backstein, David; Safir, Oleg; Gross, Allan E.
2011-01-01
Bone loss around the knee in the setting of total knee arthroplasty remains a difficult and challenging problem for orthopaedic surgeons. There are a number of options for dealing with smaller and contained bone loss; however, massive segmental bone loss has fewer options. Small, contained defects can be treated with cement, morselized autograft/allograft or metal augments. Segmental bone loss cannot be dealt with through simple addition of cement, morselized autograft/allograft, or metal augments. For younger or higher demand patients, the use of allograft is a good option as it provides a durable construct with high rates of union while restoring bone stock for future revisions. Older patients, or those who are low demand, may be better candidates for a tumour prosthesis, which provides immediate ability to weight bear and mobilize. PMID:21991418
Hydration-dependent dynamics of water in calcium-silicate-hydrate: A QENS study by global model.
Le, Peisi; Fratini, Emiliano; Chen, Sow-Hsin
2018-02-02
In a saturated cement paste, there are three different types of water: the structural water chemically reacted with cement, the constrained water absorbed to the surface of the pores, and the free water in the center of the pores. Each type has different physicochemical state and unique relation to cement porosity. The different water types have different dynamics which can be detected using quasi-elastic neutron scattering (QENS). Since the porosity of a hardened cement paste is impacted strongly by the water to cement ratio (w/c), it should be possible to extract the hydration dependence of the pores by exploiting the dynamical parameters of the confined water. Three C-S-H samples with different water levels, 8%, 17% and 30% were measured using QENS. The measurements were carried out in the scattering vector, Q, range from 0.5 Å -1 to 1.3 Å -1 , and in the temperature interval from 230 K to 280 K. The data were analyzed using a novel global model developed for cement QENS spectra. The results show that while increasing the water content, the structural water index (SWI) decreases and the confining radius, a, increases. Both SWI and a have a linear relationship with the water content. The Arrhenius plot of the translational relaxation time shows that the constrained water dominates the non-structural water at water contents lower than 17%. The rotational activation energy is smaller for lower water content. The analysis demonstrated that our newly proposed global model is practical and useful for analyzing cement QENS data. Copyright © 2018 Elsevier B.V. All rights reserved.
Lu, Minxun; Li, Yongjiang; Luo, Yi; Zhang, Wenli; Zhou, Yong; Tu, Chongqi
2018-03-06
Currently, it is challenging to treat massive bone defects of proximal tibia. Although numerous methods are available for reconstruction with epiphysis preservation, limitations in knee function and complications are noted with these methods. Our paper describes our attempt to reconstruct a marked defect in the proximal tibia with an uncemented three-dimensional (3D)-printed prosthesis and to evaluate the prosthesis design and short-term outcomes. A 15-year-old boy with metaphyseal osteosarcoma of the tibia underwent intercalary allograft reconstruction following wide tumour resection with epiphysis preservation. However, chronic allograft rejection and/or infection occurred after the surgery and a sinus tract was formed. The rejection and/or infection process was successfully stopped by the removal of the graft and implantation of an antibiotic-loaded cement spacer; however, the limb function was poor. Because of the irregular shape of the defect and the excessively short length of the residual proximal tibia, we used the 3D printing technology to design and fabricate a personalised prosthesis to reconstruct the defect, with the preservation of the knee joint. At the last follow-up at 26 months, the patient had satisfactory limb function. The 3D-printed prosthesis may be a feasible option in the reconstruction of tibial metaphyseal defects with the preservation of the knee joint. Moreover, it can result in good postoperative function and low complication rates. However, a long-term follow-up is required to clarify its long-term outcomes.
Sahu, Nabaprakash; Lakshmi, Namratha; Azhagarasan, N.S.; Agnihotri, Yoshaskam; Rajan, Manoj; Hariharan, Ramasubramanian
2014-01-01
Background: In cement-retained implant-supported restoration it is important to gain adequate retention of definitive restoration as well as retrievability of prosthesis. The surface of the abutment, alloy of the restoration and the type of cement used influences the retention of the restoration. There is a need to analyze the influence of surface modifications of abutments on the retentive capabilities of provisional implant cements. Purpose of study: To compare the effect of implant abutment surface modifications on retention of implant-supported restoration cemented with polymer based cement. Materials and method: Thirty solid titanium implant abutments (ADIN), 8mm height, were divided into 3 groups. Ten abutments with retentive grooves (Group I) as supplied by the manufacturer, Ten abutments milled to 20 taper circumferentially (Group II), and Ten abutments milled and air-abraded with 110 μm aluminum oxide (Group III) were used in this study. Ni-Cr coping were casted for each abutment and polymer based cement was used to secure them to the respective abutments. Using a universal testing machine at a crosshead speed of 0.5 cm/minute, tensile bond strength was recorded (N). Results: Mean tensile bond strength of Group I, II and III were found to be 408.3, 159.9 and 743.8 Newton respectively. The values were statistically different from each other (p<0.001). Conclusion: Abutments with milled and sandblasted surface provide the highest retention followed by abutments with retentive grooves and then by abutments with milled surface when cast copings were cemented to implant abutments with polymer based cement. Clinical implications: Retention of restoration depends on the surface of the abutment as well as the luting agents used. Incorporation of retentive grooves or particle abrasion can enhance retention especially in situation of short clinical crown. PMID:24596785
An esthetics rehabilitation with computer-aided design/ computer-aided manufacturing technology.
Mazaro, Josá Vitor Quinelli; de Mello, Caroline Cantieri; Zavanelli, Adriana Cristina; Santiago, Joel Ferreira; Amoroso, Andressa Paschoal; Pellizzer, Eduardo Piza
2014-07-01
This paper describes a case of a rehabilitation involving Computer Aided Design/Computer Aided Manufacturing (CAD-CAM) system in implant supported and dental supported prostheses using zirconia as framework. The CAD-CAM technology has developed considerably over last few years, becoming a reality in dental practice. Among the widely used systems are the systems based on zirconia which demonstrate important physical and mechanical properties of high strength, adequate fracture toughness, biocompatibility and esthetics, and are indicated for unitary prosthetic restorations and posterior and anterior framework. All the modeling was performed by using CAD-CAM system and prostheses were cemented using resin cement best suited for each situation. The rehabilitation of the maxillary arch using zirconia framework demonstrated satisfactory esthetic and functional results after a 12-month control and revealed no biological and technical complications. This article shows the important of use technology CAD/CAM in the manufacture of dental prosthesis and implant-supported.
Nakamura, Tomoki; Matsumine, Akihiko; Uchida, Atsumasa; Kawai, Akira; Nishida, Yoshihiro; Kunisada, Toshiyuki; Araki, Nobuhito; Sugiura, Hideshi; Tomita, Masato; Yokouchi, Masahiro; Ueda, Takafumi; Sudo, Akihiro
2014-04-01
The Japanese Musculoskeletal Oncology Group have developed an original prosthesis called the Kyocera Modular Limb Salvage system (KMLS system). This prosthesis has a semi-rotating hinge joint and is particularly designed for people with an Asian body type. The metallic parts of the prosthesis are made entirely of titanium alloy. The purpose of this study is to evaluate the clinical outcomes of treatment using this system following tumour resection of primary bone sarcoma of the distal femur. Between 2002 and 2010, 82 patients with primary bone sarcomas of the distal femur were treated. Seventeen patients underwent stem cementation, while 65 patients were treated with cementless prostheses. The mean follow-up period after surgery was 61 months. Complications were observed in 28 of the 82 patients. Forty-one complications occurred in these 28 patients. Thirteen prostheses (16%) required revision surgery due to complications, including five cases of stem breakage, three deep infections, three cases of aseptic loosening, one case of displacement of the shaft cap and one case of breakage of the tibial tray. The five-year overall prosthetic survival rate was 80.0%. Four of the 82 patients underwent subsequent amputation due to local recurrence. The five-year limb salvage rate was 94.5%. The mean function score according to the scoring system of the Musculoskeletal Tumour Society was 21.8 points (72.5%). Although further follow-up is required to determine the performance, this prosthesis is considered to be satisfactory for reconstruction of the distal femur after resection of bone sarcoma.
Le, Peisi; Fratini, Emiliano; Ito, Kanae; ...
2016-01-28
We present the hypothesis that the mechanical properties of cement pastes depend strongly on their porosities. In a saturated paste, the porosity links to the free water volume after hydration. Structural water, constrained water, and free water have different dynamical behavior. Hence, it should be possible to extract information on pore system by exploiting the water dynamics. With our experiments we investigated the slow dynamics of hydration water confined in calcium- and magnesium-silicate-hydrate (C-S-H and M-S-H) gels using high-resolution quasi-elastic neutron scattering (QENS) technique. C-S-H and M-S-H are the chemical binders present in calcium rich and magnesium rich cements. Wemore » measured three M-S-H samples: pure M-S-H, M-S-H with aluminum-silicate nanotubes (ASN), and M-S-H with carboxyl group functionalized ASN (ASN-COOH). A C-S-H sample with the same water content (i.e. 0.3) is also studied for comparison. We found that structural water in the gels contributes to the elastic component of the QENS spectrum, while constrained water and free water contribute the quasi-elastic component. The quantitative analysis suggests that the three components vary for different samples and indicate the variance in the system porosity, which controls the mechanical properties of cement pastes.« less
DOE Office of Scientific and Technical Information (OSTI.GOV)
Le, Peisi; Fratini, Emiliano; Ito, Kanae
We present the hypothesis that the mechanical properties of cement pastes depend strongly on their porosities. In a saturated paste, the porosity links to the free water volume after hydration. Structural water, constrained water, and free water have different dynamical behavior. Hence, it should be possible to extract information on pore system by exploiting the water dynamics. With our experiments we investigated the slow dynamics of hydration water confined in calcium- and magnesium-silicate-hydrate (C-S-H and M-S-H) gels using high-resolution quasi-elastic neutron scattering (QENS) technique. C-S-H and M-S-H are the chemical binders present in calcium rich and magnesium rich cements. Wemore » measured three M-S-H samples: pure M-S-H, M-S-H with aluminum-silicate nanotubes (ASN), and M-S-H with carboxyl group functionalized ASN (ASN-COOH). A C-S-H sample with the same water content (i.e. 0.3) is also studied for comparison. We found that structural water in the gels contributes to the elastic component of the QENS spectrum, while constrained water and free water contribute the quasi-elastic component. The quantitative analysis suggests that the three components vary for different samples and indicate the variance in the system porosity, which controls the mechanical properties of cement pastes.« less
Prymka, M; Hassenpflug, J
2003-08-01
This paper presents the case of a 63 year old female with a severe coxarthrosis. She got a robot assited implantation of a cementless hip prosthesis (Osteolock, Stryker-Howmedica, Mühlheim). As operation robot the CASPAR-System (Orto-Maquet, Rastatt) was used. Initially, the clinical progress of the patient was fine. She was nearly painfree within 14 days and showed an acceptable range of motion in the operated joint (flexion/ extension 90 degrees /05 degrees /00 degrees ). She was mobilized with crutches and 15 kg weight bearing at the operated leg. 3 weeks postoperative the patient complaint about increasing pain without trauma or intensification of the weight bearing. X-rays showed not only a dislocated fracture of the lesser trochanter, but also a sinking combined with a malrotation of the stem. A revision operation was necessary,where we implanted a cemented stem. Now clinical progress was completely satisfying.
Lee, Byoung-Joo; Kyung, Hee-Soo; Yoon, Seong-Dae
2015-09-01
The purpose of this study was to determine the degree of infection control and postoperative function for new articulating metal-on-cement spacer. A retrospective study of 19 patients (20 cases), who underwent a two-stage revision arthroplasty using mobile cement prosthesis, were followed for a minimum of 2 years. This series consisted of 16 women and 3 men, having an overall mean age of 71 years. During the first stage of revision, the femoral implant and all the adherent cement was removed, after which it was autoclaved before replacement. The tibial component was removed and a doughy state, antibiotic-impregnated cement was inserted on the tibial side. To achieve joint congruency, intraoperative molding was performed by flexing and extending the knee joint. Each patient was evaluated clinically and radiologically. The clinical assessments included range of motion, and the patients were scored as per the Hospital for Special Surgery (HSS) and Knee Society (KS) criteria. The mean range of knee joint motion was 70° prior to the first stage operation and 72° prior to the second stage revision arthroplasty; following revision arthroplasty, it was 113° at the final follow-up. The mean HSS score and KS knee and function scores were 86, 82, and 54, respectively, at the final follow-up. The success rate in terms of infection eradication was 95% (19/20 knees). No patient experienced soft tissue contracture requiring a quadriceps snip. This novel technique provides excellent radiological and clinical outcomes. It offers a high surface area of antibiotic-impregnated cement, a good range of motion between first and second stage revision surgery for the treatment of chronic infection after total knee arthroplasty, and is of a reasonable cost.
Outcome Assessment after Aptis Distal Radioulnar Joint (DRUJ) Implant Arthroplasty
Kachooei, Amir Reza; Chase, Samantha M; Jupiter, Jesse B
2014-01-01
Background: Conventional treatments after complicated injuries of the distal radioulnar joint (DRUJ) such as Darrach and Kapandji-Sauvé procedures have many drawbacks, which may eventually lead to a painful unstable distal ulna. The development of DRUJ prosthesis has significantly evolved over the past years. In this study, we assessed the outcome results of patients after DRUJ implant arthroplasty using the Aptis (Scheker) prosthesis. Methods: We identified 13 patients with 14 prosthesis during the past 10 years. Patients underwent DRUJ arthroplasty due to persistent symptoms of instability, chronic pain, and stiffness. Records and follow-up visits were reviewed to find the final post-operative symptoms, pain, range of motion, and grip strength with a mean follow-up of 12 months (range: 2-25 months). Also, patients were contacted prospectively by phone in order to administer the disabilities of the arm shoulder and hand (DASH), patient rated wrist evaluation (PRWE), and visual analogue scale (VAS), and to interview regarding satisfaction and progress in daily activities. Eleven patients out of 13 could be reached with a median follow-up time of 60 months (range: 2 to 102 months). Results: No patient required removal of the prosthesis. Only two patients underwent secondary surgeries in which both required debridement of the screw tip over the radius. The median DASH score, PRWE score, VAS, and satisfaction were 1.3, 2.5, 0, and 10, respectively. The mean range of flexion, extension, supination, and pronation was 62, 54, 51, and 64, respectively. Conclusions: Distal radioulnar joint injuries are disabling and patients usually undergo one or more salvage surgeries prior to receiving an arthroplasty. The Scheker prosthesis has shown satisfactory results with 100% survival rate in all reports. The constrained design of this prosthesis gives enough stability to prevent painful subluxation. PMID:25386579
Agonist-antagonist active knee prosthesis: a preliminary study in level-ground walking.
Martinez-Villalpando, Ernesto C; Herr, Hugh
2009-01-01
We present a powered knee prosthesis with two series-elastic actuators positioned in parallel in an agonist-antagonist arrangement. To motivate the knee's design, we developed a prosthetic knee model that comprises a variable damper and two series-elastic clutch units that span the knee joint. Using human gait data to constrain the model's joint to move biologically, we varied model parameters using an optimization scheme that minimized the sum over time of the squared difference between the model's joint torque and biological knee values. We then used these optimized values to specify the mechanical and control design of the prosthesis for level-ground walking. We hypothesized that a variable-impedance control design could produce humanlike knee mechanics during steady-state level-ground walking. As a preliminary evaluation of this hypothesis, we compared the prosthetic knee mechanics of an amputee walking at a self-selected gait speed with those of a weight- and height-matched nonamputee. We found qualitative agreement between prosthetic and human knee mechanics. Because the knee's motors never perform positive work on the knee joint throughout the level-ground gait cycle, the knee's electrical power requirement is modest in walking (8 W), decreasing the size of the onboard battery required to power the prosthesis.
Kumbuloglu, Ovul; Özcan, Mutlu
2015-06-01
This prospective clinical study evaluated the performance of indirect, anterior, surface-retained, fibre-reinforced-composite restorations (ISFRCR). Between June-2003 and January-2011, a total of 134 patients (83 females, 51 males, 16-68 years old) received 175 ISFRCRs (local ethical registration number: 14/9/4). All restorations were made indirectly on a plaster model using unidirectional E-glass fibres (everStick C&B, StickTech) in combination with a laboratory resin composite (Dialogue, Schütz Dental) and cemented according to the instructions of 4 resin cements [(RelyX ARC, 3M-ESPE, n=61), Bifix DC, VOCO, n=45), Variolink II (Ivoclar Vivadent, n=32) and Multilink (Ivoclar Vivadent, n=37)]. After baseline recordings, patients were followed at 6 months and thereafter annually up to 7.5 years. The evaluation protocol involved technical (chipping, debonding or fracture of tooth/restoration) and biological failures (caries). Mean observation period was 58 months. Altogether, 13 failures were observed [survival rate: 97.7%] (Kaplan-Meier). One catastrophic fracture [(cement: RelyX ARC), eight partial debonding (cement: Bifix DC (5), Multilink (1), RelyX ARC (1), Variolink II (1)] and four delaminations of veneering composite [(cement: Bifix DC (2), RelyX ARC (1), Multilink (1)] were observed. Except one replacement, all defective restorations were repaired or recemented. Annual failure rate of ISFRCRs was 1.73%. The survival rates with the four resin cements did not show significant differences (RelyX ARC: 98.3%; Bifix DC: 93.5%; Variolink 2: 100%; Multilink: 100%) (p=0.114). Secondary caries did not occur in any of the teeth. The 3-unit anterior indirect surface-retained resin-bonded FRC FDPs showed similar clinical survival rate when cemented with the resin cements tested. Experienced failures in general were due to debonding of the restoration or delamination of the veneering composite. 3-unit surface retained resin-bonded FRC FDPs could be considered minimal invasive and cost-effective alternatives to conventional tooth- or implant-borne FDPs. Failures were mainly repairable in the form of chipping or debonding depending on the resin cement type. Copyright © 2015 Elsevier Ltd. All rights reserved.
Is reverse hybrid hip replacement the solution?
Lindalen, Einar; Havelin, Leif I; Nordsletten, Lars; Dybvik, Eva; Fenstad, Anne M; Hallan, Geir; Furnes, Ove; Høvik, Oystein; Röhrl, Stephan M
2011-12-01
Reverse hybrid hip replacement uses a cemented all-polyethylene cup and an uncemented stem. Despite increasing use of this method in Scandinavia, there has been very little documentation of results. We have therefore analyzed the results from the Norwegian Arthroplasty Register (NAR), with up to 10 years of follow-up. The NAR has been collecting data on total hip replacement (THR) since 1987. Reverse hybrid hip replacements were used mainly from 2000. We extracted data on reverse hybrid THR from this year onward until December 31, 2009, and compared the results with those from cemented implants over the same period. Specific cup/stem combinations involving 100 cases or more were selected. In addition, only combinations that were taken into use in 2005 or earlier were included. 3,963 operations in 3,630 patients were included. We used the Kaplan-Meier method and Cox regression analysis for estimation of prosthesis survival and relative risk of revision. The main endpoint was revision for any cause, but we also performed specific analyses on different reasons for revision. We found equal survival to that from cemented THR at 5 years (cemented: 97.0% (95% CI: 96.8-97.2); reverse hybrid: 96.7% (96.0-97.4)) and at 7 years (cemented: 96.0% (95.7-96.2); reverse hybrid: 95.6% (94.4-96.7)). Adjusted relative risk of revision of the reverse hybrids was 1.1 (0.9-1.4). In patients under 60 years of age, we found similar survival of the 2 groups at 5 and 7 years, with an adjusted relative risk of revision of reverse hybrids of 0.9 (0.6-1.3) compared to cemented implants. With a follow-up of up to 10 years, reverse hybrid THRs performed well, and similarly to all-cemented THRs from the same time period. The reverse hybrid method might therefore be an alternative to all-cemented THR. Longer follow-up time is needed to evaluate whether reverse hybrid hip replacement has any advantages over all-cemented THR.
Analysis of Femoral Components of Cemented Total Hip Arthroplasty
NASA Astrophysics Data System (ADS)
Singh, Shantanu; Harsha, A. P.
2016-10-01
There have been continuous on-going revisions in design of prosthesis in Total Hip Arthroplasty (THA) to improve the endurance of hip replacement. In the present work, Finite Element Analysis was performed on cemented THA with CoCrMo trapezoidal, CoCrMo circular, Ti6Al4V trapezoidal and Ti6Al4V circular stem. It was observed that cross section and material of femoral stem proved to be critical parameters for stress distribution in femoral components, distribution of interfacial stress and micro movements. In the first part of analysis, designs were investigated for micro movements and stress developed, for different stem materials. Later part of the analysis focused on investigations with respect to different stem cross sections. Femoral stem made of Titanium alloy (Ti6Al4V) resulted in larger debonding of stem at cement-stem interface and increased stress within the cement mantle in contrast to chromium alloy (CoCrMo) stem. Thus, CoCrMo proved to be a better choice for cemented THA. Comparison between CoCrMo femoral stem of trapezium and circular cross section showed that trapezoidal stem experiences lesser sliding and debonding at interfaces than circular cross section stem. Also, trapezium cross section generated lower peak stress in femoral stem and cortical femur. In present study, femur head with diameter of 36 mm was considered for the analysis in order to avoid dislocation of the stem. Also, metallic femur head was coupled with cross linked polyethylene liner as it experiences negligible wear compared to conventional polyethylene liner and unlike metallic liner it is non carcinogenic.
Potential biomedical applications of ion beam technology
NASA Technical Reports Server (NTRS)
Banks, B. A.; Weigand, A. J.; Babbush, C. A.; Vankampen, C. L.
1976-01-01
Electron bombardment ion thrusters used as ion sources have demonstrated a unique capability to vary the surface morphology of surgical implant materials. The microscopically rough surface texture produced by ion beam sputtering of these materials may result in improvements in the biological response and/or performance of implanted devices. Control of surface roughness may result in improved attachment of the implant to soft tissue, hard tissue, bone cement, or components deposited from blood. Potential biomedical applications of ion beam texturing discussed include: vascular prostheses, artificial heart pump diaphragms, pacemaker fixation, percutaneous connectors, orthopedic pros-thesis fixtion, and dental implants.
Potential biomedical applications of ion beam technology
NASA Technical Reports Server (NTRS)
Banks, B. A.; Weigand, A. J.; Van Kampen, C. L.; Babbush, C. A.
1976-01-01
Electron bombardment ion thrusters used as ion sources have demonstrated a unique capability to vary the surface morphology of surgical implant materials. The microscopically rough surface texture produced by ion beam sputtering of these materials may result in improvements in the biological response and/or performance of implanted devices. Control of surface roughness may result in improved attachment of the implant to soft tissue, hard tissue, bone cement, or components deposited from blood. Potential biomedical applications of ion beam texturing discussed include: vascular prostheses, artificial heart pump diaphragms, pacemaker fixation, percutaneous connectors, orthopedic prosthesis fixation, and dental implants.
Residence times of reef-island sediments constrained by post-mortem precipitates
NASA Astrophysics Data System (ADS)
Mann, Thomas; Wizemann, André; Kench, Paul; Jompa, Jamaluddin; Westphal, Hildegard
2017-04-01
The precipitation of carbonate cements is a rapid process in tropical marine environments. Distinct from calcification, the onset of cementation coincides with the termination of 14C uptake within carbonate-sediment forming organisms. Here we show that this relationship presents new opportunities for examining the temporal lag between organism death and deposition in carbonate systems - the prerequisite for reliable depositional chronologies. We dated skeletal constituents collected from discretely stratified reef-island deposits in Indonesia. In each of the strata, internally least cemented segments of the calcifying green alga Halimeda yield the youngest ages. Complementary mesocosm experiments on cementation rates reveal that post-mortem cement growth initiates within months after transport commences. Continuous pore-filling cementation promptly stabilizes the initially fragile Halimeda skeleton. Furthermore, abrasion experiments show that such cementation significantly increases the durability of segments during transport. Implications of these findings are profound in two respects; first, evaluating residence times of skeletal carbonate constituents based on abrasion features is far from being adequate. Second, the absence of cements within sedimentary Halimeda segments signals that post-mortem transport through the intertidal zone occurred quasi-instantaneously. Radiometric ages from such specimens should minimize the temporal lag between organism death and deposition thus making them reliable indicators of sedimentation in supratidal environments.
Haen, T X; Lonjon, G; Vandenbussche, E
2015-12-01
Cemented versions of dual-mobility cups (DMCs), helpful in cases of bone stock alteration, are usually used in association with a reinforcement device. To simplify the intervention in elderly subjects or those with a poor bone stock, the cups can be cemented directly into the bone, but the long-term result remains uncertain. We conducted a retrospective study in this population so as to: (1) assess whether cemented fixation of a DMC without a reinforcement device leads to a higher loosening rate, (2) confirm its efficacy in preventing dislocations in subjects at high risk of instability, and (3) measure the functional results. Cemented fixation of a DMC is reliable in cases of moderate alteration of bone stock. Sixty-four patients (66 hips) undergoing implantation of a cemented DMC (Saturne™) without a reinforcement device were included in this single-center retrospective study. Their mean age was 79.8 years (range, 40-95 years). The indications varied: hip osteoarthritis (30.3%), prosthesis revision (44.0%), and trauma (25.8%). The patients were evaluated radiologically and clinically at follow-up. The main evaluation criterion was the revision rate for aseptic loosening. Dislocations, the infection rate, and the Postel Merle d'Aubigné (PMA) score were noted. At the mean follow-up of 4.2 years, three (4.6%) patients had been lost to follow-up and 22 (33.3%) had died. There was one case of aseptic loosening (1.5%). Cup survival was 98% at 5 years (95%CI [94-100]). There were no dislocations. There was one revision for infection. The mean PMA score was 15.5 (range, 9-18). The frequency of acetabular loosening was comparable to the frequency in cemented DMCs with a reinforcement device. A cemented DMC without a reinforcement device is possible and is a simple and viable option when there is moderate bone stock alteration. IV, retrospective cohort study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.
Al Moaleem, Mohammed M; Alkhayrat, Faisal M; Madkhali, Hussam A; Geathy, Ibrahim H; Qahhar, Mohammed Aw; Yaqoub, Ahmed; Mattoo, Khurshid A
2017-02-01
Esthetic perceptions could differ between the dentist and his patients among various regions and cultures. The aims of this study were to evaluate the subjective differences between the dentist and the patient in terms of esthetics of metal-ceramic crowns (MCcs). The study also aims to compare the mesiodistal (MD) and buccolingual (BL) dimensions of the cemented crown with its respective natural antimeric tooth. A total of 85 patients seeking treatment for a single crown (MC) were treated by the undergraduate students under supervision of respective academic staff. After cementation of the crowns, a 9-point questionnaire was given to patient and different dentists. A treatment cast for every single crown was poured. Then, the MD and BL dimensions of the crowns were compared against their respective antimeric tooth. The dentists and the patients agreed in the range of 50.5 to 90.5%. Least subjective differences were found for the length and width of the cemented crowns. The highest differences were noted for symmetry between the cemented crown and its antimeric natural tooth. A total of 31 to 38% of the patients differed from the dentist's evaluation for shade of the crown, color of the crown at the margin, contour of the crown, and the relationship of the crowns with the surrounding gingiva. The highest MD and BL dimensions were in the cemented crown of canines, while the lowest MD and BL diameters were for the cemented crowns of the lateral incisor crowns. Dentist and patient mostly agreed in terms of length (90%), width (81%) and relation of crown with free gingiva (74%). However, they differed mostly on the symmetry of the cemented crowns. The highest MD dimensions and BL diameter were in the cemented MCcs of canine, while the lowest were with lateral incisors. While fabricating a dental prosthesis, the dentist must know about patients' perception of esthetics; otherwise both clinical and laboratory efforts would not be enough to satisfy the esthetic needs of the patient even if the restoration is technically correct. Perceptions related to symmetry differ mostly between dentist and patient.
The Measurement Of Total Joint Loosening By X-Ray Photogrammetry
NASA Astrophysics Data System (ADS)
Lippert, Frederick G.; Veress, Sandor A.; Tiwari, Rama S.; Harrington, Richard M.
1980-07-01
Failure of total joint replacement due to loosening of the composents either between the implant and cement or between the cement and bone is emerging as a late complication with an incidence as high as 20 percent. Loosening may not only cause pain but progressive loss of support for the prosthesis with eventual structural failure. Early diagnosis is important so that revision may be carried when deterioration or pain occurs. No method is currently available which clearly establishes loosening at an early stage except surgical exploration. We have devised a method based on our in vivo photogrammetry studies of patellar tracking patterns using metallic markers placed in bone near both components of the total joint. Stereo x-rays taken with the joint loaded and unloaded are measured for relative motion between the implant and the metallic markers. Laboratory studies using prosthetic hip components mounted in plastic bone have revealed the ability of this method to detect pistoning movements as small as 80 microns. These findings were confirmed by physical measurements.
Ghonim, Mohamed; Shabana, Yousef; Ashraf, Bassem; Salem, Mohamed
2017-04-01
To discuss the different modalities for managing necrosis of the long process of the incus in revision stapedectomy on the basis of the degree of necrosis and compare the results with those reported in the literature. Thirty-six patients underwent revision stapedectomy with the necrosis of the long process of the incus from 2009 to 2016. The patients were divided into three groups on the basis of the degree of necrosis. For group A (minimal necrosis), augmentation technique with bone cement was performed. For group B (partial necrosis), the cement plug technique was performed. For group C (sever necrosis), malleus relocation with malleovestibulopexy was performed using reshaped necrosed incus. Air and bone conduction thresholds at frequencies of 500-3000 Hz were reviewed pre- and postoperatively using conventional audiometry. The air-bone gap (ABG) and bone conduction thresholds were measured. Postoperative ABG was reduced to <10 dB in 28 cases (77.8%) and <20 dB in all cases (100%). There was no significant change in postoperative bone conduction thresholds. The mean patient follow-up duration was 23 (range, 18-36) months. The cement plug technique was used in 75% of cases. Managing necrosis of the long process of the incus in revision stapedectomy should be considered according to the degree of necrosis. The cement plug technique is considered to be a reasonable option in most cases. Malleus relocation with malleovestibulopexy is an effective alternative to prosthesis.
A new silica-infiltrated Y-TZP obtained by the sol-gel method.
Campos, T M B; Ramos, N C; Machado, J P B; Bottino, M A; Souza, R O A; Melo, R M
2016-05-01
The aim of this study was to evaluate silica infiltration into dental zirconia (VITA In-Ceram 2000 YZ, Vita Zahnfabrik) and its effects on zirconia's surface characteristics, structural homogeneity and bonding to a resin cement. Infiltration was performed by immersion of the pre-sintered zirconia specimens in silica sols for five days (ZIn). Negative (pure zirconia specimens, ZCon-) and positive controls (specimens kept in water for 5 days, ZCon+) were also performed. After sintering, the groups were evaluated by X-ray diffraction (XRD), grazing angle X-ray diffraction (DRXR), scanning electron microscopy (SEM), contact angle measurements, optical profilometry, biaxial flexural test and shear bonding test. Weibull analysis was used to determine the Weibull modulus (m) and characteristic strength (σ0) of all groups. There were no major changes in strength for the infiltrated group, and homogeneity (m) was also increased. A layer of ZrSiO4 was formed on the surface. The bond strength to resin cement was improved after zirconia infiltration, acid conditioning and the use of an MDP primer. The sol-gel method is an efficient and simple method to increase the homogeneity of zirconia. Infiltration also improved bonding to resin cement. The performance of a zirconia infiltrated by silica gel improved in at least two ways: structural homogeneity and bonding to resin cement. The infiltration is simple to perform and can be easily managed in a prosthesis laboratory. Copyright © 2016 Elsevier Ltd. All rights reserved.
Kim, Wanlim; Yoon, Pil Whan; Kwak, Hong Suk; Yoo, Jeong Joon; Kim, Hee Joong; Yoon, Kang Sup
2017-07-01
The high failure rate of cemented femoral components in the 1970s facilitated the improvement of the cementing technique and surface finishes such as polymethylmethacrylate (PMMA)-precoated stems, reporting a survival rate of >95% at 10 years from some studies. However, controversy persists regarding whether precoated femoral stems are associated with a longer revision-free prosthesis survival. The purpose of this study was to evaluate the clinical and radiological outcomes of PMMA-precoated femoral stems, and analyze factors associated with implant survival. We retrospectively reviewed 73 primary hybrid total hip arthroplasties performed using PMMA-precoated femoral stems. The mean age of the patients was 61 years. During the mean follow-up period of 13 years, 18 hips (24.7%) underwent aseptic loosening, and all of the loosened stems were subjected to revision surgery 8.8 years (range 4.6-15.5 years) from the index surgery. Younger age and poor cementing were significantly associated with aseptic loosening (P = 0.013 and P < 0.001, respectively). However, the aseptic loosening rate was also high at 13.1% even with a good cementing technique. In conclusion, the PMMA-precoated stem failed to show expected advantages and needs to be replaced with other surface finish stem designs. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1300-1306, 2017. © 2016 Wiley Periodicals, Inc.
Rismanchian, Mansour; Davoudi, Amin; Shadmehr, Elham
2015-01-01
Connecting prostheses to the implant abutments has become a concern and achieving a satisfactory retention has been focused in cement-retention prostheses recently. Sandblasting is a method to make a roughened surface for providing more retention. The aim of this study was to compare effects of nano and micro airborne abrasive particles (ABAP) in roughening surface of implant abutments and further retention of cemented copings. Thirty Xive abutments and analogues (4.5 D GH1) were mounted vertically in self-cured acrylic blocks. Full metal Ni-Cr copings with a loop on the top were fabricated with appropriate marginal adaptation for each abutment. All samples were divided into 3 groups: first group (MPS) was sandblasted with 50 µm Al2O3 micro ABAP, second group (NSP) was sandblasted with 80 nm Al2O3 nano ABAP, and the third group (C) was assumed as control. The samples were cemented with provisional cement (Temp Bond) and tensile bond strength of cemented copings was evaluated by a universal testing machine after thermic cycling. The t test for independent samples was used for statistical analysis by SPSS software (version 15) at the significant level of 0.05. Final result showed significant difference among all groups (p<0.001) and MPS manifested the highest mean retention (207.88 ± 45.61 N) with significant difference among other groups (p<0.001). The control group showed the lowest bond strength as predicted (48.95 ± 10.44 N). Using nano or micro ABAP is an efficient way for increasing bond strengths significantly, but it seems that micro ABAP was more effective.
Ito, Yuki; Okawa, Takahisa; Fukumoto, Takahiro; Tsurumi, Akiko; Tatsuta, Mitsuhiro; Fujii, Takamasa; Tanaka, Junko; Tanaka, Masahiro
2016-10-01
Zirconia exhibits excellent strength and high biocompatibility in technological applications and it is has therefore been investigated for clinical applications and research. Before setting prostheses, a crown prosthesis inner surface is sandblasted with alumina to remove contaminants and form small cavities. This alumina sandblasting causes stress-induced phase transition of zirconia. Atmospheric-pressure low-temperature plasma has been applied in the dental industry, particularly for adhesives, as a surface treatment to activate the surface energy and remove contaminants. The purpose of this study was to examine the influence of atmospheric-pressure low-temperature plasma treatment on the shear bond strength between zirconia and adhesive resin cement. The surface treatment method was classified into three groups: untreated (Cont group), alumina sandblast treatment (Sb group), and atmospheric-pressure low-temperature plasma treatment (Ps group). Adhesive resin cement was applied to stainless steel and bonded to zirconia. Shear adhesion tests were performed after complete hardening of the cement. Multiple comparisons were performed using a one-way analysis of variance and the Bonferroni method. X-ray diffractometry was used to examine the change in zirconia crystal structure. Statistically significant differences were noted between the control and Sb groups and between the control and Ps groups. In contrast, no statistically significant differences were noted for the Ps and Sb bond strength. Atmospheric-pressure low-temperature plasma treatment did not affect the zirconia crystal structure. Atmospheric-pressure low-temperature plasma treatment improves the bonding strength of adhesive resin cement as effectively as alumina sandblasting, and does not alter the zirconia crystal structure. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.
Primary cement spacers: a cost-effective, durable limb salvage option for knee tumors.
Puri, Ajay; Gulia, Ashish; Pruthi, Manish; Koushik, S
2012-08-01
Of a total of 818 limb sparing resections in the lower limb requiring reconstruction between December 2002 and April 2010 at our centre, primary cement spacers were used in 15 cases. In three cases they were used as joint sparing intercalary reconstructions and in 12 cases knee arthrodesis was done. Implants used to provide stability to the construct included stacked intramedullary Kuntscher nails in four, an interlocking nail in one, plates in two and a combination of nail with plate in eight. Mean length of bone resected was 18 cm. Mean follow-up was 26 months (10-87 months). There were no local recurrences and none of the spacers needed revision for mechanical failure. The Musculoskeletal Tumor Society score for patients ranged from 20 to 29 with a mean of 24 (80%). Patients with intercalary resection had better functional scores than those with arthrodesis. The construct was successfully revised to a vascularised fibula arthrodesis or prosthesis with good eventual function in three cases. Cement spacers are a suitable cost-effective, durable reconstruction modality in selected patients with good functional outcomes. They are an option to amputation in patients with financial constraints and those that present with large volume or infected fungating tumors. Copyright © 2011 Elsevier B.V. All rights reserved.
Beaupre, Lauren A; Stampe, Kyle; Masson, Edward; O'Connor, Gregory; Clark, Marcia; Joffe, A Mark; Boychuk, Lesia R; Lavoie, Guy
2017-01-01
The study purpose was to (1) evaluate health-related quality of life (HRQL) with the PROSthesis of Antibiotic Loaded Acrylic Cement (PROSTALAC) in situ for infected total hip arthroplasty (THA), (2) determine infection resolution, and (3) compare subjects who underwent second stage surgery with those who retained the PROSTALAC on a longer term basis. Demographics, physical demand level, and comorbidities were recorded prospectively in 29 subjects followed to at least 24 months after initial PROSTALAC insertion. HRQL was evaluated using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and RAND 36-Item Health Survey. Infection resolution was determined using a pre-specified clinical definition. Twenty-five of 29 (86%) subjects' infections resolved. Three subjects died, of whom two had resolved infections. For survivors, 22/26 (85%) completed HRQL evaluations. After PROSTALAC insertion, pain and function improved within 3-6 months and was retained at 24 months. Of those followed to 24 months, 7/22 (32%) subjects underwent second stage surgery. They were higher physical demand subjects ( p = 0.03) than those not undergoing second stage surgery. We found no difference in WOMAC scores at 24 months between those who underwent second stage surgery and those who retained the PROSTALAC ( p > 0.32). The PROSTALAC system for THA appears to allow acceptable HRQL while in situ for at least 2 years in low physical demand patients. Subjects with higher physical demand levels are more likely to undergo second stage surgery. Further evaluation is required to determine whether longer term PROSTALAC retention may be appropriate for specific patient groups.
Code of Federal Regulations, 2012 CFR
2012-04-01
... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...
Code of Federal Regulations, 2011 CFR
2011-04-01
... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...
Code of Federal Regulations, 2014 CFR
2014-04-01
... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...
Code of Federal Regulations, 2013 CFR
2013-04-01
... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...
[Revision hip arthroplasty by Waldemar Link custom-made total hip prosthesis].
Medenica, Ivica; Luković, Milan; Radoicić, Dragan
2010-02-01
The number of patients undergoing hip arthroplasty revision is constantly growing. Especially, complex problem is extensive loss of bone stock and pelvic discontinuity that requires reconstruction. The paper presented a 50-year old patient, who ten years ago underwent a total cement artrhroplasty of the left hip. A year after the primary operation the patient had difficulties in walking without crutches. Problems intensified in the last five years, the patient had severe pain, totally limited movement in the left hip and could not walk at all. Radiographically, we found loose femoral component, massive loss of bone stock of proximal femur, acetabular protrusion and a consequent pelvic discontinuity. Clinically, a completely disfunctional left hip joint was registered (Harris hip score--7.1). We performed total rearthroplasty by a custom-made Waldemar Link total hip prosthesis with acetabular antiprotrusio cage and compensation of bone defects with a graft from the bone bank. A year after the operation, we found clinically an extreme improvement in Harris hip score--87.8. Radiographically, we found stability of implanted components, a complete graft integration and bone bridging across the site of pelvic discontinuity. Pelvic discontinuity and massive loss of proximal femoral bone stock is a challenging and complex entity. Conventional prostheses cannot provide an adequate fixation and stability of the hip. Application of custom-made prosthesis (measured specificaly for a patient) and additional alografting bone defects is a good method in revision surgery after unsuccessful hip arthroplasty with extensive bone defects.
[Gluteal compartment syndrome after total hip replacement. A presentation of two cases].
Villalba, J; Solernou, X
2013-01-01
Many postoperative complications have been described after a total hip arthroplasty, with early and acute, as well as late, complications being reported. Two cases of compartment syndrome of the buttock are described following a hybrid total hip arthroplasty (cemented stem and press-fit and screwed acetabulum) performed on 2 patients of 60 and 68 years old, both diagnosed and treated 24-48 hours after the surgery. Both cases had a primary prosthesis with no previous significant pathological findings. This condition is still rare, and few cases have been described at the medical literature. Copyright © 2012 SECOT. Published by Elsevier Espana. All rights reserved.
Reverse hybrid total hip arthroplasty.
Wangen, Helge; Havelin, Leif I; Fenstad, Anne M; Hallan, Geir; Furnes, Ove; Pedersen, Alma B; Overgaard, Søren; Kärrholm, Johan; Garellick, Göran; Mäkelä, Keijo; Eskelinen, Antti; Nordsletten, Lars
2017-06-01
Background and purpose - The use of a cemented cup together with an uncemented stem in total hip arthroplasty (THA) has become popular in Norway and Sweden during the last decade. The results of this prosthetic concept, reverse hybrid THA, have been sparsely described. The Nordic Arthroplasty Register Association (NARA) has already published 2 papers describing results of reverse hybrid THAs in different age groups. Based on data collected over 2 additional years, we wanted to perform in depth analyses of not only the reverse hybrid concept but also of the different cup/stem combinations used. Patients and methods - From the NARA, we extracted data on reverse hybrid THAs from January 1, 2000 until December 31, 2013. 38,415 such hips were studied and compared with cemented THAs. The Kaplan-Meier method and Cox regression analyses were used to estimate the prosthesis survival and the relative risk of revision. The main endpoint was revision for any reason. We also performed specific analyses regarding the different reasons for revision and analyses regarding the cup/stem combinations used in more than 500 cases. Results - We found a higher rate of revision for reverse hybrids than for cemented THAs, with an adjusted relative risk of revision (RR) of 1.4 (95% CI: 1.3-1.5). At 10 years, the survival rate was 94% (CI: 94-95) for cemented THAs and 92% (95% CI: 92-93) for reverse hybrids. The results for the reverse hybrid THAs were inferior to those for cemented THAs in patients aged 55 years or more (RR =1.1, CI: 1.0-1.3; p < 0.05). We found a higher rate of early revision due to periprosthetic femoral fracture for reverse hybrids than for cemented THAs in patients aged 55 years or more (RR =3.1, CI: 2.2-4.5; p < 0.001). Interpretation - Reverse hybrid THAs had a slightly higher rate of revision than cemented THAs in patients aged 55 or more. The difference in survival was mainly caused by a higher incidence of early revision due to periprosthetic femoral fracture in the reversed hybrid THAs.
Nanostructured Basaltfiberconcrete Exploitational Characteristics
NASA Astrophysics Data System (ADS)
Saraykina, K. A.; Shamanov, V. A.
2017-11-01
The article demonstrates that the mass use of basalt fiber concrete (BFC) is constrained by insufficient study of their durability and serviceability in a variety of environments. This research is aimed at the study of the basalt fiber corrosion processes in the cement stone of BFC, the control of the new products structure formation in order to protect the reinforcing fiber from alkaline destruction and thereby improve the exploitational characteristics of the composite. The research result revealed that the modification of basaltfiber concrete by the dispersion of MWNTs contributes to the directional formation of new products in the cement matrix. The HAM additive in basaltfiberconcrete provides for the binding of portlandite to low-basic calcium hydroaluminosilicates, thus reducing the aggressive effect of the cement environment on the reinforcing fibers properties. The complex modification of BFC with nanostructured additives provides for an increase in its durability and exploitational properties (strength, frost resistance and water resistance) due to basalt fiber protection from alkali corrosion on account of the compacting of the contact zone “basalt fiber - cement stone” and designing of the new products structure and morphology of cement matrix over the fiber surface.
Gungor, Harun Resit; Kiter, Esat; Akkaya, Semih; Ok, Nusret; Yorukoglu, Cagdas
2015-01-01
Following total knee arthroplasty (TKA), the most frequent cause of extension deficit and limitation of range of motion in early postoperative period is related to improper tensioning of soft tissues and failure to balance extension and flexion gaps. If a cruciate retaining (CR) prosthesis is the planned implant, then attention should be given to balancing the posterior cruciate ligament (PCL), and any factor that alters this balance may also cause deterioration of knee balance in postoperative period. Here, we report on an unusual case referred from another hospital because of continuous pain and restriction of knee motion in early postoperative period following CR-designed TKA that was initially thought to be due to flexion-extension imbalance. However, during the revision procedure, extruded cement to the intercondylar notch was found to be both mechanically blocking terminal extension and limiting flexion by possible mechanism of irritation of the synovial nerve endings around the stretched anterior fibers of PCL during flexion. This case was successfully treated by removal of extruded cement from intercondylar notch to decompress PCL, polyethylene exchange, and secondary patellar resurfacing. PMID:26185697
Havelin, Leif I; Robertsson, Otto; Fenstad, Anne M; Overgaard, Søren; Garellick, Göran; Furnes, Ove
2011-12-21
The Nordic (Scandinavian) countries have had working arthroplasty registers for several years. However, the small numbers of inhabitants and the conformity within each country with respect to preferred prosthesis brands and techniques have limited register research. A collaboration called NARA (Nordic Arthroplasty Register Association) was started in 2007, resulting in a common database for Denmark, Norway, and Sweden with regard to hip replacements in 2008 and primary knee replacements in 2009. Finland joined the project in 2010. A code set was defined for the parameters that all registers had in common, and data were re-coded, within each national register, according to the common definitions. After de-identification of the patients, the anonymous data were merged into a common database. The first study based on this common database included 280,201 hip arthroplasties and the second, 151,814 knee arthroplasties. Kaplan-Meier and Cox multiple regression analyses, with adjustment for age, sex, and diagnosis, were used to calculate prosthesis survival, with any revision as the end point. In later studies, specific reasons for revision were also used as end points. We found differences among the countries concerning patient demographics, preferred surgical approaches, fixation methods, and prosthesis brands. Prosthesis survival was best in Sweden, where cement implant fixation was used more commonly than it was in the other countries. As the comparison of national results was one of the main initial aims of this collaboration, only parameters and data that all three registers could deliver were included in the database. Compared with each separate register, this combined register resulted in reduced numbers of parameters and details. In future collaborations of registers with a focus on comparing the performances of prostheses and articulations, we should probably include only the data needed specifically for the predetermined purposes, from registers that can deliver these data, rather than compiling all data from all registers that are willing to participate.
Daentzer, Dorothea; Welke, Bastian; Hurschler, Christof; Husmann, Nathalie; Jansen, Christina; Flamme, Christian Heinrich; Richter, Berna Ida
2015-03-24
As an alternative technique to arthrodesis of the cervical spine, total disc replacement (TDR) has increasingly been used with the aim of restoration of the physiological function of the treated and adjacent motions segments. The purpose of this experimental study was to analyze the kinematics of the target level as well as of the adjacent segments, and to measure the pressures in the proximal and distal disc after arthrodesis as well as after arthroplasty with two different semi-constrained types of prosthesis. Twelve cadaveric ovine cervical spines underwent polysegmental (C2-5) multidirectional flexibility testing with a sensor-guided industrial serial robot. Additionally, pressures were recorded in the proximal and distal disc. The following three conditions were tested: (1) intact specimen, (2) single-level arthrodesis C3/4, (3) single-level TDR C3/4 using the Discover® in the first six specimens and the activ® C in the other six cadavers. Statistical analysis was performed for the total range of motion (ROM), the intervertebral ROM (iROM) and the intradiscal pressures (IDP) to compare both the three different conditions as well as the two disc prosthesis among each other. The relative iROM in the target level was always lowered after fusion in the three directions of motion. In almost all cases, the relative iROM of the adjacent segments was almost always higher compared to the physiologic condition. After arthroplasty, we found increased relative iROM in the treated level in comparison to intact state in almost all cases, with relative iROM in the adjacent segments observed to be lower in almost all situations. The IDP in both adjacent discs always increased in flexion and extension after arthrodesis. In all but five cases, the IDP in each of the adjacent level was decreased below the values of the intact specimens after TDR. Overall, in none of the analyzed parameters were statistically significantly differences between both types of prostheses investigated. The results of this biomechanical study indicate that single-level implantation of semi-constrained TDR lead to a certain hypermobility in the treated segments with lowering the ROM in the adjacent levels in almost all situations.
Does a simple syringe applicator enhance bone cement set up time in knee arthroplasty?
Sodhi, Nipun; Dalton, Sarah E.; Khlopas, Anton; Sultan, Assem A.; Curtis, Gannon L.; Harb, Matthew A.; Naziri, Qais; Barrington, John W.; Mont, Michael A.
2017-01-01
Background The time required for polymethylmethacrylate (PMMA) cement curing or hardening can be modified by a number of variables including the mixing technique, and the temperature and pressure at which the process is taking place. Therefore, the purpose of this study was to evaluate two different methods of PMMA application in terms of set up time. Specifically, we (I) compared the PMMA set up time of cement that remained in the mixing bowl to cement that was placed in a syringe and (II) extrapolated the associated annual cost difference on the national and individual surgeon levels. Methods The cement set up time was measured for a total of 146 consecutive patients who underwent either unicompartmental knee arthroplasty (n=136) or patellofemoral arthroplasty (n=10) between January 2016 and April 2017. One pack of PMMA powder and monomer were mixed, placed in a 300 mL small plastic bowl, and mixed with a tongue depressor. Then, 50 mL of the mixed PMMA was placed in a sterile 60 mL syringe with the tip cut to a 6-mm opening, and the syringe was used to apply the cement to the bone and the prosthesis surface. The remaining unused cement in the syringe (syringe group) and the remaining unused cement in the plastic bowl (bowl group) were removed and formed into a two separate 2 cm diameter cubes that were allowed to cure at room temperature on a sterile set of osteotomes. The two cubes of cement were timed for complete PMMA curing. A two-tailed student’s t-test was used to compare the curing time for the two groups. Annual cost differences were calculated on the national and individual surgeon level. The total number of daily cases performed and the operative time savings using the syringe applicator was used to find daily and annual cost savings. Results The mean time for the cement to set up in the bowl group was 16.8±2.1 minutes, and the mean time for cement set up in the syringe group was 15.1±1.7 minutes. Compared to the bowl group cement set up time, the syringe group set up time was significantly lower (P<0.0001). An estimated 350,000 cemented knee arthroplasties are performed each year in the United States. With 1.7 minutes saved per case, 595,000 operating room minutes per year could be saved, resulting in a nearly $71,000,000 national and $110,000 individual surgeon annual cost savings. Conclusions The results of the present study demonstrated that the utilization of a simple, inexpensive syringe applicator enhanced the cement set up time by over one and a half minutes. This may be a result of the pressure differences in the syringe applicator. In addition to the control of and precision of where the cement is placed, the syringe applicator could provide an important potential time advantage to the arthroplasty surgeon. PMID:29299472
Resin-bonded restorations: a strategy for managing anterior tooth loss in adolescence.
Zitzmann, Nicola U; Özcan, Mutlu; Scherrer, Susanne S; Bühler, Julia M; Weiger, Roland; Krastl, Gabriel
2015-04-01
In children or adolescents with anterior tooth loss, space closure with the patient's own teeth should be considered as the first choice to avoid lifelong restorative needs. Thorough diagnostics and treatment planning are required when autotransplantation or orthodontic space closure is considered. If these options are not indicated and a single tooth implant restoration is considered, implant placement should be postponed until adulthood, particularly in young women and in patients with hyperdivergent skeletal growth pattern. A ceramic resin-bonded fixed dental prosthesis with 1 retainer is an excellent treatment solution for the interim period; it may also serve as a long-term restoration, providing that sound enamel structure is present, sufficient framework dimensions have been provided, adhesive cementation techniques have been meticulously applied, and functional contacts of the cantilever pontic avoided. In contrast, a resin-bonded fixed dental prosthesis with a metal framework and retentive preparation is indicated if the palatal enamel structure is compromised, interocclusal clearance is limited, splinting (such as after orthodontic treatment) is required, or more than 1 tooth has to be replaced. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Unver, Bayram; Karatosun, Vasfi; Gunal, Izge; Angin, Salih
2004-02-01
Weight bearing after total hip arthroplasty is postponed in order to prevent early loosening, but this negatively affects the rehabilitation programme. For the force transfer characteristics of thrust plate prosthesis (TPP), a new type of hip prosthesis used without cement is similar to the normal hip. We evaluated the possibilities of early weight bearing after TPP by comparing early partial with early full weight bearing. Randomized controlled study. Department of orthopaedics and traumatology in a university hospital. Sixty hips of 51 patients who underwent total hip arthroplasty with TPP were randomly assigned into two groups. Both groups received accelerated rehabilitation programmes: group 1 with early partial weight bearing and group 2 with early full weight bearing. Patients were evaluated by a blind observer preoperatively, at three months after surgery by clinical (measurement of range of hip motion (universal goniometry), muscle strength (Manual Muscle Test), functional test (6-minute walk test), hip function (Harris Hip Scoring System)) and radiographical parameters and one year after surgery by clinical (Harris Hip Scoring System) and radiographical parameters. Group 2 performed transfer activities earlier, had more walking distance at the time of discharge and shorter hospital stay than group 1. At three months, Harris Hip Score, muscle strength, 6-minute walk test, and duration of crutch use were significantly (p < 0.05) in favour of group 2. None of the patients in either group showed signs of loosening one year after the operation. These results suggest that patients with TPP can tolerate an accelerated rehabilitation programme with early weight bearing and will gain the goals of rehabilitation earlier.
Suneel, Venkatesh B; Kotian, Santhosh; Jujare, Ravikanth H; Shetty, Adarsh K; Nidhi, Sneh; Grover, Shehkar
2017-09-01
Obstructive sleep apnea (OSA) is one of the common prevalent conditions present worldwide. The process of abnormal habits related to clenching and grinding of teeth is referred to as bruxism and is characterized under the heading of parafunctional activity of the masticatory system. Osseointegrated dental implants represent advancements in the field of odontology. Despite its high success rate, failure and complications are often associated with dental implant treatment due to a number of factors. Hence, we aimed for the present study to assess the incidence of prosthetic complications in patients rehabilitated with implant-borne prosthesis in a sleep disorder unit. The present study included the assessment of all the patients who underwent prosthetic rehabilitation by dental implants. An experienced registered prosthodontist was given duty for examination of all the cases from the record file data. Prosthetic complications in the patients were identified using photographs, radiographs, and all other relevant data of the patients obtained from the record files. All types of complications and other factors were recorded separately and analyzed. While correlating the prosthetic complications in OSA patients grouped based on number of dental implants, nonsignificant results were obtained. Significant correlation was observed while comparing the prosthetic complications divided based on type of prosthesis. Fracture of the porcelain was observed in four and eight cases respectively, of screwed and cemented dental implant cases. Some amount of significant correlation existed between the incidences of prosthetic complications and OSA. Proper history of the patients undergoing dental implant procedures should be taken to avoid failure.
Callaghan, John J; O'Rourke, Michael R; Goetz, Devon D; Lewallen, David G; Johnston, Richard C; Capello, William N
2004-12-01
Constrained acetabular components have been used to treat certain cases of intraoperative instability and postoperative dislocation after total hip arthroplasty. We report our experience with a tripolar constrained component used in these situations since 1988. The outcomes of the cases where this component was used were analyzed for component failure, component loosening, and osteolysis. At average 10-year followup, for cases treated for intraoperative instability (2 cases) or postoperative dislocation (4 cases), the component failure rate was 6% (6 of 101 hips in 5 patients). For cases where the constrained liner was cemented into a fixed cementless acetabular shell, the failure rate was 7% (2 of 31 hips in 2 patients) at 3.9-year average followup. Use of a constrained liner was not associated with an increased osteolysis or aseptic loosening rate. This tripolar constrained acetabular liner provided total hip arthroplasty construct stability in most cases in which it was used for intraoperative instability or postoperative dislocation.
Adaptive sports ankle prosthetics. Interview by Sarah A. Curran.
Lyle, David K
2012-09-01
Participating in sport at all levels is gaining a dedicated following and this is also apparent in individuals with an amputation. Currently, there is a wide variety of ankle prostheses available which attempt to provide function, control, and comfort, as well as good aesthetic appeal. Participation in sport, however, increases the demands placed upon ankle prostheses. This can compromise function and performance, and constrain the opportunities of participation in various outdoor and water sports. In acknowledging this limitation and the need to develop more versatile ankle prostheses, this article introduces the evolution of a prototype ankle prosthesis referred to as "Adaptive Sports Ankle." The ankle prosthesis, which is compatible with any foot pyramid adapter, offers the same range of motion as the normal human ankle joint and is made up of components that are chemical and corrosion resistant. These design features that are specifically created to accommodate below-the-knee amputees provide an ideal prosthesis for those wishing to lead an active lifestyle and participate in aquatic (i.e. swimming, surfing, and scuba diving), snowboarding, and equestrian activities. Although it is acknowledged that there is a need to establish research on the Adaptive Sports Ankle, its introduction to the market will enhance and expand opportunities of those individuals with a lower limb amputation to lead an active and healthy lifestyle.
Dual Mobility Cemented Cups Have Low Dislocation Rates in THA Revisions
Langlais, Frantz L.; Gaucher, François; Musset, Thierry; Chaix, Olivier
2008-01-01
THA revisions using standard cups are at risk of dislocation (5.1% to 14.4% incidence), especially in patients over 70 years of age. Constrained tripolar cups have reduced this risk (6% incidence) but are associated with substantial loosening rates (9%). The nonconstrained dual mobility cup was designed to improve prosthetic stability (polyethylene head ≥ 40 mm diameter) without increasing loosening rates by reducing wear and limiting impingement (rotation range of 108°). We implanted 88 cemented dual mobility cups for THA revisions in 82 patients at high risk of dislocation. Average patient age was 72 years (range, 65–86 years). Eighty-five of the 88 hips were reviewed at 2 to 5 years followup. One patient (1.1%) had a traumatic dislocation at 2 years postoperatively. Two patients (2.3%) had asymptomatic early loosening and three patients (3.5%) had localized radiographic lucencies. These results confirm those with press-fit dual mobility cups suggesting a low dislocation rate at 5 years and a cup survival of 94.6%. At middle term followup, cemented dual mobility cup achieved better results than constrained cups in cases at risk of dislocation and recurrent loosening. Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196422
Mason, James; Baker, Paul; Gregg, Paul J; Porter, Martyn; Deehan, David J; Reed, Mike R
2015-01-01
Background and purpose The optimal hip replacement for young patients remains unknown. We compared patient-reported outcome measures (PROMs), revision risk, and implant costs over a range of hip replacements. Methods We included hip replacements for osteoarthritis in patients under 60 years of age performed between 2003 and 2010 using the commonest brand of cemented, cementless, hybrid, or resurfacing prosthesis (11,622 women and 13,087 men). The reference implant comprised a cemented stem with a conventional polyethylene cemented cup and a standard-sized head (28- or 32-mm). Differences in implant survival were assessed using competing-risks models, adjusted for known prognostic influences. Analysis of covariance was used to assess improvement in PROMs (Oxford hip score (OHS) and EQ5D index) in 2014 linked procedures. Results In males, PROMs and implant survival were similar across all types of implants. In females, revision was statistically significantly higher in hard-bearing and/or small-stem cementless implants (hazard ratio (HR) = 4) and resurfacings (small head sizes (< 48 mm): HR = 6; large head sizes (≥ 48 mm): HR = 5) when compared to the reference cemented implant. In component combinations with equivalent survival, women reported significantly greater improvements in OHS with hybrid implants (22, p = 0.006) and cementless implants (21, p = 0.03) (reference, 18), but similar EQ5D index. For men and women, National Health Service (NHS) costs were lowest with the reference implant and highest with a hard-bearing cementless replacement. Interpretation In young women, hybrids offer a balance of good early functional improvement and low revision risk. Fully cementless and resurfacing components are more costly and do not provide any additional benefit for younger patients. PMID:25285617
Brand, Henk S; Kamell, Hassib; Kharbanda, Aron K; Dozic, Alma
2013-09-01
The aim of this study was to explore the materials and procedures used by students in dental schools across Europe for teaching fixed prosthodontics. An online questionnaire, containing twenty-eight dichotomous, multiple-choice, and Likert scale rating questions, was sent to students in forty dental schools. After excluding dental schools in which less than 10 percent of the students responded, 775 questionnaires from ten schools remained for statistical analysis. Among these respondents, acrylic resin teeth were said to be the most commonly used material during preclinical practice (46-96 percent), and use of extracted teeth varied from 8 to 65 percent. At nine of the ten institutions, metal-ceramic was reported to be most commonly used for fixed dental prostheses. There was large variation in the type of finish line for a metal-ceramic fixed dental prosthesis: students at five institutions reported using a shoulder finish line, three a chamfer finish line, and two a shoulder-bevel finish line. A similar variation was observed with regard to the final cementation of metal-ceramic fixed dental prostheses: students at four institutions reporting most frequently using glass ionomer cement, with three using zinc phosphate cement and three using carboxylate cement. The responding European dental students varied considerably in their opinions about whether they were preclinically properly trained for the first preparation on a patient and in their overall rating of their education in fixed prosthodontics. Responding students in the United Kingdom, Sweden, and Nijmegen, The Netherlands, rated their fixed prosthodontics training overall the highest. Overall, this study found a wide variation amongst dental schools with regard to their education in fixed prosthodontics and their rating of this teaching.
Jiang, Ling; Liu, Yan-Qing; Cui, Li-Gang; Meng, Ying; Tian, Hua; Zhang, Ke; Wang, Jin-Rui
2016-10-10
Objective To explore the feasibility and clinical value of ultrasonography in evaluating the morphology and function of medial collateral ligaments (MCL) after total knee arthroplasty (TKA). Methods Totally 38 patients undergoing routine KTA (group A) and 22 patients undergoing constrained condylar knee arthroplasty KTA with MCL injury (group B) were included. Long axis views of MCL were taken and the MCL thickness was measured on femur side and tibial side 1 cm away from the joint line, respectively. The thicknesses were compared between the two groups. Subsequently, the gap between the metal part of the femoral prosthesis and the spacer after dynamic valgus stress was measured. The distribution and composition of the gap between the two groups were compared. Results High-frequency ultrasound clearly showed the prosthesis and MCL after TKA. MCL fiber structures of both groups were intact. The MCL thickness on the tibial side in group B was (0.25±0.06)cm, which was significantly thinner than group A [(0.32±0.14)cm] (t=2.12, P=0.040).For the femur side, there was no significant difference (t=1.65, P=0.110) between these two groups [(0.37±0.09) cm in group B versus (0.42±0.12)cm in group A]. Under the condition of valgus stress, the gaps between the metal part of the femoral prosthesis and the spacer could be found in 11 cases in group B but only in 1 case in group A. The proportion of gaps in group B was significantly higher than that in group A (Fisher's exact test, P=0.000). Conclusions High-frequency ultrasound can clearly show the prosthesis and MCL after TKA. The injured MCL can be well joined but the thickness is thinner. Under the condition of valgus stress of the knee, the stability of the TKA can be evaluated according to the gap between the prosthesis and the spacer.
Revision Rates after Primary Hip and Knee Replacement in England between 2003 and 2006
Sibanda, Nokuthaba; Copley, Lynn P; Lewsey, Jim D; Borroff, Mick; Gregg, Paul; MacGregor, Alex J; Pickford, Martin; Porter, Martyn; Tucker, Keith; van der Meulen, Jan H
2008-01-01
Background Hip and knee replacement are some of the most frequently performed surgical procedures in the world. Resurfacing of the hip and unicondylar knee replacement are increasingly being used. There is relatively little evidence on their performance. To study performance of joint replacement in England, we investigated revision rates in the first 3 y after hip or knee replacement according to prosthesis type. Methods and Findings We linked records of the National Joint Registry for England and Wales and the Hospital Episode Statistics for patients with a primary hip or knee replacement in the National Health Service in England between April 2003 and September 2006. Hospital Episode Statistics records of succeeding admissions were used to identify revisions for any reason. 76,576 patients with a primary hip replacement and 80,697 with a primary knee replacement were included (51% of all primary hip and knee replacements done in the English National Health Service). In hip patients, 3-y revision rates were 0.9% (95% confidence interval [CI] 0.8%–1.1%) with cemented, 2.0% (1.7%–2.3%) with cementless, 1.5% (1.1%–2.0% CI) with “hybrid” prostheses, and 2.6% (2.1%–3.1%) with hip resurfacing (p < 0.0001). Revision rates after hip resurfacing were increased especially in women. In knee patients, 3-y revision rates were 1.4% (1.2%–1.5% CI) with cemented, 1.5% (1.1%–2.1% CI) with cementless, and 2.8% (1.8%–4.5% CI) with unicondylar prostheses (p < 0.0001). Revision rates after knee replacement strongly decreased with age. Interpretation Overall, about one in 75 patients needed a revision of their prosthesis within 3 y. On the basis of our data, consideration should be given to using hip resurfacing only in male patients and unicondylar knee replacement only in elderly patients. PMID:18767900
Messori, Andrea; Trippoli, Sabrina; Marinai, Claudio
2017-01-01
Objectives In most European countries, innovative medical devices are not managed according to cost–utility methods, the reason being that national agencies do not generally evaluate these products. The objective of our study was to investigate the cost-utility profile of prostheses for hip replacement and to calculate a value-based score to be used in the process of procurement and tendering for these devices. Methods The first phase of our study was aimed at retrieving the studies reporting the values of QALYs, direct cost, and net monetary benefit (NMB) from patients undergoing total hip arthroplasty (THA) with different brands of hip prosthesis. The second phase was aimed at calculating, on the basis of the results of cost–utility analysis, a tender score for each device (defined according to standard tendering equations and adapted to a 0–100 scale). This allowed us to determine the ranking of each device in the simulated tender. Results We identified a single study as the source of information for our analysis. Nine device brands (cemented, cementless, or hybrid) were evaluated. The cemented prosthesis Exeter V40/Elite Plus Ogee, the cementless device Taperloc/Exceed, and the hybrid device Exeter V40/Trident had the highest NMB (£152 877, £156 356, and £156 210, respectively) and the best value-based tender score. Conclusions The incorporation of value-based criteria in the procurement process can contribute to optimising the value for money for THA devices. According to the approach described herein, the acquisition of these devices does not necessarily converge on the product with the lowest cost; in fact, more costly devices should be preferred when their increased cost is offset by the monetary value of the increased clinical benefit. PMID:29259062
Bone Graft Substitute Provides Metaphyseal Fixation for a Stemless Humeral Implant.
Kim, Myung-Sun; Kovacevic, David; Milks, Ryan A; Jun, Bong-Jae; Rodriguez, Eric; DeLozier, Katherine R; Derwin, Kathleen A; Iannotti, Joseph P
2015-07-01
Stemless humeral fixation has become an alternative to traditional total shoulder arthroplasty, but metaphyseal fixation may be compromised by the quality of the trabecular bone that diminishes with age and disease, and augmentation of the fixation may be desirable. The authors hypothesized that a bone graft substitute (BGS) could achieve initial fixation comparable to polymethylmethacrylate (PMMA) bone cement. Fifteen fresh-frozen human male humerii were randomly implanted using a stemless humeral prosthesis, and metaphyseal fixation was augmented with either high-viscosity PMMA bone cement (PMMA group) or a magnesium-based injectable BGS (OsteoCrete; Bone Solutions Inc, Dallas, Texas) (OC group). Both groups were compared with a control group with no augmentation. Initial stiffness, failure load, failure displacement, failure cycle, and total work were compared among groups. The PMMA and OC groups showed markedly higher failure loads, failure displacements, and failure cycles than the control group (P<.01). There were no statistically significant differences in initial stiffness, failure load, failure displacement, failure cycle, or total work between the PMMA and OC groups. The biomechanical properties of magnesium-based BGS fixation compared favorably with PMMA bone cement in the fixation of stemless humeral prostheses and may provide sufficient initial fixation for this clinical application. Future work will investigate the long-term remodeling characteristics and bone quality at the prosthetic-bone interface in an in vivo model to evaluate the clinical efficacy of this approach. Copyright 2015, SLACK Incorporated.
Constraining the Texture and Composition of Pore-Filling Cements at Gale Crater, Mars
NASA Technical Reports Server (NTRS)
Siebach, K. L.; Grotzinger, J. P.; McLennan, S. M.; Hurowitz, J. A.; Ming, D. W.; Vaniman, D. T.; Rampe, E. B.; Blaney, D. L.; Kah, L. C.
2015-01-01
The Mars Science Laboratory (MSL) rover Curiosity has encountered a wide variety of sedimentary rocks deposited in fluvio-lacuestrine sequences at the base of Gale Crater. The presence of sedimentary rocks requires that initial sediments underwent diagenesis and were lithified. Lithification involves sediment compaction, cementation, and re-crystallization (or authigenic) processes. Analysis of the texture and composition of the cement can reveal the environmental conditions when the cements were deposited, enabling better understanding of early environments present within Gale Crater. The first step in lithification is sediment compaction. The Gale crater sediments do not show evidence for extensive compaction prior to cementation; the Sheepbed mudstone in Yellowknife Bay (YKB) has preserved void spaces ("hollow nodules"), indicating that sediments were cemented around the hollow prior to compaction, and conglomerates show imbrication, indicating minimal grain reorganization prior to lithification. Furthermore, assuming the maximum burial depth of these sediments is equivalent to the depth of Gale Crater, the sediments were never under more than 1 kb of pressure, and assuming a 15 C/km thermal gradient in the late Noachian, the maximum temperature of diagenesis would have been approximately 75 C. This is comparable to shallow burial diagenetic conditions on Earth. The cementation and recrystallization components of lithification are closely intertwined. Cementation describes the precipitation of minerals between grains from pore fluids, and recrystallization (or authigenesis) is when the original sedimentary mineral grains are altered into secondary minerals. The presence of authigenic smectites and magnetite in the YKB formation suggests that some recrystallization has taken place. The relatively high percentage of XRD-amorphous material (25-40%) detected by CheMin suggests that this recrystallization may be limited in scope, and therefore may not contribute significantly to the cementing material. However, relatively persistent amorphous components could exist in the Martian environment (e.g. amorphous MgSO4), so recrystallization, including loss of crystallinity, cannot yet be excluded as a method of cementation. In order to describe the rock cementation, both the rock textures and their composition must be considered. Here, we attempt to summarize the current understanding of the textural and compositional aspects of the cement across the rocks analyzed by Curiosity to this point.
NASA Astrophysics Data System (ADS)
Oldani, C. R.; Dominguez, A. A.
2007-11-01
In a previous work a finite elements model was constructed to simulate a fatigue assay according to the norm IRAM 9422-3. Three materials were studied, two of them are the most used in this type of implant (Stainless steel 3161 and alloy T16A14V) and the third was a new developed titanium alloy (Ti35Nb7Zr5Ta). Static loads were applied to the model according to the highest requirements of the norm and the stress - strain distribution were determined. In this study a simplified analysis of the material's fatigue was done according to the previous work. The best behavior of the titanium alloys vs. the stainless steel was evident. With the objective of studying the behavior of both: the implant and the femur bone, new finite elements models were realized, in which the presence of the bone was considered. Inside the bone, the femoral component of the implant was placed in a similar way of a cemented prosthesis in a total hip arthroplasty. The advantage of the titanium implant related to the stainless steel one, was very clear.
Experimental Study of Cement - Sandstone/Shale - Brine - CO2 Interactions
2011-01-01
Background Reactive-transport simulation is a tool that is being used to estimate long-term trapping of CO2, and wellbore and cap rock integrity for geologic CO2 storage. We reacted end member components of a heterolithic sandstone and shale unit that forms the upper section of the In Salah Gas Project carbon storage reservoir in Krechba, Algeria with supercritical CO2, brine, and with/without cement at reservoir conditions to develop experimentally constrained geochemical models for use in reactive transport simulations. Results We observe marked changes in solution composition when CO2 reacted with cement, sandstone, and shale components at reservoir conditions. The geochemical model for the reaction of sandstone and shale with CO2 and brine is a simple one in which albite, chlorite, illite and carbonate minerals partially dissolve and boehmite, smectite, and amorphous silica precipitate. The geochemical model for the wellbore environment is also fairly simple, in which alkaline cements and rock react with CO2-rich brines to form an Fe containing calcite, amorphous silica, smectite and boehmite or amorphous Al(OH)3. Conclusions Our research shows that relatively simple geochemical models can describe the dominant reactions that are likely to occur when CO2 is stored in deep saline aquifers sealed with overlying shale cap rocks, as well as the dominant reactions for cement carbonation at the wellbore interface. PMID:22078161
Bernthal, Nicholas M; Price, Shawn L; Monument, Michael J; Wilkinson, Brandon; Jones, Kevin B; Randall, R Lor
2015-11-01
Metastatic disease to the acetabulum presents a difficult technical and philosophical challenge: complicated surgeries in patients with often short life expectancies force us to examine both the outcome and cost of these operations. Therefore, we studied the durability of a cement-screw rebar reconstruction technique and risk factors for failure, and we compare the results to other reconstruction options. This is a retrospective review of 52 acetabular reconstructions in 50 patients for nonprimary disease using a retrograde screw-rebar-cement all-polyethylene technique. Mean age was 57 years (range 25-81 years). Twenty-four lesions were classified as Harrington class II; 28 were Harrington class III. Mean follow-up was 17.7 months (range 1-92 months). Outcomes included patient survival, prosthesis survival, and complications. Forty-eight of 50 (96 %) patients ambulated after surgery. Five of 52 (9.6 %) of prostheses failed, three from loosening due to tumor progression, one from aseptic loosening, and one from soft tissue instability (dislocation). The three cases of tumor progression failure occurred in patients with massive preoperative ischial tumor burden. Mean surgical time was 198 min, and hospital stay was 5.2 days. The screw-cement-rebar all-polyethylene cup reconstruction technique is a comparatively successful and inexpensive reconstruction option for treating nonprimary oncologic disease in the acetabulum. All cases of loosening occurred beyond the median patient survival. Surgeons should be wary of massive ischial tumor burden in patients with projected longevity, as it may be associated with implant failure. Surgical time and hospital stay are consistent with historical data for alternative implants, and implant cost is lower.
[Anterior bridges with the IPS-Empress-2 System after alveolar ridge augmentation. A case report].
Zawta, C; Bernhard, M
2000-01-01
The success of a prosthesis is judged according to optimal function, good chewing comfort, adequate phonetics and white and pink esthetics. The aim of a treatment is to approach the perfection of nature. For anterior bridgework, the all-ceramic System IPS Empress 2 offers light transmission and reflection comparable to that of natural teeth, provided that the pink esthetics are optimised in the preprosthetic phase. The provision of an anterior bridge in the IPS Empress 2-system is presented here in the form of a case report. After extraction of the anterior teeth, a ridge augmentation including preparation of the pontic bed was carried out. The type of post and core, preparation and cementation are important parameters for the success of all-ceramic restorations.
[Technology of cementless hip endoprosthetics].
Ungethüm, M; Blömer, W
1987-06-01
The success achieved with non-cemented hip arthroplasty depends mainly on the stability of the fixation, the quality of the stabilizing bone being just as important as favourable biomechanical conditions. The results of the intensive research and development with respect to the particular features of a non-cemented hip endoprosthesis can be divided into the following basic categories: Biomechanical aspects with special reference to bone related to the design of the prosthesis; material characteristics, such as fatigue strength, tribology, corrosion resistance, and biocompatibility; and development of new materials and coatings to permit direct bonding of implant and bone. With regard to the stem of hip prostheses, the different design parameters of various types are examined to determine their typical design characteristics, such as bearing surface of the collar, geometry of cross section, anatomically adapted shaping, and surface of the implant forming the contact with the bone. The latter can be divided into macroprofiles and macro- and micro-porous coated surfaces. On the other hand, the methods of cementless fixation of acetabular cups can be primarily divided into conical and spherical screw fixation and pegged fixation with additional macroprofiles of porous surfaces. In a separate study of the biomechanical aspects of screwed sockets, the special importance of socket shape and thread geometry are presented with reference to primary stability and long-term fixation of prostheses.
[Tumor prostheses : Important in modern revision arthroplasty].
Hillmann, A; Ipach, I
2015-05-01
Due to demographic aging, an increasing number of revision arthroplasty procedures is expected during upcoming years. While the use of a megaprosthesis for bone reconstruction after tumor resection is gold standard, this type of prosthesis still meets with reservation in the field of revision arthroplasty because of numerous risk factors. The purpose of this article is to present the importance of modular megaprostheses in revision arthroplasty, taking into consideration the risks of periprosthetic infection, aseptic loosening, material failure, and hip dislocation. Because of improvements in the field of megaprostheses during the last 30 years, the risks after implantation of this type of prosthesis have significantly decreased. The risk of periprosthetic infection has been reduced about 1/3 by the use of silver surface coating. Improvements in stem design, cement technique, and the additional use of locking screws have minimized the risk of aseptic loosening. Improvements in material composition have reduced the risk of material failure. The risk of hip dislocation could also be minimized by careful tissue preparation and appropriate suture technique. There is no need for the conservative use of megaprostheses in revision arthroplasty. There are many benefits in the use of megaprostheses in multimorbid patients (i.e., reduced operating time, the possibility of early full weight bearing, and a reduced risk of periprosthetic infection by the use of silver surface coating) instead of complex bone reconstruction during revision arthroplasty.
Quilez, María Paz; Seral, Belen; Pérez, María Angeles
2017-01-01
The best methods to manage tibial bone defects following total knee arthroplasty remain under debate. Different fixation systems exist to help surgeons reconstruct knee osseous bone loss (such as tantalum cones, cement, modular metal augments, autografts, allografts and porous metaphyseal sleeves) However, the effects of the various solutions on the long-term outcome remain unknown. In the present work, a bone remodeling mathematical model was used to predict bone remodeling after total knee arthroplasty (TKA) revision. Five different types of prostheses were analyzed: one with a straight stem; two with offset stems, with and without supplements; and two with sleeves, with and without stems. Alterations in tibia bone density distribution and implant Von Mises stresses were quantified. In all cases, the bone density decreased in the proximal epiphysis and medullary channels, and an increase in bone density was predicted in the diaphysis and around stem tips. The highest bone resorption was predicted for the offset prosthesis without the supplement, and the highest bone formation was computed for the straight stem. The highest Von Mises stress was obtained for the straight tibial stem, and the lowest was observed for the stemless metaphyseal sleeves prosthesis. The computational model predicted different behaviors among the five systems. We were able to demonstrate the importance of choosing an adequate revision system and that in silico models may help surgeons choose patient-specific treatments. PMID:28886100
Shahrbaf, Shirin; vanNoort, Richard; Mirzakouchaki, Behnam; Ghassemieh, Elaheh; Martin, Nicolas
2013-08-01
The effect of preparation design and the physical properties of the interface lute on the restored machined ceramic crown-tooth complex are poorly understood. The aim of this work was to determine, by means of three-dimensional finite element analysis (3D FEA) the effect of the tooth preparation design and the elastic modulus of the cement on the stress state of the cemented machined ceramic crown-tooth complex. The three-dimensional structure of human premolar teeth, restored with adhesively cemented machined ceramic crowns, was digitized with a micro-CT scanner. An accurate, high resolution, digital replica model of a restored tooth was created. Two preparation designs, with different occlusal morphologies, were modeled with cements of 3 different elastic moduli. Interactive medical image processing software (mimics and professional CAD modeling software) was used to create sophisticated digital models that included the supporting structures; periodontal ligament and alveolar bone. The generated models were imported into an FEA software program (hypermesh version 10.0, Altair Engineering Inc.) with all degrees of freedom constrained at the outer surface of the supporting cortical bone of the crown-tooth complex. Five different elastic moduli values were given to the adhesive cement interface 1.8GPa, 4GPa, 8GPa, 18.3GPa and 40GPa; the four lower values are representative of currently used cementing lutes and 40GPa is set as an extreme high value. The stress distribution under simulated applied loads was determined. The preparation design demonstrated an effect on the stress state of the restored tooth system. The cement elastic modulus affected the stress state in the cement and dentin structures but not in the crown, the pulp, the periodontal ligament or the cancellous and cortical bone. The results of this study suggest that both the choice of the preparation design and the cement elastic modulus can affect the stress state within the restored crown-tooth complex. Copyright © 2013 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
Comparative study of design and PCL-substituting systems of total knee prosthesis.
Adam, R; Orban, C; Orban, H
2014-01-01
The aim of this study is to assess postoperative results obtained by different knee implants. The main implant types differences are given by generally implant design and by PCL substituting systems that are used. Between 04.2004 - 02.2012 we have performed 506 total knee arthroplasties (TKA), on a group of 460 patients. Our choice, was for cemented total knee prostheses, using PCL-substituting systems. Regarding general design and PCL-substituting systems of the implant we had divided the main group in three lots. In order to assess post operative result we had used the American Knee Society Score(AKSS). All prostheses types that we had implanted, had registered satisfactory values of AKSS. Our study showed that one group scored higher values of AKSS, compared the other two, but there are not statistical semnificative differences (p=0,09). Celsius.
Konan, Sujith; Rayan, Faizal; Manketelow, Andrew R J; Haddad, Fares S
2011-12-01
Infected periprosthetic fractures around total hip arthroplasties are an extremely challenging problem. We describe our experience of managing infected periprosthetic femoral fractures using interlocking long-stem femoral prostheses either as temporary functional spacers or as definitive implants. The Cannulock (Orthodesign, Christchurch, United Kingdom) uncoated stem was used in 12 cases, and the Kent hip prosthesis (Biomet Merck, Bridgend, United Kingdom), in 5 cases. Satisfactory outcome was noted in all cases, and in 11 cases, revision to a definitive stem has been undertaken after successful control of infection and fracture union. The use of interlocking stems offers a relatively appealing solution for a complex problem and avoids the complications that would be associated with resection of the entire femur or the use of large quantities of bone cement. Copyright © 2011 Elsevier Inc. All rights reserved.
Image-Based Macro-Micro Finite Element Models of a Canine Femur with Implant Design Implications
NASA Astrophysics Data System (ADS)
Ghosh, Somnath; Krishnan, Ganapathi; Dyce, Jonathan
2006-06-01
In this paper, a comprehensive model of a bone-cement-implant assembly is developed for a canine cemented femoral prosthesis system. Various steps in this development entail profiling the canine femur contours by computed tomography (CT) scanning, computer aided design (CAD) reconstruction of the canine femur from CT images, CAD modeling of the implant from implant blue prints and CAD modeling of the interface cement. Finite element analysis of the macroscopic assembly is conducted for stress analysis in individual components of the system, accounting for variation in density and material properties in the porous bone material. A sensitivity analysis is conducted with the macroscopic model to investigate the effect of implant design variables on the stress distribution in the assembly. Subsequently, rigorous microstructural analysis of the bone incorporating the morphological intricacies is conducted. Various steps in this development include acquisition of the bone microstructural data from histological serial sectioning, stacking of sections to obtain 3D renderings of void distributions, microstructural characterization and determination of properties and, finally, microstructural stress analysis using a 3D Voronoi cell finite element method. Generation of the simulated microstructure and analysis by the 3D Voronoi cell finite element model provides a new way of modeling complex microstructures and correlating to morphological characteristics. An inverse calculation of the material parameters of bone by combining macroscopic experiments with microstructural characterization and analysis provides a new approach to evaluating properties without having to do experiments at this scale. Finally, the microstructural stresses in the femur are computed using the 3D VCFEM to study the stress distribution at the scale of the bone porosity. Significant difference is observed between the macroscopic stresses and the peak microscopic stresses at different locations.
Effect of Temperature on Film Thickness of Two Types of Commonly used Luting Cements.
Kumar, M Praveen; Priyadarshini, Reddy; Kumar, Yasangi M; Priya, K Shanthi; Chunchuvyshnavi, Chunchuvyshnavi; Yerrapragada, Harika
2017-12-01
The aim of this study is to evaluate the effect of temperature change on film thickness of both types of cements. Totally, 60 samples were prepared with 10 in each subgroup, thus comprising 30 in each group. Materials tested were glass ionomer cement (GIC) type I and zinc phosphate type I. Samples were manipulated with manufacturer's instructions and tested according to American Dental Association (ADA) guidelines. The mean values of film thickness were recorded for both groups I and II. In intragroup comparison of group 1, subgroup III (26.560 ± 0.489 urn) was found to have the highest film thickness followed by subgroup II (24.182 ± 0.576 urn) and the lowest in subgroup I (20.209 ± 0.493 urn). In intragroup comparison of group II, the film thickness recorded in subgroup III (25.215 ± 0.661 urn) was the highest followed by subgroup II (21.471 ± 0.771 urn) and the least in subgroup I (17.951 ± 0.654 urn; p < 0.01). In intergroup comparison of groups I and II, group II (21.545 ± 0.841) was found to have less film thickness than group I (23.650 ± 0.271). The results were found to be statistically significant (p < 0.01). Both zinc phosphate and GICs can be used satisfactorily for luting purpose. The temperature fluctuations have a direct influence on the film thickness. Zinc phosphate has less film thickness than GIC. Zinc phosphate should be preferred over GIC in clinical practice, and more stress should be given in mechanical preparation of crowns for better retentive quality of prosthesis.
Ramdev, Poojya; Shruthi, C S
2017-01-01
Introduction Yttria stabilised tetragonal zirconia opens new vistas for all ceramic restoration by the mechanism of transformation toughening, making it much stronger compared to all other ceramic materials. Currently, it is the most recent core material for all ceramic fixed partial dentures due to its ability to withstand high simulated masticatory loads. Problems which have been reported with zirconia restorations involve the core cement interface leading to loss of retention of the prosthesis. Different reasons which have been reported for the same include the lack of adhesion between zirconia and commonly used cements due to absence of silica phase which makes zirconia not etchable. In addition, the hydrophobic nature of zirconia causes low wettability of zirconia surface by the adhesive cements which are commonly used. Aim The purpose of this in vitro study was to compare and evaluate the effect of two pre-treatments of zirconia, using plasma of argon and silane, on the shear bond strength values of two composite resin cements to zirconia and to evaluate the failure pattern of the debonded areas using stereomicroscopic analysis. Materials and Methods Sixty zirconia discs (10 mm×2 mm) were randomly divided into three groups (n=20), following surface treatment, with airborne particle abrasion, using 110 µm Al2O3: Group I (control), Group II (plasma of argon cleaning), and Group III (application of silane primer). Each group had two subgroups based on the type of resin cement used for bonding: subgroup A; Rely X Ultimate (3M ESPE) and subgroup B; Panavia F (Kuraray). In subgroup A, Rely X universal silane primer and in subgroup B Clearfil ceramic primer was used. Shear bond strengths were determined after water storage for one day and thermocycling for 5000 cycles. Data (megapascal) were analyzed using ANOVA and Bonferroni test. Specimens were subjected to stereomicroscopic analysis, for evaluation of failure pattern. Results Group III produced the highest shear bond strength followed by Group II and Group I. Subgroup A showed higher shear bond strength than Subgroup B. Stereomicroscopic analysis showed cohesive failure in Group III, while in Group I adhesive failure was seen. Conclusion Silane primer application caused maximum increase in shear bond strength due to increased wettability. Argon plasma treatment was less effective in comparison to silane treatment. Air abrasion when used alone resulted in lower bond strength values, thereby making it necessary to use a combination of surface treatments. Rely X Ultimate cement was superior to Panavia F in terms of adhesive bonding to zirconia. PMID:28969271
Marx, B; Marx, R; Reisgen, U; Wirtz, D
2015-04-01
CoCrMo alloys are contraindicated for allergy sufferers. For these patients, uncemented and cemented prostheses made of titanium alloy are indicated. Knee prostheses machined from that alloy, however, may have poor tribological behaviour, especially in relation to UHMWPE inlays. Therefore, for knee replacement cemented high-strength oxide ceramic prostheses are suitable for allergy sufferers and in cases of particle-induced aseptic loosening. For adhesion of bone cement, the ceramic surface, however, only exposes inefficient mechanical retention spots as compared with a textured metal surface. Undercuts generated by corundum blasting which in the short-term are highly efficient on a CoCrMo surface are not possible on a ceramic surface due to the brittleness of ceramics. Textures due to blasting may initiate cracks which will weaken the strength of a ceramic prosthesis. Due to the lack of textures mechanical retention is poor or even not existent. Micromotions are promoted and early aseptic loosening is predictable. Instead silicoating of the ceramic surface will allow specific adhesion and result in better hydrolytic stability of bonding thereby preventing early aseptic loosening. Silicoating, however, presupposes a clean and chemically active surface which can be achieved by atmospheric plasma or thermal surface treatment. In order to evaluate the effectiveness of silicoating the bond strengths of atmospheric plasma versus thermal surface treated and silicate layered ZPTA surfaces were compared with "as-fired" surfaces by utilising TiAlV probes (diameter 6 mm) for traction-adhesive strength tests. After preparing samples for traction-adhesive strength tests (sequence: ceramic substrate, silicate and silane, protective lacquer [PolyMA], bone cement, TiAlV probe) they were aged for up to 150 days at 37 °C in Ringer's solution. The bond strengths observed for all ageing intervals were well above 20 MPa and much higher and more hydrolytically stable for silicate layered compared with "as-fired" ZPTA samples. Silicoating may be effective for achieving high initial bond strength of bone cement on surfaces of oxide ceramics and also suitable to stabilise bond strength under hydrolytic conditions as present in the human body in the long-term. Activation by atmospheric plasma or thermal surface treatment seems to be effective for activation prior to silicoating. Due the proposed silicate layer migration, micromotions and debonding should be widely reduced or even eliminated. Georg Thieme Verlag KG Stuttgart · New York.
Neoproterozoic marine carbonates and their paleoceanographic significance
NASA Astrophysics Data System (ADS)
Hood, Ashleigh van Smeerdijk; Wallace, Malcolm William
2018-01-01
The primary mineralogy of marine carbonate precipitates has been a crucial factor in constraining the major element composition of ancient oceans. Secular changes in Phanerozoic marine chemistry, including Mg/Ca, have been well-documented using the original carbonate mineralogy of ooids, marine cements and biominerals. However, the history of Precambrian seawater chemistry is not as well constrained, partially due to the prevalence of dolomitisation in the Precambrian geological record. The Neoproterozoic ( 1000 Ma to 541 Ma) record of primary carbonate mineralogy is documented here using a combination of literature data and new analysis of marine carbonate precipitates from the Otavi Fold Belt, Namibia, the Death Valley succession, USA and the Adelaide Fold Belt, Australia. These data suggest that the last 460 million years of the Proterozoic were dominated by aragonite and high-Mg calcite precipitation in shallow marine settings. In contrast, low-Mg calcite has only been recognised in a small number of formations. In addition to aragonite and calcite precipitation, marine dolomite precipitation was widespread in Neoproterozoic oceans, including mimetic (syn-sedimentary) dolomitisation and primary dolomite marine cementation. The combination of marine aragonite, high Mg-calcite and dolomite precipitation during the Neoproterozoic suggests extremely high seawater Mg/Ca conditions relative to Phanerozoic oceans. Marine dolomite precipitation may also be linked to widespread marine anoxia during this time.
Quantitative assessment of four men using above-elbow prosthetic control.
Popat, R A; Krebs, D E; Mansfield, J; Russell, D; Clancy, E; Gill-Body, K M; Hogan, N
1993-07-01
We studied the relationship between kinematically unconstrained activities of daily living (ADL) tasks and a kinematically constrained task in above-elbow (AE) amputee subjects using myoelectrically controlled prostheses. Four men, 24 to 49 years old, with unilateral AE amputation wore a prosthesis interfaced to a programmable controller to emulate two different elbow control schemes, conventional velocity and a new "natural" controller. Subjects were timed during three ADL tasks--cutting meat, donning socks, and rolling dough--with both controllers. The prosthesis emulator was then connected to a crank device with a handle, and the subjects turned the crank from bottom to top positions in a vertical plane using each controller. Synergistic shoulder-elbow joint coordination required for crank turning was quantified as the maximum slope of the change in elbow torque versus the change in crank-angle. Performance between the two controllers differed significantly for the crank test but not for ADL tasks. One subject did not complete all crank turning tests. Positive canonical correlation of 0.77 was found between time and crank domain measures. We conclude that biomechanical assessments should be integrated with time-based clinical tests to comprehensively evaluate performance of AE amputee subjects with a myoelectric device.
Hydroxyapatite clay for gap filling and adequate bone ingrowth.
Maruyama, M; Terayama, K; Ito, M; Takei, T; Kitagawa, E
1995-03-01
In uncemented total hip arthroplasty, a complete filling of the gap between femoral prosthesis and the host bone is difficult and defects would remain, because the anatomy of the reamed intramedullary canal cannot fit the prosthesis. Therefore, it seems practical to fill the gap with a clay containing hydroxyapatite (HA), which has an osteoconductive character. The clay (HA clay) is made by mixing HA granules (size 0.1 mm or more) having a homogeneous pore distribution and a porosity of 35-48 vol%, and a viscous substance such as a saline solution of sodium alginate (SSSA). In the first experiment, the ratio of HA granules and sodium alginate in SSSA is set for the same handling properties of HA clay and polymethylmethacrylate bone cement (standard viscosity) before hardening. As a result, the ratio is set for 55 wt% of HA in the clay and 12.5 wt% of sodium alginate in SSSA (i.e., HA:sodium alginate:saline solution = 9.8:1:7). In the second study, the gap between the femoral stem and bone model is completely filled with HA clay. However, the gap is not filled only with HA granules or HA granules mixed with saline solution. In the third animal experiment, using an unloaded model, histology shows that HA clay has an osteoconductive property bridging the gap between the implant and the cortical bone without any adverse reaction. HA clay is considered a useful biomaterial to fill the gap with adequate bone ingrowth.
Saisadan, D; Manimaran, P; Meenapriya, P K
2016-10-01
Materials used to fabricate provisional restorations can be classified as acrylics or resin composites. Provisional crows can be either prefabricated or custom made. These materials have been used to fabricate provisional restorations since the 1930s and usually available as powder and liquid. They are the most commonly used materials today for both single-unit and multiple-unit restorations. In general, their popularity is due to their low cost, acceptable esthetics, and versatility. Composite provisional materials use bis-acryl resin, a hydrophobic material that is similar to bis-GMA. Composites are available as auto-polymerized, dualpolymerized and visible light polymerized. Preformed provisional crowns or matrices usually consist of tooth-shaped shells of plastic, cellulose acetate or metal. They are commercially available in various tooth sizes and are usually selected for a particular tooth anatomy. They are commonly relined with acrylic resin to provide a more custom fit before cementation, but the plastic and metal crown shells can also be cemented directly onto prepared teeth. The aim of this study is to choose a material to serve as a better interim prosthesis and to compare three different properties - flexural strength, compressive strength, and color stability. The samples were made with three different provisional materials (Revotek LC, Protemp 4, TemSpan). It was inferred from the study that no one material was superior in all three tested parameters.
[Treatment of periprosthetic and peri-implant fractures : modern plate osteosynthesis procedures].
Raschke, M J; Stange, R; Kösters, C
2012-11-01
Periprosthetic fractures are increasing not only due to the demographic development with high life expectancy, the increase in osteoporosis and increased prosthesis implantation but also due to increased activity of the elderly population. The therapeutic algorithms are manifold but general valid rules for severe fractures are not available. The most commonly occurring periprosthetic fractures are proximal and distal femoral fractures but in the clinical routine fractures of the tibial head, ankle, shoulder, elbow and on the borders to other implants (peri-implant fractures) and complex interprosthetic fractures are being seen increasingly more. It is to be expected that in the mid-term further options, such as cement augmentation of cannulated polyaxial locking screws will extend the portfolio of implants for treatment of periprosthetic fractures. The aim of this review article is to present the new procedures for osteosynthesis of periprosthetic fractures.
[Treatment of periprosthetic and peri-implant fractures : modern plate osteosynthesis procedures].
Raschke, M J; Stange, R; Kösters, C
2012-08-01
Periprosthetic fractures are increasing not only due to the demographic development with high life expectancy, the increase in osteoporosis and increased prosthesis implantation but also due to increased activity of the elderly population. The therapeutic algorithms are manifold but general valid rules for severe fractures are not available. The most commonly occurring periprosthetic fractures are proximal and distal femoral fractures but in the clinical routine fractures of the tibial head, ankle, shoulder, elbow and on the borders to other implants (peri-implant fractures) and complex interprosthetic fractures are being seen increasingly more. It is to be expected that in the mid-term further options, such as cement augmentation of cannulated polyaxial locking screws will extend the portfolio of implants for treatment of periprosthetic fractures. The aim of this review article is to present the new procedures for osteosynthesis of periprosthetic fractures.
Ramu, D; Ramesh, Rakesh S; Manjunath, Suraj; Shivakumar; Goel, Vipin; Hemnath, G N; Alexander, Annie
2015-12-01
In India, Breast cancer is now the most common cancer in urban and 2nd most common in rural areas [1]. The incidence is rising, more younger women are getting affected and due to increase in survival rates there is an increase in the total number of women suffering from breast Cancer. So far there are no studies evaluating the pattern of breast prosthesis use in Indian scenario. The aim of this study is to address the patterns of external breast prosthesis used in India and view of Indian women on such prosthesis after mastectomy for breast cancer. This was a descriptive longitudinal study. In this study we interviewed (telephonic) 63 people, after three years of completing treatment under The Department of Surgical Oncology, St. Johns medical college, Bangalore. Among the study group, 27 members (40 %) were using various prosthesis, rest 36 women were not using any type of prosthesis. Among the users of prosthesis, silicon prosthesis was used by 6 women, padded cups by 8 women, cloth or cotton by 12 women and 1 woman used other type of prosthesis. Most women use simple items like cloth and cotton (44 %). Next most commonly used prosthesis are padded cups(). Only 22 % of women were found using silicon prosthesis in this study. Most of the well educated patients used external prosthesis either in the form of silicon prosthesis or padded cups. Most of women below age of 50 used external breast prosthesis. Use of prosthesis was more in urban compared to rural population (48 % vs 25 %). Prosthesis users worried more about the body image than women not using prosthesis. 25 % of women using prosthesis had body image issues where as only 5 % of non prosthesis users had such problems. Prosthesis users need improvement in terms of comfort, size, shape and affordability. Most common reasons for not using prosthesis are age, lack of motivation and awareness. Less than half of the women included in this study used external prosthesis after mastectomy for breast cancer. Most of the women are used home made prosthesis like cloth and cotton (44.4 %). Education, age and urban status are the strong factors which influences use of prosthesis. Prosthesis users are those who are more concerned about their body image. There is a palpable need to develop better prosthesis at affordable price.
Julin, Jaakko; Jämsen, Esa; Puolakka, Timo; Konttinen, Yrjö T; Moilanen, Teemu
2010-08-01
Total knee replacements (TKRs) are being increasingly performed in patients aged < or = 65 years who often have high physical demands. We investigated the relation between age of the patient and prosthesis survival following primary TKR using nationwide data collected from the Finnish Arthroplasty Register. From Jan 1, 1997 through Dec 31, 2003, 32,019 TKRs for primary or secondary osteoarthritis were reported to the Finnish Arthroplasty Register. The TKRs were followed until the end of 2004. During the follow-up, 909 TKRs were revised, 205 (23%) due to infection and 704 for other reasons. Crude overall implant survival improved with increasing age between the ages of 40 and 80. The 5-year survival rates were 92% and 95% in patients aged < or = 55 and 56-65 years, respectively, compared to 97% in patients who were > 65 years of age (p < 0.001). The difference was mainly attributable to reasons other than infections. Sex, diagnosis, type of TKR (condylar, constrained, or hinge), use of patellar component, and fixation method were also associated with higher revision rates. However, the differences in prosthesis survival between the age groups < or = 55, 56-65, and > 65 years remained after adjustment for these factors (p < 0.001). Young age impairs the prognosis of TKR and is associated with increased revision rates for non-infectious reasons. Diagnosis, sex, type of TKR, use of patellar component, and fixation method partly explain the differences, but the effects of physical activity, patient demands, and obesity on implant survival in younger patients warrant further research.
Pillai, Rajath Sasidharan; Mathur, Vijay Prakash; Jain, Veena; Shah, Naseem; Kalra, Sandeep; Kumar, Pravesh; Dey, A B
2015-12-01
To determine the effect of prosthesis need on nutritional status and oral health-related quality of life (OHrQoL) in elderly and to check the disparity between prosthesis need and prosthesis want in the Indian elderly. A total of 946 geriatric participants reporting to a geriatric medicine clinic were recruited in the study. Mini-nutritional assessment (MNA), geriatric oral health assessment (GOHAI) indices, prosthesis need according to WHO criteria, and prosthesis want was recorded along with age, gender, socioeconomic status and posterior occluding pair. Significant associations exist between prosthesis need and age (p = 0.005), MNA (p = 0.006) and GOHAI (p = 0.000). Prosthesis demand too was influenced by age (p = 0.004), posterior occluding pairs (p = 0.000), MNA (p = 0.012) and GOHAI (p = 0.000). GOHAI was negatively correlated with upper (r = -0.445) and lower prosthesis need (r = -0.460). Participants with some prosthesis need had significantly lower MNA and GOHAI scores as compared to those with no prosthesis need. Though prosthesis need was high (79.7 %), demand was low (39.3 %). Prosthesis need affects nutritional status and OHrQoL in elderly, and a wide gap exists between need and want of prosthesis.
Telescopic Partial Dentures-Concealed Technology.
Bhagat, Tushar Vitthalrao; Walke, Ashwini Nareshchandra
2015-09-01
The ideal goal of good dentist is to restore the missing part of oral structure, phonetics, his look and the most important is restored the normal health of the patient, which is hampered due to less or insufficient intake of food. Removable partial denture (RPD) treatment option is considered as a notion, which precludes the inevitability of "floating plastic" in edentulous mouth, that many times fail to fulfill the above essential of the patients. In modern dentistry, though the dental implants or fixed partial denture is the better options, but they have certain limitations. However, overdentures and particularly telescopic denture is the overlooked technology in dentistry that would be a boon for such needy patients. Telescopic denture is especially indicated in the distal edentulous area with minimum two teeth bilaterally present with a good amount of periodontal support. This treatment modality is sort of preventive prosthodontics remedy, which in a conservative manner preserve the remaining teeth and helps in conservation of alveolar bone ultimately. There are two tenets related to this option, one is constant conservation edentulous ridge around the retained tooth and the most important is the endless existence of periodontal sensory action that directs and monitor gnathodynamic task. In this option the primary coping or inner coping are cemented on the prepared tooth, and a similar removable outer or inner telescopic crown placed tightly by using a mechanism of tenso-friction, this is firmly attached to a removable RPD in place without moving or rocking of the prosthesis, which is the common compliant of almost all patients of RPD. Copings are also protecting the abutment from tooth decay and also offers stabilization and maintaining of the outer crown. The outer crown engages the inner coping and gives as an anchor for the remainder of the dentition. This work is the review of telescopic prosthesis which is well supported by the case discussion, and designates the utilization of favorable retained tooth/teeth as abutment that drastically minimized alveolar bone resorption beneath the prosthesis and give the maximum tactile sensation of natural teeth to the patient, which is not possible with other type of RPD.
Telescopic Partial Dentures-Concealed Technology
Bhagat, Tushar Vitthalrao; Walke, Ashwini Nareshchandra
2015-01-01
The ideal goal of good dentist is to restore the missing part of oral structure, phonetics, his look and the most important is restored the normal health of the patient, which is hampered due to less or insufficient intake of food. Removable partial denture (RPD) treatment option is considered as a notion, which precludes the inevitability of “floating plastic” in edentulous mouth, that many times fail to fulfill the above essential of the patients. In modern dentistry, though the dental implants or fixed partial denture is the better options, but they have certain limitations. However, overdentures and particularly telescopic denture is the overlooked technology in dentistry that would be a boon for such needy patients. Telescopic denture is especially indicated in the distal edentulous area with minimum two teeth bilaterally present with a good amount of periodontal support. This treatment modality is sort of preventive prosthodontics remedy, which in a conservative manner preserve the remaining teeth and helps in conservation of alveolar bone ultimately. There are two tenets related to this option, one is constant conservation edentulous ridge around the retained tooth and the most important is the endless existence of periodontal sensory action that directs and monitor gnathodynamic task. In this option the primary coping or inner coping are cemented on the prepared tooth, and a similar removable outer or inner telescopic crown placed tightly by using a mechanism of tenso-friction, this is firmly attached to a removable RPD in place without moving or rocking of the prosthesis, which is the common compliant of almost all patients of RPD. Copings are also protecting the abutment from tooth decay and also offers stabilization and maintaining of the outer crown. The outer crown engages the inner coping and gives as an anchor for the remainder of the dentition. This work is the review of telescopic prosthesis which is well supported by the case discussion, and designates the utilization of favorable retained tooth/teeth as abutment that drastically minimized alveolar bone resorption beneath the prosthesis and give the maximum tactile sensation of natural teeth to the patient, which is not possible with other type of RPD. PMID:26435635
Mulier, Michiel; Pastrav, Cesar; Van der Perre, Georges
2008-01-01
Defining the stem insertion end point during total hip replacement still relies on the surgeon's feeling. When a custom-made stem prosthesis with an optimal fit into the femoral canal is used, the risk of per-operative fractures is even greater than with standard prostheses. Vibration analysis is used in other clinical settings and has been tested as a means to detect optimal stem insertion in the laboratory. The first per-operative use of vibration analysis during non-cemented custom-made stem insertion in 30 patients is reported here. Thirty patients eligible for total hip replacement with uncemented stem prosthesis were included. The neck of the stem was connected with a shaker that emitted white noise as excitation signal and an impedance head that measured the frequency response. The response signal was sent to a computer that analyzed the frequency response function after each insertion phase. A technician present in the operating theatre but outside the laminated airflow provided feed-back to the surgeon. The correlation index between the frequency response function measured during the last two insertion hammering sessions was >0.99 in 86.7% of the cases. In four cases the surgeon stopped the insertion procedure because of a perceived risk of fracture. Two special cases illustrating the potential benefit of per-operative vibration analysis are described. The results of intra-operative vibration analysis indicate that this technique may be a useful tool assisting the orthopaedic surgeon in defining the insertion endpoint of the stem. The development of a more user-friendly device is therefore warranted.
[Patellar bone deficiency in revision total knee arthroplasty].
Kloiber, J; Goldenitsch, E; Ritschl, P
2016-05-01
Patellar bone deficiency in revision total knee arthroplasty (TKA) determines the surgical procedure. Different reconstructive and ablative techniques, dependent on the remaining bone stock, are described. The primary patella implant can be retained in up to 50 % of revision situations. Reasons for replacement are aseptic and septic loosening, implant failure, expanding osteolysis, maltracking of the patella and "metal-backed" prosthesis. The aim of the reconstruction is the stable fixation and proper tracking of the implant by restoring the extensor mechanism. Dependent on the extent of bone loss and the availability of a patellar rim, the following surgical procedures are recommended. When the remaining bone thickness is 10 mm or more: implantation of a polyethylene "onlay-type" patella; when it is between 6-9 mm and there is an intact patellar rim: reconstruction with a biconvex "inlay-type" patella implant, where the biconvex shape replaces the bone defect partially. When there is deficient bone stock (less than 6 mm) or no cortical patellar rim then augmenting procedures with autologous spongiosa and procedures such as "impaction bone grafting", "trabecular metal" prosthesis, where the trabecular part of the implant serves as the base for the cemented polyethylene button, "gull-wing" osteotomy, which is an adapting and configuring technique of osteotomy; and in exceptional cases patelloplasty or patellectomy are used. Regarding the importance of the patellar component in biomechanics of the joint and function of the extensor mechanism, the reconstruction of the patella should be the primary aim. Patelloplasty or patellectomy should be avoided.
Custom-made ocular prosthesis.
Gunaseelaraj, Rajkumar; Karthikeyan, Suma; Kumar, Mohan N; Balamurugan, T; Jagadeeshwaran, A R
2012-08-01
An ocular defect may affect a patient psychologically. An ocular prosthesis is given to uplift the patient psychologically and improve the confidence. Ocular prosthesis can be custom made or a stock shell. To improve the comfort and matching of the prosthesis with that of the adjacent natural eye an custom made ocular prosthesis is preferred. Different techniques are available to fabricate a custom ocular prosthesis, here we have used paper iris disk technique.
Gallagher, P; Buckmaster, A; O'Carroll, S; Kiernan, G; Geraghty, J
2009-11-01
A good-quality external breast prosthesis and prosthesis-fitting service is integral to recovery post-mastectomy. However, this area of care has minimal information or research available. The aim of this study was to investigate women's experience of the provision, fitting, supply and use of breast prostheses in Ireland. Three national surveys were undertaken with women (n = 527), breast care nurses (BCNs) (n = 32) and retail prosthesis fitters (n = 12). The findings identified the importance of the prosthesis for shape, appearance to self, appearance to others, sense of well-being, self-confidence and femininity. Dissatisfaction with weight, comfort and movement of the prosthesis was identified. Cost and travel distance were found to influence the replacement of the prosthesis. Dissatisfaction emerged with the display and choice of products, and brochure availability at the prosthesis fitting. Women preferred to be fitted for the first silicone prosthesis by a BCN in a hospital setting whereas for the replacement prosthesis they preferred a trained fitter at a specialized prosthesis supplier. BCNs and retail fitters identified the need for service guidelines and increased availability of professional development opportunities in prosthesis-fitting. These findings contributed to the development of standards of care for breast prosthesis-fitting services to benefit women and to provide guidelines for those providing the service.
Singh, Kunwarjeet; Gupta, Nidhi
2012-01-01
To suggest a custom bar supported overdenture treatment modality for prosthodontic management of patients with severe gag reflex. Some patients have a severe gag reflex and cannot tolerate conventional maxillary complete dentures with maximum palatal coverage and extensions of all borders. The condition further gets complicated in patients suffering from respiratory problems along with severe gag reflex. Severe gagging acts as a barrier to treat such patients with accepted clinical procedures and prevent patients from wearing the prosthesis. By saving some of the remaining natural teeth and fabricating, a horse shoe shape palateless simple tooth or bar supported overdenture can be successfully used for treating such patients. The remaining maxillary right and left canines were prepared with the tapered round end diamond bur to receive copings of custom bar after intentional root canal treatment of same teeth. Impression was made with light body and putty of the polyvinyl siloxane elastomer with double step putty wash technique. Impression was poured with die stone. Wax pattern of copings with bar was fabricated with inlay wax which was invested and casted. After retrieving the bar, it was finished and its fit was evaluated. The coping-bar assembly was finally cemented with the glass ionomer cement. Palateless overdenture was fabricated by conventional technique used for the fabrication of complete denture. Palateless custom bar supported overdenture procedure can be successfully used for the management of patients with severe gag reflex with improved denture retention, stability, chewing efficiency and comfort of the patient.
HEMIARTHROPLASTY IN THE TREATMENT FRACTURES OF THE FEMORAL NECK
Ono, Nelson Keiske; de Andrade Lima, Guilherme Didier; Honda, Emerson Kiyoshi; Polesello, Giancarlo Cavalli; Guimarães, Rodrigo Pereira; Júnior, Walter Ricioli; de Queiroz, Marcelo Cavalheiro
2015-01-01
Objective: To epidemiologically and clinically evaluate patients with displaced femoral neck fractures that were surgically treatment with cemented hip hemiarthroplasty. Methods: All patients with displaced femoral neck fractures (Garden III and IV) who underwent cemented hip hemiarthroplasty using a unipolar prosthesis (Thompson), by means of a posterolateral access between June 2005 and September 2008 were retrospectively evaluated. Results: Seventy patients were initially evaluated. Their mean age was 83.1 years. The patients were predominantly female (84.3%). Thirty-six patients were monitored as outpatients for periods ranging from 10 to 48 months (mean of 26.5 months). Fifteen patients were lost to follow-up. Nineteen patients died, and the mortality rate within the first year was 25.4%. Patients classified as ASA III had a mortality rate of 25.7% and ASA II patients, a rate of 12.1%. Two patients had symptomatic deep vein thrombosis; one patient had an operative wound infection; and none of the patients presented hip dislocation. Most of the patients did not experience pain. Twelve patients (33%) showed deterioration of their walking ability. Conclusion: There were no cases of hip dislocation. Patients classified as ASA III had a higher mortality rate than did patients with ASA I or II. There was a worsening of walking ability in 33% of the patients. No revision due to loosening or pain was needed for any patient. Thirty patients did not present any pain (83.3%), four presented moderate pain (11.1%) and two presented intense pain (5.5%). PMID:27022567
Saisadan, D.; Manimaran, P.; Meenapriya, P. K.
2016-01-01
Introduction: Materials used to fabricate provisional restorations can be classified as acrylics or resin composites. Provisional crows can be either prefabricated or custom made. Acrylics: These materials have been used to fabricate provisional restorations since the 1930s and usually available as powder and liquid. They are the most commonly used materials today for both single-unit and multiple-unit restorations. In general, their popularity is due to their low cost, acceptable esthetics, and versatility. Composites: Composite provisional materials use bis-acryl resin, a hydrophobic material that is similar to bis-GMA. Composites are available as auto-polymerized, dualpolymerized and visible light polymerized. Preformed Crowns: Preformed provisional crowns or matrices usually consist of tooth-shaped shells of plastic, cellulose acetate or metal. They are commercially available in various tooth sizes and are usually selected for a particular tooth anatomy. They are commonly relined with acrylic resin to provide a more custom fit before cementation, but the plastic and metal crown shells can also be cemented directly onto prepared teeth. Aims and Objectives: The aim of this study is to choose a material to serve as a better interim prosthesis and to compare three different properties – flexural strength, compressive strength, and color stability. Materials and Methods: The samples were made with three different provisional materials (Revotek LC, Protemp 4, TemSpan). Result: It was inferred from the study that no one material was superior in all three tested parameters. PMID:27829758
Karakoç, Mehmet; Batmaz, İbrahim; Sariyildiz, Mustafa Akif; Yazmalar, Levent; Aydin, Abdülkadir; Em, Serda
2017-08-01
Patients with amputation need prosthesis to comfortably move around. One of the most important parts of a good prosthesis is the socket. Currently, the most commonly used method is the traditional socket manufacturing method, which involves manual work; however, computer-aided design/computer-aided manufacturing (CAD/CAM) is also being used in the recent years. The present study aimed to investigate the effects of sockets manufactured by traditional and CAD/CAM method on clinical characteristics and quality of life of patients with transtibial amputation. The study included 72 patients with transtibial amputation using prosthesis, 36 of whom had CAD/CAM prosthetic sockets (group 1) and 36 had traditional prosthetic sockets (group 2). Amputation reason, prosthesis lifetime, walking time and distance with prosthesis, pain-free walking time with prosthesis, production time of the prosthesis, and adaptation time to the prosthesis were questioned. Quality of life was assessed using the 36-item Short Form Health Survey questionnaire and the Trinity Amputation and Prosthesis Experience Scales. Walking time and distance and pain-free walking time with prosthesis were significantly better in group 1 than those in group 2. Furthermore, the prosthesis was applied in a significantly shorter time, and socket adaptation time was significantly shorter in group 1. Except emotional role limitation, all 36-item Short Form Healthy Survey questionnaire parameters were significantly better in group 1 than in group 2. Trinity Amputation and Prosthesis Experience Scales activity limitation scores of group 1 were lower, and Trinity Amputation and Prosthesis Experience Scales satisfaction with the prosthesis scores were higher than those in group 2. Our study demonstrated that the sockets manufactured by CAD/CAM methods yield better outcomes in quality of life of patients with transtibial amputation than the sockets manufactured by the traditional method.
Women's Satisfaction with Their Breast Prosthesis: What Determines a Quality Prosthesis?
ERIC Educational Resources Information Center
Livingston, Patricia M.; White, Victoria M.; Roberts, Susan B.; Pritchard, Emma; Hayman, Jane; Gibbs, Anne; Hill, David J.
2005-01-01
The aim of this study is to determine what factors constitute a quality prosthesis and ascertain which factors affect prosthesis satisfaction. Sixty-four women who received full funding for their prosthesis and 38 women who received their hospital's usual funding were recruited. Women rated the information provided about breast prostheses very…
Chung, Eric
2017-02-01
Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades.
2017-01-01
Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades. PMID:28217449
Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center.
Toda, Mitsunori; Chin, Takaaki; Shibata, Yaeko; Mizobe, Futoshi
2015-01-01
There has been no research investigating the use of powered prosthetic for children in Japan. To gain better insight into the state of powered prosthesis usage and identify a ratio of rejection among children. Subjects were 37 unilateral below elbow amputees between the ages of 0 and 16 at the time of their first experienced fitting with a powered prosthesis at our Center. The information was collected from medical records and through face-to-face interviews, and we examined rejection rate and the factors affecting the use of powered prosthesis. The rate of discontinuation was 21.6% as 8 of the 37 children stopped using powered prosthesis. All of them were fitted their prosthesis after 2 years of age, and they rejected prosthesis between 5 to 19 years. We found that the level of amputation had no influence on the use of a powered prosthesis. Children fitted before 2 years of age tend to accept their powered prosthesis than those fitted after 2 years. Multidisciprinary team approach, adequate rehabilitation, detailed follow-up and involvement of parents are quite important for introducing powered prosthesis for children.
Kamath, Atul F; Austin, Daniel; Lee, Gwo-Chin
2012-08-01
Reconstruction for concurrent infection of an ipsilateral total hip arthroplasty (THA) and total knee arthroplasty (TKA) is a challenge. We report a 2-stage reconstruction of a THA for chronic infection of both the THA and TKA with severe femoral bone loss secondary to interprosthetic fractures. The reconstruction involved using a custom-made, temporary, antibiotic-impregnated PROSTALAC spacer mated with an intramedullary nail. The acetabulum was then exposed and the necrotic cartilage was removed and curetted. The acetabulum was reamed to accept a PROSTALAC acetabular shell. The shell was cemented into the acetabulum with antibiotic cement. The custom-made spacer was then inserted distally first into the tibia. The distal end of the intramedullary nail was interlocked with a bicortical bolt to minimise nail rotation. Antibiotic-impregnated cement was moulded around the nail and spacer. The proximal end of the spacer was then reduced into the acetabular socket, and the joint was irrigated and the wound closed. A customised abduction brace was fitted, and partial weight bearing was allowed. Sufficient leg length, soft-tissue tension, and range of hip motion were restored, and a total femur and constrained liner was re-implanted 4 months later. Mating of an intramedullary nail with a PROSTALAC spacer is a viable reconstructive option.
Kogbara, Reginald B
2017-01-28
Relationships among selected performance properties have been established using experimental data from a cement-stabilized mixed contaminated soil. The sandy soil was spiked with 3,000 mg/kg each of Cd, Cu, Pb, Ni and Zn, and 10,000 mg/kg of diesel. It was then treated with 5%, 10%, 15%, and 20% dosages of Portland cement. Different water contents were considered for lower dosage mixes. Selected geotechnical and leaching properties were determined on 28-day old samples. These include unconfined compressive strength (UCS), bulk density, porosity, hydraulic conductivity, leachate pH and granular leachability of contaminants. Interrelationships among these properties were deduced using the most reasonable best fits determined by specialized curve fitting software. Strong quadratic and log-linear relationships exist between hydraulic conductivity and UCS, with increasing binder and water contents, respectively. However, the strength of interrelationships between hydraulic conductivity and porosity, UCS and porosity, and UCS and bulk density varies with binder and water contents. Leachate pH and granular leachability of contaminants are best related to UCS and hydraulic conductivity by a power law and an exponential function, respectively. These results suggest how the accuracy of not-easily-measurable performance properties may be constrained from simpler ones. Comparisons with some published performance properties data support this.
Prosthetic management of mid-facial defect with magnet-retained silicone prosthesis.
Buzayan, Muaiyed M
2014-02-01
Mid-facial defect is one of the most disfiguring and impairing defects. A design of prosthesis that is aesthetic and stable can be precious to a patient who has lost part of his face due to surgical excision. Prosthesis can restore the patients' self-esteem and confidence, which affects the patients and their life style. The aim of this case report is to describe a technique of mid-facial silicone prosthesis fabrication. To provide an aesthetic and stable facial prosthesis, the extra-oral prosthesis was fabricated using silicone material, while the intra-oral defect was restored with obturator prosthesis, and then both prostheses were connected and attached to each other using magnets. This clinical report describes the rehabilitation of a large mid-facial defect with a two-piece prosthesis. The silicone facial prosthesis was made hollow and lighter by using an acrylic framework. Two acrylic channels were included within the facial prosthesis to provide the patient with clean and patent airways. A sectional mid-facial prosthesis was made and retained in place by using magnets, which resulted in a significant improvement in the aesthetical and functional outcome without the need for plastic surgery. Silicone prostheses are reliable alternatives to surgery and should be considered in selected cases.
A Novel Thermal-activated Shape Memory Penile Prosthesis: Comparative Mechanical Testing.
Le, Brian; McVary, Kevin; McKenna, Kevin; Colombo, Alberto
2017-01-01
To compare a novel nickel-titanium (Ni-Ti) shape memory alloy (SMA) penile prosthesis of our own design with commercially available prostheses using a format similar to mechanical testing done at major penile prosthesis manufacturers. We evaluated the mechanical parameters of commercially available penile prostheses and used this information to guide the development of the Ni-Ti-based physiological penile prosthesis that expands and becomes erect with a small amount of heat applied. A penile prosthesis consisting of an exoskeleton of temperature-tuned Nitinol was designed and prototyped. Mechanical testing was performed in a model of penile buckling, penile lateral deviation, and original penile shape recovery commonly used by penile prosthesis manufacturers for testing. Our SMA penile prosthesis demonstrated useful mechanical characteristics, including rigidity to buckling when activated similar to an inflatable penile prosthesis (2.62 kgf SMA vs 1.42 kgf inflatable penile prosthesis vs 6.45 kgf for a malleable prosthesis). The Ni-Ti also became more pliable when deactivated within acceptable mechanical ranges of existing devices. It could be repeatedly cycled and generate a restorative force to become erect. An SMA-based penile prosthesis represents a promising new technology in the treatment of erectile dysfunction. We demonstrated that an Ni-Ti-based prosthesis can produce the mechanical forces necessary for producing a simulated erection without the need for a pump or reservoir, comparable with existing prostheses. Copyright © 2016 Elsevier Inc. All rights reserved.
Penile Prosthesis Implantation in Patients with a History of Total Phallic Construction.
Zuckerman, Jack M; Smentkowski, Katherine; Gilbert, David; Storme, Oscar; Jordan, Gerald; Virasoro, Ramon; Tonkin, Jeremy; McCammon, Kurt
2015-12-01
Outcomes following penile prosthesis implantation in patients with a history of total phallic construction are not well described. The aim of this study was to evaluate outcomes following neophallus penile prosthesis placement. Retrospective review penile prosthesis placement in patients with prior total phallic construction. GORE-TEX® (Gore Medical, Flagstaff, AZ) sleeve neotunica construction was utilized in all patients. Success defined as patient sexual activity with a functioning prosthesis. Thirty-one patients underwent neophallic prosthesis implantation at a mean 35.6 years of age. Prosthesis placement occurred at an average 56.3 months following phallic construction and follow-up was a mean of 59.7 months. Malleable prostheses were placed in 21 patients and inflatable in 10; implants were bilateral in 94%. Six percent experienced operative complications including a bladder injury (1) and phallic flap arterial injury (1). Postoperative complications occurred in 23% at a median 5.5 months following placement. Five prostheses were explanted secondary to infection or erosion and two additional required revisions. Of the explanted prosthesis two were later replaced without further complication. Eighty-one percent of patients were sexually active following prosthesis placement. Penile prosthesis placement is possible in patients with prior penile reconstruction/phallic construction. Although complications rates appear to be elevated in this population compared with historic controls of normal anatomic men, the majority of patients in this series were sexually active following prosthesis placement. This demonstrates the utility of prosthesis implantation in these difficult patients. © 2015 International Society for Sexual Medicine.
Goudarz Mehdikhani, Kaveh; Morales Moreno, Beatriz; Reid, Jeremy J; de Paz Nieves, Ana; Lee, Yuo-Yu; González Della Valle, Alejandro
2016-07-01
We studied the need to use a constrained insert for residual intraoperative instability and the 1-year result of patients undergoing total knee arthroplasty (TKA) for a varus deformity. In a control group, a "classic" subperiosteal release of the medial soft tissue sleeve was performed as popularized by pioneers of TKA. In the study group, an algorithmic approach that selectively releases and pie-crusts posteromedial structures in extension and anteromedial structures in flexion was used. All surgeries were performed by a single surgeon using measured resection technique, and posterior-stabilized, cemented implants. There were 228 TKAs in the control group and 188 in the study group. Outcome variables included the use of a constrained insert, and the Knee Society Score at 6 weeks, 4 months, and 1 year postoperatively. The effect of the release technique on use of constrained inserts and clinical outcomes were analyzed in a multivariate model controlling for age, sex, body mass index, and severity of deformity. The use of constrained inserts was significantly lower in study than in control patients (8% vs 18%; P = .002). There was no difference in the Knee Society Score and range of motion between the groups at last follow-up. No patient developed postoperative medial instability. This algorithmic, pie-crusting release technique resulted in a significant reduction in the use of constrained inserts with no detrimental effects in clinical results, joint function, and stability. As constrained TKA implants are more costly than nonconstrained ones, if the adopted technique proves to be safe in the long term, it may cause a positive shift in value for hospitals and cost savings in the health care system. Copyright © 2016 Elsevier Inc. All rights reserved.
Multivariate prediction of upper limb prosthesis acceptance or rejection.
Biddiss, Elaine A; Chau, Tom T
2008-07-01
To develop a model for prediction of upper limb prosthesis use or rejection. A questionnaire exploring factors in prosthesis acceptance was distributed internationally to individuals with upper limb absence through community-based support groups and rehabilitation hospitals. A total of 191 participants (59 prosthesis rejecters and 132 prosthesis wearers) were included in this study. A logistic regression model, a C5.0 decision tree, and a radial basis function neural network were developed and compared in terms of sensitivity (prediction of prosthesis rejecters), specificity (prediction of prosthesis wearers), and overall cross-validation accuracy. The logistic regression and neural network provided comparable overall accuracies of approximately 84 +/- 3%, specificity of 93%, and sensitivity of 61%. Fitting time-frame emerged as the predominant predictor. Individuals fitted within two years of birth (congenital) or six months of amputation (acquired) were 16 times more likely to continue prosthesis use. To increase rates of prosthesis acceptance, clinical directives should focus on timely, client-centred fitting strategies and the development of improved prostheses and healthcare for individuals with high-level or bilateral limb absence. Multivariate analyses are useful in determining the relative importance of the many factors involved in prosthesis acceptance and rejection.
Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center
Shibata, Yaeko; Mizobe, Futoshi
2015-01-01
Background There has been no research investigating the use of powered prosthetic for children in Japan. Objective To gain better insight into the state of powered prosthesis usage and identify a ratio of rejection among children. Methods Subjects were 37 unilateral below elbow amputees between the ages of 0 and 16 at the time of their first experienced fitting with a powered prosthesis at our Center. The information was collected from medical records and through face-to-face interviews, and we examined rejection rate and the factors affecting the use of powered prosthesis. Results The rate of discontinuation was 21.6% as 8 of the 37 children stopped using powered prosthesis. All of them were fitted their prosthesis after 2 years of age, and they rejected prosthesis between 5 to 19 years. We found that the level of amputation had no influence on the use of a powered prosthesis. Conclusions Children fitted before 2 years of age tend to accept their powered prosthesis than those fitted after 2 years. Multidisciprinary team approach, adequate rehabilitation, detailed follow-up and involvement of parents are quite important for introducing powered prosthesis for children. PMID:26125974
Laser-assisted fixation of a nitinol stapes prosthesis.
Schrötzlmair, Florian; Suchan, Fabian; Pongratz, Thomas; Krause, Eike; Müller, Joachim; Sroka, Ronald
2018-02-01
Otosclerosis is an inner ear bone disease characterized by fixation of the stapes and consequently progressive hearing loss. One treatment option is the surgical replacement of the stapes by a prosthesis. When so called "smart materials" like nitinol are used, prosthesis fixation can be performed using a laser without manual crimping on the incus. However, specific laser-prosthesis interactions have not been described yet. The aim of the present study was to elucidate the thermo-mechanical properties of the NiTiBOND® prosthesis as a basis for handling instructions for laser-assisted prosthesis fixation. Closure of the NiTiBOND® prosthesis was induced ex vivo by either a diode laser emitting at λ = 940 nm or a CO 2 laser (λ = 10,600 nm). Total energy for closure was determined. Suitable laser parameters (pulse duration, power per pulse, distance between tip of the laser fiber and prosthesis) were assessed. Specific laser-prosthesis interactions were recorded. Especially the diode laser was found to be an appropriate energy source. A total energy deposit of 60 mJ by pulses in near contact application was found to be sufficient for prosthesis closure ex vivo. Energy should be transmitted through a laser fiber equipollent to the prosthesis band diameter. Specific deformation characteristics due to the zonal prosthesis composition have to be taken into account. NiTiBOND® stapes prosthesis can be closed by very little energy when appropriate energy sources like diode lasers are used, suggesting a relatively safe application in vivo. Lasers Surg. Med. 50:153-157, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.
Toia, Marco; Galli, Silvia; Cecchinato, Denis; Wennerberg, Ann; Jimbo, Ryo
2017-08-23
This retrospective study sought to compare a new implant (Astra Tech OsseoSpeed EV) with its predecessor (Astra Tech OsseoSpeed TX) by scanning electron microscopy and interferometry. Radiographic data from 19 patients who underwent implant restoration with EV (n = 49) with a median follow-up of 16 months were evaluated for mean bone level (MBL) changes from delivery of the definitive prosthesis. EV and TX did not differ in surface roughness, and both systems had a tight seal at the implant-abutment interface. The median MBL change of the EV was -0.02 mm mesiodistally after a median follow-up period of 16 months. Greater maintenance of MBL was found in the screw-retained restorations (n = 17) compared to cemented (0.35 ± 0.33 mm and -0.38 ± 0.76 mm, respectively; P = .03). The data suggest that EV shows minimal levels of bone loss and high implant survival.
Agnihotri, Hema; Bhatnagar, Naresh; Rao, G. Venugopal; Jain, Veena; Parkash, Hari; Kar, Aswini Kumar
2010-01-01
Long-term clinical failures of cemented prosthesis depend, to a large extent, on the integrity of the luting agent. The causative factors that lead to microfracture and, hence, failure of the luting agents are the stresses acting inside the oral cavity. Therefore, the present study was designed to develop an understanding of the relationship between stresses in the tooth and the failure potential of the luting agent. Two-dimensional finite element stress analysis was performed on the mandibular second premolar. The behavior of zinc-phosphate and glass-ionomer were studied under different crowns (metal–ceramic and metal crown) and loading conditions (mechanical force of 450 N acting vertically over the occlusal surface, thermal loads of 60° and 0°C). It was observed from the study that failure threshold of the luting agent was influenced both by the elastic modulus of the luting agent and by the type of the crown. PMID:22114426
Hip prostheses in young adults. Surface prostheses and short-stem prostheses.
Gallart, X; Riba, J; Fernández-Valencia, J A; Bori, G; Muñoz-Mahamud, E; Combalia, A
The poor results obtained in young patients when using a conventional prosthesis led to the resurgence of hip resurfacing to find less invasive implants for the bone. Young patients present a demand for additional activity, which makes them a serious challenge for the survival of implants. In addition, new information technologies contribute decisively to the preference for non-cemented prostheses. Maintaining quality of life, preserving the bone and soft tissues, as well as achieving a very stable implant, are the goals of every hip orthopaedic surgeon for these patients. The results in research point to the use of smaller prostheses, which use the metaphyseal zone more and less the diaphyseal zone, and hence the large number of the abovementioned short stem prostheses. Both models are principally indicated in the young adult. Their revision should be a more simple operation, but this is only true for hip resurfacing, not for short stems. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.
Computer-assisted revision total knee replacement.
Sikorski, J M
2004-05-01
A technique for performing allograft-augmented revision total knee replacement (TKR) using computer assistance is described, on the basis of the results in 14 patients. Bone deficits were made up with impaction grafting. Femoral grafting was made possible by the construction of a retaining wall or dam which allowed pressurisation and retention of the graft. Tibial grafting used a mixture of corticocancellous and morsellised allograft. The position of the implants was monitored by the computer system and adjusted while the cement was setting. The outcome was determined using a six-parameter, quantitative technique (the Perth CT protocol) which measured the alignment of the prosthesis and provided an objective score. The final outcomes were not perfect with errors being made in femoral rotation and in producing a mismatch between the femoral and tibial components. In spite of the shortcomings the alignments were comparable in accuracy with those after primary TKR. Computer assistance shows considerable promise in producing accurate alignment in revision TKR with bone deficits.
NASA Astrophysics Data System (ADS)
Huntington, K. W.; Sumner, K. K.; Camp, E. R.; Cladouhos, T. T.; Uddenberg, M.; Swyer, M.; Garrison, G. H.
2015-12-01
Subsurface fluid flow is strongly influenced by faults and fractures, yet the transmissivity of faults and fractures changes through time due to deformation and cement precipitation, making flow paths difficult to predict. Here we assess past fracture connectivity in an active hydrothermal system in the Basin and Range, Nevada, USA, using clumped isotope geochemistry and cold cathodoluminescence (CL) analysis of fracture filling cements from the Blue Mountain geothermal field. Calcite cements were sampled from drill cuttings and two cores at varying distances from faults. CL microscopy of some of the cements shows banding parallel to the fracture walls as well as brecciation, indicating that the cements record variations in the composition and source of fluids that moved through the fractures as they opened episodically. CL microscopy, δ13C and δ18O values were used to screen homogeneous samples for clumped isotope analysis. Clumped isotope thermometry of most samples indicates paleofluid temperatures of around 150°C, with several wells peaking at above 200°C. We suggest that the consistency of these temperatures is related to upwelling of fluids in the convective hydrothermal system, and interpret the similarity of the clumped isotope temperatures to modern geothermal fluid temperatures of ~160-180°C as evidence that average reservoir temperatures have changed little since precipitation of the calcite cements. In contrast, two samples, one of which was associated with fault gauge observed in drill logs, record significantly cooler temperatures of 19 and 73°C and anomalous δ13C and δ18Owater values, which point to fault-controlled pathways for downwelling meteoric fluid. Finally, we interpret correspondence of paleofluid temperatures and δ18Owater values constrained by clumped isotope thermometry of calcite from different wells to suggest past connectivity of fractures among wells within the geothermal field. Results show the ability of clumped isotope geothermometry to assess fracture connectivity and geothermal reservoir characteristics in the past—with the potential to help optimize resource production and injection programs and better understand structural controls on mass and heat transfer in the subsurface.
Mundell, Benjamin F; Kremers, Hilal Maradit; Visscher, Sue; Hoppe, Kurtis M; Kaufman, Kenton R
2016-08-01
Prior studies have identified age as a factor in determining an individual's likelihood of receiving a prosthesis following a lower limb amputation. These studies are limited to specific subsets of the general population and are unable to account for preamputation characteristics within their study populations. Our study seeks to determine the effect of preamputation characteristics on the probability of receiving a prosthesis for the general population in the United States. To identify preamputation characteristics that predict of the likelihood of receiving a prosthesis following an above-knee amputation. A retrospective, population-based cohort study. Olmsted County, Minnesota (2010 population: 144,248). Individuals (n = 93) over the age of 18 years who underwent an above-knee amputation, that is, knee disarticulation or transfemoral amputation, while residing in Olmsted County, MN, between 1987 and 2013. Characteristics affecting the receipt of a prosthesis were analyzed using a logistic regression and a random forest algorithm for classification trees. Preamputation characteristics included age, gender, amputation etiology, year of amputation, mobility, cognitive ability, comorbidities, and time between surgery and the prosthesis decision. The association of preamputation characteristics with the receipt of a prosthesis following an above-knee amputation. Twenty-four of the participants received a prosthesis. The odds of receiving a prosthesis were almost 30 times higher in those able to walk independently prior to an amputation relative to those who could not walk independently. A 10-year increase in age was associated with a 53.8% decrease in the likelihood of being fit for a prosthesis (odds ratio = 0.462, P =.030). Time elapsed between surgery and the prosthesis decision was associated with a rise in probability of receiving a prosthesis for the first 3 months in the random forest algorithm. No other observed characteristics were associated with receipt of a prosthesis. The association of preamputation mobility and age with the likelihood of being fit for a prosthesis is well understood. The effect of age, after controlling for confounders, still persists and is associated with the likelihood of being fit for a prosthesis. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.
NASA Astrophysics Data System (ADS)
Handford, Matthew L.; Srinivasan, Manoj
2016-02-01
Robotic lower limb prostheses can improve the quality of life for amputees. Development of such devices, currently dominated by long prototyping periods, could be sped up by predictive simulations. In contrast to some amputee simulations which track experimentally determined non-amputee walking kinematics, here, we explicitly model the human-prosthesis interaction to produce a prediction of the user’s walking kinematics. We obtain simulations of an amputee using an ankle-foot prosthesis by simultaneously optimizing human movements and prosthesis actuation, minimizing a weighted sum of human metabolic and prosthesis costs. The resulting Pareto optimal solutions predict that increasing prosthesis energy cost, decreasing prosthesis mass, and allowing asymmetric gaits all decrease human metabolic rate for a given speed and alter human kinematics. The metabolic rates increase monotonically with speed. Remarkably, by performing an analogous optimization for a non-amputee human, we predict that an amputee walking with an appropriately optimized robotic prosthesis can have a lower metabolic cost - even lower than assuming that the non-amputee’s ankle torques are cost-free.
NASA Astrophysics Data System (ADS)
Blank, J. G.
2015-12-01
Serpentinization, the reaction at moderate pressure and temperature of water with olivine and pyroxene that are common in basalts and ultramafic rocks, results in the formation of alkaline fluids and the precipitation of a variety of secondary minerals. Terrestrial localities where active serpentinization is occurring are ideal Mars analogs for examining the characteristics of an environment that possesses two of the key features that we assume necessary to host life: water and an internally generated energy source. This study focuses on a related but different feature present where active serpentinization is occurring - namely, carbonate cements forming under plain air in the vicinity of Adobe Springs, CA. This site is located in the Del Puerto ophiolite about 150 km ESE of San Francisco, in the Coast Range of California. Two alkaline spring water compositions have been described at the site, a Ca-OH water (which is not currently being emitted by the active springs), and a Mg-CO3 water. Abundant dolomitic and calcitic carbonate cements are found in the creek drainages near the springs, associated with a diverse microbial community. We conducted a systematic study of the carbonate cements using SEM, EMP, XRD, TEM, and SIMS, focusing on sub-mm variations in texture, mineral chemistry and stable isotope (COH) composition. We compared our measurements with thermodynamic modeling results constrained by chemical analysis of water chemistry from the site and known partition coefficients and stable isotope fractionation factors. The wide range of carbonate compositions and textures observed at the Adobe Springs site suggests that more than one process is involved in their precipitation, including the possibility of microbially mediated dolomite mineralization. These carbonate cements could be a mineralogic biomarker of serpentinization and microbiological processes on Mars and other rocky planets and, therefore, prime targets for future astrobiological investigations.
Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human
2014-10-01
Intracortical Visual Prosthesis in a Human PRINCIPAL INVESTIGATOR: Philip R Troyk, PhD... Prosthesis in a Human 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-12-1-0394 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Philip R Troyk...visual prosthesis (ICVP) for testing in a human. No human trial testing of the prosthesis will occur under the funded work. Preparatory tasks include
Titanium clip ball joint: a partial ossicular reconstruction prosthesis.
Beutner, Dirk; Luers, Jan Christoffer; Bornitz, Matthias; Zahnert, Thomas; Huttenbrink, Karl-Bernd
2011-06-01
To describe a new titanium clip prosthesis for partial ossicular reconstruction with a micro ball joint in the headplate for compensation of tympanic membrane displacements. Laboratory experiments followed by 18 consecutive patients. A micro ball joint was implemented into a headplate of titanium middle ear prosthesis. First, the new prosthesis was tested in the laboratory in temporal bone experiments. Second, the new prosthesis was clinically installed in 18 patients. Results of laser Doppler vibrometry and force measurements in the laboratory experiments, analysis of a questionnaire, and preoperative and postoperative pure tone audiometry. The frictional resistance in the joint was measured to be 12 mN that should allow for adequate mobility under physiologic conditions. The effective sound transmission of the prosthesis was demonstrated by laser Doppler vibrometry. Intraoperatively, the installation of the prosthesis was always straightforward with headplate prosthesis shaft angles between 60 and 90 degrees. Postoperatively, pure tone audiometry revealed satisfying hearing results with a remaining average air-bone gap of 18.2 dB over the frequencies 500, 1,000, 2,000, and 3,000 Hz. No signs of prosthesis dislocation were discovered within the follow-up period of approximately 6 months. The experimental data show that the new modified prosthesis headplate fulfills the requirements necessary for sound transmission. The joint allows the plate to follow movements of the tympanic membrane. This characteristic in conjunction with the proven clip design ensure for optimal prosthesis placement and effectiveness.
Long-term role of external breast prostheses after total mastectomy.
Glaus, Simone W; Carlson, Grant W
2009-01-01
After total mastectomy, many women choose to wear external breast prosthesis rather than undergo breast reconstruction. The purpose of this study was to evaluate long-term satisfaction among external breast prosthesis wearers and the impact of satisfaction on prosthesis use. A questionnaire was designed to assess demographic information, prosthesis information provision, prosthesis use, and satisfaction with prosthesis. Fifty-nine women who had undergone total mastectomy without breast reconstruction completed the questionnaire. The majority of women (68%) were at least 5 years out from mastectomy. Approximately half (49%) of the women had received information about breast prostheses prior to mastectomy; 29% received information from the surgeon performing the operation. Frequent and prolonged prosthesis use was prevalent with 64% of participants reporting prosthesis use all the time, 6-7 days/week. Participants showed high rates (83%) of overall satisfaction. However, women who wore their prosthesis out in public only were less satisfied than more frequent wearers (50% versus 89%, chi(2) = 8.83, d.f. = 1, alpha = 0.05). Satisfaction increased over time, as women who were greater than 5 years out from mastectomy were more satisfied than women less that 5 years post-mastectomy (90% versus 67%, chi(2) = 4.43, d.f. = 1, alpha = 0.05). The vast majority of women are satisfied with their external breast prosthesis several years after mastectomy. Most women used their prosthesis all the time and overall satisfaction contributed to higher levels of prosthesis use. Given the long-term importance of external breast prostheses for women who have undergone mastectomy, a greater effort to inform patients about external breast prostheses prior to surgery is needed.
Horehledova, Barbora; Mihl, Casper; Hendriks, Babs M F; Eijsvoogel, Nienke G; Vainer, Jindrich; Veenstra, Leo F; Wildberger, Joachim E; Das, Marco
2018-06-16
Incorrect prosthesis size has direct impact on patient outcome after transcatheter aortic valve implantation (TAVI) procedure. Currently, annular diameter, area or perimeter may be used for prosthesis size selection. The aim was to evaluate whether the use different annular dimensions would result in the selection of different prosthesis sizes, when assessed in the same TAVI-candidate during the same phase of a cardiac cycle. Fifty consecutive TAVI-candidates underwent retrospectively ECG-gated computed tomography angiography (CTA). Aortic root dimensions were assessed in the 20% phase of the R-R interval. Annular short diameter, perimeter and area were used to select the prosthesis size, based on the industry recommendations for a self-expandable (Medtronic CoreValve; MCV) and balloon-expandable (Edwards Sapien XT Valve; ESV) valve. Complete agreement on selected prosthesis size amongst all three annular dimensions was observed in 62% (31/50; ESV) and 30% (15/50; MCV). Short aortic annulus measurement resulted in a smaller prosthesis size in 20% (10/50; ESV) and in 60% of cases (30/50; MCV) compared to the size suggested by both annular perimeter and area. In 18% (9/50; ESV) and 10% of cases (5/50; MCV) a larger prosthesis would have been selected based on annular perimeter compared to annular diameter and area. Prosthesis size derived from area was always in agreement with at least one other parameter in all cases. Aortic annulus area appears to be the most robust parameter for TAVI-prosthesis size selection, regardless of the specific prosthesis size. Short aortic annulus diameter may underestimate the prosthesis size, while use of annular perimeter may lead to size overestimation in some cases.
Calvert, George T; Cummings, Judd E; Bowles, Austin J; Jones, Kevin B; Wurtz, L Daniel; Randall, R Lor
2014-03-01
Aseptic failure of massive endoprostheses used in the reconstruction of major skeletal defects remains a major clinical problem. Fixation using compressive osseointegration was developed as an alternative to cemented and traditional press-fit fixation in an effort to decrease aseptic failure rates. The purpose of this study was to answer the following questions: (1) What is the survivorship of this technique at minimum 2-year followup? (2) Were patient demographic variables (age, sex) or anatomic location associated with implant failure? (3) Were there any prosthesis-related variables (eg, spindle size) associated with failure? (4) Was there a discernible learning curve associated with the use of the new device as defined by a difference in failure rate early in the series versus later on? The first 50 cases using compressive osseointegration fixation from two tertiary referral centers were retrospectively studied. Rates of component removal for any reason and for aseptic failure were calculated. Demographic, surgical, and oncologic factors were analyzed using regression analysis to assess for association with implant failure. Minimum followup was 2 years with a mean of 66 months. Median age at the time of surgery was 14.5 years. A total of 15 (30%) implants were removed for any reason. Of these revisions, seven (14%) were the result of aseptic failure. Five of the seven aseptic failures occurred at less than 1 year (average, 8.3 months), and none occurred beyond 17 months. With the limited numbers available, no demographic, surgical, or prosthesis-related factors correlated with failure. Most aseptic failures of compressive osseointegration occurred early. Longer followup is needed to determine if this technique is superior to other forms of fixation.
Röhner, Eric; Pfitzner, Tilman; Preininger, Bernd; Zippelius, Timo; Perka, Carsten
2016-01-01
The present study describes a new temporary arthrodesis procedure, which aims for septic knee prosthesis replacement, in particular for larger bone and soft tissue defects. Our technique offers high stability and full weight-bearing capacity of the knee joint. The study included 16 patients with major bone defects (AORI type IIb or greater) after receiving a radical debridement and a septic two-stage revision total knee arthroplasty. After removing the infected prosthesis and debridement, two AO fixator rods were positioned into the intramedullary space of the femur and tibia. Subsequently, both rods were joined tube-to-tube and adjusted in the center of the knee joint. Finally, the whole cavity of the knee joint was filled with PMMA. The number of previous surgeries, bacterial spectrum, risk factors for further infection and reinfection rates was recorded. Immediately after the temporary arthrodesis, radiographs of the knee with the enclosed spacers were taken in order to compare to previous radiographs and avoiding to miss possible spacer loosening. Nine of sixteen patients underwent more than two revision surgeries before receiving our new arthrodesis technique. No cases of spacer loosening were observed in all 16 patients; further, there were no peri-implant fractures, and four persistent infections were noted. Temporary arthrodesis using AO fixator rods offers a high stability without loosening. Its potential to replace conventional augmentation techniques should be taken into account, particularly in the case of larger bone and tissue defects. In clinical practice, the cemented spacer using AO fixator rods could be an alternative technique for temporary knee arthrodesis after septic debridement. Retrospective case series, Level IV.
Scintigraphy of infected total hip arthroplasty (THA): A canine model
DOE Office of Scientific and Technical Information (OSTI.GOV)
Merkel, K.D.; Brown, M.L.; Fitzgerald, R.H.
1984-01-01
Differentiating low-grade sepsis from aseptic loosening of an orthopedic prosthesis is difficult. This study was designed to compare the ability of Tc-99m-HMDP, Ga-67, and In-111 leukocytes (WC) to differentiate low-grade sepsis from aseptic THA component loosening in a canine model. A canine THA was implanted in 14 dogs. Six dogs were given infected femoral components by injecting 10/sup 5/ colony-forming units of Staphylococcus aureus into the femoral canal 6y0 to 90 seconds prior to cementing. Four dogs had an aseptic loose femoral component, and four dogs had an aseptic tight femoral component (control). At six months all dogs were evaluatedmore » with X-ray, lab scintigraphy, and tissue quantitation of each tracer. Diagnosis was confirmed by histology and quantitative microbiology. White blood cell counts and differentials were normal in all dogs, and in only one out of six infected dogs was the sedimentation rate abnormal. X-rays were interpreted as possible infection in five dogs and probable infection in only one dog. In-111 WBC scans were more accurate than sequential Tc-Ga scans (sensitivity 94% vs 61%, specificity 86% vs 71% accuracy 90% vs 67%). Quantitative counting of gamma camera data and tissue samples demonstrated significantly (P < .01) higher accumulation of In-111 WBC about the infected than the loose or control component. No significant difference was demonstrated between the loose and septic components with TC-HMDP or Ga. These results correlate well and confirm our clinical data that In-111 WBC scanning is accurate and useful in the workup of the painful orthopedic prosthesis.« less
Parisotto, Thaís Manzano; de Souza-E-Silva, Cintia Maria; Steiner-Oliveira, Carolina; Nobre-dos-Santos, Marinês; Gavião, Maria Beatriz Duarte
2009-03-01
The purpose of this case report was to describe the oral rehabilitation of a 4-year-old girl presenting early childhood caries (ECC). ECC is highly prevalent in developing countries and its severity increases with age. This disease implies serious consequences for the development of the stomatognathic system and for the child's quality of life. As young children are usually anxious about dental treatment, their level of co-operation is limited, leading to a challenging situation. A 4-year-old girl was brought by her mother for dental treatment with the complaint of pain. The clinical examination revealed extensive carious coronary destructions. After preventive and curative measures, the oral rehabilitation was performed; it included the use of stainless steel crowns, resin filled celluloid crowns with previous cementation of glass post pins when necessary, an amalgam restoration, orthodontic treatment, and a partial removable prosthesis. The child has been monitored in the Pediatric Dentistry Clinic at 4-monthly intervals. The oral rehabilitation was able to reestablish the oral health in the primary arches mutilated by early childhood caries. This is important for the establishment of an adequate mixed and permanent dentition, for proper facial and maxillary growth, and to the child's psychological and social development. The full management, including preventive, psychological, and curative measures of a young child with severe ECC was found successful after 8 months of follow up. This result can encourage the clinicians to seek a cost-effective technique such as stainless steel crowns, resin filled celluloid crowns, and partial removable prosthesis to reestablish the oral functions and improve the child's psycho-social development.
Restoration of the joint geometry and outcome after stemless TESS shoulder arthroplasty
von Engelhardt, Lars V; Manzke, Michael; Breil-Wirth, Andreas; Filler, Timm J; Jerosch, Joerg
2017-01-01
AIM To evaluate the joint geometry and the clinical outcome of stemless, anatomical shoulder arthroplasty with the TESS system. METHODS Twenty-one shoulders with a mean follow-up 18 of months were included. On scaled digital radiographs the premorbid center of rotation (CoR) was assessed and compared to the CoR of the prosthesis by using the MediCAD® software. Additionally, the pre- and post-operative geometry of the CoR was assessed in relation to the glenoid, the acromion as well as to the proximal humerus. Radiological changes, such as radiolucencies, were also assessed. Clinical outcome was assessed with the Constant and DASH score. RESULTS Both, the Constant and DASH scores improved significantly from 11% to 75% and from 70 to 30 points, P < 0.01 respectively. There were no significant differences regarding age, etiology, cemented or metal-backed glenoids, etc. (P > 0.05). The pre- and postoperative humeral offset, the lateral glenohumeral offset, the height of the CoR, the acromiohumeral distance as well as neck-shaft angle showed no significant changes (P > 0.05). The mean deviation of the CoR of the prosthesis from the anatomic center was 1.0 ± 2.8 mm. Three cases showed a medial deviation of more than 3 mm. These deviations of 5.1, 5.7 and 7.6 mm and were caused by an inaccurate humeral neck cut. These 3 patients showed a relatively poor outcome scoring. CONCLUSION TESS arthroplasty allows an anatomical joint reconstruction with a very good outcome. Outliers described in this study sensitize the surgeon for an accurate humeral neck cut. PMID:29094010
Permanent Quadriplegia Following Replacement of Voice Prosthesis.
Ozturk, Kayhan; Erdur, Omer; Kibar, Ertugrul
2016-11-01
The authors presented a patient with quadriplegia caused by cervical spine abscess following voice prosthesis replacement. The authors present the first reported permanent quadriplegia patient caused by voice prosthesis replacement. The authors wanted to emphasize that life-threatening complications may be faced during the replacement of voice prosthesis. Care should be taken during the replacement of voice prosthesis and if some problems have been faced during the procedure patients must be followed closely.
Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human
2013-10-01
Intracortical Visual Prosthesis in a Human PRINCIPAL INVESTIGATOR: Philip R Troyk, PhD... Prosthesis in a Human 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-12-1-0394 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Philip R Troyk, PhD...to prepare an intracortical visual prosthesis (ICVP) for testing in a human. No human trial testing of the prosthesis will occur under the funded
Burt, C F; Garvin, K L; Otterberg, E T; Jardon, O M
1998-07-01
Seventy-four total hip arthroplasties in sixty-six patients were performed, between 1983 and 1986, with use of a Tri-Lock femoral component inserted without cement. This tapered cobalt-chromium component has a fixed head and a circumferential proximal porous coating. Follow-up was conducted with use of a questionnaire, physical examination, and radiographic analysis. At the time of the latest follow-up, fifteen patients (eighteen hips) had died, three patients (four hips) had been lost to follow-up, and one patient (one hip) had refused to participate in the follow-up study; however, the status of fifteen hips at the time of death could be verified. Thus, clinical follow-up data were available for sixty-six of the original seventy-four hips. The average age at the time of the operation was sixty-two years (range, seventeen to eighty-four years), and the average interval between the operation and the latest follow-up evaluation was 10.0 years (range, 8.3 to 11.6 years). The Harris hip score was determined for forty-three hips (forty-one patients) in which the prosthesis was in situ at the time of the latest follow-up. The score was good for thirteen hips and excellent for twenty-eight, so the rate of clinical success was 95 per cent. Two patients had a fair result. One of them had persistent pain and the other had limited motion, but neither had radiographic evidence of loosening of the femoral or acetabular component. All forty-one patients were satisfied with the result. The probability (with standard error) of survival of the femoral component at ten years, with revision as the end point, was 0.95 +/- 0.03. The rate of revision of the femoral component because of aseptic loosening was one (2 per cent) of sixty-six. The overall rate of aseptic loosening of the femoral component in the hips that were followed radiographically was two (4 per cent) of forty-seven. Only one (2 per cent) of the forty-seven acetabular cups had evidence of aseptic loosening. There was no radiographic evidence of distal osteolysis around the prostheses that were well fixed. Proximal osteolysis was present in five (11 per cent) of forty-seven hips, but none of the lesions compromised the stability of the prosthesis or the bone and there were no associated fractures. At an average of ten years postoperatively, the Tri-Lock femoral component functioned well overall and patient satisfaction was high.
[Mid-term results after post-traumatic knee joint replacement in elderly patients].
Weber, O; Goost, H; Mueller, M; Burger, C; Wirtz, D; Pagenstert, G; Gravius, S
2011-04-01
Due to the increasing prevalence of elderly people in Germany, the number of geriatric fractures will continue to increase. Typical geriatric skeletal and physical changes are osteoporosis, arthrosis, and reduced ability of coordination. Altogether, these factors may lead to a failure of a performed osteosynthesis, or may make the classical fracture treatment of reduction and internal fixation appear to be impossible. The aim of this study was to examine the results of peri-knee fractures treated directly or within 3 months by implantation of a knee prosthesis. 15 geriatric patients could be identified who were treated in the described way in the last 4 years. The follow-up time was 39 months. The knee injury occurred in all cases after a banal trauma. 14 patients could be examined by applying the HSS scoring system. We furthermore checked the operative management and postoperative course. The patients reached a good score level and showed few complications. For elderly patients, the primary knee arthroplasty after periarticular fractures of the knee is a valid treatment option. Nevertheless, the surgeon has to identify those fractures which are impossible to treat by a classical osteosynthesis. Furthermore, the application of the appropriate knee prosthesis, regarding the degree of hinge constrainment or augmentation of the tibial or femoral bone stock, is important. © Georg Thieme Verlag KG Stuttgart · New York.
Intermittent, noncyclic dysfunction of a mechanical aortic prosthesis by pannus formation.
Giroux, Sylvie K; Labinaz, Marino X; Grisoli, Dominique; Klug, Andrew P; Veinot, John P; Burwash, Ian G
2010-01-01
Mechanical aortic prosthesis dysfunction can result from thrombosis or pannus formation. Pannus formation usually restricts systolic excursion of the occluding disk, resulting in progressive stenosis of the aortic prosthesis. Intermittent dysfunction of a mechanical aortic prosthesis is usually ascribed to thrombus formation. We describe an unusual case of intermittent, noncyclic dysfunction of a mechanical aortic prosthesis due to pannus formation in the absence of systolic restriction of disk excursion that presented with intermittent massive aortic regurgitation, severe ischemia, and shock. Pannus formation should be considered as a potential cause of acute intermittent severe aortic regurgitation in a patient with a mechanical aortic prosthesis.
BIORESORBABLE POLYMERIC MENISCAL PROSTHESIS: STUDY IN RABBITS
Cardoso, Tulio Pereira; de Rezende Duek, Eliana Aparecida; Amatuzzi, Marco Martins; Caetano, Edie Benedito
2015-01-01
Objective: To induce growth of a neomeniscus into the pores of a prosthesis in order to protect the knee joint cartilage. Methods: 70 knees of 35 New Zealand rabbits were operated. The rabbits were five to seven months old, weighed 2 to 3.8 kilograms, and 22 were male and 13 were female. Each animal underwent medial meniscectomy in both knees during a single operation. A bioabsorbable polymeric meniscal prosthesis composed of 70% polydioxanone and 30% L-lactic acid polymer was implanted in one side. The animals were sacrificed after different postoperative time intervals. The femoral condyles and neomeniscus were subjected to histological analysis. Histograms were used to measure the degradation and absorption of the prosthesis, the growth of meniscal tissue in the prosthesis and the degree of degradation of the femoral condyle joint cartilage. Results: The data obtained showed that tissue growth histologically resembling a normal meniscus occurred, with gradual absorption of the prosthesis, and the percentages of chondrocytes on the control side and prosthesis side. Conclusion: Tissue growth into the prosthesis pores that histologically resembled the normal rabbit meniscus was observed. The joint cartilage of the femoral condyles on the prosthesis side presented greater numbers of chondrocytes in all its layers. PMID:27022549
Trouilloud, P; Gonzalvez, M; Martz, P; Charles, H; Handelberg, F; Nyffeler, R W; Baulot, E
2014-05-01
We describe our experience with a new system of patient-specific template called Personal Fit(®), which is unique in shoulder surgery and used in combination with Duocentric(®) prosthesis. The reverse prosthesis's concept is the invention of Paul Grammont, developed with Grammont's team of Dijon University as from 1981, which led to the first reversed total shoulder prosthesis called Trumpet in 1985. The Duocentric(®) prosthesis developed in 2001 is the third-generation prosthesis, coming from the Trumpet and the second-generation prosthesis Delta(®) (DePuy). This prosthesis provides a novel solution to the notching problem with an inferior overhang integrated onto the glenoid baseplate. Personal Fit(®) system is based on reconstructing the shoulder joint bones in three dimensions using CT scan data, placing a landmark on the scapula and locating points on the glenoid and humerus. That will be used as a reference for the patient-specific templates. We study the glenoid position planned with Personal Fit(®) software relative to native glenoid position in 30 cases. On average, the difference between the planned retroversion (or anteversion in one case) and native retroversion was 8.6°.
21 CFR 872.3940 - Total temporomandibular joint prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...
21 CFR 872.3940 - Total temporomandibular joint prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...
MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance.
Fang, Yanqing; Wang, Bing; Galvin, John J; Tao, Duoduo; Deng, Rui; Ou, Xiong; Liu, Yangwenyi; Dai, Peidong; Sha, Yan; Zhang, Tianyu; Chen, Bing
2016-04-01
The aims of this article are: 1) to re-evaluate the accuracy of multiple planar reconstruction computed tomography (MPR-CT) imaging on stapes-prosthesis parameters, and 2) to clarify possible relationships between prosthesis intravestibular depth and postoperative hearing outcomes. Seventy patients (46 women and 24 men; 32 right and 38 left sides) with the mean age of 40 years (range, 19-62 yr) with clinical otosclerosis. All patients underwent stapedotomy and were implanted with the same type of titanium piston prosthesis by the same surgeon. Postoperative MPR-CTs were obtained at patients' follow-up visits. The length and intravestibular depth of the stapes prosthesis (including absolute and relative depth) were calculated from the MPR-CT imaging. Relationships between the intravestibular depth of the prosthesis and hearing outcomes (pre- and postoperative audiograms) were analyzed using Spearman correlation analyses. The length of the prosthesis was overestimated by 1.8% (0.1 mm) by the MPR-CT imaging. Axial and coronal measurements were significantly correlated (p < 0.05). There was great intersubject variability in hearing outcomes differed insignificantly, regardless of intravestibular depth within the security range. No relationships were found between the intravestibular depth of the stapes prosthesis, as measured with MPR-CT, and postoperative hearing results. MPR-CT can provide an accurate estimation of stapes prosthesis parameters. However, the prosthesis intravestibular depth did not seem to affect postoperative hearing outcomes.
Alam, Md Shahid; Sugavaneswaran, M; Arumaikkannu, G; Mukherjee, Bipasha
2017-08-01
Ocular prosthesis is either a readymade stock shell or custom made prosthesis (CMP). Presently, there is no other technology available, which is either superior or even comparable to the conventional CMP. The present study was designed to fabricate ocular prosthesis using computer aided design (CAD) and rapid manufacturing (RM) technology and to compare it with custom made prosthesis (CMP). The ocular prosthesis prepared by CAD was compared with conventional CMP in terms of time taken for fabrication, weight, cosmesis, comfort, and motility. Two eyes of two patients were included. Computerized tomography scan of wax model of socket was converted into three dimensional format using Materialize Interactive Medical Image Control System (MIMICS)software and further refined. This was given as an input to rapid manufacturing machine (Polyjet 3-D printer). The final painting on prototype was done by an ocularist. The average effective time required for fabrication of CAD prosthesis was 2.5 hours; and weight 2.9 grams. The same for CMP were 10 hours; and 4.4 grams. CAD prosthesis was more comfortable for both the patients. The study demonstrates the first ever attempt of fabricating a complete ocular prosthesis using CAD and rapid manufacturing and comparing it with conventional CMP. This prosthesis takes lesser time for fabrication, and is more comfortable. Studies with larger sample size will be required to further validate this technique.
Surface pretreatments for medical application of adhesion
Erli, Hans J; Marx, Rudolf; Paar, Othmar; Niethard, Fritz U; Weber, Michael; Wirtz, Dieter C
2003-01-01
Medical implants and prostheses (artificial hips, tendono- and ligament plasties) usually are multi-component systems that may be machined from one of three material classes: metals, plastics and ceramics. Typically, the body-sided bonding element is bone. The purpose of this contribution is to describe developments carried out to optimize the techniques , connecting prosthesis to bone, to be joined by an adhesive bone cement at their interface. Although bonding of organic polymers to inorganic or organic surfaces and to bone has a long history, there remains a serious obstacle in realizing long-term high-bonding strengths in the in vivo body environment of ever present high humidity. Therefore, different pretreatments, individually adapted to the actual combination of materials, are needed to assure long term adhesive strength and stability against hydrolysis. This pretreatment for metal alloys may be silica layering; for PE-plastics, a specific plasma activation; and for bone, amphiphilic layering systems such that the hydrophilic properties of bone become better adapted to the hydrophobic properties of the bone cement. Amphiphilic layering systems are related to those developed in dentistry for dentine bonding. Specific pretreatment can significantly increase bond strengths, particularly after long term immersion in water under conditions similar to those in the human body. The bond strength between bone and plastic for example can be increased by a factor approaching 50 (pealing work increasing from 30 N/m to 1500 N/m). This review article summarizes the multi-disciplined subject of adhesion and adhesives, considering the technology involved in the formation and mechanical performance of adhesives joints inside the human body. PMID:14561228
Artificial limb representation in amputees
van den Heiligenberg, Fiona M Z; Orlov, Tanya; Macdonald, Scott N; Duff, Eugene P; Henderson Slater, David; Beckmann, Christian F; Johansen-Berg, Heidi; Culham, Jody C; Makin, Tamar R
2018-01-01
Abstract The human brain contains multiple hand-selective areas, in both the sensorimotor and visual systems. Could our brain repurpose neural resources, originally developed for supporting hand function, to represent and control artificial limbs? We studied individuals with congenital or acquired hand-loss (hereafter one-handers) using functional MRI. We show that the more one-handers use an artificial limb (prosthesis) in their everyday life, the stronger visual hand-selective areas in the lateral occipitotemporal cortex respond to prosthesis images. This was found even when one-handers were presented with images of active prostheses that share the functionality of the hand but not necessarily its visual features (e.g. a ‘hook’ prosthesis). Further, we show that daily prosthesis usage determines large-scale inter-network communication across hand-selective areas. This was demonstrated by increased resting state functional connectivity between visual and sensorimotor hand-selective areas, proportional to the intensiveness of everyday prosthesis usage. Further analysis revealed a 3-fold coupling between prosthesis activity, visuomotor connectivity and usage, suggesting a possible role for the motor system in shaping use-dependent representation in visual hand-selective areas, and/or vice versa. Moreover, able-bodied control participants who routinely observe prosthesis usage (albeit less intensively than the prosthesis users) showed significantly weaker associations between degree of prosthesis observation and visual cortex activity or connectivity. Together, our findings suggest that altered daily motor behaviour facilitates prosthesis-related visual processing and shapes communication across hand-selective areas. This neurophysiological substrate for prosthesis embodiment may inspire rehabilitation approaches to improve usage of existing substitutionary devices and aid implementation of future assistive and augmentative technologies. PMID:29534154
Artificial limb representation in amputees.
van den Heiligenberg, Fiona M Z; Orlov, Tanya; Macdonald, Scott N; Duff, Eugene P; Henderson Slater, David; Beckmann, Christian F; Johansen-Berg, Heidi; Culham, Jody C; Makin, Tamar R
2018-05-01
The human brain contains multiple hand-selective areas, in both the sensorimotor and visual systems. Could our brain repurpose neural resources, originally developed for supporting hand function, to represent and control artificial limbs? We studied individuals with congenital or acquired hand-loss (hereafter one-handers) using functional MRI. We show that the more one-handers use an artificial limb (prosthesis) in their everyday life, the stronger visual hand-selective areas in the lateral occipitotemporal cortex respond to prosthesis images. This was found even when one-handers were presented with images of active prostheses that share the functionality of the hand but not necessarily its visual features (e.g. a 'hook' prosthesis). Further, we show that daily prosthesis usage determines large-scale inter-network communication across hand-selective areas. This was demonstrated by increased resting state functional connectivity between visual and sensorimotor hand-selective areas, proportional to the intensiveness of everyday prosthesis usage. Further analysis revealed a 3-fold coupling between prosthesis activity, visuomotor connectivity and usage, suggesting a possible role for the motor system in shaping use-dependent representation in visual hand-selective areas, and/or vice versa. Moreover, able-bodied control participants who routinely observe prosthesis usage (albeit less intensively than the prosthesis users) showed significantly weaker associations between degree of prosthesis observation and visual cortex activity or connectivity. Together, our findings suggest that altered daily motor behaviour facilitates prosthesis-related visual processing and shapes communication across hand-selective areas. This neurophysiological substrate for prosthesis embodiment may inspire rehabilitation approaches to improve usage of existing substitutionary devices and aid implementation of future assistive and augmentative technologies.
21 CFR 872.3960 - Mandibular condyle prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...
Reverse Shoulder Arthroplasty Prosthesis Design Classification System.
Routman, Howard D; Flurin, Pierre-Henri; Wright, Thomas W; Zuckerman, Joseph D; Hamilton, Matthew A; Roche, Christopher P
2015-12-01
Multiple different reverse total shoulder arthroplasty (rTSA) prosthesis designs are available in the global marketplace for surgeons to perform this growing procedure. Subtle differences in rTSA prosthesis design parameters have been shown to have significant biomechanical impact and clinical consequences. We propose an rTSA prosthesis design classification system to objectively identify and categorize different designs based upon their specific glenoid and humeral prosthetic characteristics for the purpose of standardizing nomenclature that will help the orthopaedic surgeon determine which combination of design configurations best suit a given clinical scenario. The impact of each prosthesis classification type on shoulder muscle length and deltoid wrapping are also described to illustrate how each prosthesis classification type impacts these biomechanical parameters.
Development and clinical application of a new testicular prosthesis
Ning, Ye; Cai, Zhikang; Chen, Huixing; Ping, Ping; Li, Peng; Wang, Zhong; Li, Zheng
2011-01-01
A new type of testicular prosthesis made of silastic with an elliptical shape to mimic a normal testis was developed by our team and submitted for patenting in China. The prosthesis was produced in different sizes to imitate the normal testis of the patient. To investigate the effects and safety of the testicular prosthesis, 20 patients receiving testicular prosthesis implantation were recruited for this study. Follow-up after 6 months revealed no complications in the patients. All the patients answered that they were satisfied with their body image and the position of the implants, 19 patients were satisfied with the size and 16 patients were satisfied with the weight. These results show that the testicular prosthesis used in this study can meet patient's expectations. Patients undergoing orchiectomy should be offered the option to receive a testicular prosthesis implantation. The dimensions and weight of the available prosthetic implants should be further addressed to improve patient satisfaction. PMID:21927041
House, Chad M; Nelson, William B; Kroshus, Timothy J; Dahiya, Ranjan; Pibarot, Philippe
2012-01-01
Prosthesis-patient mismatch (PPM) occurs when an implanted prosthesis is too small relative to the patient's body surface area (BSA). However, mismatch can often be prevented by indexing the expected effective orifice area (EOA) of a prosthesis to the patient's BSA and then selecting the largest implantable prosthesis to avoid mismatch. Previously, prosthesis manufacturers have attempted to simplify this process by providing charts that include the expected EOA for their prosthesis, already indexed into an array of BSA values. One caveat with these charts is that the expected EOA data must truly be reliable, or the charts will misguide the implanting surgeon. Manufacturer-provided charts could be improved by standardizing the EOA data, with one potential source being the hemodynamic data submitted to the United States Food and Drug Administration. This review discusses PPM, manufacturer-provided EOA charts, and the regulation of EOA data.
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
Prosthesis rejection in acquired major upper-limb amputees: a population-based survey.
Østlie, Kristin; Lesjø, Ingrid Marie; Franklin, Rosemary Joy; Garfelt, Beate; Skjeldal, Ola Hunsbeth; Magnus, Per
2012-07-01
To estimate the rates of primary and secondary prosthesis rejection in acquired major upper-limb amputees (ULAs), to describe the most frequently reported reasons for rejection and to estimate the influence of background factors on the risk of rejection. Cross-sectional study analysing population-based questionnaire data (n = 224). Effects were analysed by logistic regression analyses and Cox regression analyses. Primary prosthesis rejection was found in 4.5% whereas 13.4% had discontinued prosthesis use. The main reasons reported for primary non-wear were a perceived lack of need and discrepancies between perceived need and the prostheses available. The main reasons reported for secondary prosthesis rejection were dissatisfaction with prosthetic comfort, function and control. Primary prosthesis rejection was more likely in ULAs amputated at high age and in ULAs with proximal amputations. Secondary prosthesis rejection was more likely in proximal ULAs and in women. Clinicians should be aware of the increased risk of rejection in proximal ULAs, elderly ULAs and in women. Emphasising individual needs will probably facilitate successful prosthetic fitting. Improved prosthesis quality and individualised prosthetic training may increase long-term prosthesis use. Further studies of the effect of prosthetic training and of the reasons for rejection of different prosthetic types are suggested.
Novel knee joint mechanism of transfemoral prosthesis for stair ascent.
Inoue, Koh; Wada, Takahiro; Harada, Ryuchi; Tachiwana, Shinichi
2013-06-01
The stability of a transfemoral prosthesis when walking on flat ground has been established by recent advances in knee joint mechanisms and their control methods. It is, however, difficult for users of a transfemoral prosthesis to ascend stairs. This difficulty is mainly due to insufficient generation of extension moment around the knee joint of the prosthesis to lift the body to the next step on the staircase and prevent any unexpected flexion of the knee joint in the stance phase. Only a prosthesis with an actuator has facilitated stair ascent using a step-over-step gait (1 foot is placed per step). However, its use has issues associated with the durability, cost, maintenance, and usage environment. Therefore, the purpose of this research is to develop a novel knee joint mechanism for a prosthesis that generates an extension moment around the knee joint in the stance phase during stair ascent, without the use of any actuators. The proposed mechanism is based on the knowledge that the ground reaction force increases during the stance phase when the knee flexion occurs. Stair ascent experiments with the prosthesis showed that the proposed prosthesis can realize stair ascent without any undesirable knee flexion. In addition, the prosthesis is able to generate a positive knee joint moment power in the stance phase even without any power source.
Highsmith, M. Jason; Kahle, Jason T.; Miro, Rebecca M.; Mengelkoch, Larry J.
2016-01-01
Transfemoral amputation (TFA) patients require considerably more energy to walk and run than non-amputees. The purpose of this study was to examine potential bioenergetic differences (oxygen uptake (VO2), heart rate (HR), and ratings of perceived exertion (RPE)) for TFA patients utilizing a conventional running prosthesis with an articulating knee mechanism versus a running prosthesis with a non-articulating knee joint. Four trained TFA runners (n = 4) were accommodated to and tested with both conditions. VO2 and HR were significantly lower (p ≤ 0.05) in five of eight fixed walking and running speeds for the prosthesis with an articulating knee mechanism. TFA demonstrated a trend for lower RPE at six of eight walking speeds using the prosthesis with the articulated knee condition. A trend was observed for self-selected walking speed, self-selected running speed, and maximal speed to be faster for TFA subjects using the prosthesis with the articulated knee condition. Finally, all four TFA participants subjectively preferred running with the prosthesis with the articulated knee condition. These findings suggest that, for trained TFA runners, a running prosthesis with an articulating knee prosthesis reduces ambulatory energy costs and enhances subjective perceptive measures compared to using a non-articulating knee prosthesis. PMID:28066524
Postpneumonectomy syndrome in children: advantages and long-term follow-up of expandable prosthesis.
Podevin, G; Larroquet, M; Camby, C; Audry, G; Plattner, V; Heloury, Y
2001-09-01
Pneumonectomy in children can be complicated by a severe mediastinal shift, which leads to bronchial stretching resulting in severe respiratory failure. This postpneumonectomy syndrome can be corrected by inserting a prosthesis in the empty side of the chest. Forty-two children, from 6 months to 15 years old, underwent a pneumonectomy. Seven of these patients were treated surgically for severe manifestations of postpneumonectomy syndrome. First insertion of an expandable prosthesis was followed up in 5 cases by its replacement with a breast prosthesis in adolescence. The expandable prosthesis was injected periodically with saline solution to maintain the mediastinum in a midline position as the children grew. The mean delay between pneumonectomy and first prosthesis implantation was 5 years (range, 11 months to 8 years). Pulmonary function tests showed a substantial improvement in the obstructive syndrome in all patients except one, in whom the functional improvement was moderate. The mean follow-up after the expandable prosthesis implantation was 6 years (range, 6 months to 10 years) and all patients are doing well. The insertion of an intrathoracic prosthesis can dramatically improve the clinical symptoms and reduce the functional obstructive syndrome. The expandable prosthesis allowed for progressive, well-tolerated recentering of the mediastinum and adjustment for growth. Copyright 2001 by W.B. Saunders Company.
Malrotation of the McGhan Style 510 prosthesis.
Schots, Jeroen M P; Fechner, Maarten R; Hoogbergen, Maarten M; van Tits, Herm W H J
2010-07-01
Anatomically shaped cohesive silicone breast implants are frequently used in aesthetic and reconstructive surgery. After successful results with the Style 410 prosthesis, McGhan (Natrelle, Allergan) introduced the Style 510 prosthesis. After using this novel prosthesis, the authors encountered a high number of prosthesis malrotations on self-reported follow-up. Therefore, a retrospective medical record review was performed to determine the prevalence of malrotation of the Style 510 prosthesis. From January of 2005 to December of 2006, 73 (146 prostheses) aesthetic augmentation mammaplasty procedures were performed using Style 510 prostheses. All prostheses were placed subglandularly through an inframammary incision. The postsurgical protocol for the first 3 weeks involved wearing a nonwired compression bra, abstinence from sports activities, and abstinence from heavy labor. Standard follow-up was at 1 week, 3 months, and if necessary. On self-reported follow-up, 8.2 percent of all prostheses were rotated. These rotations all occurred unilaterally after a mean period of 10 months (range, 3 to 19 months). No relation to an inciting incident or prosthesis volume could be found. The number of rotations of the Style 510 prosthesis seen after primary aesthetic breast augmentation is high. An obvious cause of this major problem has not been found. This led the authors to discontinue using the Style 510 prosthesis for primary aesthetic mammary augmentations in their practice.
Fottner, Andreas; Schmid, Markus; Birkenmaier, Christof; Mazoochian, Farhad; Plitz, Wolfgang; Volkmar, Jansson
2009-06-01
Stemless and short-stemmed hip prostheses have been developed to preserve femoral bone stock. While all these prostheses claim a more or less physiological load transfer, clinical long-term results are only available for the stemless thrust plate prosthesis. In this study, the in vitro primary stability of the thrust plate prosthesis was compared to two types of short-stemmed prostheses. In addition to the well-established Mayo prosthesis, the modular Metha prosthesis was tested using cone adapters with 130 degrees and 140 degrees neck-shaft-angles. The prostheses were implanted in composite femurs and loaded dynamically (300-1700 N). Three-dimensional micromotions at the bone-prosthesis interface were measured. In addition, the three-dimensional deformations at the surface of the composite femur were measured to gain data on the strain distribution. For all tested prostheses, the micromotions did not exceed 150 microm, the critical value for osteointegration. The thrust plate prosthesis revealed similar motions as the short-stemmed prostheses. The short-stemmed prosthesis with the 130 degrees cone tended to have the highest micromotions of all tested short-stemmed prostheses. The thrust plate prosthesis revealed the lowest alteration of bone surface deformation after implantation. The comparably low micromotions of the thrust plate prosthesis and the short-stemmed prostheses should be conducive to osseous integration. The higher alteration of load transmission after implantation reveals a higher risk of stress shielding for the short-stemmed prostheses.
Can We Improve the Tolerance of an Ocular Prosthesis by Enhancing Its Surface Finish?
Litwin, Andre S; Worrell, Emma; Roos, Jonathan C P; Edwards, Barry; Malhotra, Raman
Patients who wear an ocular prosthesis frequently suffer with dry eye symptoms and socket discharge, often on a daily basis. The aim of the study was to determine whether a smoother, optical quality polish of the prosthesis' surface could improve symptoms and wear tolerance. The study was designed as single-center, single-masked, prospective randomized controlled trial. Eighty-eight consecutive patients undergoing annual ocular prosthesis maintenance review were approached from the prosthesis clinic. Forty-one out of 49 eligible patients were recruited. Participants were randomized to either a standard or a higher "optical quality" polish of their prosthesis. At entry to the trial, at 1 month, and 12 months they completed a questionnaire covering cleaning, lubricant use, inflammation, discomfort, and discharge. Lower scores indicated better tolerance of the prosthesis. At each visit, the prosthesis was stained and photographed against a standard background to assess deposit build up. Primary outcome measures were 1) a subjective questionnaire score and 2) an objective assessment of surface deposit build-up on prosthetic eyes by standardized photographic grading. Forty-one patients participated in the study. The median age of their prosthesis was 36 months (range 9 months-40 years). There was no statistically significant difference in questionnaire scores or deposit build up between the 2 groups at baseline. By 12-months, the higher optical quality polish showed a statistically significant reduction in symptoms and frequency of discharge (2.19 vs. 3.85; p = 0.05-lower scores better). Scoring of the prosthesis' deposit build-up showed a significant difference at 1 month, but this was not sustained at 12 months. Creating an optical quality finish to an ocular prosthesis reduces deposit build up on artificial eyes. The authors found this modification improved patient tolerance at 12 months.
Chadwell, Alix; Kenney, Laurence; Granat, Malcolm; Thies, Sibylle; Head, John S; Galpin, Adam
2018-02-01
Current outcome measures used in upper limb myoelectric prosthesis studies include clinical tests of function and self-report questionnaires on real-world prosthesis use. Research in other cohorts has questioned both the validity of self-report as an activity assessment tool and the relationship between clinical functionality and real-world upper limb activity. Previously, 1 we reported the first results of monitoring upper limb prosthesis use. However, the data visualisation technique used was limited in scope. Methodology development. To introduce two new methods for the analysis and display of upper limb activity monitoring data and to demonstrate the potential value of the approach with example real-world data. Upper limb activity monitors, worn on each wrist, recorded data on two anatomically intact participants and two prosthesis users over 1 week. Participants also filled in a diary to record upper limb activity. Data visualisation was carried out using histograms, and Archimedean spirals to illustrate temporal patterns of upper limb activity. Anatomically intact participants' activity was largely bilateral in nature, interspersed with frequent bursts of unilateral activity of each arm. At times when the prosthesis was worn prosthesis users showed very little unilateral use of the prosthesis (≈20-40 min/week compared to ≈350 min/week unilateral activity on each arm for anatomically intact participants), with consistent bias towards the intact arm throughout. The Archimedean spiral plots illustrated participant-specific patterns of non-use in prosthesis users. The data visualisation techniques allow detailed and objective assessment of temporal patterns in the upper limb activity of prosthesis users. Clinical relevance Activity monitoring offers an objective method for the assessment of upper limb prosthesis users' (PUs) activity outside of the clinic. By plotting data using Archimedean spirals, it is possible to visualise, in detail, the temporal patterns of upper limb activity. Further work is needed to explore the relationship between traditional functional outcome measures and real-world prosthesis activity.
Jiang, Fei-Fei; Hou, Yan; Lu, Li; Ding, Xiao-Xu; Li, Wei; Yan, Ai-Hui
2015-01-01
To evaluate the facial profiles and functional recovery of 18 patients treated by a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis) after total maxillectomy for malignant maxillary sinus tumor. A retrospective observational study was performed to evaluate the facial profiles and functional recovery of 18 patients with T3-4a N0 M0 maxillary sinus cancer, who were treated by total maxillectomy and simultaneous implantation of a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis). Follow-ups were performed 1, 3, 6, and 12 months after surgery. Facial measurements, speech intelligibility, and chewing and swallowing functions were examined. Thirteen patients converted to a permanent prosthesis 6 months after surgery. Comparisons were made between patients with and without the CAD/CAM or permanent prosthesis at various times using SPSS13.0 statistical software (SPSS Inc., Chicago, IL, USA). Speech intelligibility, facial depression, and eyeball prolapse results showed improvements with prosthesis use at 1, 3, and 6 months after surgery (p < 0.05). Swallowing function improved from level V to level II-IV with prosthesis use at 1, 3, and 6 months, and reached level I or II with permanent prosthesis use at 12 months after surgery. Simultaneous CAD/CAM prosthesis implantation recovered the facial profile, enhanced the speaking, swallowing, and chewing functions, and improved the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. Therefore, this operation is recommended for simultaneous excision repair and functional reconstruction after total maxillectomy. This surgical treatment of maxillary sinus cancer is applied rarely in China, but it has a good effect based on our observation. Simultaneous CAD/CAM prosthesis implantation after total maxillectomy can recover the facial profile, enhance the speaking, swallowing, and chewing functions, and improve the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. This technique avoids the need for dental implants because the bottom part of the prosthesis contains a palatal plate with dentures. © 2014 Wiley Periodicals, Inc.
Total knee replacement with natural rollback.
Wachowski, Martin Michael; Walde, Tim Alexander; Balcarek, Peter; Schüttrumpf, Jan Philipp; Frosch, Stephan; Stauffenberg, Caspar; Frosch, Karl-Heinz; Fiedler, Christoph; Fanghänel, Jochen; Kubein-Meesenburg, Dietmar; Nägerl, Hans
2012-03-20
A novel class of total knee replacement (AEQUOS G1) is introduced which features a unique design of the articular surfaces. Based on the anatomy of the human knee and differing from all other prostheses, the lateral tibial "plateau" is convexly curved and the lateral femoral condyle is posteriorly shifted in relation to the medial femoral condyle. Under compressive forces the configuration of the articular surfaces of human knees constrains the relative motion of femur and tibia in flexion/extension. This constrained motion is equivalent to that of a four-bar linkage, the virtual 4 pivots of which are given by the centres of curvature of the articulating surfaces. The dimensions of the four-bar linkage were optimized to the effect that constrained motion of the total knee replacement (TKR) follows the flexional motion of the human knee in close approximation, particularly during gait. In pilot studies lateral X-ray pictures have demonstrated that AEQUOS G1 can feature the natural rollback in vivo. Rollback relieves the load of the patello-femoral joint and minimizes retropatellar pressure. This mechanism should reduce the prevalence of anterior knee pain. The articulating surfaces roll predominantly in the stance phase. Consequently sliding friction is replaced by the lesser rolling friction under load. Producing rollback should minimize material wear due to friction and maximize the lifetime of the prosthesis. To definitely confirm these theses one has to wait for the long term results. Copyright © 2011 Elsevier GmbH. All rights reserved.
Replacement of the valvular prosthesis in a patient with a Bentall procedure.
Panos, A L; Teoh, K T; Wilson, J K; Salerno, T A
1992-09-01
Patients who have had the Bentall-DeBono procedure using a composite conduit with a tissue valvular prosthesis pose a great challenge when problems develop with the tissue prosthesis. We herein report the surgical management of one such case, in which the valvular prosthesis was removed and replaced without replacement of the conduit.
Vacuum form sheet as a guide for fabrication of orbital prosthesis.
Dugad, Jinesh A; Dholam, Kanchan P; Chougule, Arati T
2014-08-01
Rehabilitation with an orbital prosthesis is done when surgical reconstruction is not possible or affordable in patients with orbital exenteration. Fabrication of orbital prosthesis requires precision in placement of the ocular portion of the prosthesis on the facial moulage. This method describes the use of a vacuum formed sheet for making an orbital template that acts as a guide for achieving optimum orientation of the ocular portion of the prosthesis. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Management of an Anophthalmic Patient by the Fabrication of Custom Made Ocular Prosthesis
SINGH, Meenakshi; NAYAK, Meghanand; SOLANKI, Jitender; GUPTA, Sarika; SINGH, Anjali
2015-01-01
The loss or disfigurement of a body parts specially that pertaining to the face has a deep psychological and social impact on the patient. After enucleation, evisceration or exteneration of the eye, the aim of an ocular prosthesis should be to restore the natural appearance, install confidence and a sense social acceptability in the patient. Custom made prosthesis has several advantages over the stock eye prosthesis. This article illustrates rehabilitation of the enucleated right eye of a patient with a custom made ocular prosthesis. PMID:26715901
Design and preliminary biomechanical analysis of artificial cervical joint complex.
Jian, Yu; Lan-Tao, Liu; Zhao, Jian-ning; Jian-ning, Zhao
2013-06-01
To design an artificial cervical joint complex (ACJC) prosthesis for non-fusion reconstruction after cervical subtotal corpectomy, and to evaluate the biomechanical stability, preservation of segment movements and influence on adjacent inter-vertebral movements of this prosthesis. The prosthesis was composed of three parts: the upper/lower joint head and the middle artificial vertebrae made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy and polyethylene with a ball-and-socket joint design resembling the multi-axial movement in normal inter-vertebral spaces. Biomechanical tests of intact spine (control), Orion locking plate system and ACJC prosthesis were performed on formalin-fixed cervical spine specimens from 21 healthy cadavers to compare stability, range of motion (ROM) of the surgical segment and ROM of adjacent inter-vertebral spaces. As for stability of the whole lower cervical spine, there was no significant difference of flexion, extension, lateral bending and torsion between intact spine group and ACJC prosthesis group. As for segment movements, difference in flexion, lateral bending or torsion between ACJC prosthesis group and control group was not statistically significant, while ACJC prosthesis group showed an increase in extension (P < 0.05) compared to that of the control group. In addition, ACJC prosthesis group demonstrated better flexion, extension and lateral bending compared to those of Orion plating system group (P < 0.05). Difference in adjacent inter-vertebral ROM of the ACJC prosthesis group was not statistically significant compared to that of the control group. After cervical subtotal corpectomy, reconstruction with ACJC prosthesis not only obtained instant stability, but also reserved segment motions effectively, without abnormal gain of mobility at adjacent inter-vertebral spaces.
Use of prostheses in lower limb amputee patients due to peripheral arterial disease
Chamlian, Therezinha Rosane
2014-01-01
Objective To evaluate the indication of prosthesis during rehabilitation and the maintenance of their use or abandonment rate after discharge, as well as mortality of lower limb amputees due to peripheral arterial disease. Methods A retrospective and cross-sectional study carried out with lower limb amputee patients, at transfemoral and transtibial levels, due to vascular conditions. The sample was composed of 310 patients (205 men, 105 women, mean age 61.8 years), transfemoral (142) and transtibial (150) levels, unilateral or bilateral (18). A total of 217 were fitted with prosthesis and 93 did not. Nonparametric statistical tests with equality of two proportions, 95% confidence interval and p value <0,05 were used. Results Out of 195 patients we contacted, 151 were fitted with prosthesis and 44 not. Of those that were fitted with prosthesis, 54 still use it, 80 abandoned and 17 died. In the group without prosthesis, 27 were on wheelchair and 17 died. Mortality is statistically higher among patients who were not fitted with prosthesis and 34 death occur, on average, 3.91 years after amputation. Survival time of patients who were not fitted with prosthesis was smaller than those were fitted. Conclusion The use of prosthesis in lower limb amputees, due to vascular conditions, during rehabilitation is high. However, maintenance of prosthesis is not frequent after discharge. Early and high mortality is observed mainly among diabetic patients. PMID:25628194
Østlie, Kristin; Lesjø, Ingrid Marie; Franklin, Rosemary Joy; Garfelt, Beate; Skjeldal, Ola Hunsbeth; Magnus, Per
2012-11-01
To describe patterns of prosthesis wear and perceived prosthetic usefulness in adult acquired upper-limb amputees (ULAs). To describe prosthetic skills in activities of daily life (ADL) and the actual use of prostheses in the performance of ADL tasks. To estimate the influence of prosthetic skills on actual prosthesis use and the influence of background factors on prosthetic skills and actual prosthesis use. Cross-sectional study analysing population-based questionnaire data (n = 224) and data from interviews and clinical testing in a referred/convenience sample of prosthesis-wearing ULAs (n = 50). Effects were analysed using linear regression. 80.8% wore prostheses. 90.3% reported their most worn prosthesis as useful. Prosthetic usefulness profiles varied with prosthetic type. Despite demonstrating good prosthetic skills, the amputees reported actual prosthesis use in only about half of the ADL tasks performed in everyday life. In unilateral amputees, increased actual use was associated with sufficient prosthetic training and with the use of myoelectric vs cosmetic prostheses, regardless of amputation level. Prosthetic skills did not affect actual prosthesis use. No background factors showed significant effect on prosthetic skills. Most major ULAs wear prostheses. Individualised prosthetic training and fitting of myoelectric rather than passive prostheses may increase actual prosthesis use in ADL.
Kim, Young-Hoo; Yoon, Sung-Hwan; Kim, Jun-Shik
2009-02-01
Although the design features of the Medial Pivot fixed-bearing prosthesis reportedly improve kinematics compared with TKAs using fixed-bearings, clinical improvements have not been reported. We asked whether the clinical and radiographic outcomes, ranges of motion of the knee, patient satisfaction, and complication rates would be better in knees with a Medial Pivot fixed-bearing prosthesis than in those with a PFC Sigma mobile-bearing prosthesis. We compared the results of 92 patients who had a Medial Pivot fixed-bearing prosthesis implanted in one knee and a PFC Sigma mobile-bearing prosthesis implanted in the other. There were 85 women and seven men with a mean age of 69.5 years (range, 55-81 years). The minimum followup was 2 years (mean, 2.6 years; range, 2-3 years). The patients were assessed clinically and radiographically using the rating systems of the Hospital for Special Surgery and the Knee Society at 3 months, 1 year, and annually thereafter. Contrary to expectations, we found worse early clinical outcomes, smaller ranges of knee motion, less patient satisfaction, and a higher complication rate for the Medial Pivot fixed-bearing prosthesis than for the PFC Sigma mobile-bearing prosthesis. Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
Corona, Pablo S; Barro, Victor; Mendez, Marye; Cáceres, Enric; Flores, Xavier
2014-03-01
Industrially preformed antibiotic-loaded cement spacers are useful to facilitate the second stage of two-stage exchange arthroplasty for infected THAs and TKAs. However, whether gentamicin alone or a combination of antibiotics (such as vancomycin and gentamicin) is more effective is not known. We therefore sought to compare industrially prefabricated spacers containing either gentamicin or gentamicin and vancomycin with respect to (1) infection control, (2) complications, and (3) quality of life, pain, and patient satisfaction. We performed a review of 51 patients with chronic infections treated at one center using either gentamicin or vancomycin and gentamicin-prefabricated spacers. The former were used exclusively from January 2006 until May 2009, and the latter from June 2009 until July 2011, and there was no overlap. We collected data on demographics, immunologic status (McPherson classification), prosthetic joint infection location, type of prosthesis, microbiologic results, and time between stages. We evaluated the primary outcome of infection control or recurrence after at least 12 months followup. We also recorded complications. Each patient completed a quality-of-life survey, VAS, and a self-administered satisfaction scale. The overall infection control rate was 83% after a mean followup of 35 months (range, 12.4-64.7 months). There were no differences between gentamicin and vancomycin and gentamicin spacers in terms of infection eradication (80 % versus 85 %, respectively; p = 0.73), nor in terms of complications, quality of life, pain, or satisfaction scores. Prefabricated, antibiotic-loaded cement spacers has been proven effective for infection control in TKAs and THAs but with the numbers available, we did not find any differences between a gentamicin or vancomycin and gentamicin-prefabricated spacer, and therefore, we are unable to validate the superiority of the combination of vancomycin and gentamicin over gentamicin alone. Because of the higher costs involved with vancomycin and gentamicin spacers, and the potential risks of unselective use of vancomycin, further comparative studies are necessary to evaluate their role in the treatment of infected THAs or TKAs. Level III, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.
Anitua, Eduardo; Flores, Carlos; Piñas, Laura; Alkhraisat, Mohammad
2018-06-05
CAD-CAM technology permits the angular correction of screw emergence into the prosthesis, however there is lack of controlled clinical studies that assess the frequency of technical complications in angled screw channel restorations. This controlled clinical study was designed to assess technical incidences in angled screw channel restorations. Patients having implant prosthesis placed between November, 2014 and December, 2015 were screened. The patients were selected if they received prosthesis with up to 30º correction of the prosthesis screw emergence and had at least one non-angulated prosthesis (screw-retained). All the prostheses were located completely/partially in the posterior region. The frequency of technical complications was the principal variable. A total of 52 patients with a mean age of 62 ± 10 years participated with a total 110 prostheses (55 in the test group and 55 in the control group). A total of 11 technical complications occurred (7 in the test group and 4 in the control group). These differences were not statistically significant. All the prostheses in both groups survived the follow-up. The correction of the screw emergence into the prosthesis has not increased the risk of technical complications in CAD-CAM implant prostheses.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Janik, Gregory
Renders, saves, and analyzes pressure from several sensors in a prosthesis socket. The program receives pressure data from 64 manometers and parses the pressure for each individual sensor. The program can then display those pressures as number in a table. The program also interpolates pressures between manometers to create a larger set of data. This larger set of data is displayed as a simple contour plot. That same contour plot can also be placed on a three-dimensional surface in the shape of a prosthesis.This program allows for easy identification of high pressure areas in a prosthesis to reduce the usersmore » discomfort. The program parses the sensor pressures into a human-readable numeric format. The data may also be used to actively adjust bladders within the prosthesis to spread out pressure in real time, according to changing demands placed on the prosthesis. Interpolation of the pressures to create a larger data set makes it even easier for a human to identify particular areas of the prosthesis that are under high pressure. After identifying pressure points, a prosthetician can then redesign the prosthesis and/or command the bladders in the prosthesis to attempt to maintain constant pressures.« less
NASA Astrophysics Data System (ADS)
Kelly, Jacque L.; Fu, Bin; Kita, Noriko T.; Valley, John W.
2007-08-01
A detailed oxygen isotope study of detrital quartz and authigenic quartz overgrowths from shallowly buried (<1 km) quartz arenites of the St. Peter Sandstone (in SW Wisconsin) constrains temperature and fluid sources during diagenesis. Quartz overgrowths are syntaxial (optically continuous) and show complex luminescent zonation by cathodoluminescence. Detrital quartz grains were separated from 53 rocks and analyzed for oxygen isotope ratio by laser fluorination, resulting in an average δ 18O of 10.0 ± 0.2‰ (1SD, n = 109). Twelve thin sections were analyzed by CAMECA-1280 ion microprobe (6-10 μm spot size, analytical precision better than ±0.2‰, 1SD). Detrital quartz grains have an average δ 18O of 10.0 ± 1.4‰ (1SD, n = 91) identical to the data obtained by laser fluorination. The ion microprobe data reveal true variability that is otherwise lost by homogenization of powdered samples necessary for laser fluorination. Laser fluorination uses samples that are one million times larger than the ion microprobe. Whole rock (WR) samples from the 53 rocks were analyzed by laser fluorination, giving δ 18O between 9.8‰ and 16.7‰ ( n = 110). Quartz overgrowths in thin sections from 10 rocks were analyzed by ion microprobe and average δ 18O = 29.3 ± 1.0‰ (1SD, n = 161). Given the similarity, on average, of δ 18O for all detrital quartz grains and for all quartz overgrowths, samples with higher δ 18O(WR) values can be shown to have more cement. The quartz cement in the 53 rocks, calculated by mass balance, varies from <1 to 21 vol.% cement, with one outlier at 33 vol.% cement. Eolian samples have an average of 11% cement compared to marine samples, which average 4% cement. Two models for quartz cementation have been investigated: high temperature (50-110 °C) formation from ore-forming brines related to Mississippi Valley Type (MVT) mineralization and formation as silcretes at low temperature (10-30 °C). The homogeneity of δ 18O for quartz overgrowths determined by ion microprobe rules out a systematic regional variation of temperature as predicted for MVT brines and there are no other known heating events in these sediments that were never buried to depths >1 km. The data in this study suggest that quartz overgrowths formed as silcretes in the St. Peter Sandstone from meteoric water with δ 18O values of -10‰ to -5‰ at 10-30 °C. This interpretation runs counter to conventional wisdom based on fibrous or opaline silica cements suggesting that the formation of syntaxial quartz overgrowths requires higher temperatures. While metastable silica cements commonly form at high degrees of silica oversaturation following rapid break-down reactions of materials such as of feldspars or glass, the weathering of a clean quartz arenite is slower facilitating chemical equilibrium and precipitation of crystallographically oriented overgrowths of α-quartz.
Simulation of a slope adapting ankle prosthesis provided by semi-active damping.
LaPrè, Andrew K; Sup, Frank
2011-01-01
Modern passive prosthetic foot/ankles cannot adapt to variations in ground slope. The lack of active adaptation significantly compromises an amputee's balance and stability on uneven terrains. To address this deficit, this paper proposes an ankle prosthesis that uses semi-active damping as a mechanism to provide active slope adaptation. The conceptual ankle prosthesis consists of a modulated damper in series with a spring foot that allows the foot to conform to the angle of the surface in the sagittal plane. In support of this approach, biomechanics data is presented showing unilateral transtibial amputees stepping on a wedge with their daily-use passive prosthesis. Based on this data, a simulation of the ankle prosthesis with semi-active damping is developed. The model shows the kinematic adaptation of the prosthesis to sudden changes in ground slope. The results show the potential of an ankle prosthesis with semi-active damping to actively adapt to the ground slope at each step.
Ishii, Yoshinori; Noguchi, Hideo; Sato, Junko; Sakurai, Tetsuya; Toyabe, Shin-Ichi
2017-11-01
It is still controversial whether anteroposterior (AP) translation magnitude after total knee arthroplasty (TKA) affects clinical outcomes, particularly range of motion (ROM). This study examined the following two questions: (1) are AP translations at the mid- and long-term follow-up different for knees within the same patient treated with posterior cruciate ligament-retaining (PCLR) versus posterior cruciate ligament-substituting (PCLS) mobile-bearing TKA prosthesis designs? (2) Is the ROM at the mid- and long-term follow-up for knees treated with PCLR and PCLS designs correlated with the AP translation? Thirty-seven patients undergoing sequential bilateral TKA for osteoarthritis were prospectively enrolled. Patients received a PCLR implant in one knee and a PCLS implant in the other and were followed-up for an average 9.8 ± 3.2 years. The AP translations at 30° and 75° of knee flexion and the ROM of both knees were assessed. The implant design (p < 0.001), but not flexion angle (n.s.), had a significant effect on AP translation. AP translation values were larger in PCLR knees than in PCLS knees at both flexion angles (p < 0.0001). The ROM at the final follow-up in the two implant designs was similar (both 115°, n.s.). There was a weak correlation between ROM and AP translation at 30° in the PCLR knees (r = 0.397, p = 0.015), but no correlation at 75° or in the PCLS knees. Differently constrained prosthesis designs resulted in significantly different AP translational values within the same patient. This indicates that achieving good clinical outcomes and ROM after TKA may not be strongly influenced by the specifics of each patient's anatomical characteristics, but instead by knee constrainment. Clinically, this means that surgeons should familiarize themselves with the AP translation of the implant being used, as this may be the most important factor for optimizing outcomes after mobile-bearing TKA. Level of evidence II, prospective, comparative study.
Ozkunt, Okan; Sariyilmaz, Kerim; Gemalmaz, Halil Can; Dikici, Fatih
2018-01-01
It is a randomized study to compare cement penetration on x-rays after total knee arthroplasty (TKA) among 3 different ways to use tourniquets; application during the surgery, application only with implantation prosthesis and with no tourniquet use. A total 69 knees of 59 patients were included in the study in a quasirandom manner. Each patient had physical exams and standard radiographic evaluations at 6 weeks after the TKA procedure. Outcome evaluations included visual analog scale (VAS) scores, Knee Society Scores (KSS), blood transfusion, and drainage status after surgery for all groups. For radiographic review, the tibial plateau was divided into zones in the anterior-posterior and lateral views, according to the Knee Society Scoring System. The average age of the patients who were eligible for the study was 65.05 (range 46-81) years. All 59 patients included in the study were female patients. Group 1 consisted of 24 patients who had TKA with use of a tourniquet during the entire operation. Group 2 consisted of 20 patients who had TKA with use of tourniquet only at the time of cementing and group 3 consisted of 25 patients with no use tourniquet. There is no significant difference in early cement penetration among the groups (group 1 2.50 mm, group 2 2.28 mm, group 3 2.27 mm; group 1 vs 2 P = .083, group 1 vs 3 P = .091, group 2 vs 3 P = .073). There is no significant difference for postoperative drainage among the 3 groups (group 1 245 mL, group 2 258.76 mL, group 3 175.88 mL; group 1 vs 2 P = .081, group 1 vs 3 P = .072, group 2 vs 3 P = .054). There was no need to transfuse more than 1 unit in any patient. The VAS score was significantly higher (group 1 3.58, group 2 1.55, group 3 1.52; group 1 vs 2 P = .022, group 1 vs 3 P = .018, group 2 vs 3 P = .062) and KSS was significantly lower in the tourniquet group (group 1 63, group 2 79, group 3 82; group 1 vs 2 P = .017, group 1 vs 3 P = .02, group 2 vs 3 P = .082). We do not suggest long-duration tourniquet use, which can lead higher pain scores and reduce functional recovery after total knee arthroplasty.
Lou, Jigang; Li, Yuanchao; Wang, Beiyu; Meng, Yang; Wu, Tingkui; Liu, Hao
2017-01-01
Abstract In vitro biomechanical analysis after cervical disc replacement (CDR) with a novel artificial disc prosthesis (mobile core) was conducted and compared with the intact model, simulated fusion, and CDR with a fixed-core prosthesis. The purpose of this experimental study was to analyze the biomechanical changes after CDR with a novel prosthesis and the differences between fixed- and mobile-core prostheses. Six human cadaveric C2–C7 specimens were biomechanically tested sequentially in 4 different spinal models: intact specimens, simulated fusion, CDR with a fixed-core prosthesis (Discover, DePuy), and CDR with a mobile-core prosthesis (Pretic-I, Trauson). Moments up to 2 Nm with a 75 N follower load were applied in flexion–extension, left and right lateral bending, and left and right axial rotation. The total range of motion (ROM), segmental ROM, and adjacent intradiscal pressure (IDP) were calculated and analyzed in 4 different spinal models, as well as the differences between 2 disc prostheses. Compared with the intact specimens, the total ROM, segmental ROM, and IDP at the adjacent segments showed no significant difference after arthroplasty. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment (C5/6) and total ROM than CDR with a fixed-core prosthesis (P > .05). Besides, the difference in IDP at C4/5 after CDR with 2 prostheses was without statistical significance in all the directions of motion. However, the IDP at C6/7 after CDR with a mobile-core prosthesis was lower than CDR with a fixed-core prosthesis in flexion, extension, and lateral bending, with significant difference (P < .05), but not under axial rotation. CDR with a novel prosthesis was effective to maintain the ROM at the target segment and did not affect the ROM and IDP at the adjacent segments. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment and total ROM, but lower IDP at the inferior adjacent segment than CDR with a fixed-core prosthesis. PMID:29019902
Yi, Seong; Kim, Keung Nyun; Yang, Moon Sul; Yang, Joong Won; Kim, Hoon; Ha, Yoon; Yoon, Do Heum; Shin, Hyun Chul
2010-07-15
Retrospective study of the difference of heterotopic ossification (HO) occurrence according to 3 different types of prosthesis. This study was designed to investigate the difference of HO occurrence according to different type of prosthesis. HO is defined as formation of the bone outside the skeletal system. Reported HO occurrence rate in cervical artificial disc replacement (ADR) was unexpectedly high and varied. But the influencing factors of HO in cervical ADR have not been elucidated well. The prosthesis-related factors for making difference of HO occurrence were investigated in this study. A total of 170 patients undergoing cervical arthroplasty with the Bryan cervical disc prosthesis (Medtroic Sofamor Danek, Memphis, TN), Mobi-C disc prosthesis (LDR Medical, Troyes, France), and ProDisc-C (Synthes, Inc., West Chester, PA) were included. Cervical lateral radiographs obtained before and after surgery were used to identify HO. Occurrence rate, occurrence-free period, location, and grade of HOs were investigated according to the different prosthesis. Each prosthesis group included patients as follows: Bryan disc, 81 patients; Mobi-C, 61 patients; and ProDisc-C, 28 patients. Overall HO rate was 40.6% (69 of 170 patients). Each HO occurrence rate by prosthesis was as follows: the Bryan disc group, 21.0%; Mobi-C group, 52.5%; and the ProDisc-C group, 71.4%. In the survival analysis, all patients showed 27.1 +/- 3.7 months as the median survival. The Bryan disc group showed statistically longer survival (48.4 +/- 7.4 months) than the other groups. Occurrence of HO is an inevitable postoperative complication after cervical ADR. The occurrence rate of HO was higher than our expectation. Moreover, definite differences in occurrence rate according to the prosthesis type were identified by this study.
Hu, Jia; Qian, Hong; Li, Ya-jiao; Gu, Jun; Zhao, Jing Janice; Zhang, Er-yong
2014-01-17
The study was designed to evaluate the effects of moderate prosthesis-patient mismatch (defined as 0.65 cm(2)/m(2)
Yu, Xiu-chun; Xu, Ming; Song, Ruo-xian; Fu, Zhi-hou; Liu, Xiao-ping
2010-08-01
To study the long-term outcomes and complications of giant cell tumors around the knee treated with en bloc resection and reconstruction with prosthesis. From January 1991 to March 2005, 19 patients (11 men, 8 women, average age 35.4 years) were treated in our hospital with en bloc resection and reconstruction with domestic prosthesis (15 hinge knee and 4 rotating-hinge knee). The distal femur was involved in 12 and the proximal tibia in 7 cases. Nine tumors were primary and 10 recurrent. All cases were Campanacci grade III. The affected limb functions were evaluated by the Musculoskeletal Tumor Society scoring system. All patients underwent operation successfully with no complications. The mean follow-up time was 128.9 months (60 to 216 months). Apart from one patient who underwent amputation because of wound infection two years after reoperation, the range of knee motion of 18 patients was 30°-110°. The mean functional score of the affected limb was 22.7 (15 to 27 points). The length of the lower extremities was equal in nine cases; the affected limb was 2-9 cm shorter in the other ten cases. Prosthesis fracture and loosening developed in one, prosthesis aseptic loosening in three, and delayed deep infection and prosthesis loosening in two cases. The prosthesis loosening rate was 31.6%. One patient developed a proximal femur fracture. En bloc resection and reconstruction with prosthesis is a feasible method for treating giant cell tumor of bone around the knee. Complications related to the prosthesis, mainly prosthesis loosening and limb shortening, increase gradually with longer survival time. © 2010 Tianjin Hospital and Blackwell Publishing Asia Pty Ltd.
Kaneko, Takahiro; Yamagishi, Kiyoshi; Horie, Norio; Shimoyama, Tetsuo
2013-01-01
To evaluate the clinical outcome of a novel open-tray impression technique for fabrication of a provisional prosthesis supported by immediately loaded implants in a completely edentulous arch. An open-tray impression technique was evaluated in this retrospective study that included patients treated between March 2006 and October 2009. Preoperatively, a diagnostic prosthesis was delivered, and a novel open tray was fabricated based on this prosthesis. After implant placement, the impression and interocclusal record were taken simultaneously using the novel open tray. Laboratory-fabricated, screw-retained, all-acrylic resin provisional restorations were delivered on the same day of surgery. The prosthesis was assessed from the day of surgery until replacement with a definitive prosthesis. The study included 21 patients (mean age, 64.5 years) and a total of 125 implants. Of these, 104 implants were immediately loaded. In all patients, well-fitting provisional restorations supported by a minimum of four implants were delivered. Fracture of the first molar cusp was observed in one case after 30 days. However, there was no extensive fracture in the framework or functional disorder of the prosthesis. No implant failed during the follow-up after implant surgery. This protocol enabled fabrication of a well-fitting acrylic resin provisional prosthesis supported by immediately loaded implants because the impression was taken while in centric occlusion and an occlusion identical to the diagnostic prosthesis could be reconstructed.
2015-10-01
Modulated Sensory Feedback from, a Hand Prosthesis PRINCIPAL INVESTIGATOR: Bradley Greger, PhD CONTRACTING ORGANIZATION: Arizona State University...Residual Peripheral Nerves to Provide Dextrous Control of, and Modulated Sensory Feedback from, a Hand Prosthesis 5a. CONTRACT NUMBER 5b. GRANT...Peripheral Nerve Interface, Prosthetic Hand, Neural Prosthesis , Sensory Feedback, Micro-stimulation, Electrophysiology, Action Potentials, Micro
Liu, Hongwei; Weng, Yiping; Zhang, Yunkun; Xu, Nanwei; Tong, Jing; Wang, Caimei
2015-09-01
To study the feasibility of preparation of the individualized femoral prosthesis through computer assisted design and electron beammelting rapid prototyping (EBM-RP) metal three-dimensional (3D) printing technology. One adult male left femur specimen was used for scanning with 64-slice spiral CT; tomographic image data were imported into Mimics15.0 software to reconstruct femoral 3D model, then the 3D model of individualized femoral prosthesis was designed through UG8.0 software. Finally the 3D model data were imported into EBM-RP metal 3D printer to print the individualized sleeve. According to the 3D model of individualized prosthesis, customized sleeve was successfully prepared through the EBM-RP metal 3D printing technology, assembled with the standard handle component of SR modular femoral prosthesis to make the individualized femoral prosthesis. Customized femoral prosthesis accurately matching with metaphyseal cavity can be designed through the thin slice CT scanning and computer assisted design technology. Titanium alloy personalized prosthesis with complex 3D shape, pore surface, and good matching with metaphyseal cavity can be manufactured by the technology of EBM-RP metal 3D printing, and the technology has convenient, rapid, and accurate advantages.
Deijs, M; Bongers, R M; Ringeling-van Leusen, N D M; van der Sluis, C K
2016-03-15
The current study examines the relevance of prosthetic wrist movement to facilitate activities of daily living or to prevent overuse complaints. Prosthesis hands with wrist flexion/extension capabilities are commercially available, but research on the users' experiences with flexible wrists is limited. In this study, eight transradial amputees using a myoelectric prosthesis tested two prosthesis wrists with flexion/extension capabilities, the Flex-wrist (Otto Bock) and Multi-flex wrist (Motion Control), in their flexible and static conditions. Differences between the wrists were assessed on the levels of functionality, user satisfaction and compensatory movements after two weeks use. No significant differences between flexible and static wrist conditions were found on activity performance tests and standardized questionnaires on satisfaction. Inter-individual variation was remarkably large. Participants' satisfaction tended to be in favour of flexible wrists. All participants but one indicated that they would choose a prosthesis hand with wrist flexion/extension capabilities if allowed a new prosthesis. Shoulder joint angles, reflecting compensatory movements, showed no clear differences between wrist conditions. Overall, positive effects of flexible wrists are hard to objectify. Users seem to be more satisfied with flexible wrists. A person's needs, work and prosthesis skills should be taken into account when prescribing a prosthesis wrist. Nederlands Trial Register NTR3984 .
Berookhim, Boback M; Karpman, Edward; Carrion, Rafael
2015-11-01
The surgical treatment of comorbid erectile dysfunction and Peyronie's disease has long included the implantation of an inflatable penile prosthesis as well as a number of adjuvant maneuvers to address residual curvature after prosthesis placement. To review the various surgical options for addressing curvature after prosthesis placement, with specific attention paid to an original article by Wilson et al. reporting on modeling over a penile prosthesis for the management of Peyronie's disease. A literature review was performed analyzing articles reporting the management of penile curvature in patients undergoing implantation of an inflatable penile prosthesis. Reported improvement in Peyronie's deformity as well as the complication rate associated with the various surgical techniques described. Modeling is a well-established treatment modality among patients with Peyronie's disease undergoing penile prosthesis implantation. A variety of other adjuvant maneuvers to address residual curvature when modeling alone is insufficient has been presented in the literature. Over 20 years of experience with modeling over a penile prosthesis have proven the efficacy and safety of this treatment option, providing the surgeon a simple initial step for the management of residual curvature after penile implantation which allows for the use of additional adjuvant maneuvers in those with significant deformities. © 2015 International Society for Sexual Medicine.
Active upper limb prosthesis based on natural movement trajectories.
Ramírez-García, Alfredo; Leija, Lorenzo; Muñoz, Roberto
2010-03-01
The motion of the current prostheses is sequential and does not allow natural movements. In this work, complex natural motion patterns from a healthy upper limb were characterized in order to be emulated for a trans-humeral prosthesis with three degrees of freedom at the elbow. Firstly, it was necessary to define the prosthesis workspace, which means to establish a relationship using an artificial neural network (ANN), between the arm-forearm (3-D) angles allowed by the prosthesis, and its actuators length. The 3-D angles were measured between the forearm and each axis of the reference system attached at the elbow. Secondly, five activities of daily living (ADLs) were analyzed by means of the elbow flexion (EF), the forearm prono-supination (FPS) and the 3-D angles, from healthy subjects, by using a video-based motion analysis system. The 3-D angles were fed to the prosthesis model (ANN) in order to analyze which ADLs could be emulated by the prosthesis. As a result, a prosthesis kinematics approximation was obtained. In conclusion, in spite of the innovative mechanical configuration of the actuators, it was possible to carry out only three of the five ADLs considered. Future work will include improvement of the mechanical configuration of the prosthesis to have greater range of motion.
Vallejo, Luis A; Manzano, María T; Hidalgo, Antonio; Hernández, Alberto; Sabas, Juan; Lara, Hugo; Gil-Carcedo, Elisa; Herrero, David
One of the problems with total ossicular replacement prostheses is their stability. Prosthesis dislocations and extrusions are common in middle ear surgery. This is due to variations in endo-tympanic pressure as well as design defects. The design of this new prosthesis reduces this problem by being joined directly to the malleus handle. The aim of this study is to confirm adequate acoustic-mechanical behaviour in fresh cadaver middle ear of a new total ossicular replacement prosthesis, designed using the finite elements method. Using the doppler vibrometer laser, we analysed the acoustic-mechanical behaviour of a new total ossicular replacement prosthesis in the human middle ear using 10 temporal bones from fresh cadavers. The transfer function of the ears in which we implanted the new prosthesis was superimposed over the non-manipulated ear. This suggests optimum acoustic-mechanical behaviour. The titanium prosthesis analysed in this study demonstrated optimum acoustic-mechanical behaviour. Together with its ease of implantation and post-surgical stability, these factors make it a prosthesis to be kept in mind in ossicular reconstruction. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.
Zollinger, Paul E; Unal, Halil; Ellis, Maarten L; Tuinebreijer, Wim E
2010-02-17
Complex regional pain syndrome (CRPS) type I may occur as complication after any type of surgery for basal joint arthritis of the thumb. We investigated prospectively in an ongoing study our results after a fully standardized treatment with a total joint prosthesis under vitamin C prophylaxis.Patients with trapeziometacarpal arthritis stage II or III according to Dell, and no benefit from conservative treatment, were selected to undergo joint replacement with a semi-constrained hydroxyapatite coated prosthesis.First web opening and visual analogue scale (VAS) scores for pain, activities of daily living (ADL) and satisfaction were taken pre and postoperatively. Vitamin C 500 mg daily was started two days prior to surgery during 50 days as prevention for CRPS. Post-operative treatment was functional.We performed 40 implantations for trapeziometacarpal arthritis in 34 patients (mean age 60.8 years; 27 females, 7 males) with a mean follow-up of 44 months. Operations were performed in day care under regional (or general) anesthesia.First web opening increased with 15.4 degrees and there was a significant improvement for pain, ADL and satisfaction as well (p = 0.000). Patient satisfaction was strongly associated with the amount of pain reduction. According to the Veldman and IASP criteria, there were no cases of CRPS.The overall complication rate for this procedure is high. Literature reports 5 cases of CRPS after 38 operations with the same implant (13%). We advise vitamin C as prophylaxis against CRPS in trapeziometacarpal joint replacement.
Basic Science Considerations in Primary Total Hip Replacement Arthroplasty
Mirza, Saqeb B; Dunlop, Douglas G; Panesar, Sukhmeet S; Naqvi, Syed G; Gangoo, Shafat; Salih, Saif
2010-01-01
Total Hip Replacement is one of the most common operations performed in the developed world today. An increasingly ageing population means that the numbers of people undergoing this operation is set to rise. There are a numerous number of prosthesis on the market and it is often difficult to choose between them. It is therefore necessary to have a good understanding of the basic scientific principles in Total Hip Replacement and the evidence base underpinning them. This paper reviews the relevant anatomical and biomechanical principles in THA. It goes on to elaborate on the structural properties of materials used in modern implants and looks at the evidence base for different types of fixation including cemented and uncemented components. Modern bearing surfaces are discussed in addition to the scientific basis of various surface engineering modifications in THA prostheses. The basic science considerations in component alignment and abductor tension are also discussed. A brief discussion on modular and custom designs of THR is also included. This article reviews basic science concepts and the rationale underpinning the use of the femoral and acetabular component in total hip replacement. PMID:20582240
Post and core build-ups in crown and bridge abutments: Bio-mechanical advantages and disadvantages.
Mamoun, John
2017-06-01
Dentists often place post and core buildups on endodontically treated abutments for crown and bridge restorations. This article analyzes the bio-mechanical purposes, advantages and disadvantages of placing a core or a post and core in an endodontically treated tooth and reviews literature on post and core biomechanics. The author assesses the scientific rationale of the claim that the main purpose of a post is to retain a core, or the claim that posts weaken teeth. More likely, the main function of a post is to help prevent the abutment, on which a crown is cemented, from fracturing such that the abutment separates from the tooth root, at a fracture plane that is located approximately and theoretically at the level of the crown (or ferrule) margin. A post essentially improves the ferrule effect that is provided by the partial fixed denture prosthesis. This paper also explores the difference between bio-mechanical failures of crowns caused by lack of retention or excess taper, versus failures due to a sub-optimal ferrule effect in crown and bridge prostheses.
Polat, Beldan; Orhan, Kadir Serkan; Kesimli, Mustafa Caner; Gorgulu, Yasemin; Ulusan, Murat; Deger, Kemal
2015-11-01
This study aims to evaluate the effects of voice rehabilitation with indwelling voice prosthesis on quality of life, depression, anxiety, self-esteem, and sexual functions in laryngectomy patients. Provox-1 was applied to 30 patients who underwent total laryngectomy by opening a tracheoesophageal fistula. WHO Quality of Life-BREF, Beck Depression Inventory, Beck Anxiety Inventory, Rosenberg Self-Esteem Scale, Arizona Sexual Experience Scale forms were asked to be filled out by the patients before voice prosthesis application. These tests were asked to be filled out again 3 months later after the voice prosthesis application. Paired samples and Wilcoxon tests were used to compare before and after operation values. Indwelling voice prosthesis was found to improve quality of life, self-esteem, and sexual function (p < 0.05). Additionally, symptoms of depression and anxiety were regressed (p < 0.05). Indwelling voice prosthesis was found to especially increase the quality of life and decrease depression (p < 0.05). This study is an uncontrolled single-arm study comparing patients' psychosocial statuses pre- and post-voice prosthesis.
Effect of Framework in an Implant-Supported Full-Arch Fixed Prosthesis: 3D Finite Element Analysis.
Menini, Maria; Pesce, Paolo; Bevilacqua, Marco; Pera, Francesco; Tealdo, Tiziano; Barberis, Fabrizio; Pera, Paolo
2015-01-01
The aim of this study was to analyze through a three-dimensional finite element analysis (3D-FEA) stress distribution on four implants supporting a full-arch implant-supported fixed prosthesis (FFP) using different prosthesis designs. A 3D edentulous maxillary model was created and four implants were virtually placed into the maxilla and splinted, simulating an FFP without framework, with a cast metal framework, and with a carbon fiber framework. An occlusal load of 150 N was applied, stresses were transmitted into peri-implant bone, and prosthodontic components were recorded. 3D-FEA revealed higher stresses on the implants (up to +55.16%), on peri-implant bone (up to +56.93%), and in the prosthesis (up to +70.71%) when the full-acrylic prosthesis was simulated. The prosthesis with a carbon fiber framework showed an intermediate behavior between that of the other two configurations. This study suggests that the presence of a rigid framework in full-arch fixed prostheses provides a better load distribution that decreases the maximum values of stress at the levels of implants, prosthesis, and maxillary bone.
Babiak, Ireneusz
2012-07-03
Deep infection of a joint endoprosthesis constitutes a threat to the stability of the implant and joint function. It requires a comprehensive and interdisciplinary approach, involving the joint revision and removal of the bacterial biofilm from all tissues, the endoprosthesis must be often removed and bone stock infection treated. The paper presents the author's experience with the use of acrylic cement spacers, custom-made during the surgery and containing low dose of an antibiotic supplemented with 5% of a selected, targeted antibiotic for the infection of hip and knee endoprostheses. 33 two-stage revisions of knee and hip joints with the use of a spacer were performed. They involved 24 knee joints and 9 hip joints. The infections were mostly caused by staphylococci MRSA (18) and MSSA (8), and in some cases Enterococci (4), Salmonella (1), Pseudomonas (1) and Acinetobacter (1). The infection was successfully treated in 31 out of 33 cases (93.93%), including 8 patients with the hip infection and 23 patients with the knee infection. The endoprosthesis was reimplanted in 30 cases: for 7 hips and 23 knees, in 3 remaining cases the endoprosthesis was not reimplanted. Mechanical complications due to the spacer occurred in 4 cases: 3 dislocations and 1 fracture (hip spacer). The patients with hip spacers were ambulatory with a partial weight bearing of the operated extremity and those with knee spacers were also ambulatory with a partial weight bearing, but the extremity was initially protected by an orthosis. The spacer enables to maintain a limb function, and making it by hand allows the addition of the specific bacteria targeted antibiotic thus increasing the likelihood of the effective antibacterial treatment.
Nawaz, S Z; Keightley, A J; Desai, A; Granville-Chapman, J; Elliott, D; Newman, K; Khaleel, A
2017-04-01
A Cochrane review influenced new NICE guidelines, which recommended surgeons: Offer cemented implants to patients undergoing surgery with arthroplasty. However our trust routinely uses HAC uncemented stem (Taperloc ® , Biomet) hemiarthroplasties. A review of a consecutive series of uncemented HAC stem hemiarthroplasties including measures such as intro-operative complications, mortality and revision surgery. Prospectively collected data between January 2008 and June 2014 was used, with medical record and radiographic reviews performed. 810 consecutive Taperloc uncemented hemiarthroplasty with monopolar heads were performed in 763 patients, with a minimum 12 month follow-up (12-90) follow-up. Mean age 83yrs; 71% female. Meantime to operation was 28.5h. 30day mortality: 4.4% (33/763). One year mortality was 11.2% (89/763). 2.5% (20/810) were admitted on a separate admission with the periprosthetic fracture. 0.6% (5/810) were revised to total hip replacement for subsidence and associated pain. Only 1% (8/810) had intraoperative calcar fractures, all of which were treated with intraoperative cabling with no evidence of clinically relevant subsidence or medium term complications requiring revision surgery within a year. To the author's knowledge this is largest outcome series for modern design uncemented hemiarthroplasty. Our study shows comparable data to cemented hemiarthroplasty but no deaths in the first 2days post-op. Our series also demonstrates a well below average mortality figures which are clearly multifactorial but believe uncemented prosthesis play a role. We believe that uncemented proven stem design hemiarthroplasty remains a safe and good surgical option for displaced intracapsular fractures. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.
Wang, Yu-guang; Xing, Yan-xi; Sun, Yu-chun; Zhao, Yi-jiao; Lü, Pei-jun; Wang, Yong
2013-06-01
To evaluate clinical effects of computer aided design and computer aided manufacturing (CAD/CAM) milled zirconia crown in three aspects: aesthetic, contact wear and fracture. Sixty patients were divided into two groups.In one group, 35 full contour CAD/CAM zirconia crown were made on molars of 30 patients. The manufacturing process of zirconia crown was as follow. First, the three dimensional(3-D) data of working models, antagonist impression and check records were acquired by 3-D laser scanning Dental wings S50. Then full contour zirconia crowns, which had functional occlusal contacts with antagonistic teeth, and appropriate contact with adjacent teeth were designed with Zeno-CAD(V4.2.5.5.12919) software. ZENOSTAR Zr pure zirconia material was milled in digital controlled machine WIELAND 4030 M1.In the end, the zirconia crown were completed with the method of second sintering and polishing. After clinical try-in, the crown was cemented.In the control group, thirty gold alloy full crown were made and cemented on molars of 30 patients. According to the modified U S Public Health Service Criteria(USPHS) evaluation standard, all crowns were evaluated on the same day, at three months, half a year, one year and two years following delivery. There were three aspects we were focusing on in the evaluation: aesthetic, contact wear(restoration and antagonist), and fracture. In all the prosthesis we evaluated during the 24 months, no fracture was found. Contact wear of crowns varies according to different antagonist teeth. The zirconia crowns show privilege in aesthesis, toughness and anti-wearing.However, there is contact wear on antagonistic natural teeth. Thus it is a good choice when full zirconia crowns are indicated on two antagonistic teeth in both jaws.
Control and Evaluation of a Powered Transfemoral Prosthesis for Stair Ascent.
Ledoux, Elissa D; Goldfarb, Michael
2017-07-01
This paper assesses the metabolic effort exerted by three transfemoral amputees, when using a powered knee and ankle prosthesis for stair ascent, relative to ascending stairs with passive knee and ankle prostheses. The paper describes a controller that provides step-over stair ascent behavior reflective of healthy stair ascent biomechanics, and describes its implementation in a powered prosthesis prototype. Stair ascent experiments were performed with three unilateral transfemoral amputee subjects, comparing the oxygen consumption required to ascend stairs using the powered prosthesis (with a step-over gait), relative to using their daily-use energetically passive prostheses (with a step-to gait). Results indicate on average a 24% reduction in oxygen consumption and a 30% reduction in stair ascent timewhen using the powered prosthesis, relative to when using the passive prostheses. All subjects expressed a strong preference for ascending stairs using the powered prosthesis.
Jain, Sumeet; Jain, Parul
2016-01-01
Squamous cell carcinoma of the eyelid is the second most common malignant neoplasm of the eye with the incidence of 0.09 and 2.42 cases/100 000 people. Orbital invasion is a rare complication but, if recognized early, can be treated effectively with exenteration. Although with advancements in technology such as computer-aided design and computer-aided manufacturing, material science, and retentive methods like implants, orbital prosthesis with stock ocular prosthesis made of methyl methacrylate retained by anatomic undercuts is quiet effective and should not be overlooked and forgotten. This clinical report describes prosthetic rehabilitation of two male patients with polymethyl methacrylate resin orbital prosthesis after orbital exenteration, for squamous cell carcinoma of the upper eyelid. The orbital prosthesis was sufficiently retained by hard and soft tissue undercuts without any complications. The patients using the prosthesis are quite satisfied with the cosmetic results and felt comfortable attending the social events.
Catastrophic metallosis after tumoral knee prosthesis failure: A case report.
La Verde, Luca; Fenga, Domenico; Spinelli, Maria Silvia; Campo, Francesco Rosario; Florio, Michela; Rosa, Michele Attilio
2017-01-01
Metallosis is a condition characterized by an infiltration of periprosthetic soft tissues and bone by metallic debris resulting from wear or failure of joint arthroplasties. Authors describe a case of a 45-year-old man treated for an osteosarcoma of the distal femur with a modular prosthesis when he was 18 years old, he developed massive metallosis with skin dyspigmentation after 17 years. His medical\\surgical history was remarkable for a left tumoral knee prosthesis implanted 21 years ago. Two years before revision, the patient had a car accident with a two-points prosthesis breakage and despite the surgeon's advice, the patient refused surgery. In two years, prosthesis malfunction caused a progressive catastrophic soft tissues infiltration of metallic debris. Authors suggest that if prosthesis fracture is detected, revision surgery should be attempted as earlier as possible. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.