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 888.3200 - 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...

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 888.3310 - 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 888.3800 - 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 888.3120 - 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 888.3160 - 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 888.3310 - 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 888.3800 - 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 888.3310 - 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 888.3110 - 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 888.3310 - 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 888.3800 - 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 888.3120 - 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 888.3160 - 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 888.3310 - 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 888.3110 - 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 888.3120 - 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...

Allograft-prosthesis composites after bone tumor resection at the proximal tibia.

PubMed

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 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated 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/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...

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...

21 CFR 888.3550 - Knee joint patellofemorotibial polymer/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 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...

21 CFR 888.3550 - Knee joint patellofemorotibial polymer/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 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...

21 CFR 888.3550 - Knee joint patellofemorotibial polymer/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 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...

21 CFR 888.3550 - Knee joint patellofemorotibial polymer/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 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 888.3550 - Knee joint patellofemorotibial polymer/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 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 888.3350 - 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, 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 888.3300 - 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...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/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...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/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...

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 888.3560 - Knee joint patellofemorotibial polymer/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 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 888.3560 - Knee joint patellofemorotibial polymer/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 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 888.3660 - 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 888.3560 - Knee joint patellofemorotibial polymer/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 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 888.3560 - Knee joint patellofemorotibial polymer/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 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 888.3560 - Knee joint patellofemorotibial polymer/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 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 888.3660 - 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 888.3200 - 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 888.3210 - 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...

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...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/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...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/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...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/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...

Mobile-bearing total knee arthroplasty: a full traumatic rotation of 180°.

PubMed

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.

Nontraumatic Fracture of the Femoral Condylar Prosthesis in a Total Knee Arthroplasty Leading to Mechanical Failure

PubMed Central

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

Nontraumatic fracture of the femoral condylar prosthesis in a total knee arthroplasty leading to mechanical failure.

PubMed

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.

21 CFR 888.3410 - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing 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 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...

21 CFR 888.3410 - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing 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 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...

21 CFR 888.3410 - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing 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 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...

21 CFR 888.3410 - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing 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 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...

21 CFR 888.3410 - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing 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 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...

A fully organic retinal prosthesis restores vision in a rat model of degenerative blindness

NASA Astrophysics Data System (ADS)

Maya-Vetencourt, José Fernando; Ghezzi, Diego; Antognazza, Maria Rosa; Colombo, Elisabetta; Mete, Maurizio; Feyen, Paul; Desii, Andrea; Buschiazzo, Ambra; di Paolo, Mattia; di Marco, Stefano; Ticconi, Flavia; Emionite, Laura; Shmal, Dmytro; Marini, Cecilia; Donelli, Ilaria; Freddi, Giuliano; Maccarone, Rita; Bisti, Silvia; Sambuceti, Gianmario; Pertile, Grazia; Lanzani, Guglielmo; Benfenati, Fabio

2017-06-01

The degeneration of photoreceptors in the retina is one of the major causes of adult blindness in humans. Unfortunately, no effective clinical treatments exist for the majority of retinal degenerative disorders. Here we report on the fabrication and functional validation of a fully organic prosthesis for long-term in vivo subretinal implantation in the eye of Royal College of Surgeons rats, a widely recognized model of retinitis pigmentosa. Electrophysiological and behavioural analyses reveal a prosthesis-dependent recovery of light sensitivity and visual acuity that persists up to 6-10 months after surgery. The rescue of the visual function is accompanied by an increase in the basal metabolic activity of the primary visual cortex, as demonstrated by positron emission tomography imaging. Our results highlight the possibility of developing a new generation of fully organic, highly biocompatible and functionally autonomous photovoltaic prostheses for subretinal implants to treat degenerative blindness.

A fully organic retinal prosthesis restores vision in a rat model of degenerative blindness

PubMed Central

Antognazza, Maria Rosa; Colombo, Elisabetta; Mete, Maurizio; Feyen, Paul; Desii, Andrea; Buschiazzo, Ambra; Di Paolo, Mattia; Di Marco, Stefano; Ticconi, Flavia; Emionite, Laura; Shmal, Dmytro; Marini, Cecilia; Donelli, Ilaria; Freddi, Giuliano; Maccarone, Rita; Bisti, Silvia; Sambuceti, Gianmario; Pertile, Grazia; Lanzani, Guglielmo; Benfenati, Fabio

2017-01-01

The degeneration of photoreceptors in the retina is one of the major causes of adult blindness in humans. Unfortunately, no effective clinical treatments exist for the majority of retinal degenerative disorders. Here we report on the fabrication and functional validation of a fully organic prosthesis for long-term in vivo subretinal implantation in the eye of Royal College of Surgeons rats, a widely recognized model of Retinitis pigmentosa. Electrophysiological and behavioral analyses reveal a prosthesis-dependent recovery of light-sensitivity and visual acuity that persists up to 6-10 months after surgery. The rescue of the visual function is accompanied by an increase in the basal metabolic activity of the primary visual cortex, as demonstrated by positron emission tomography imaging. Our results highlight the possibility of developing a new generation of fully organic, highly biocompatible and functionally autonomous photovoltaic prostheses for subretinal implants to treat degenerative blindness. PMID:28250420

21 CFR 888.3670 - Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented...

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...

Design of a power-asymmetric actuator for a transtibial prosthesis.

PubMed

Bartlett, Harrison L; Lawson, Brian E; Goldfarb, Michael

2017-07-01

This paper presents the design and characterization of a power-asymmetric actuator for a transtibial prosthesis. The device is designed to provide the combination of: 1) joint locking, 2) high power dissipation, and 3) low power generation. This actuator functionality allows for a prosthesis to be designed with minimal mass and power consumption relative to a fully-powered robotic prosthesis while maintaining much of the functionality necessary for activities of daily living. The actuator achieves these design characteristics while maintaining a small form factor by leveraging a combination of electromechanical and hydraulic components. The design of the actuator is described herein, and results of an experimental characterization are provided that indicate that the actuator is capable of providing the functional capabilities required of an ankle prosthesis in a compact and lightweight package.

Enhanced lubricant film formation through micro-dimpled hard-on-hard artificial hip joint: An in-situ observation of dimple shape effects.

PubMed

Choudhury, Dipankar; Rebenda, David; Sasaki, Shinya; Hekrle, Pavel; Vrbka, Martin; Zou, Min

2018-05-01

This study evaluates the impact of dimple shapes on lubricant film formation in artificial hip joints. Micro-dimples with 20-50 µm lateral size and 1 ± 0.2 µm depths were fabricated on CrCoMo hip joint femoral heads using a picosecond laser. Tribological studies were performed using a pendulum hip joint simulator to apply continuous swing flexion-extension motions. The results revealed a significantly enhanced lubricant film thickness (≥ 500 nm) with micro-dimpled prosthesis heads at equilibrium position after the lubricant film has fully developed. The average lubricant film thickness of dimpled prostheses with square- and triangular-shaped dimple arrays over time is about 3.5 that of the non-dimpled prosthesis (204 nm). Remarkably, the prosthesis with square-shaped dimple arrays showed a very fast lubricant film formation reaching their peak values within 0.5 s of pendulum movement, followed by prosthesis with triangular-shaped dimple arrays with a transition period of 42.4 s. The fully developed lubricant film thicknesses (≥ 700 nm) are significantly higher than the surface roughness (≈ 25 nm) demonstrating a hydrodynamic lubrication. Hardly any scratches appeared on the post-experimental prosthesis with square-shaped dimple array and only a few scratches were found on the post-experimental prosthesis with triangular-shaped dimple arrays. Thus, prostheses with square-shaped dimple arrays could be a potential solution for durable artificial hip joints. Copyright © 2018 Elsevier Ltd. All rights reserved.

Prosthetic Rehabilitation of Completely Blind Subject with Bilateral Customised Ocular Prosthesis: A Case Report

PubMed Central

Pawah, Salil; Singh, Gurpreet; Yadav, Ila; Kundra, Shrey

2017-01-01

The special sensory organs play significant role in our daily lives. Until one of them is totally or partially lost, its real value is not fully appreciated. The most tragic, yet common loss of sensory organ is that of an eye. Restoration of unilateral ocular defects is very challenging for a maxillofacial prosthodontist and requires great skill to mimic bilateral eye. Restoration of bilateral defects using customized eye prosthesis presents even more difficult task for clinician especially in communication with patient, impression procedures, and patient education regarding insertion, removal and maintenance of prosthesis. Such loss of eyes may have a tremendous emotional and psychological impact on the patient. This article presents a technique for fabrication of bilateral ocular prosthesis of completely blind patient. PMID:28274064

Implant prostheses for convertibility, stress control, esthetics, and hygiene.

PubMed

Garfield, R E

1988-07-01

A method of connecting "fixed partial denture" prostheses to osseointegrated implant fixtures has been described. The advantages of this system of restoration for partially and fully edentulous mouths are that it is more effective in addressing the problems of (1) stress-control on abutments, (2) a back-up system for abutment failures, (3) esthetics, and (4) control of bacterial plaques around abutments. To accomplish this procedure, the application of convertible periodontal prosthesis techniques with modifications to some existing implant systems is undertaken. The disadvantages of this method seem insignificant when one considers the complexities and risks involved with the present array of implant prosthesis alternatives. Some patients and dentists might consider the necessity of the prosthesis being detachable as one disadvantage. In reality, the prosthesis can be used as a fixed restoration until the patient has fully adapted to the new proprioception and appearance. A large percentage of patients feel uncomfortable with the word "removable" because it immediately creates a perception of unsightly metallic clasp display, palatal coverage, tongue interference, and negative body image. The use of the term "detachable" coupled with the doctor's offer to perform this task for the patient "whenever necessary" will usually relieve the patient's anxiety and allow the treatment to proceed. Once neuromuscular and esthetic adaptation have occurred and the patient has accepted the prosthesis, daily detaching and home-care hygiene by the patient will follow without incident. Esthetic improvement is obvious (Fig. 3).

Evaluation of direct and indirect additive manufacture of maxillofacial prostheses.

PubMed

Eggbeer, Dominic; Bibb, Richard; Evans, Peter; Ji, Lu

2012-09-01

The efficacy of computer-aided technologies in the design and manufacture of maxillofacial prostheses has not been fully proven. This paper presents research into the evaluation of direct and indirect additive manufacture of a maxillofacial prosthesis against conventional laboratory-based techniques. An implant/magnet-retained nasal prosthesis case from a UK maxillofacial unit was selected as a case study. A benchmark prosthesis was fabricated using conventional laboratory-based techniques for comparison against additive manufactured prostheses. For the computer-aided workflow, photogrammetry, computer-aided design and additive manufacture (AM) methods were evaluated in direct prosthesis body fabrication and indirect production using an additively manufactured mould. Qualitative analysis of position, shape, colour and edge quality was undertaken. Mechanical testing to ISO standards was also used to compare the silicone rubber used in the conventional prosthesis with the AM material. Critical evaluation has shown that utilising a computer-aided work-flow can produce a prosthesis body that is comparable to that produced using existing best practice. Technical limitations currently prevent the direct fabrication method demonstrated in this paper from being clinically viable. This research helps prosthesis providers understand the application of a computer-aided approach and guides technology developers and researchers to address the limitations identified.

Biomechanical evaluation of a novel Limb Prosthesis Osseointegrated Fixation System designed to combine the advantages of interference-fit and threaded solutions.

PubMed

Prochor, Piotr; Piszczatowski, Szczepan; Sajewicz, Eugeniusz

2016-01-01

The study was aimed at biomechanical evaluation of a novel Limb Prosthesis Osseointegrated Fixation System (LPOFS) designed to combine the advantages of interference-fit and threaded solutions. Three cases, the LPOFS (designed), the OPRA (threaded) and the ITAP (interference-fit) implants were studied. Von-Mises stresses in bone patterns and maximal values generated while axial loading on an implant placed in bone and the force reaction values in contact elements while extracting an implant were analysed. Primary and fully osteointegrated connections were considered. The results obtained for primary connection indicate more effective anchoring of the OPRA, however the LPOFS provides more appropriate stress distribution (lower stress-shielding, no overloading) in bone. In the case of fully osteointegrated connection the LPOFSs kept the most favourable stress distribution in cortical bone which is the most important long-term feature of the implant usage and bone remodelling. Moreover, in fully bound connection its anchoring elements resist extracting attempts more than the ITAP and the OPRA. The results obtained allow us to conclude that in the case of features under study the LPOFS is a more functional solution to direct skeletal attachment of limb prosthesis than the referential implants during short and long-term use.

21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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...

21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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...

21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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...

21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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...

21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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...

Clinical Results of 40 Consecutive Basal Thumb Prostheses and No CRPS Type I After Vitamin C Prophylaxis.

PubMed

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.

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

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...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

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...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

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...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

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...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

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...

Implications of prosthesis funding structures on the use of prostheses: experiences of individuals with upper limb absence.

PubMed

Biddiss, Elaine; McKeever, Patricia; Lindsay, Sally; Chau, Tom

2011-06-01

While sparsely researched, funding structures may play an important role in use of and satisfaction with prostheses and related health services. The objectives of this study were to (1) quantify the direct costs of prosthesis wear, (2) explore variations in funding distribution, and (3) describe the role of affordability in prosthesis selection and wear. An anonymous, online cross-sectional descriptive survey was administered. Analyses were conducted of qualitative and quantitative data extracted from an international sample of 242 individuals with upper limb absence. Access to prosthesis funding was variable and fluctuated with age, level of limb absence and country of care. Of individuals who gave details on prosthetic costs, 63% (n = 69) were fully reimbursed for their prosthetic expenses, while 37% (n = 40) were financially disadvantaged by the cost of components (mean [SD] US$9,574 [$9,986]) and their ongoing maintenance (US$1,936 [$3,179]). Of the 71 non-wearers in this study, 48% considered cost an influential factor in their decision not to adopt prosthesis use. Prosthesis funding is neither homogeneous nor transparent and can be influential in both the selection and use of a prosthetic device. Inequitable access to prosthesis funding is evident in industrialized nations and may lead to prosthesis abandonment and/or diminished quality of life for individuals with upper limb absences. Increased efforts are required to ensure equitable access to upper limb prosthetics and related services in line with individuals' needs.

Limb Prosthetics

MedlinePlus

... For example, some go skydiving, climb mountains, run marathons, complete triathlons, participate fully in sports, or return ... only for activities at home or for a marathon, the prosthesis can provide profound psychologic benefits. How ...

Maxillary implant-retained partial overdenture with Dolder bar attachment: a clinical report.

PubMed

Kim, Hyeongil; Buhite, Robert J; Monaco, Edward A

2015-03-01

This article describes a technique for maintaining a maxillary Kennedy III partial removable dental prosthesis design in a patient who had non-restorable failing abutments by replacing the abutments with dental implants. Two implants were placed immediately after extraction of the abutment teeth in the anterior maxilla. After the implants were fully integrated, a Dolder bar attachment was fitted onto the implants. A new maxillary partial removable dental prosthesis was fabricated using the implants and the remaining natural teeth as abutments to restore function and esthetics. With the aid of dental implants, this Kennedy III maxillary removable dental prosthesis design could provide additional retention and support by promoting cross-arch stability and tissue, implant and tooth support. The patient's satisfaction was significantly increased.

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...

Early failure mechanisms of constrained tripolar acetabular sockets used in revision total hip arthroplasty.

PubMed

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 888.3540 - 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...

Outcome Assessment after Aptis Distal Radioulnar Joint (DRUJ) Implant Arthroplasty

PubMed Central

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.

PubMed

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.

Periprosthetic Fractures Following Total Knee Arthroplasty

PubMed Central

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

Leg or foot amputation

MedlinePlus

... limb until it is fully healed. Fitting for prosthesis, a manmade part to replace your limb, may occur when your wound is mostly healed and the surrounding area is no longer tender to the touch. Outlook (Prognosis) Your recovery and ability to function ...

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...

Upper extremity prosthesis user perspectives on unmet needs and innovative technology.

PubMed

Benz, Heather L; Jia Yao; Rose, Laura; Olgac, Okan; Kreutz, Karen; Saha, Anindita; Civillico, Eugene F

2016-08-01

The needs of individuals with upper limb amputation and congenital limb difference are not being fully met by current prostheses, as evidenced by prosthesis rejection, non-wear, and user reports of pain and challenging activities. Emerging technologies such as dexterous sensorized robotic limbs, osseointegrated prostheses, implantable EMG electrodes, and electrical stimulation for sensory feedback have the potential to address unmet needs, but pose additional risks. We plan to assess upper limb prosthesis user needs and perspectives on these new benefits and risks using an extensive quantitative survey. In preparation for this survey, we report here on qualitative interviews with seven individuals with upper limb amputation or congenital limb difference. Unstructured text was mined using topic modeling and the results compared with identified themes. A more complete understanding of how novel technologies could address real user concerns will inform implementation of new technologies and regulatory decision-making.

Upper Extremity Prosthesis User Perspectives on Unmet Needs and Innovative Technology

PubMed Central

Benz, Heather L.; Yao, Jia; Rose, Laura; Olgac, Okan; Kreutz, Karen; Saha, Anindita; Civillico, Eugene F.

2017-01-01

The needs of individuals with upper limb amputation and congenital limb difference are not being fully met by current prostheses, as evidenced by prosthesis rejection, non-wear, and user reports of pain and challenging activities. Emerging technologies such as dexterous sensorized robotic limbs, osseointegrated prostheses, implantable EMG electrodes, and electrical stimulation for sensory feedback have the potential to address unmet needs, but pose additional risks. We plan to assess upper limb prosthesis user needs and perspectives on these new benefits and risks using an extensive quantitative survey. In preparation for this survey, we report here on qualitative interviews with seven individuals with upper limb amputation or congenital limb difference. Unstructured text was mined using topic modeling and the results compared with identified themes. A more complete understanding of how novel technologies could address real user concerns will inform implementation of new technologies and regulatory decision-making. PMID:28268333

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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...

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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...

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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...

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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...

Photovoltaic Retinal Prosthesis with High Pixel Density

PubMed Central

Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I.; Galambos, Ludwig; Smith, Richard; Harris, James S.; Sher, Alexander; Palanker, Daniel

2012-01-01

Retinal degenerative diseases lead to blindness due to loss of the “image capturing” photoreceptors, while neurons in the “image processing” inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems, which deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation was produced in normal and degenerate rat retinas, with pulse durations from 0.5 to 4 ms, and threshold peak irradiances from 0.2 to 10 mW/mm2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 μm bipolar pixel, demonstrating the possibility of a fully-integrated photovoltaic retinal prosthesis with high pixel density. PMID:23049619

Biofilm formation and design features of indwelling silicone rubber tracheoesophageal voice prostheses--an electron microscopical study.

PubMed

Leunisse, C; van Weissenbruch, R; Busscher, H J; van der Mei, H C; Dijk, F; Albers, F W

2001-01-01

After total laryngectomy, voice can be restored with a silicone rubber tracheoesophageal voice prosthesis. However, biofilm formation and subsequent deterioration of the silicone material of the prosthesis will limit device life by impairing valve function. To simulate the natural process of biofilm development under dynamic nutrient conditions, a modified Robbins device was used to evaluate the biofilm-related valve dysfunction of the Groningen, Provox2, Blom-Singer indwelling, and VoiceMaster voice prostheses. Obstruction of the semicircular slit-valved Groningen prosthesis leading to increased airway resistance was caused not only by a buildup of deposits on the esophageal flange and valve hat, but also by accumulation of deposits on the semicircular valve seating. The hinged flap valved Provox2 and indwelling Blom-Singer prostheses failed to close sufficiently because of biofilm formation on the valve seating. The esophageal flange of the VoiceMaster prosthesis was affected, but the tripod structure of the ball valve was fully colonized up to the titanium sleeve, which interfered with proper valve opening and closure. These findings on biofilm formation could be used for the further development and modification of critical design features of voice prostheses to facilitate tracheoesophageal speech. Copyright 2001 John Wiley & Sons, Inc.

Tactile feedback is an effective instrument for the training of grasping with a prosthesis at low- and medium-force levels.

PubMed

De Nunzio, Alessandro Marco; Dosen, Strahinja; Lemling, Sabrina; Markovic, Marko; Schweisfurth, Meike Annika; Ge, Nan; Graimann, Bernhard; Falla, Deborah; Farina, Dario

2017-08-01

Grasping is a complex task routinely performed in an anticipatory (feedforward) manner, where sensory feedback is responsible for learning and updating the internal model of grasp dynamics. This study aims at evaluating whether providing a proportional tactile force feedback during the myoelectric control of a prosthesis facilitates learning a stable internal model of the prosthesis force control. Ten able-bodied subjects controlled a sensorized myoelectric prosthesis performing four blocks of consecutive grasps at three levels of target force (30, 50, and 70%), repeatedly closing the fully opened hand. In the first and third block, the subjects received tactile and visual feedback, respectively, while during the second and fourth block, the feedback was removed. The subjects also performed an additional block with no feedback 1 day after the training (Retest). The median and interquartile range of the generated forces was computed to assess the accuracy and precision of force control. The results demonstrated that the feedback was indeed an effective instrument for the training of prosthesis control. After the training, the subjects were still able to accurately generate the desired force for the low and medium target (30 and 50% of maximum force available in a prosthesis), despite the feedback being removed within the session and during the retest (low target force). However, the training was substantially less successful for high forces (70% of prosthesis maximum force), where subjects exhibited a substantial loss of accuracy as soon as the feedback was removed. The precision of control decreased with higher forces and it was consistent across conditions, determined by an intrinsic variability of repeated myoelectric grasping. This study demonstrated that the subject could rely on the tactile feedback to adjust the motor command to the prosthesis across trials. The subjects adjusted the mean level of muscle activation (accuracy), whereas the precision could not be modulated as it depends on the intrinsic myoelectric variability. They were also able to maintain the feedforward command even after the feedback was removed, demonstrating thereby a stable learning, but the retention depended on the level of the target force. This is an important insight into the role of feedback as an instrument for learning of anticipatory prosthesis force control.

Development and Application of a Tendon Prosthesis for Early Functional Restoration of the Hand.

DTIC Science & Technology

1975-09-01

number of studies to fully elucidate this problem. A. Human Foetus Circulation This study dealt with the intrinsic microcirculation in the human... foetus . The work was done by Dr. Howard Caplan. This study resulted in an entirely new understanding of tendon vasculature. A copy of his paper is

In vitro-analysis of kinematics and intradiscal pressures in cervical arthroplasty versus fusion--A biomechanical study in a sheep model with two semi-constrained prosthesis.

PubMed

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.

Adaptive sports ankle prosthetics. Interview by Sarah A. Curran.

PubMed

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.

Evaluation of the Morphology and Function of Medial Collateral Ligament afterTotal Knee Arthroplasty with High-frequency Ultrasound.

PubMed

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.

A new three-dimensional, print-on-demand temporomandibular prosthetic total joint replacement system: Preliminary outcomes.

PubMed

Dimitroulis, George; Austin, Stephen; Sin Lee, Peter Vee; Ackland, David

2018-05-16

The aim of this study is to present the preliminary clinical data on the OMX Temporomandibular Joint (TMJ) Prosthetic total joint replacement system. A prospective, cohort, clinical study was undertaken of consecutive adult patients with Category 5 end-stage joint disease who were implanted with the OMX TMJ prosthesis between May 2015 and April 2017. A total of 50 devices were implanted in 38 patients, with 12 patients receiving bilateral prosthetic joints. There were 31 females and 7 males in this cohort, who ranged in age from 20 to 66 years, with a mean of 43.8 years (±14.0 years). Ten of the 50 prosthetic joints (20%) were fully customized, while the remaining were patient matched using virtual planning software. Based on a mean follow-up period of 15.3 months (range 12-24 months) following the TMJ total joint replacement, preliminary results suggest the OMX TMJ prosthesis has made a positive impact on clinical outcomes, with a mean 74.4% reduction in joint pain levels and significant improvements (p < 0.05) in jaw function as measured by the visual analogue scales for mouth opening (30.8%), diet (77.1%), and function (59.2%). No device failures were reported during the study period. This study suggests that the print-on-demand OMX TMJ prosthesis, designed for rapid delivery of both patient-matched and fully customize devices, represents a safe, reliable and versatile implantable joint replacement system for the treatment of category 5 end-stage TMJ disease. Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Impact of removable partial denture prosthesis on chewing efficiency

PubMed Central

BESSADET, Marion; NICOLAS, Emmanuel; SOCHAT, Marine; HENNEQUIN, Martine; VEYRUNE, Jean-Luc

2013-01-01

Removable partial denture prostheses are still being used for anatomic, medical and economic reasons. However, the impact on chewing parameters is poorly described. Objectives The objective of this study was to estimate the impact of removable partial denture prosthesis on masticatory parameters. Material and Methods Nineteen removable partial denture prosthesis (RPDP) wearers participated in the study. Among them, 10 subjects were Kennedy Class III partially edentulous and 9 with posterior edentulism (Class I). All presented a complete and full dentate opposing arch. The subjects chewed samples of carrots and peanuts with and without their prosthesis. The granulometry of the expectorated boluses from carrot and peanuts was characterized by median particle size (D50), determined at the natural point of swallowing. Number of chewing cycles (CC), chewing time (CT) and chewing frequency (CF=CC/CT) were video recorded. Results With RPDP, the mean D50 values for carrot and peanuts were lower [Repeated Model Procedures (RMP), F=15, p<0.001] regardless of the type of Kennedy Class. For each food, mean CC, CT and CF values recorded decreased (RMP, F=18, F=9, and F=20 respectively, p<0.01). With or without RPD, the boluses' granulometry values were above the masticatory normative index (MNI) determined as 4,000 µm. Conclusion RPDP rehabilitation improves the ability to reduce the bolus particle size, but does not reestablish fully the masticatory function. Clinical relevance This study encourages the clinical improvement of oral rehabilitation procedure. PMID:24212983

Restoring visual perception using microsystem technologies: engineering and manufacturing perspectives.

PubMed

Krisch, I; Hosticka, B J

2007-01-01

Microsystem technologies offer significant advantages in the development of neural prostheses. In the last two decades, it has become feasible to develop intelligent prostheses that are fully implantable into the human body with respect to functionality, complexity, size, weight, and compactness. Design and development enforce collaboration of various disciplines including physicians, engineers, and scientists. The retina implant system can be taken as one sophisticated example of a prosthesis which bypasses neural defects and enables direct electrical stimulation of nerve cells. This micro implantable visual prosthesis assists blind patients to return to the normal course of life. The retina implant is intended for patients suffering from retinitis pigmentosa or macular degeneration. In this contribution, we focus on the epiretinal prosthesis and discuss topics like system design, data and power transfer, fabrication, packaging and testing. In detail, the system is based upon an implantable micro electro stimulator which is powered and controlled via a wireless inductive link. Microelectronic circuits for data encoding and stimulation are assembled on flexible substrates with an integrated electrode array. The implant system is encapsulated using parylene C and silicone rubber. Results extracted from experiments in vivo demonstrate the retinotopic activation of the visual cortex.

Finite element analysis of constrained total Condylar Knee Prosthesis

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1998-07-13

Exactech, Inc., is a prosthetic joint manufacturer based in Gainesville, FL. The company set the goal of developing a highly effective prosthetic articulation, based on scientific principles, not trial and error. They developed an evolutionary design for a total knee arthroplasty system that promised improved performance. They performed static load tests in the laboratory with similar previous designs, but dynamic laboratory testing was both difficult to perform and prohibitively expensive for a small business to undertake. Laboratory testing also cannot measure stress levels in the interior of the prosthesis where failures are known to initiate. To fully optimize their designsmore » for knee arthroplasty revisions, they needed range-of-motion stress/strain data at interior as well as exterior locations within the prosthesis. LLNL developed computer software (especially NIKE3D) specifically designed to perform stress/strain computations (finite element analysis) for complex geometries in large displacement/large deformation conditions. Additionally, LLNL had developed a high fidelity knee model for other analytical purposes. The analysis desired by Exactech could readily be performed using NIKE3D and a modified version of the high fidelity knee that contained the geometry of the condylar knee components. The LLNL high fidelity knee model was a finite element computer model which would not be transferred to Exactech during the course of this CRADA effort. The previously performed laboratory studies by Exactech were beneficial to LLNL in verifying the analytical capabilities of NIKE3D for human anatomical modeling. This, in turn, gave LLNL further entree to perform work-for-others in the prosthetics field. There were two purposes to the CRADA (1) To modify the LLNL High Fidelity Knee Model to accept the geometry of the Exactech Total Knee; and (2) To perform parametric studies of the possible design options in appropriate ranges of motion so that an optimum design could be selected for production. Because of unanticipated delays in the CRADA funding, the knee design had to be finalized before the analysis could be accomplished. Thus, the scope of work was modified by the industrial partner. It was decided that it would be most beneficial to perform FEA that would closely replicate the lab tests that had been done as the basis of the design. Exactech was responsible for transmitting the component geometries to Livermore, as well as providing complete data from the quasi-static laboratory loading tests that were performed on various designs. LLNL was responsible for defining the basic finite element mesh and carrying out the analysis. We performed the initial computer simulation and verified model integrity, using the laboratory data. After performing the parametric studies, the results were reviewed with Exactech. Also, the results were presented at the Orthopedic Research Society meeting in a poster session.« less

Regenerative Engineering and Bionic Limbs.

PubMed

James, Roshan; Laurencin, Cato T

2015-03-01

Amputations of the upper extremity are severely debilitating, current treatments support very basic limb movement, and patients undergo extensive physiotherapy and psychological counselling. There is no prosthesis that allows the amputees near-normal function. With increasing number of amputees due to injuries sustained in accidents, natural calamities and international conflicts, there is a growing requirement for novel strategies and new discoveries. Advances have been made in technological, material and in prosthesis integration where researchers are now exploring artificial prosthesis that integrate with the residual tissues and function based on signal impulses received from the residual nerves. Efforts are focused on challenging experts in different disciplines to integrate ideas and technologies to allow for the regeneration of injured tissues, recording on tissue signals and feed-back to facilitate responsive movements and gradations of muscle force. A fully functional replacement and regenerative or integrated prosthesis will rely on interface of biological process with robotic systems to allow individual control of movement such as at the elbow, forearm, digits and thumb in the upper extremity. Regenerative engineering focused on the regeneration of complex tissue and organ systems will be realized by the cross-fertilization of advances over the past thirty years in the fields of tissue engineering, nanotechnology, stem cell science, and developmental biology. The convergence of toolboxes crated within each discipline will allow interdisciplinary teams from engineering, science, and medicine to realize new strategies, mergers of disparate technologies, such as biophysics, smart bionics, and the healing power of the mind. Tackling the clinical challenges, interfacing the biological process with bionic technologies, engineering biological control of the electronic systems, and feed-back will be the important goals in regenerative engineering over the next two decades.

Regenerative Engineering and Bionic Limbs

PubMed Central

James, Roshan; Laurencin, Cato T.

2015-01-01

Amputations of the upper extremity are severely debilitating, current treatments support very basic limb movement, and patients undergo extensive physiotherapy and psychological counselling. There is no prosthesis that allows the amputees near-normal function. With increasing number of amputees due to injuries sustained in accidents, natural calamities and international conflicts, there is a growing requirement for novel strategies and new discoveries. Advances have been made in technological, material and in prosthesis integration where researchers are now exploring artificial prosthesis that integrate with the residual tissues and function based on signal impulses received from the residual nerves. Efforts are focused on challenging experts in different disciplines to integrate ideas and technologies to allow for the regeneration of injured tissues, recording on tissue signals and feed-back to facilitate responsive movements and gradations of muscle force. A fully functional replacement and regenerative or integrated prosthesis will rely on interface of biological process with robotic systems to allow individual control of movement such as at the elbow, forearm, digits and thumb in the upper extremity. Regenerative engineering focused on the regeneration of complex tissue and organ systems will be realized by the cross-fertilization of advances over the past thirty years in the fields of tissue engineering, nanotechnology, stem cell science, and developmental biology. The convergence of toolboxes crated within each discipline will allow interdisciplinary teams from engineering, science, and medicine to realize new strategies, mergers of disparate technologies, such as biophysics, smart bionics, and the healing power of the mind. Tackling the clinical challenges, interfacing the biological process with bionic technologies, engineering biological control of the electronic systems, and feed-back will be the important goals in regenerative engineering over the next two decades. PMID:25983525

Bio-inspired mechanical design of a tendon-driven dexterous prosthetic hand.

PubMed

Controzzi, Marco; Cipriani, Christian; Jehenne, Beryl; Donati, Marco; Carrozza, Maria Chiara

2010-01-01

This paper presents the preliminary design of a new dexterous upper-limb prosthesis provided with a novel anthropomorphic hand, a compact wrist based on bevel gears and a modular forearm able to cover different levels of upper-limb amputations. The hand has 20 DoFs and 11 motors, with a dexterous three fingered subsystem composed by a fully actuated thumb, and an hybrid index and middle fingers to enable dexterous manipulation and enhance grasp performance.

Quantitative assessment of four men using above-elbow prosthetic control.

PubMed

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.

[Retrieval of crown closure of moso bamboo forest using unmanned aerial vehicle (UAV) remotely sensed imagery based on geometric-optical model].

PubMed

Wang, Cong; Du, Hua-qiang; Zhou, Guo-mo; Xu, Xiao-jun; Sun, Shao-bo; Gao, Guo-long

2015-05-01

This research focused on the application of remotely sensed imagery from unmanned aerial vehicle (UAV) with high spatial resolution for the estimation of crown closure of moso bamboo forest based on the geometric-optical model, and analyzed the influence of unconstrained and fully constrained linear spectral mixture analysis (SMA) on the accuracy of the estimated results. The results demonstrated that the combination of UAV remotely sensed imagery and geometric-optical model could, to some degrees, achieve the estimation of crown closure. However, the different SMA methods led to significant differentiation in the estimation accuracy. Compared with unconstrained SMA, the fully constrained linear SMA method resulted in higher accuracy of the estimated values, with the coefficient of determination (R2) of 0.63 at 0.01 level, against the measured values acquired during the field survey. Root mean square error (RMSE) of approximate 0.04 was low, indicating that the usage of fully constrained linear SMA could bring about better results in crown closure estimation, which was closer to the actual condition in moso bamboo forest.

Pattern of External Breast Prosthesis Use by Post Mastectomy Breast Cancer Patients in India: Descriptive Study from Tertiary Care Centre.

PubMed

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.

Side-by-side placement of bilateral endoscopic metal stents for the treatment of postoperative biliary stricture.

PubMed

Kaino, Seiji; Sen-Yo, Manabu; Shinoda, Shuhei; Kawano, Michitaka; Harima, Hirofumi; Suenaga, Shigeyuki; Sakaida, Isao

2017-02-01

Postoperative biliary strictures are usually complications of cholecystectomy. Endoscopic plastic stent prosthesis is generally undertaken for treating benign biliary strictures. Recently, fully covered metal stents have been shown to be effective for treating benign distal biliary strictures. We present the case of a 53-year-old woman with liver injury in which imaging studies showed a common hepatic duct stricture. Endoscopic retrograde cholangiopancreatography also confirmed the presence of a common hepatic duct stricture. Temporally fully covered metal stents with dilated diameters of 6 mm were placed in a side-by-side fashion in the left and right hepatic ducts, respectively. We removed the stents 2 months after their placement. Subsequent cholangiography revealed an improvement in the biliary strictures. Although we were apprehensive about the fully covered metal stents obstructing the biliary side branches, we noted that careful placement of the bilateral metal stents did not cause any complications. Side-by-side deployment of bilateral endoscopic fully covered metal stents can be one of the safe and effective therapies for postoperative biliary stricture.

Younger age increases the risk of early prosthesis failure following primary total knee replacement for osteoarthritis. A follow-up study of 32,019 total knee replacements in the Finnish Arthroplasty Register.

PubMed

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.

Computational reverse shoulder prosthesis model: Experimental data and verification.

PubMed

Martins, A; Quental, C; Folgado, J; Ambrósio, J; Monteiro, J; Sarmento, M

2015-09-18

The reverse shoulder prosthesis aims to restore the stability and function of pathological shoulders, but the biomechanical aspects of the geometrical changes induced by the implant are yet to be fully understood. Considering a large-scale musculoskeletal model of the upper limb, the aim of this study is to evaluate how the Delta reverse shoulder prosthesis influences the biomechanical behavior of the shoulder joint. In this study, the kinematic data of an unloaded abduction in the frontal plane and an unloaded forward flexion in the sagittal plane were experimentally acquired through video-imaging for a control group, composed of 10 healthy shoulders, and a reverse shoulder group, composed of 3 reverse shoulders. Synchronously, the EMG data of 7 superficial muscles were also collected. The muscle force sharing problem was solved through the minimization of the metabolic energy consumption. The evaluation of the shoulder kinematics shows an increase in the lateral rotation of the scapula in the reverse shoulder group, and an increase in the contribution of the scapulothoracic joint to the shoulder joint. Regarding the muscle force sharing problem, the musculoskeletal model estimates an increased activity of the deltoid, teres minor, clavicular fibers of the pectoralis major, and coracobrachialis muscles in the reverse shoulder group. The comparison between the muscle forces predicted and the EMG data acquired revealed a good correlation, which provides further confidence in the model. Overall, the shoulder joint reaction force was lower in the reverse shoulder group than in the control group. Copyright © 2015 Elsevier Ltd. All rights reserved.

Association between dental prosthesis need, nutritional status and quality of life of elderly subjects.

PubMed

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.

Radial Neck Dilatory Remodeling After Radial Head Arthroplasty With an Uncemented, Press Fit, Fully Chemically Etched Stem Design.

PubMed

Sullivan, Matthew P; Firoozabadi, Reza; Kennedy, Stephen A; Agel, Julie; Magnusson, Eric; Schiffman, Brett; Folchert, Matthew; Beingessner, Daphne

2017-09-01

To compare the radiographic outcomes of 2 widely used side loading, press fit, RHA implants used to reconstruct complex elbow trauma. Retrospective cohort study. Level-1 Academic trauma center. Patients undergoing RHA. Cohort 1 received Synthes Radial Head Prosthesis. Cohort 2 received Biomet ExploR Radial Head Replacement. Radial neck dilatory remodeling. Eighty-two subjects were included in final analysis, 63 from the Biomet Cohort, and 19 from Synthes cohort. Demographic and injury characteristics were similar among cohorts. Radial neck dilatory remodeling as well as periprosthetic radiographic lucency were seen significantly more frequently and to a significantly greater degree in the Synthes cohort. The average percentage of dilatory remodeling of the Synthes cohort was 34.9% and that of the Biomet cohort was 2.7%. There were no differences in rates of revision surgery. Our study demonstrates significant radiographic differences between 2 frequently used RHA implants. Radial neck dilatory remodeling is a common, rapidly progressive, and dramatic finding frequently seen with the Synthes Radial Head Prosthesis. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Geometric constrained variational calculus. II: The second variation (Part I)

NASA Astrophysics Data System (ADS)

Massa, Enrico; Bruno, Danilo; Luria, Gianvittorio; Pagani, Enrico

2016-10-01

Within the geometrical framework developed in [Geometric constrained variational calculus. I: Piecewise smooth extremals, Int. J. Geom. Methods Mod. Phys. 12 (2015) 1550061], the problem of minimality for constrained calculus of variations is analyzed among the class of differentiable curves. A fully covariant representation of the second variation of the action functional, based on a suitable gauge transformation of the Lagrangian, is explicitly worked out. Both necessary and sufficient conditions for minimality are proved, and reinterpreted in terms of Jacobi fields.

Custom-made ocular prosthesis.

PubMed

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.

Experiences in the provision, fitting and supply of external breast prostheses: findings from a national survey.

PubMed

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.

Sockets Manufactured by CAD/CAM Method Have Positive Effects on the Quality of Life of Patients With Transtibial Amputation.

PubMed

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…

Penile prosthesis implant: scientific advances and technological innovations over the last four decades.

PubMed

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.

Penile prosthesis implant: scientific advances and technological innovations over the last four decades

PubMed Central

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.

PubMed

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.

Prosthetic management of mid-facial defect with magnet-retained silicone prosthesis.

PubMed

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.

Influence of callosal transfer on visual cortical evoked response and the implication in the development of a visual prosthesis.

PubMed

Siu, Timothy L; Morley, John W

2007-12-01

The development of a visual prosthesis has been limited by an incomplete understanding of functional changes of the visual cortex accompanying deafferentation. In particular, the role of the corpus callosum in modulating these changes has not been fully evaluated. Recent experimental evidence suggests that through synaptic modulation, short-term (4-5 days) visual deafferentation can induce plastic changes in the visual cortex, leading to adaptive enhancement of residual visual input. We therefore investigated whether a compensatory rerouting of visual information can occur via the indirect transcallosal linkage after deafferentation and the influence of this interhemispheric communication on the visual evoked response of each hemisphere. In albino rabbits, misrouting of uncrossed optic fibres reduces ipsilateral input to a negligible degree. We thus took advantage of this congenital anomaly to model unilateral cortical and ocular deafferentation by eliminating visual input from one eye and recorded the visual evoked potential (VEP) from the intact eye. In keeping with the chiasmal anomaly, no VEP was elicited from the hemisphere ipsilateral to the intact eye. This remained unchanged following unilateral visual deafferentation. The amplitude and latency of the VEP in the fellow hemisphere, however, were significantly decreased in the deafferented animals. Our data suggest that callosal linkage does not contribute to visual evoked responses and this is not changed after short-term deafferentation. The decrease in amplitude and latency of evoked responses in the hemisphere ipsilateral to the treated eye, however, confirms the facilitatory role of callosal transfer. This observation highlights the importance of bicortical stimulation in the future design of a cortical visual prosthesis.

A Novel Thermal-activated Shape Memory Penile Prosthesis: Comparative Mechanical Testing.

PubMed

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.

PubMed

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.

Multivariate prediction of upper limb prosthesis acceptance or rejection.

PubMed

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

PubMed Central

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.

PubMed

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.

Neural Network Assisted Inverse Dynamic Guidance for Terminally Constrained Entry Flight

PubMed Central

Chen, Wanchun

2014-01-01

This paper presents a neural network assisted entry guidance law that is designed by applying Bézier approximation. It is shown that a fully constrained approximation of a reference trajectory can be made by using the Bézier curve. Applying this approximation, an inverse dynamic system for an entry flight is solved to generate guidance command. The guidance solution thus gotten ensures terminal constraints for position, flight path, and azimuth angle. In order to ensure terminal velocity constraint, a prediction of the terminal velocity is required, based on which, the approximated Bézier curve is adjusted. An artificial neural network is used for this prediction of the terminal velocity. The method enables faster implementation in achieving fully constrained entry flight. Results from simulations indicate improved performance of the neural network assisted method. The scheme is expected to have prospect for further research on automated onboard control of terminal velocity for both reentry and terminal guidance laws. PMID:24723821

Predictors of Receiving a Prosthesis for Adults With Above-Knee Amputations in a Well-Defined Population.

PubMed

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.

Robotic lower limb prosthesis design through simultaneous computer optimizations of human and prosthesis costs

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.

Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human

DTIC Science & Technology

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.

PubMed

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.

PubMed

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.

Do CTA measurements of annular diameter, perimeter and area result in different TAVI prosthesis sizes?

PubMed

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.

Permanent Quadriplegia Following Replacement of Voice Prosthesis.

PubMed

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

DTIC Science & Technology

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

[Mid-term results after post-traumatic knee joint replacement in elderly patients].

PubMed

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.

Full-mouth rehabilitation with immediate loading of implants inserted with computer-guided flap-less surgery: a 3-year multicenter clinical evaluation with oral health impact profile.

PubMed

Marra, Roberto; Acocella, Alessandro; Rispoli, Alessandra; Sacco, Roberto; Ganz, Scott D; Blasi, Andrea

2013-10-01

The purpose of this report is to present the clinical outcomes and patients' satisfaction of full-mouth rehabilitation using computer-aided flapless implant placement and immediate loading of a prefabricated prosthesis. The study included 30 consecutive fully edentulous patients who received 312 implants. Mandible and maxilla were treated in the same surgical session with computer-guided flapless approach using the NobelGuide protocol. Prefabricated screw-retained fixed prostheses were inserted at the end of surgery. Clinical and radiographic evaluations were assessed at 6, 12, and 36 months. At baseline and 6 months after surgery, patients answered Oral Health Impact Profile in Edentulous Adults questionnaire to assess satisfaction. The implant survival rate was 97.9%, whereas the average marginal bone loss was 1.9 ± 1.3 mm after 3 years. At 6 months, patients showed significantly greater satisfaction with their fixed rehabilitation when compared with conventional dentures. The results of this study confirm that rehabilitation with a prefabricated fixed prosthesis supported by implants placed with NobelGuide protocol is a viable and predictable treatment and increases patients' satisfaction and improves oral health-related quality of life.

Intermittent, noncyclic dysfunction of a mechanical aortic prosthesis by pannus formation.

PubMed

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.

Management of long span partially edentulous maxilla with fixed removable denture prosthesis

PubMed Central

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.

PubMed

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.

BIORESORBABLE POLYMERIC MENISCAL PROSTHESIS: STUDY IN RABBITS

PubMed Central

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

Duocentric® reversed shoulder prosthesis and Personal Fit® templates: innovative strategies to optimize prosthesis positioning and prevent scapular notching.

PubMed

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.

PubMed

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.

An innovative method of ocular prosthesis fabrication by bio-CAD and rapid 3-D printing technology: A pilot study.

PubMed

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.

Computational Evaluation of the Effects of Bone Ingrowth on Bone Resorptive Remodeling after a Cementless Total Hip Arthroplasty

NASA Astrophysics Data System (ADS)

Jung, Duk-Young; Kang, Yu-Bong; Tsutsumi, Sadami; Nakai, Ryusuke; Ikeuchi, Ken; Sekel, Ron

In this study, we simulated a wide cortex separation from a cementless hip prosthesis using the bone resorption remodeling method that is based on the generation of high compressive stress around the distal cortical bone. Thereafter, we estimated the effect on late migration quantities of the hip prosthesis produced by the interface state arising from bone ingrowth. This was accomplished using cortical bone remodeling over a long period of time. Two-dimensional natural hip and implanted hip FEM models were constructed with each of the following interface statements between the bone and prosthesis: (1) non-fixation, (2) proximal 1/3, (3) proximal 2/3 and (4) full-fixation. The fixation interfaces in the fully and partially porous coated regions were rigidly fixed by bony ingrowth. The non-fixation model was constructed as a critical situation, with the fibrous or bony tissue not integrated at all into the implant surface. The daily load history was generated using the three loading cases of a one-legged stance as well as abduction and adduction motions. With the natural hip and one-legged stance, the peak compressive principal stresses were found to be under the criteria value for causing bone resorption, while no implant movement occurred. The migration magnitude of the stem of the proximal 1/3 fixation model with adduction motion was much higher, reaching 6%, 11%and 21%greater than those of the non-fixation, proximal 2/3 fixation and all-fixation models, respectively. The full-fixation model showed the lowest compressive principal stress and implant movement. Thus, we concluded that the late loosening and subsequent movement of the stem in the long term could be estimated with the cortical bone remodeling method based on a high compressive stress at the bone-implant interface. The change caused at the bone-prosthesis interface by bony or fibrous tissue ingrowth constituted the major factor in determining the extent of cortical bone resorption occurring with clinical loosening and subsequent implant movement.

User surveys support designing a prosthetic wrist that incorporates the Dart Thrower's Motion.

PubMed

Davidson, Matthew; Bodine, Cathy; Weir, Richard F Ff

2018-03-07

Prosthetic devices are not meeting the needs of people with upper limb amputations. Due to controlsidelimitations, prosthetic wrists cannot yet be fully articulated. This study sought to determine which wrist motions users felt were most important for completing activities of daily living. We specifically invstigated whether adding a combinationof flexion and deviation known as the Dart Thrower's Motion to a prosthetic wrist would help improve functionality. Fifteen participants with a trans-radial amputation, aged 25-64 years, who use a prosthesis completed an online survey and answered interview questions to determine which types of tasks pose particular challenges. Participants were asked what kinds of improvements they would like to see in a new prosthesis. A subset of five participants were interviewed in-depth to provide further information about difficulties they face using their device. The survey showed that participants had difficulty performing activities of daily living that involve a combination of wrist flexion and deviation known as the "Dart Throwers Motion". Interview responses confirmed that users have difficulty performing these tasks, especially those that require tools. Additionally, users said that they were more interested in having flexion and deviation than rotation in a prosthetic wrist. This research indicates that including the Dart Thrower's Motion in future designs of prosthetic wrists would improve these devices and people with upper limb amputations would be excited to see this improvement in their devices. Implications for Rehabilitation • Over one third of people with upper limb amputations do not use a prosthesis because prosthetic devices do not meet their needs.• The number of motions possible in state of the art prosthetic devices is limited by the small number of control sites available.• The Dart Thrower?s Motion is a wrist motion used for many activities of daily living but unavailable in commercial prosthetics leading many prosthetics users to have difficulty with these tasks.• Prosthetic use, and therefore quality of life, could be improved by including the Dart Thrower's Motion in a prosthesis.

Artificial limb representation in amputees

PubMed Central

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.

PubMed

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...

Constrained fixed-fulcrum reverse shoulder arthroplasty improves functional outcome in epileptic patients with recurrent shoulder instability

PubMed Central

Thangarajah, Tanujan; Higgs, Deborah; Bayley, J I L; Lambert, Simon M

2016-01-01

AIM: To report the results of fixed-fulcrum fully constrained reverse shoulder arthroplasty for the treatment of recurrent shoulder instability in patients with epilepsy. METHODS: A retrospective review was conducted at a single facility. Cases were identified using a computerized database and all clinic notes and operative reports were reviewed. All patients with epilepsy and recurrent shoulder instability were included for study. Between July 2003 and August 2011 five shoulders in five consecutive patients with epilepsy underwent fixed-fulcrum fully constrained reverse shoulder arthroplasty for recurrent anterior shoulder instability. The mean duration of epilepsy in the cohort was 21 years (range, 5-51) and all patients suffered from grand mal seizures. RESULTS: Mean age at the time of surgery was 47 years (range, 32-64). The cohort consisted of four males and one female. Mean follow-up was 4.7 years (range, 4.3-5 years). There were no further episodes of instability, and no further stabilisation or revision procedures were performed. The mean Oxford shoulder instability score improved from 8 preoperatively (range, 5-15) to 30 postoperatively (range, 16-37) (P = 0.015) and the mean subjective shoulder value improved from 20 (range, 0-50) preoperatively to 60 (range, 50-70) postoperatively (P = 0.016). Mean active forward elevation improved from 71° preoperatively (range, 45°-130°) to 100° postoperatively (range, 80°-90°) and mean active external rotation improved from 15° preoperatively (range, 0°-30°) to 40° (20°-70°) postoperatively. No cases of scapular notching or loosening were noted. CONCLUSION: Fixed-fulcrum fully constrained reverse shoulder arthroplasty should be considered for the treatment of recurrent shoulder instability in patients with epilepsy. PMID:27458554

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

PubMed

Schofer, Joachim; Nietlispach, Fabian; Bijuklic, Klaudija; Colombo, Antonio; Gatto, Fernando; De Marco, Federico; Mangieri, Antonio; Hansen, Lorenz; Bruschi, Giuseppe; Ruparelia, Neil; Rieß, Friedrich-Christian; Maisano, Franscesco; Latib, Azeem

2015-12-21

This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Reverse Shoulder Arthroplasty Prosthesis Design Classification System.

PubMed

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

PubMed Central

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

Manufacturer-provided effective orifice area index charts and the prevention of prosthesis-patient mismatch.

PubMed

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.

PubMed

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.

PubMed

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.

BIOENERGETIC DIFFERENCES DURING WALKING AND RUNNING IN TRANSFEMORAL AMPUTEE RUNNERS USING ARTICULATING AND NON-ARTICULATING KNEE PROSTHESES

PubMed Central

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.

PubMed

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.

PubMed

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.

Biomechanical evaluation of two types of short-stemmed hip prostheses compared to the trust plate prosthesis by three-dimensional measurement of micromotions.

PubMed

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?

PubMed

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.

Visualisation of upper limb activity using spirals: A new approach to the assessment of daily prosthesis usage.

PubMed

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.

Functional evaluation of a CAD/CAM prosthesis for immediate defect repair after total maxillectomy: a case series of 18 patients with maxillary sinus cancer.

PubMed

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.

PubMed

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.

PubMed

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.

PubMed

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

PubMed Central

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.

PubMed

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

PubMed Central

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

Prosthesis use in adult acquired major upper-limb amputees: patterns of wear, prosthetic skills and the actual use of prostheses in activities of daily life.

PubMed

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.

Early outcome of TKA with a medial pivot fixed-bearing prosthesis is worse than with a PFC mobile-bearing prosthesis.

PubMed

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.

Frequency of technical complications in fixed implant prosthesis: the effect of prosthesis screw emergence correction by CAD-CAM.

PubMed

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 user™smore » 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

Simulation of a slope adapting ankle prosthesis provided by semi-active damping.

PubMed

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.

Anteroposterior translation and range of motion after total knee arthroplasty using posterior cruciate ligament-retaining versus posterior cruciate ligament-substituting prostheses.

PubMed

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.

In vitro biomechanical comparison after fixed- and mobile-core artificial cervical disc replacement versus fusion

PubMed Central

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

Difference in occurrence of heterotopic ossification according to prosthesis type in the cervical artificial disc replacement.

PubMed

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.

Seventeen-millimeter St. Jude Medical Regent valve in patients with small aortic annulus: dose moderate prosthesis-patient mismatch matter?

PubMed

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) 

Long-term outcome of giant cell tumors of bone around the knee treated by en bloc resection of tumor and reconstruction with prosthesis.

PubMed

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.

A novel open-tray impression technique for fabrication of a provisional prosthesis on immediate load implants in a completely edentulous arch.

PubMed

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.

Using Arrays of Microelectrodes Implanted in Residual Peripheral Nerves to Provide Dextrous Control of, and Modulated Sensory Feedback from, a Hand Prosthesis

DTIC Science & Technology

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

[COMPUTER ASSISTED DESIGN AND ELECTRON BEAMMELTING RAPID PROTOTYPING METAL THREE-DIMENSIONAL PRINTING TECHNOLOGY FOR PREPARATION OF INDIVIDUALIZED FEMORAL PROSTHESIS].

PubMed

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.

Flexible and static wrist units in upper limb prosthesis users: functionality scores, user satisfaction and compensatory movements.

PubMed

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 .

Adjuvant Maneuvers for Residual Curvature Correction During Penile Prosthesis Implantation in Men with Peyronie's Disease.

PubMed

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.

PubMed

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.

A new malleostapedotomy prosthesis. Experimental analysis by laser doppler vibrometer in fresh cadaver temporal bones.

PubMed

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.

The effects of indwelling voice prosthesis on the quality of life, depressive symptoms, and self-esteem in patients with total laryngectomy.

PubMed

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.

PubMed

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.

Novel technique for laparoscopic harvesting of latissimus dorsi flap with prosthesis implantation for breast reconstruction

PubMed Central

Xu, Shuman; Tang, Peng; Chen, Xianchun; Yang, Xi; Pan, Qinwen; Gui, Yu; Chen, Li

2016-01-01

Abstract Backgroud: An important drawback of the traditional technique for harvesting latissimus dorsi (LD) myocutaneous flap is a long, posterior donor-site incision. Current techniques involve endoscopic or robotic harvesting via a combined approach of open and closed surgery, which necessitates an open axillary incision and the use of special retractors. In this paper, we introduce a fully enclosed laparoscopic technique for harvesting LD flap (LDF) using only 3 small trocar ports. This technique eliminates the need for axillary and donor-site incisions and specialized retractors and considerably reduces the incision size. Methods: We performed laparoscopic harvesting of LDF with prosthesis implantation for immediate breast reconstruction (IBR) after nipple-sparing mastectomy in 2 patients with malignant breast neoplasm who wished to avoid a long scar on the back. Results: IBR using this technique was uneventful in both cases, without any donor-site complications or flap failure. Both patients were satisfied with the esthetic results of the procedure, especially the absence of a visible scar on the back. Conclusion: Enclosed laparoscopic harvesting of LDF is simpler and less invasive than the traditional methods. These preliminary results warrant further evaluation in a larger population to validate the benefits of this technique. PMID:27861385

Control and Evaluation of a Powered Transfemoral Prosthesis for Stair Ascent.

PubMed

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.

Rehabilitation of orbital cavity after orbital exenteration using polymethyl methacrylate orbital prosthesis.

PubMed

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.

PubMed

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.

Microbial biofilms on facial prostheses.

PubMed

Ariani, Nina; Vissink, Arjan; van Oort, Robert P; Kusdhany, Lindawati; Djais, Ariadna; Rahardjo, Tri Budi W; van der Mei, Henny C; Krom, Bastiaan P

2012-01-01

The composition of microbial biofilms on silicone rubber facial prostheses was investigated and compared with the microbial flora on healthy and prosthesis-covered skin. Scanning electron microscopy showed the presence of mixed bacterial and yeast biofilms on and deterioration of the surface of the prostheses. Microbial culturing confirmed the presence of yeasts and bacteria. Microbial colonization was significantly increased on prosthesis-covered skin compared to healthy skin. Candida spp. were exclusively isolated from prosthesis-covered skin and from prostheses. Biofilms from prostheses showed the least diverse band-profile in denaturing gradient gel electrophoresis (DGGE) whereas prosthesis-covered skin showed the most diverse band-profile. Bacterial diversity exceeded yeast diversity in all samples. It is concluded that occlusion of the skin by prostheses creates a favorable niche for opportunistic pathogens such as Candida spp. and Staphylococcus aureus. Biofilms on healthy skin, skin underneath the prosthesis and on the prosthesis had a comparable composition, but the numbers present differed according to the microorganism.

Amputation and prosthesis implantation shape body and peripersonal space representations

PubMed Central

Canzoneri, Elisa; Marzolla, Marilena; Amoresano, Amedeo; Verni, Gennaro; Serino, Andrea

2013-01-01

Little is known about whether and how multimodal representations of the body (BRs) and of the space around the body (Peripersonal Space, PPS) adapt to amputation and prosthesis implantation. In order to investigate this issue, we tested BR in a group of upper limb amputees by means of a tactile distance perception task and PPS by means of an audio-tactile interaction task. Subjects performed the tasks with stimulation either on the healthy limb or the stump of the amputated limb, while wearing or not wearing their prosthesis. When patients performed the tasks on the amputated limb, without the prosthesis, the perception of arm length shrank, with a concurrent shift of PPS boundaries towards the stump. Conversely, wearing the prosthesis increased the perceived length of the stump and extended the PPS boundaries so as to include the prosthetic hand, such that the prosthesis partially replaced the missing limb. PMID:24088746

Carbon/PEEK composite materials as an alternative for stainless steel/titanium hip prosthesis: a finite element study.

PubMed

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.

Development and performance of a new prosthesis system using ultrasonic sensor for wrist movements: a preliminary study

PubMed Central

2014-01-01

Background The design and performance of a new development prosthesis system known as biomechatronics wrist prosthesis is presented in this paper. The prosthesis system was implemented by replacing the Bowden tension cable of body powered prosthesis system using two ultrasonic sensors, two servo motors and microcontroller inside the prosthesis hand for transradial user. Methods The system components and hand prototypes involve the anthropometry, CAD design and prototyping, biomechatronics engineering together with the prosthetics. The modeler construction of the system develop allows the ultrasonic sensors that are placed on the shoulder to generate the wrist movement of the prosthesis. The kinematics of wrist movement, which are the pronation/supination and flexion/extension were tested using the motion analysis and general motion of human hand were compared. The study also evaluated the require degree of detection for the input of the ultrasonic sensor to generate the wrist movements. Results The values collected by the vicon motion analysis for biomechatronics prosthesis system were reliable to do the common tasks in daily life. The degree of the head needed to bend to give the full input wave was about 45° - 55° of rotation or about 14 cm – 16 cm. The biomechatronics wrist prosthesis gave higher degree of rotation to do the daily tasks but did not achieve the maximum degree of rotation. Conclusion The new development of using sensor and actuator in generating the wrist movements will be interesting for used list in medicine, robotics technology, rehabilitations, prosthetics and orthotics. PMID:24755242

Virtual transplantation in designing a facial prosthesis for extensive maxillofacial defects that cross the facial midline using computer-assisted technology.

PubMed

Feng, Zhi-hong; Dong, Yan; Bai, Shi-zhu; Wu, Guo-feng; Bi, Yun-peng; Wang, Bo; Zhao, Yi-min

2010-01-01

The aim of this article was to demonstrate a novel approach to designing facial prostheses using the transplantation concept and computer-assisted technology for extensive, large, maxillofacial defects that cross the facial midline. The three-dimensional (3D) facial surface images of a patient and his relative were reconstructed using data obtained through optical scanning. Based on these images, the corresponding portion of the relative's face was transplanted to the patient's where the defect was located, which could not be rehabilitated using mirror projection, to design the virtual facial prosthesis without the eye. A 3D model of an artificial eye that mimicked the patient's remaining one was developed, transplanted, and fit onto the virtual prosthesis. A personalized retention structure for the artificial eye was designed on the virtual facial prosthesis. The wax prosthesis was manufactured through rapid prototyping, and the definitive silicone prosthesis was completed. The size, shape, and cosmetic appearance of the prosthesis were satisfactory and matched the defect area well. The patient's facial appearance was recovered perfectly with the prosthesis, as determined through clinical evaluation. The optical 3D imaging and computer-aided design/computer-assisted manufacturing system used in this study can design and fabricate facial prostheses more precisely than conventional manual sculpturing techniques. The discomfort generally associated with such conventional methods was decreased greatly. The virtual transplantation used to design the facial prosthesis for the maxillofacial defect, which crossed the facial midline, and the development of the retention structure for the eye were both feasible.

Hierarchically Parallelized Constrained Nonlinear Solvers with Automated Substructuring

NASA Technical Reports Server (NTRS)

Padovan, Joe; Kwang, Abel

1994-01-01

This paper develops a parallelizable multilevel multiple constrained nonlinear equation solver. The substructuring process is automated to yield appropriately balanced partitioning of each succeeding level. Due to the generality of the procedure,_sequential, as well as partially and fully parallel environments can be handled. This includes both single and multiprocessor assignment per individual partition. Several benchmark examples are presented. These illustrate the robustness of the procedure as well as its capability to yield significant reductions in memory utilization and calculational effort due both to updating and inversion.

[The influence of the stapes prosthesis on the long-term results of stapedectomy (author's transl)].

PubMed

Schöndorf, J; Pilorget, J; Gräber, S

1980-05-01

In comparing two groups of patients following stapedectomies, significantly better long-term results were obtained by using the Robinson steel piston prosthesis (n = 85) as opposed to the wire prosthesis (n = 74). By so doing, the impairment of sound transmission was reduced and the Carhart depression counterbalanced. This improvement is thought to result from the increased mass and stability of the steel prosthesis as well as from its more correct anatomical positioning.

Functional Performance Evaluation of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket for Persons with Transfemoral Amputation

DTIC Science & Technology

2016-10-01

satisfaction with device’’ (i.e. prosthesis) than the IC Socket. During year 1, we received all required IRB approvals, registered the clinical... satisfaction with device” (i.e. prosthesis) than the IC Socket. 2. KEYWORDS: Prosthetic Socket, Artificial Limbs, Prosthesis, Transfemoral Amputee, Gait...FlexSIV Socket will result in better quality of life and “ satisfaction with device” (i.e. prosthesis) than the IC socket. Accomplishments under

Categorization of compensatory motions in transradial myoelectric prosthesis users.

PubMed

Hussaini, Ali; Zinck, Arthur; Kyberd, Peter

2017-06-01

Prosthesis users perform various compensatory motions to accommodate for the loss of the hand and wrist as well as the reduced functionality of a prosthetic hand. Investigate different compensation strategies that are performed by prosthesis users. Comparative analysis. A total of 20 able-bodied subjects and 4 prosthesis users performed a set of bimanual activities. Movements of the trunk and head were recorded using a motion capture system and a digital video recorder. Clinical motion angles were calculated to assess the compensatory motions made by the prosthesis users. The video recording also assisted in visually identifying the compensations. Compensatory motions by the prosthesis users were evident in the tasks performed (slicing and stirring activities) as compared to the benchmark of able-bodied subjects. Compensations took the form of a measured increase in range of motion, an observed adoption of a new posture during task execution, and prepositioning of items in the workspace prior to initiating a given task. Compensatory motions were performed by prosthesis users during the selected tasks. These can be categorized into three different types of compensations. Clinical relevance Proper identification and classification of compensatory motions performed by prosthesis users into three distinct forms allows clinicians and researchers to accurately identify and quantify movement. It will assist in evaluating new prosthetic interventions by providing distinct terminology that is easily understood and can be shared between research institutions.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

PubMed

Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan

2015-07-01

The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Improvements in survival of the uncemented Nottingham Total Shoulder prosthesis: a prospective comparative study

PubMed Central

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

[Analysis of the failures of a cemented constrained liner model in patients with a high dislocation risk].

PubMed

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.

Experience with the use of a partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft.

PubMed

Birk, Stephanie; Brase, Christoph; Hornung, Joachim

2014-08-01

In the further development of alloplastic prostheses for use in middle ear surgery, the Dresden and Cologne University Hospitals, working together with a company, introduced a new partial ossicular replacement prosthesis in 2011. The ball-and-socket joint between the prosthesis and the shaft mimics the natural articulations between the malleus and incus and between the incus and stapes, allowing reaction to movements of the tympanic membrane graft, particularly during the healing process. Retrospective evaluation To reconstruct sound conduction as part of a type III tympanoplasty, partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft was implanted in 60 patients, with other standard partial ossicular replacement prosthesis implanted in 40 patients and 64 patients. Pure-tone audiometry was carried out, on average, 19 and 213 days after surgery. Results of the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft were compared with those of the standard prostheses. Early measurements showed a mean improvement of 3.3 dB in the air-bone gap (ABG) with the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft, giving similar results than the standard implants (6.6 and 6.0 dB, respectively), but the differences were not statistically significant. Later measurements showed a statistically significant improvement in the mean ABG, 11.5 dB, compared with 4.4 dB for one of the standard partial ossicular replacement prosthesis and a tendency of better results to 6.9 dB of the other standard prosthesis. In our patients, we achieved similarly good audiometric results to those already published for the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft. Intraoperative fixation posed no problems, and the postoperative complication rate was low.

Comparative experimental re-evaluation of the two implanting methods of silicone gel testicular prostheses in beagle dogs

PubMed Central

2011-01-01

Background Testicular prosthesis has been applied clinically for decades, and implantation of testis prosthesis under the tunica albuginea has been considered to be the standard method in the most of the reports. However, postoperative scrotal appearance, the mobilization and the palpitation of the prosthesis are not always satisfactory to all the patients. Modifications in surgical techniques might be necessary to bring improvements to the clinical outcomes in testicular prosthesis implantation. Findings In a group of 9 beagle dogs in this study, an orchiectomy succeeded with a testicular prosthesis implantation under the tunica vaginalis, and a complete mechanical denudation of the testicular parenchyma succeeded with an implantation under the tunica albuginea were performed, respectively. Histopathological evaluations of the scrotal tissues and the implants, which were made at the end of the follow-up, showed that all the tested animals lived uneventful lives during the follow-up period, and no rejections or infections were found. Prostheses implanted under the tunica vaginalis showed a more satisfying mobilization and palpation than those implanted under the tunica albuginea. Chronic inflammation in the para-prosthesis tissues with vascular proliferation and fibrinogenesis were more common in the "under tunica albuginea" group than that in the "under tunica vaginalis" group, although differences in fibrinogenesis between the two groups were found to be statistically insignificant. Conclusions In this comparative study, we have re-evaluated the two most popular implantation methods of testicular prosthesis, the "under the tunica albuginea" and the "under the tunica vaginalis" pathways, in animal models. We found that the testicular prosthesis were all well tolerated, but the prosthesis implanted under the tunica vaginalis showed a more satisfying result concerning appearance, palpability, and histopathological findings than that of the "under the tunica albuginea" group. The "under the tunica vaginalis" method might become a more practical method for future testicular prosthesis implantation. PMID:21457571

[Imaging evaluation on adaptability of proximal humeral anatomy after shoulder replacement with individualized shoulder prosthesis].

PubMed

Shi, Youxing; Tang, Kanglai; Yuan, Chengsong; Tao, Xu; Wang, Huaqing; Chen, Bo; Guo, Yupeng

2015-03-24

Modern shoulder prosthesis has evolved through four generations. And the fourth generation technology has a core three-dimensional design of restoring 3D reconstruction of proximal humeral anatomy. Thus a new shoulder prosthesis is developed on the basis of the technology of 3D prosthesis. Assessment of whether shoulder prosthesis can restore individualized reconstruction of proximal humeral anatomy is based on the adaptability of proximal humeral anatomy. To evaluate the adaptability of proximal humeral anatomy through measuring the parameters of proximal humeral anatomy after shoulder replacement with individualized shoulder prosthesis and compare with normal data. The parameters of proximal humeral anatomy were analyzed and evaluated for a total of 12 cases undergoing shoulder replacement with individualized shoulder prosthesis. The relevant anatomical parameters included neck-shaft angle (NSA), retroversion angle (RA), humeral head height (HH) and humeral head diameter (HD). And the anatomical parameters were compared with the data from normal side. All underwent shoulder replacement with individualized shoulder prosthesis. The postoperative parameters of proximal humeral anatomy were compared with those of normal side. And the difference of NSA was < 3°, RA < 3°, HH < 3 mm and HD < 2 mm. And paired-sample t test was used to study the parameters of proximal humeral anatomy between postoperative and normal side. The normal and postoperative NSA was (140.2 ± 6.8)° and (139.5 ± 6.6)° respectively, RA (34.4 ± 3.3)° and (33.8-3.1)°, HH (15.3 ± 2.1) mm and (14.6+0.9) mm, HW (42.2 ± 2.82) mm and (41.8 ± 2.33) mm respectively. No significant difference existed between two groups (P > 0.05). Individualized shoulder prosthesis has excellent adaptability to shoulder. All core parameters are freely adjustable and specification models may be optimized. With matching tools, individualized shoulder prosthesis improves the accuracy and reliability in shoulder replacement.

A custom-made temporomandibular joint prosthesis for fabrication by selective laser melting: Finite element analysis.

PubMed

Xu, Xiangliang; Luo, Danmei; Guo, Chuanbin; Rong, Qiguo

2017-08-01

A novel and custom-made selective laser melting (SLM) 3D-printed alloplastic temporomandibular joint (TMJ) prosthesis is proposed. The titanium-6aluminium-4vanadium (Ti-6Al-4V) condyle component and ultra-high molecular weight polyethylene (UHMWPE) fossa component comprised the total alloplastic TMJ replacement prosthesis. For the condyle component, an optimized tetrahedral open-porous scaffold with combined connection structures, i.e. an inlay rod and an onlay plate, between the prosthesis and remaining mandible was designed. The trajectory of movement of the intact condyle was assessed via kinematic analysis to facilitate the design of the fossa component. The behaviours of the intact mandible and mandible with the prosthesis were compared. The biomechanical behaviour was analysed by assessing the stress distribution on the prosthesis and strain distribution on the mandible. After muscle force was applied, the magnitude of the compressive strain on the condyle neck of the mandible with the prosthesis was lower than that on the condyle neck of the intact mandible, with the exception of the area about the screws; additionally, the magnitude of the strain at the scaffold-bone interface was relatively high. Copyright © 2017. Published by Elsevier Ltd.

[The endo-exo femur prosthesis--a new concept of bone-guided, prosthetic rehabilitation following above-knee amputation].

PubMed

Aschoff, H H; Clausen, A; Hoffmeister, T

2009-01-01

The implantation of an intramedullary transcutaneously conducted femur prosthesis presents a rather new procedure for the rehabilitation of above-knee amputated patients. The aim of the so-called endo-exo prosthesis is to avoid the well-known problems at the interface between the sleeve of the prosthesis and the soft tissue coat of the femur stump which often impedes an inconspicuous and harmonic gait. The company ERSKA Implants in Lübeck/Germany has developed an intramedullary femur prosthesis with a spongiosa metal-configurated relief surface which, when implanted cementless, enables a secure osseointegration and allows a more direct transmission of muscle power to the lower leg prosthesis. A minimum length of 16-18 cm and a sufficient soft tissue coverage of the femur stump is needed. The problems at the perforation point of the implant through the soft tissue coat can be handled or even be avoided and they do not necessarily provoke an intramedullary infection. We report on 30 cases that were operated between 1999 and 2008. The design of the prosthesis, aspects of the operative procedure and latest results are presented.

Evaluation of a new composite prosthesis for the repair of abdominal wall defects.

PubMed

Losi, Paola; Munaò, Antonella; Spiller, Dario; Briganti, Enrica; Martinelli, Ilaria; Scoccianti, Marco; Soldani, Giorgio

2007-10-01

The degree of integration of biomaterials used in the repair of abdominal wall defects seems to depend upon the structure of the prosthesis. The present investigation evaluates the behaviour in terms of adhesion formation and integration of a new composite prosthesis that could be employed in this clinical application. Full-thickness abdominal wall defects (7 x 5 cm) were created in 16 anaesthetized New Zealand white rabbits and the prosthesis were placed in direct contact with the visceral peritoneum during the experiment. The defects were repaired with a composite prosthesis or pure polypropylene mesh to establish two study groups (n = 8 each). The composite device was constituted by a polypropylene mesh physically attached to a poly(ether)urethane-polydimethylsiloxane laminar sheet. Animals were sacrificed 7, 14, 21 and 30 days after implant and prosthesis/surrounding tissue specimens subjected to light and electron microscopy. Firm adhesions were detected in the polypropylene implants, while they were not present in the composite implants. The excellent behaviour of the composite prosthesis shown in this study warrants further investigation on its use for the repair of abdominal wall defects when a prosthetic device needs to be placed in contact with the intestinal loops.

Linking of total elbow prosthesis during surgery; a biomechanical analysis.

PubMed

De Vos, Maarten J; Wagener, Marc L; Hendriks, Jan C M; Eygendaal, Denise; Verdonschot, Nico

2013-09-01

Presently, 2 types of elbow prostheses are used: unlinked and linked. The Latitude total elbow prosthesis allows the surgeon to decide during the implantation whether the prosthesis is placed unlinked or linked, and whether the native radial head is retained, resected, or replaced. The purpose of this study is to assess and to compare the varus and valgus laxity of the unlinked and linked version of the latitude total elbow prosthesis with: (1) the native radial head preserved, (2) the native radial head excised, and (3) the native radial head replaced by a radial head component. Biomechanical testing was performed on 14 fresh-frozen upper limb specimens. Linking the prosthesis predominantly influences the valgus laxity of the elbow. Linking the Latitude total elbow prosthesis results in increased valgus stability. In the linked version of the total elbow prosthesis, the radial head only plays a small part in both valgus and varus stability. An unlinked situation is not advised in absence of a native radial head or in case of inability to replace the radial head. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

[Osseointegration as a method of direct stabilization of amputation prostheses to the bone].

PubMed

Rochmiński, Robert; Sibński, Marcin; Synder, Marek

2011-01-01

This article summarizes important advantages, disadvantages and the process of treatment of patients after lower limb amputation on the level of the femur, with osseointegrated prosthesis. In the process of treatment bone-integrated material is implanted to the femur, with allows for structural and functional connection between live tissue and the prosthesis. This solution allows the patient for easy usage and direct steerage of the prosthesis, transferring of body weight to the floor and detection of sensation in the moment of contact between prosthesis and the ground. Osseointegrated prostheses in the femur gives the opportunity not to use the traditional solutions and socket-related problems as: mobility difficulties, skin sores, rush, pain during weight bearing, temporary changes of the stump volume, difficulty donning the prosthesis, unreliability of prosthesis being securely suspended. Osseointegration is possible even in cases, when quality of skin and short stump enables to use the traditional prosthetic socket. It is used after lower and upper limbs amputations. This kind of prosthetic solutions has some disadvantages and limitations. It is expensive and demanding. It can be used in cooperative patients, who take active part in the process of implantation, rehabilitation and in future usage if the prosthesis.

"Bail out" procedures for malpositioning of aortic valve prosthesis (CoreValve).

PubMed

Vavouranakis, Manolis; Vrachatis, Dimitrios A; Toutouzas, Konstantinos P; Chrysohoou, Christina; Stefanadis, Christodoulos

2010-11-05

Two techniques for correcting malpositioning occurring during percutaneous aortic valve replacement (PAVR) with the CoreValve ReValving™ System are described in this article. The "Removing and Reinserting Technique" was used in 2 patients, in whom the prosthesis was positioned too high. The "Snare Technique" was used in 1 patient, in whom the prosthesis was implanted too low. In all patients the aortic valve prosthesis was successfully re-implanted. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

A fiber-reinforced composite prosthesis restoring a lateral midfacial defect: a clinical report.

PubMed

Kurunmäki, Hemmo; Kantola, Rosita; Hatamleh, Muhanad M; Watts, David C; Vallittu, Pekka K

2008-11-01

This clinical report describes the use of a glass fiber-reinforced composite (FRC) substructure to reinforce the silicone elastomer of a large facial prosthesis. The FRC substructure was shaped into a framework and embedded into the silicone elastomer to form a reinforced facial prosthesis. The prosthesis is designed to overcome the disadvantages associated with traditionally fabricated prostheses; namely, delamination of the silicone of the acrylic base, poor marginal adaptation over time, and poor simulation of facial expressions.

Negative Gauge Pressure Moisture Management and Secure Adherence Device for Prosthetic Limbs

DTIC Science & Technology

2013-03-01

prosthesis feels like it is sliding up and down or falling off when I am active. D. I have been more active than normal as a result of this prosthesis ...temperature. 3. My prosthesis feels like it is sliding up and down or falling off when I am active. 4. I have been more active than normal as a result of...objective of this research was to develop and test a novel prosthesis incorporating a negative gauge pressure moisture management and secure

Development and Application of a Tendon Prosthesis for Early Functional Restoration of the Hand.

DTIC Science & Technology

1975-09-01

F’A-AOk 322 JEFFERSON MEDICAL COLL PHILADELPHIA PA F/B 6/5 DEVELOPMENT AND APPLICATION OF A TENDON PROSTHESIS FOR EARLY FU--ETC(U) SEP 75 J M HUNTER...LEVEL INVENTORY DEELOPKWTI AND APPLICATION OF A TENDON PROSTHESIS FOR EARLY FUNCTIOKAL RESTORATION OF THE RAND BIDETICATION DISTRIBUTION STATEMENT A...AND RETURN TO DTIC-DDA-2 FORM DOCUMENT PROCESSING SHEETCToc 79 0 AD DEVELOPNDT AND APPLICATION OF A TENDOR PROSTHESIS FOR EARLY FUNCTIONAL

Evaluating an image-fusion algorithm with synthetic-image-generation tools

NASA Astrophysics Data System (ADS)

Gross, Harry N.; Schott, John R.

1996-06-01

An algorithm that combines spectral mixing and nonlinear optimization is used to fuse multiresolution images. Image fusion merges images of different spatial and spectral resolutions to create a high spatial resolution multispectral combination. High spectral resolution allows identification of materials in the scene, while high spatial resolution locates those materials. In this algorithm, conventional spectral mixing estimates the percentage of each material (called endmembers) within each low resolution pixel. Three spectral mixing models are compared; unconstrained, partially constrained, and fully constrained. In the partially constrained application, the endmember fractions are required to sum to one. In the fully constrained application, all fractions are additionally required to lie between zero and one. While negative fractions seem inappropriate, they can arise from random spectral realizations of the materials. In the second part of the algorithm, the low resolution fractions are used as inputs to a constrained nonlinear optimization that calculates the endmember fractions for the high resolution pixels. The constraints mirror the low resolution constraints and maintain consistency with the low resolution fraction results. The algorithm can use one or more higher resolution sharpening images to locate the endmembers to high spatial accuracy. The algorithm was evaluated with synthetic image generation (SIG) tools. A SIG developed image can be used to control the various error sources that are likely to impair the algorithm performance. These error sources include atmospheric effects, mismodeled spectral endmembers, and variability in topography and illumination. By controlling the introduction of these errors, the robustness of the algorithm can be studied and improved upon. The motivation for this research is to take advantage of the next generation of multi/hyperspectral sensors. Although the hyperspectral images will be of modest to low resolution, fusing them with high resolution sharpening images will produce a higher spatial resolution land cover or material map.

Fitting a hand-glove prosthesis to enhance the reconstructed mutilated hand.

PubMed

Leow, M E; Kour, A K; Pereira, B P; Pho, R W

1998-03-01

Microsurgical reconstruction of the severely mutilated hand aimed at improving prehensile functions often does not address the esthetic aspects of the hand. The poor appearance of the reconstructed hand affects its active display and use. A hand-glove prosthesis may be prescribed in this instance to enhance the overall form and function of the mutilated hand. We reviewed 16 cases of mutilating hand injuries in which surgical reconstructions were performed and the patients were subsequently fitted with a hand-glove prosthesis to augment the outcome. An improved appearance was achieved in all patients fitted with the prosthesis. The patients' sense of confidence was also enhanced, which in turn promoted the active and open use of the reconstructed hands. While prescribed primarily to improve the appearance of the reconstructed hands, these prostheses were documented to enhance the physical hand functions in 11 cases by increasing the span of the hand and providing an opposable post and a palmar base for holding and for anchorage. The prosthesis enhanced assistive functions of the reconstructed hands and freed the contralateral normal hand for use in bimanual activities, such as holding a wallet and taking out money, supporting a note pad for writing, and holding a plate at buffet receptions. At the 18-month follow-up visit, 13 (87%) of the patients continued to use their prosthesis. Wear and tear were problems associated with the frequent use of the prosthesis. The expected life span of the prosthesis with daily use ranged from 2 to 3 years. All the patients acknowledged that the prosthesis played a role in their rehabilitation and that it helped them to overcome the initial psychological trauma and to come to terms with their physical loss.

Kinematic analysis of a posterior-stabilized knee prosthesis.

PubMed

Zhao, Zhi-Xin; Wen, Liang; Qu, Tie-Bing; Hou, Li-Li; Xiang, Dong; Bin, Jia

2015-01-20

The goal of total knee arthroplasty (TKA) is to restore knee kinematics. Knee prosthesis design plays a very important role in successful restoration. Here, kinematics models of normal and prosthetic knees were created and validated using previously published data. Computed tomography and magnetic resonance imaging scans of a healthy, anticorrosive female cadaver were used to establish a model of the entire lower limbs, including the femur, tibia, patella, fibula, distal femur cartilage, and medial and lateral menisci, as well as the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments. The data from the three-dimensional models of the normal knee joint and a posterior-stabilized (PS) knee prosthesis were imported into finite element analysis software to create the final kinematic model of the TKA prosthesis, which was then validated by comparison with a previous study. The displacement of the medial/lateral femur and the internal rotation angle of the tibia were analyzed during 0-135° flexion. Both the output data trends and the measured values derived from the normal knee's kinematics model were very close to the results reported in a previous in vivo study, suggesting that this model can be used for further analyses. The PS knee prosthesis underwent an abnormal forward displacement compared with the normal knee and has insufficient, or insufficiently aggressive, "rollback" compared with the lateral femur of the normal knee. In addition, a certain degree of reverse rotation occurs during flexion of the PS knee prosthesis. There were still several differences between the kinematics of the PS knee prosthesis and a normal knee, suggesting room for improving the design of the PS knee prosthesis. The abnormal kinematics during early flexion shows that the design of the articular surface played a vital role in improving the kinematics of the PS knee prosthesis.

An integrated CAD/CAM/robotic milling method for custom cementless femoral prostheses.

PubMed

Wen-ming, Xi; Ai-min, Wang; Qi, Wu; Chang-hua, Liu; Jian-fei, Zhu; Fang-fang, Xia

2015-09-01

Aseptic loosening is the primary cause of cementless femoral prosthesis failure and is related to the primary stability of the cementless femoral prosthesis in the femoral cavity. The primary stability affects both the osseointegration and the long-term stability of cementless femoral prostheses. A custom cementless femoral prosthesis can improve the fit and fill of the prosthesis in the femoral cavity and decrease the micromotion of the proximal prosthesis such that the primary stability of the custom prosthesis can be improved, and osseointegration of the proximal prosthesis is achieved. These results will help to achieve long-term stability in total hip arthroplasty (THA). In this paper, we introduce an integrated CAD/CAM/robotic method of milling custom cementless femoral prostheses. The 3D reconstruction model uses femoral CT images and 3D design software to design a CAD model of the custom prosthesis. After the transformation matrices between two units of the robotic system are calibrated, consistency between the CAM software and the robotic system can be achieved, and errors in the robotic milling can be limited. According to the CAD model of the custom prosthesis, the positions of the robotic tool points are produced by the CAM software of the CNC machine. The normal vector of the three adjacent robotic tool point positions determines the pose of the robotic tool point. In conclusion, the fit rate of custom pig femur stems in the femoral cavities was 90.84%. After custom femoral prostheses were inserted into the femoral cavities, the maximum gaps between the prostheses and the cavities measured less than 1 mm at the diaphysis and 1.3 mm at the metaphysis. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

Survival of various implant-supported prosthesis designs following 36 months of clinical function.

PubMed

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.

Next generation shape memory prosthesis (NiTiBOND) for stapedotomy: Short-term results.

PubMed

Green, J Douglas; McElveen, John T

2017-04-01

To review hearing results and complications for the NiTiBOND next generation shape memory prosthesis and compare them with results for the current shape memory prosthesis (SMart). Retrospective, multicenter chart review. Primary laser stapedotomy was performed using either a NiTiBOND or a SMart prosthesis. Ninety-two ears in 79 patients were included in the study (67.4% female), 52 with the NiTiBOND prosthesis and 40 with the SMart prosthesis. Data collected included demographic variables, pre- and postoperative pure-tone air and bone conduction thresholds, speech discrimination scores, complications, and the need for revision surgery. Pure-tone average (PTA) and PTA air-bone gap (ABG) pre- and postoperative were computed. Success was defined as a postoperative ABG of ≤10 dB. There were no significant differences between groups in hearing results, including improvement in ABG, change in speech discrimination, change in air or bone PTA, or change in high-frequency bone PTA. Short-term (mean = 4.4 and 4.9 weeks, respectively) success rates for the NiTiBOND and SMart prostheses were 84.6% and 70.0%, respectively, with this difference closing at the most recent test (83.7% and 80.0%, respectively). No revision surgery took place in either group, and there were no differences in complications such as dizziness, tinnitus, or taste disturbance, though the NiTiBOND group tended to have a lower rate of transient or permanent vertigo. Compared with the SMart prosthesis, the NiTiBOND prosthesis is a safe prosthesis that achieves at least comparable hearing results and may offer some surgical advantages. 4 Laryngoscope, 127:915-920, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Metabolics of stair ascent with a powered transfemoral prosthesis.

PubMed

Ledoux, E D; Lawson, B E; Shultz, A H; Bartlett, H L; Goldfarb, M

2015-01-01

This paper evaluates the effectiveness of a powered knee and ankle prosthesis for stair ascent through a metabolic assessment comparing energy expenditure of a single transfemoral amputee subject while ascending stairs with the powered prosthesis relative to his passive daily use device, as well as comparing the kinematics and kinetics obtained with the passive prosthesis to healthy biomechanics. The subject wore a portable system that measured pulmonary gaseous exchange rates of oxygen and carbon dioxide while he ascended stairs with each of the prostheses in alternating tests. The results indicated that the amputee's energy expenditure decreased by 32 percent while climbing with the powered prosthesis as compared to his passive one, and the kinematics and kinetics achieved were representative of healthy biomechanics.

Prosthetic Rehabilitation of Mandibular Defects with Fixed-removable Partial Denture Prosthesis Using Precision Attachment: A Twin Case Report.

PubMed

Munot, Vimal Kantilal; Nayakar, Ramesh P; Patil, Raghunath

2017-01-01

The restoration of normal function and esthetic appearance with a dental prosthesis is a major challenge in the rehabilitation of patients who have lost their teeth and surrounding bone because of surgery for oral cyst or tumor. Rehabilitation with fixed or removable prosthesis is even more challenging when the edentulous span is long and the ridge is defective. Anatomic deformities and unfavorable biomechanics encountered in the region of resection add to the misery. In such situation, a fixed-removable prosthesis allows favorable biomechanical stress distribution along with restoration of esthetics, phonetics, comfort, hygiene, and better postoperative care and maintenance. This article describes rehabilitation of two cases with mandibular defects with an attachment-retained fixed-removable hybrid prosthesis.

21 CFR 876.3750 - Testicular prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a...

Development of Subischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2012-10-01

materials to facilitate dissemination of this technique. 15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted...an appropriate mechanical pump to create suitable vacuum for suspension of the prosthesis ...sockets of highly active prosthesis users

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

An interim prosthesis program for lower limb amputees: comparison of public and private models of service.

PubMed

Gordon, Robert; Magee, Christopher; Frazer, Anna; Evans, Craig; McCosker, Kathryn

2010-06-01

This study compared the outcomes of an interim mechanical prosthesis program for lower limb amputees operated under a public and private model of service. Over a two-year period, 60 transtibial amputees were fitted with an interim prosthesis as part of their early amputee care. Thirty-four patients received early amputee care under a public model of service, whereby a prosthetist was employed to provide the interim mechanical prosthesis service. The remaining 26 patients received early amputee care under a private model of service, where an external company was contracted to provide the interim mechanical prosthesis service. The results suggested comparable clinical outcomes between the two patient groups. However, the public model appeared to be less expensive with the average labour cost per patient being 29.0% lower compared with the private model. The results suggest that a public model of service may provide a more comprehensive and less expensive interim prosthesis program for lower limb amputees.

A clinical and radiostereometric study of the cemented PFC-sigma prosthesis: a 5-year study of 29 cases with a fixed bearing.

PubMed

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.

Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review

PubMed Central

S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi

2016-01-01

Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed. PMID:28959744

Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review.

PubMed

S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi

2016-06-01

Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed.

Sensory feedback add-on for upper-limb prostheses.

PubMed

Fallahian, Nader; Saeedi, Hassan; Mokhtarinia, Hamidreza; Tabatabai Ghomshe, Farhad

2017-06-01

Sensory feedback systems have been of great interest in upper-limb prosthetics. Despite tremendous research, there are no commercial modality-matched feedback systems. This article aims to introduce the first detachable and feedback add-on option that can be attached to in-use prostheses. A sensory feedback system was tested on a below-elbow myoelectric prosthesis. The aim was to have the amputee grasp fragile objects without crushing while other accidental feedback sources were blocked. A total of 8 successful trials (out of 10) showed that sensory feedback system decreased the amputee's visual dependency by improving awareness of his prosthesis. Sensory feedback system can be used either as post-fabrication (prosthetic add-on option) or para-fabrication (incorporated into prosthetic design). The use of these direct feedback systems can be explored with a current prosthesis before ordering new high-tech prosthesis. Clinical relevance This technical note introduces the first attach/detach-able sensory feedback system that can simply be added to in-use (myo)electric prosthesis, with no obligation to change prosthesis design or components.

Laryngeal complications after type 1 thyroplasty.

PubMed

Cotter, C S; Avidano, M A; Crary, M A; Cassisi, N J; Gorham, M M

1995-12-01

Type I thyroplasty has become a primary surgical choice for voice restoration in patients with glottal incompetence. This study examines factors associated with laryngeal complications after type I thyroplasty. Ten laryngoscopic variables were analyzed from preoperative, intraoperative, and postoperative videolaryngoscopies of 51 patients undergoing 58 medialization procedures. Ten patient and operative variables were examined by medical record review. Major complications were defined as wound hemorrhage, airway obstruction, or prosthesis extrusion. Minor complications were defined as vocal fold hematoma without airway obstruction or prosthesis movement. The major complication rate was 8.6%, and the minor complication rate was 29%. No delayed hemorrhage or airway obstruction occurred. Prosthesis extrusion occurred in five (8.6%) patients 1 week to 5 months after surgery. Extrusion was associated with suboptimal prosthesis placement in 80% of cases. Two patients retained excellent glottal closure despite extrusion. Vocal fold hematoma was identified in 14 (24%) cases and resolved within 1 week. Prosthesis movement occurred in three (5%) patients 1 week to 6 months after surgery and resulted in poor glottal closure. All patients with prosthesis extrusion or movement were female. Type I thyroplasty remains a safe outpatient procedure with few major complications. Prosthesis extrusion was associated with suboptimal prosthesis placement and may or may not result in poor glottal closure. Minor vocal fold hematomas were relatively frequent, resolved rapidly, and were not associated with airway obstruction. Female patients may be more prone to complications because of their small laryngeal size.

Mobile-bearing TKA improved the anteroposterior joint stability in mid-flexion range comparing to fixed-bearing TKA.

PubMed

Minoda, Yukihide; Ikebuchi, Mitsuhiko; Mizokawa, Shigekazu; Ohta, Yoichi; Nakamura, Hiroaki

2016-11-01

Proper anteroposterior (AP) joint displacement is an important indicator of good clinical outcome following total knee arthroplasty (TKA). We hypothesized that a newly introduced mobile-bearing posterior stabilized (PS) prosthesis reduces the AP joint displacement. The aim of this study is to compare the AP joint displacement between a newly introduced mobile-bearing PS TKA in one knee and a conventional fixed-bearing PS TKA in other knee. 82 knees in 41 patients who had bilateral TKAs were investigated. All the patients received a conventional fixed-bearing PS prosthesis in one knee and a highly congruent mobile-bearing PS prosthesis in the other knee. AP joint displacement was measured using the KT-2000 arthrometer, at 30° and 75° in flexion, at average of 3.3 years after the operation. AP joint displacements at 30° in flexion were 6 ± 3 mm in the knees with the mobile-bearing PS prosthesis and 9 ± 4 mm in the knee with fixed-bearing PS prosthesis (p < 0.001). AP joint displacements at 75° in flexion were 4 ± 2 mm in the knees with the mobile-bearing PS prosthesis and 6 ± 3 mm in the knee with fixed-bearing PS prosthesis (p < 0.001). This study suggested that the design of the prosthesis can improve the AP joint stability in mid-flexion range.

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular condyle prosthesis. 872.3960 Section 872.3960 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a...

21 CFR 872.3950 - Glenoid fossa prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872.3950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3720 - Tracheal prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

Facial recognition using enhanced pixelized image for simulated visual prosthesis.

PubMed

Li, Ruonan; Zhhang, Xudong; Zhang, Hui; Hu, Guanshu

2005-01-01

A simulated face recognition experiment using enhanced pixelized images is designed and performed for the artificial visual prosthesis. The results of the simulation reveal new characteristics of visual performance in an enhanced pixelization condition, and then new suggestions on the future design of visual prosthesis are provided.

21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

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 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

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 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

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 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

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...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

Development of Sub-Ischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2013-10-01

15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted suspension 16. SECURITY CLASSIFICATION OF: 17...vacuum for suspension of the prosthesis ...14 Task 6 Determine range of volumes to be evacuated from transfemoral sockets of highly active prosthesis users

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 888.6 - Degree of constraint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either... translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces... total joint replacement and restricts minimally prosthesis movement in one or more planes. Its...

Prosthetic Rehabilitation of Mandibular Defects with Fixed-removable Partial Denture Prosthesis Using Precision Attachment: A Twin Case Report

PubMed Central

Munot, Vimal Kantilal; Nayakar, Ramesh P.; Patil, Raghunath

2017-01-01

The restoration of normal function and esthetic appearance with a dental prosthesis is a major challenge in the rehabilitation of patients who have lost their teeth and surrounding bone because of surgery for oral cyst or tumor. Rehabilitation with fixed or removable prosthesis is even more challenging when the edentulous span is long and the ridge is defective. Anatomic deformities and unfavorable biomechanics encountered in the region of resection add to the misery. In such situation, a fixed-removable prosthesis allows favorable biomechanical stress distribution along with restoration of esthetics, phonetics, comfort, hygiene, and better postoperative care and maintenance. This article describes rehabilitation of two cases with mandibular defects with an attachment-retained fixed-removable hybrid prosthesis. PMID:29042738

Consumer design priorities for upper limb prosthetics.

PubMed

Biddiss, Elaine; Beaton, Dorcas; Chau, Tom

2007-11-01

To measure consumer satisfaction with upper limb prosthetics and provide an enumerated list of design priorities for future developments. A self-administered, anonymous survey collected information on participant demographics, history of and goals for prosthesis use, satisfaction, and design priorities. The questionnaire was available online and in paper format and was distributed through healthcare providers, community support groups, and one prosthesis manufacturer; 242 participants of all ages and levels of upper limb absence completed the survey. Rates of rejection for myoelectric hands, passive hands, and body-powered hooks were 39%, 53%, and 50%, respectively. Prosthesis wearers were generally satisfied with their devices while prosthesis rejecters were dissatisfied. Reduced prosthesis weight emerged as the highest priority design concern of consumers. Lower cost ranked within the top five design priorities for adult wearers of all device types. Life-like appearance is a priority for passive/cosmetic prostheses, while improved harness comfort, wrist movement, grip control and strength are required for body-powered devices. Glove durability, lack of sensory feedback, and poor dexterity were also identified as design priorities for electric devices. Design priorities reflect consumer goals for prosthesis use and vary depending on the type of prosthesis used and age. Future design efforts should focus on the development of more light-weight, comfortable prostheses.

Rehabilitation of a missing ear with an implant retained auricular prosthesis

PubMed Central

Guttal, Satyabodh Sheshraj; Shanbhag, Shruti; Kulkarni, Sudhindra S.; Thakur, Srinath L.

2015-01-01

Burns can leave a patient with a severely debilitating disability even after treatment. The objectives of burn rehabilitation are to minimize the adverse effects caused by the injury while rehabilitating the patient's physical and psychological well-being, maximizing social integration. Long-term success of maxillofacial prostheses mainly depends on the retention. Extra oral implant retained prostheses have proved to be a predictable treatment option for maxillofacial rehabilitation. Replacement of a severely deformed external ear with burned tissues may be satisfactorily accomplished by a cosmetic prosthesis anchored by implants integrated in the skull. The use of such implants is now a well-recognized method for creating a stable result in maxillofacial rehabilitation. This case report describes a safe, simple and economical method for the rehabilitation of a patient with missing right auricle using an implant supported silicone prosthesis. The implant was placed in the mastoid region of the temporal bone. Reconstruction of the ear was done with auricular silicone prosthesis, retained using magnets incorporated in an autopolymerizing resin shim to decrease the weight of the prosthesis on a single implant. This method eliminates the need of tedious laboratory procedures and exact casting and fitting requirements of a metal substructure while minimizing the overall weight and cost of the prosthesis while maintaining adequate support, esthetics and retention of the prosthesis. PMID:26929490

Tracheal replacement in rabbits with a new composite silicone-metallic prosthesis.

PubMed

Dodge-Khatami, Ali; Niessen, Hans W M; Koole, Leo H; Klein, Marloes G; van Gulik, Thomas M; de Mol, Bas A J M

2003-09-01

A new composite silicone-metallic prosthesis was tested, studying the potential for respiratory epithelial covering over the biocompatible inner lining, in a rabbit survival model. Seven New Zealand White rabbits underwent near-total excision of their trachea and implantation of a sterile prosthesis. After 2 months, they were sacrificed and the prostheses were retrieved. Specimens were fixed and histologically examined for tissue reaction around the prosthesis, at the anastomotic lines, and particularly for the presence or absence of epithelialization of the inner lumen over the biocompatible surface. All rabbits survived the operation. At 2 months, the outer layer of the prosthesis was consistently covered with fibrosis and neutrophils. The inner layer showed necrotic cells and scant re-epithelialization over the biocompatible lining, up to 5 mm beyond the anastomosis, with no evidence of organized respiratory epithelium in the middle sections. The new prosthesis is a viable temporary solution for airway replacement in rabbits. Granulation tissue was not observed at the anastomosis, and re-epithelialization did occur, but failed to achieve full-length luminal covering. The potential for granulation tissue does not yet make this an ideal long-term solution. Improvements in prosthesis design or biocompatibility are required, and need to be re-evaluated before applicability for chronic use.

Design and Characterization of a Quasi-Passive Pneumatic Foot-Ankle Prosthesis.

PubMed

Lee, Jeffrey D; Mooney, Luke M; Rouse, Elliott J

2017-07-01

The majority of commercially available passive prosthetic feet are not capable of providing joint mechanics that match that of the intact human ankle. Due to their cantilever design, their stiffness characteristics contrast with what has been observed in the biological ankle, namely, an increase in stiffness during the stance phase of walking. In this paper, we introduce the design and control of a pneumatic foot-ankle prosthesis that attempts to provide biomimetic mechanics. The prosthesis is comprised of a pneumatic cylinder in series with a fiberglass leaf spring, and a solenoid valve to control the flow of air between the two sides of the cylinder. The solenoid valve acts as a mechanical clutch, enabling resetting of the ankle's equilibrium position. By adjusting the pressure inside the cylinder, the prosthesis can be customized to provide a range of ankle mechanics. A mechanical testing machine is used to compare the torque-angle curve of the pneumatic prosthesis with a low-profile passive prosthetic foot. Finally, data are presented of one transtibial amputee walking with the prosthesis at 1.2 m/s. The testing shows that the pneumatic prosthesis is capable of providing an appropriate range of motion as well a maximum torque of 94 Nm, while returning approximately 11.5 J of energy.

Developing an Ear Prosthesis Fabricated in Polyvinylidene Fluoride by a 3D Printer with Sensory Intrinsic Properties of Pressure and Temperature

PubMed Central

Suaste-Gómez, Ernesto; Rodríguez-Roldán, Grissel; Reyes-Cruz, Héctor; Terán-Jiménez, Omar

2016-01-01

An ear prosthesis was designed in 3D computer graphics software and fabricated using a 3D printing process of polyvinylidene fluoride (PVDF) for use as a hearing aid. In addition, the prosthesis response to pressure and temperature was observed. Pyroelectric and piezoelectric properties of this ear prosthesis were investigated using an astable multivibrator circuit, as changes in PVDF permittivity were observed according to variations of pressure and temperature. The results show that this prosthesis is reliable for use under different conditions of pressure (0 Pa to 16,350 Pa) and temperature (2 °C to 90 °C). The experimental results show an almost linear and inversely proportional behavior between the stimuli of pressure and temperature with the frequency response. This 3D-printed ear prosthesis is a promising tool and has a great potentiality in the biomedical engineering field because of its ability to generate an electrical potential proportional to pressure and temperature, and it is the first time that such a device has been processed by the additive manufacturing process (3D printing). More work needs to be carried out to improve the performance, such as electrical stimulation of the nervous system, thereby extending the purpose of a prosthesis to the area of sensory perception. PMID:26959026

Developing an Ear Prosthesis Fabricated in Polyvinylidene Fluoride by a 3D Printer with Sensory Intrinsic Properties of Pressure and Temperature.

PubMed

Suaste-Gómez, Ernesto; Rodríguez-Roldán, Grissel; Reyes-Cruz, Héctor; Terán-Jiménez, Omar

2016-03-04

An ear prosthesis was designed in 3D computer graphics software and fabricated using a 3D printing process of polyvinylidene fluoride (PVDF) for use as a hearing aid. In addition, the prosthesis response to pressure and temperature was observed. Pyroelectric and piezoelectric properties of this ear prosthesis were investigated using an astable multivibrator circuit, as changes in PVDF permittivity were observed according to variations of pressure and temperature. The results show that this prosthesis is reliable for use under different conditions of pressure (0 Pa to 16,350 Pa) and temperature (2 °C to 90 °C). The experimental results show an almost linear and inversely proportional behavior between the stimuli of pressure and temperature with the frequency response. This 3D-printed ear prosthesis is a promising tool and has a great potentiality in the biomedical engineering field because of its ability to generate an electrical potential proportional to pressure and temperature, and it is the first time that such a device has been processed by the additive manufacturing process (3D printing). More work needs to be carried out to improve the performance, such as electrical stimulation of the nervous system, thereby extending the purpose of a prosthesis to the area of sensory perception.

Interdisciplinary interface between fixed prosthodontics and periodontics.

PubMed

Abduo, Jaafar; Lyons, Karl M

2017-06-01

Although periodontal factors do not usually have a direct effect on the survival of a fixed prosthesis, harmony between the prosthesis and the periodontium is critical otherwise esthetics, the longevity of the prosthesis and the periodontium will be compromised. A close interdisciplinary relationship between periodontics and prosthodontics is therefore necessary to avoid an unsatisfactory treatment outcome, requiring extensive and expensive retreatment. The design of the prosthesis, the number and quality of the abutment teeth, the preparation and the pontic, the occlusion and the material need to be considered when planning prosthodontic treatment. The location of the preparation margin and the contour and emergence profile of the prosthesis will influence the response of the gingival tissues to the prosthesis. Pontic design and cleansibility also contribute to the response of the gingival tissues as well as to the clinical and esthetic outcome. Even an optimal pontic design will not prevent inflammation of the mucosa adjacent to the pontic if pontic hygiene is not maintained by removal of plaque. Case selection and the patients' ability to carry out adequate oral hygiene are therefore essential for longevity of the prosthesis, and regular reviews provide an opportunity for early detection and treatment of failures. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Design and experimental analysis of a new malleovestibulopexy prosthesis using a finite element model of the human middle ear.

PubMed

Vallejo Valdezate, Luis A; Hidalgo Otamendi, Antonio; Hernández, Alberto; Lobo, Fernando; Gil-Carcedo Sañudo, Elisa; Gil-Carcedo García, Luis M

2015-01-01

Many designs of prostheses are available for middle ear surgery. In this study we propose a design for a new prosthesis, which optimises mechanical performance in the human middle ear and improves some deficiencies in the prostheses currently available. Our objective was to design and assess the theoretical acoustic-mechanical behaviour of this new total ossicular replacement prosthesis. The design of this new prosthesis was based on an animal model (an iguana). For the modelling and mechanical analysis of the new prosthesis, we used a dynamic 3D computer model of the human middle ear, based on the finite elements method (FEM). The new malleovestibulopexy prosthesis design demonstrates an acoustical-mechanical performance similar to that of the healthy human middle ear. This new design also has additional advantages, such as ease of implantation and stability in the middle ear. This study shows that computer simulation can be used to design and optimise the vibroacoustic characteristics of middle ear implants and demonstrates the effectiveness of a new malleovestibulopexy prosthesis in reconstructing the ossicular chain. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

Advanced engineering tools for design and fabrication of a custom nasal prosthesis

NASA Astrophysics Data System (ADS)

Oliveira, Inês; Leal, Nuno; Silva, Pedro; da Costa Ferreira, A.; Neto, Rui J.; Lino, F. Jorge; Reis, Ana

2012-09-01

Unexpected external defects resulting from neoplasms, burns, congenital malformations, trauma or other diseases, particularly when involving partial or total loss of an external organ, can be emotionally devastating. These defects can be restored with prosthesis, obtained by different techniques, materials and methods. The increase of patient numbers and cost constraints lead to the need of exploring new techniques that can increase efficiency. The main goal of this project was to develop a full engineering-based manufacturing process to obtain soft-tissue prosthesis that could provide faster and less expensive options in the manufacturing of customized prosthesis, and at the same time being able to reproduce the highest degree of details, with the maximum comfort for the patient. Design/methodology/approach - This case report describes treatment using silicone prosthesis with an anatomic retention for an 80-years-old woman with a rhinectomy. The proposed methodology integrates non-contact structured light scanning, CT and reverse engineering with CAD/CAM and additive manufacturing technology. Findings - The proposed protocol showed encouraging results since reveals being a better solution for fabricating custom-made facial prostheses for asymmetrical organs than conventional approaches. The process allows the attainment of prosthesis with the minimum contact and discomfort for the patient, disclosing excellent results in terms of aesthetic, prosthesis retention and in terms of time and resources consumed.

Dual-energy CT and ceramic or titanium prostheses material reduce CT artifacts and provide superior image quality of total knee arthroplasty.

PubMed

Kasparek, Maximilian F; Töpker, Michael; Lazar, Mathias; Weber, Michael; Kasparek, Michael; Mang, Thomas; Apfaltrer, Paul; Kubista, Bernd; Windhager, Reinhard; Ringl, Helmut

2018-06-07

To evaluate the influence of different scan parameters for single-energy CT and dual-energy CT, as well as the impact of different material used in a TKA prosthesis on image quality and the extent of metal artifacts. Eight pairs of TKA prostheses from different vendors were examined in a phantom set-up. Each pair consisted of a conventional CoCr prosthesis and the corresponding anti-allergic prosthesis (full titanium, ceramic, or ceramic-coated) from the same vendor. Nine different (seven dual-energy CT and two single-energy CT) scan protocols with different characteristics were used to determine the most suitable CT protocol for TKA imaging. Quantitative image analysis included assessment of blooming artifacts (metal implants appear thicker on CT than they are, given as virtual growth in mm in this paper) and streak artifacts (thick dark lines around metal). Qualitative image analysis was used to investigate the bone-prosthesis interface. The full titanium prosthesis and full ceramic knee showed significantly fewer blooming artifacts compared to the standard CoCr prosthesis (mean virtual growth 0.6-2.2 mm compared to 2.9-4.6 mm, p < 0.001). Dual-energy CT protocols showed less blooming (range 3.3-3.8 mm) compared to single-energy protocols (4.6-5.5 mm). The full titanium and full ceramic prostheses showed significantly fewer streak artifacts (mean standard deviation 77-86 Hounsfield unit (HU)) compared to the standard CoCr prosthesis (277-334 HU, p < 0.001). All dual-energy CT protocols had fewer metal streak artifacts (215-296 HU compared to single-energy CT protocols (392-497 HU)). Full titanium and ceramic prostheses were ranked superior with regard to the image quality at the bone/prosthesis interface compared to a standard CoCr prosthesis, and all dual-energy CT protocols were ranked better than single-energy protocols. Dual-energy CT and ceramic or titanium prostheses reduce CT artifacts and provide superior image quality of total knee arthroplasty at the bone/prosthesis interface. These findings support the use of dual-energy CT as a solid imaging base for clinical decision-making and the use of full-titanium or ceramic prostheses to allow for better CT visualization of the bone-prosthesis interface.

Biomechanical Analysis of a Novel Intercalary Prosthesis for Humeral Diaphyseal Segmental Defect Reconstruction.

PubMed

Zhao, Li-Ming; Tian, Dong-Mu; Wei, Yue; Zhang, Jun-Hui; Di, Zheng-Lin; He, Zhi-Yong; Hu, Yong-Cheng

2018-02-01

To study the biomechanical properties of a novel modular intercalary prosthesis for humeral diaphyseal segmental defect reconstruction, to establish valid finite element humerus and prosthesis models, and to analyze the biomechanical differences in modular intercalary prostheses with or without plate fixation. Three groups were set up to compare the performance of the prosthesis: intact humerus, humerus-prosthesis and humerus-prosthesis-plate. The models of the three groups were transferred to finite element software. Boundary conditions, material properties, and mesh generation were set up for both the prosthesis and the humerus. In addition, 100 N or 2 N.m torsion was loaded to the elbow joint surface with the glenohumeral joint surface fixed. Humeral finite element models were established according to CT scans of the cadaveric bone; reverse engineering software Geomagic was used in this procedure. Components of prosthetic models were established using 3-D modeling software Solidworks. To verify the finite element models, the in vitro tests were simulated using a mechanical testing machine (Bionix; MTS Systems Corporation, USA). Starting with a 50 N preload, the specimen was subjected to 5 times tensile (300 N) and torsional (5 N.m) strength; interval time was 30 min to allow full recovery for the next specimen load. Axial tensile and torsional loads were applied to the elbow joint surface to simulate lifting heavy objects or twisting something, with the glenohumeral joint surface fixed. Stress distribution on the humerus did not change its tendency notably after reconstruction by intercalary prosthesis whether with or without a plate. The special design which included a plate and prosthesis effectively diminished stress on the stem where aseptic loosening often takes place. Stress distribution major concentrate upon two stems without plate addition, maximum stress on proximal and distal stem respectively diminish 27.37% and 13.23% under tension, 10.66% and 11.16% under torsion after plate allied. The novel intercalary prosthesis has excellent ability to reconstruct humeral diaphyseal defects. The accessory fixation system, which included a plate and prosthesis, improved the rigidity of anti-tension and anti-torsion, and diminished the risk of prosthetic loosening and dislocation. A finite element analysis is a kind of convenient and practicable method to be used as the confirmation of experimental biomechanics study. © 2018 Chinese Orthopaedic Association and John Wiley & Sons Australia, Ltd.

Estimating free-body modal parameters from tests of a constrained structure

NASA Technical Reports Server (NTRS)

Cooley, Victor M.

1993-01-01

Hardware advances in suspension technology for ground tests of large space structures provide near on-orbit boundary conditions for modal testing. Further advances in determining free-body modal properties of constrained large space structures have been made, on the analysis side, by using time domain parameter estimation and perturbing the stiffness of the constraints over multiple sub-tests. In this manner, passive suspension constraint forces, which are fully correlated and therefore not usable for spectral averaging techniques, are made effectively uncorrelated. The technique is demonstrated with simulated test data.

Making pro formas perform.

PubMed

Bryan, Stephen; Lilien, Steven

2003-10-01

Regulators are trying to clear up the muddle created by earnings-report adjustments called "pro formas" that companies issue. Constraining such reporting, as the regulators seem bent on doing, isn't the solution. Firms should increase alternative reporting--and fully account for their accounting.

Effect of joining the sectioned implant-supported prosthesis on the peri-implant strain generated in simulated mandibular model.

PubMed

Singh, Ipsha; Nair, K Chandrasekharan; Shetty, Jayakar

2017-01-01

The aim of this study is to evaluate the strain developed in simulated mandibular model before and after the joining of an implant-supported screw-retained prosthesis by different joining techniques, namely, arc welding, laser welding, and soldering. A specimen simulating a mandibular edentulous ridge was fabricated in heat-cured acrylic resin. 4-mm holes were drilled in the following tooth positions; 36, 33, 43, 46. Implant analogs were placed in the holes. University of California, Los Angeles, abutment was attached to the implant fixture. Eight strain gauges were attached to the acrylic resin model. Six similar models were made. Implant-supported screw-retained fixed prosthesis was fabricated in nickel-chromium alloy. A load of 400 N was applied on the prosthesis using universal testing machine. Resultant strain was measured in each strain gauge. All the prostheses were sectioned at the area between 36 and 33, 33 and 43, and 43 and 46 using 35 micrometer carborundum disc, and strain was measured in each strain gauge after applying a load of 400 N on the prosthesis. Specimens were joined by arc welding, soldering, and laser welding. After joining, a load of 400 N was applied on each prosthesis and the resultant strain was measured in each strain gauge. Highest mean strain values were recorded before sectioning of the prostheses (889.9 microstrains). Lowest mean strain values were recorded after sectioning the prosthesis and before reuniting it (225.0 microstrains). Sectioning and reuniting the long-span implant prosthesis was found to be a significant factor in influencing the peri-implant strain.

Sexual Function and Quality of Life Before and After Penile Prosthesis Implantation Following Radial Forearm Flap Phalloplasty.

PubMed

Young, Ezekiel E; Friedlander, Daniel; Lue, Kathy; Anele, Uzoma A; Khurgin, Jacob L; Bivalacqua, Trinity J; Burnett, Arthur L; Redett, Richard J; Gearhart, John P

2017-06-01

To provide sexual function and quality of life outcomes in patients with severe penile deficiency who underwent radial forearm flap phalloplasty with and without penile prosthesis implantation. Patients with history of severe penile deficiency who underwent microsurgical radial forearm flap phalloplasty with and without penile prosthesis implantation between 2007 and 2014 were identified. They completed a set of web-based validated questionnaires including the International Index of Erectile Function, the Pediatric Penile Perception Score, the Sexual Quality of Life for Men, and several items addressing general quality of life. Outcomes were compared between groups. Nine of the 12 identified patients who had prosthesis after phalloplasty and 4 out of the 7 phalloplasty-only patients completed the survey, resulting in an overall response rate of 68%. Among the phalloplasty-prosthesis patients, 66% reported current sexual activity and 78% reported regular masturbation, whereas 1 of the 4 phalloplasty-only patients reported both. Prosthesis patients scored notably higher in all domains of the International Index of Erectile Function except for sexual desire. In contrast, they demonstrated similar scores of penile perception, as well as general and sexual quality of life. Among patients who have undergone flap phalloplasty, the subsequent placement of penile prosthesis appears to effectively allow for both intercourse and masturbation, resulting in measurable improvements in orgasmic function, intercourse satisfaction, and overall sexual satisfaction. Despite these important benefits, prosthesis placement does not appear to result in improvements in penile perception scores, or general or sexual quality of life. Copyright © 2017 Elsevier Inc. All rights reserved.

The Evolution and Utility of the Small-Carrion Prosthesis, Its Impact, and Progression to the Modern-Day Malleable Penile Prosthesis.

PubMed

Martinez, Daniel R; Terlecki, Ryan; Brant, William O

2015-11-01

Erectile dysfunction has plagued humanity for millennia. For years, treatment had been in the hands of mental health professionals. It was not until the 1970s that urologists created a modality that was marketable, reproducible, and consistently successful at treating impotence, the Small-Carrion Penile Prosthesis. We present the evolution of the malleable/semi-rigid penile prosthesis, concentrating our efforts reviewing and critiquing the pivotal article published by Drs. Michael P. Small, Hernan M. Carrion, and Julian A. Gordon. We then discuss its continued advancement, current-day utilization, and the future of the malleable prosthesis. From the early 1900s, surgeons have been toying with the idea of creating a penile implant. These initial attempts utilized rib cartilage, and eventually synthetic materials, including acrylic, silicone, and polyethylene. In 1975, Drs. Carrion and Small presented their initial experience of 31 patients utilizing their silicone implant. In their manuscript titled, "The Small-Carrion Penile Prosthesis: New Implant for the Management of Impotence," they discuss their technique, perioperative management of complications, and results. The malleable penile prosthesis continued to evolve throughout the years to the current day Genesis and Spectra. Although the current market is dominated by the inflatable penile prosthesis, there are specific situations where the malleable is ideally utilized. The pivotal article by Drs. Carrion and Small helped pave the way for the "New Era" of penile prosthetics and still remains one of the most impactful contributions to the management of erectile dysfunction. © 2015 International Society for Sexual Medicine.

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 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint tibial (hemi-knee) metallic resurfacing... Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted...

21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellar (hemi-knee) metallic... § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. A...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

Femoral Prosthesis Infection by Rhodotorula mucilaginosa▿

PubMed Central

Savini, Vincenzo; Sozio, Federica; Catavitello, Chiara; Talia, Marzia; Manna, Assunta; Febbo, Fabio; Balbinot, Andrea; Di Bonaventura, Giovanni; Piccolomini, Raffaele; Parruti, Giustino; D'Antonio, Domenico

2008-01-01

This case report is a case history of a femoral prosthesis infection caused by Rhodotorula mucilaginosa in a human immunodeficiency virus patient. Though the pathogenicity of this organism for bone tissue has been previously reported, this is the first reported case of an orthopedic prosthesis infection by this species of the genus Rhodotorula. PMID:18753353

Design and Control of a Pneumatically Actuated Transtibial Prosthesis.

PubMed

Zheng, Hao; Shen, Xiangrong

2015-04-01

This paper presents the design and control of a pneumatically actuated transtibial prosthesis, which utilizes a pneumatic cylinder-type actuator to power the prosthetic ankle joint to support the user's locomotion. The pneumatic actuator has multiple advantages over the traditional electric motor, such as light weight, low cost, and high power-to-weight ratio. The objective of this work is to develop a compact and lightweight transtibial prosthesis, leveraging the multiple advantages provided by this highly competitive actuator. In this paper, the design details of the prosthesis are described, including the determination of performance specifications, the layout of the actuation mechanism, and the calculation of the torque capacity. Through the authors' design calculation, the prosthesis is able to provide sufficient range of motion and torque capacity to support the locomotion of a 75 kg individual. The controller design is also described, including the underlying biomechanical analysis and the formulation of the finite-state impedance controller. Finally, the human subject testing results are presented, with the data indicating that the prosthesis is able to generate a natural walking gait and sufficient power output for its amputee user.

Teflon-wire piston or stainless-steel bucket stapes prosthesis: does it make a difference?

PubMed

Farrior, J B; Temple, A E

1999-04-01

The goal of this study was to determine whether postoperative (implantation of a stapes prosthesis) hearing gain and the amount of air-bone gap overclosure are more improved with the Teflon-wire piston or with the stainless-steel bucket prosthesis. We retrospectively reviewed the outcomes of 82 surgeries that had been performed by the primary author; 41 of these patients had received a Fisch Teflon-wire piston, and 41 had received a Bailey-modified Robinson stainless-steel bucket prosthesis. The mean hearing gain for the patients who received the Teflon-wire piston was 23.3 dB after primary stapes surgery and 20.5 dB after revision surgery. Patients who received the stainless-steel bucket prosthesis experienced a mean hearing gain of 20.7 and 20.3 dB, respectively. Following primary stapes surgery, the air-bone gap overclosure was 4.4 dB with the Teflon-wire piston and 5.2 dB with the stainless-steel bucket prosthesis. There was no statistically significant difference in either hearing gain or air-bone gap overclosure between the two prostheses.

Design and Control of a Pneumatically Actuated Transtibial Prosthesis

PubMed Central

Zheng, Hao; Shen, Xiangrong

2015-01-01

This paper presents the design and control of a pneumatically actuated transtibial prosthesis, which utilizes a pneumatic cylinder-type actuator to power the prosthetic ankle joint to support the user's locomotion. The pneumatic actuator has multiple advantages over the traditional electric motor, such as light weight, low cost, and high power-to-weight ratio. The objective of this work is to develop a compact and lightweight transtibial prosthesis, leveraging the multiple advantages provided by this highly competitive actuator. In this paper, the design details of the prosthesis are described, including the determination of performance specifications, the layout of the actuation mechanism, and the calculation of the torque capacity. Through the authors’ design calculation, the prosthesis is able to provide sufficient range of motion and torque capacity to support the locomotion of a 75 kg individual. The controller design is also described, including the underlying biomechanical analysis and the formulation of the finite-state impedance controller. Finally, the human subject testing results are presented, with the data indicating that the prosthesis is able to generate a natural walking gait and sufficient power output for its amputee user. PMID:26146497

A hollow definitive obturator fabrication technique for management of partial maxillectomy.

PubMed

Patil, Pravinkumar Gajanan; Patil, Smita Pravinkumar

2012-11-01

Maxillary obturator prosthesis is the most frequent treatment option for management of partial or total maxillectomy. Heavy weight of the obturators is often a dislocating factor. Hollowing the prosthesis to reduce its weight is the well established fact. The alternate technique to hollow-out the prosthesis has been described in this article which is a variation of previously described processing techniques. A pre-shaped wax-bolus was incorporated inside the flasks during packing of the heat-polymerized acrylic resin to automatically create the hollow space. The processing technique described is a single step flasking procedure to construct a closed-hollow-obturator prosthesis as a single unit. To best understand the technique, this article describes management of a patient who had undergone partial maxillectomy secondary to squamous cell carcinoma rehabilitated with a hollow-obturator prosthesis.

A hollow definitive obturator fabrication technique for management of partial maxillectomy

PubMed Central

Patil, Smita Pravinkumar

2012-01-01

Maxillary obturator prosthesis is the most frequent treatment option for management of partial or total maxillectomy. Heavy weight of the obturators is often a dislocating factor. Hollowing the prosthesis to reduce its weight is the well established fact. The alternate technique to hollow-out the prosthesis has been described in this article which is a variation of previously described processing techniques. A pre-shaped wax-bolus was incorporated inside the flasks during packing of the heat-polymerized acrylic resin to automatically create the hollow space. The processing technique described is a single step flasking procedure to construct a closed-hollow-obturator prosthesis as a single unit. To best understand the technique, this article describes management of a patient who had undergone partial maxillectomy secondary to squamous cell carcinoma rehabilitated with a hollow-obturator prosthesis. PMID:23236579

A new biomechanical hand prosthesis controlled by surface electromyographic signals.

PubMed

Andrade, Nei A; Borges, Geovany A; de O Nascimento, Francisco A; Romariz, Alexandre R S; da Rocha, Adson F

2007-01-01

This paper describes the development of a low-cost hand prosthesis for use in patients with an amputated hand due to congenital problems or to trauma wound, who possess a part or the forearm endowed with muscular activity. The paper covers the constructive aspects of both mechanical and electronic designs. The prototype is controlled by electromyographic signals measured at the remaining part of the injured limb of the patient. The EMG signals are measured at the surface of the skin, at a point that is close to a working muscle of the amputated arm. The prosthesis allows the patient to hold objects by means of a three finger clamp. The prosthesis presented an excellent performance in preliminary tests with an amputated patient. These tests showed that the prosthesis had a very good performance regarding force and speed.

Transition from a fixed implant dental prosthesis to an implant overdenture in an edentulous patient: a clinical report.

PubMed

Ali, Bolouri; Bhavani, Venkatachalam

2014-09-01

The lack of planning before implant placement and restoration in edentulous patients can lead to a number of problems. Prosthodontists are often faced with the challenge of re-treating patients who have only recently been treated. Although many reports discuss retreatment by fabricating all new prosthetic components, few discuss salvaging parts of the patient's existing prosthesis. This report details the treatment of an edentulous patient who presented with an implant-retained fixed dental prosthesis in the maxillary arch and no opposing prosthesis. The transition from an implant-retained fixed dental prosthesis to a removable implant- and tissue-supported overdenture that uses the patient's existing computer-aided design/computer-aided manufacturing milled titanium substructure is described. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Vent-induced prosthetic leaflet thrombosis treated by open-heart valve-in-valve implantation.

PubMed

Stamm, Christof; Pasic, Miralem; Buz, Semih; Hetzer, Roland

2015-09-01

A patient required emergency mitral valve replacement and extracorporeal membrane oxygenation (ECMO) support for acute biventricular failure. The left ventricular (LV) vent inserted via the left upper pulmonary vein induced thrombotic immobilization of a prosthetic valve leaflet, with significant intra-prosthesis regurgitation after ECMO explantation. Therefore, the left atrium was opened on the beating heart during conventional extracorporeal circulation, all prosthesis leaflets were excised and a 29-mm expandable Edwards Sapien prosthesis was inserted within the scaffold of the original prosthesis under direct vision. This case illustrates the benefits and potential problems of LV venting on ECMO support, and a rapid and safe way of replacing the prosthesis leaflets in a critical situation. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Rehabilitation with dental prosthesis can increase cerebral regional blood volume.

PubMed

Miyamoto, Ikuya; Yoshida, Kazuya; Tsuboi, Yoichi; Iizuka, Tadahiko

2005-12-01

Treatment with denture for edentulous people is highly important for maintaining quality of life. However, its effect on the brain is unknown. In this experimental study, we hypothesized that dental prosthesis can recover not only the physical condition of mastication system but also the regional brain activity. We evaluated functional brain imaging of edentulous subjects fixed by dental implant prosthesis with clenching tasks by multi-channel near-infrared optical topography. Results revealed a significantly (P<0.001; paired t-test) increased cerebral regional blood volume during maximum voluntary clenching task by implant-retained prosthesis. There were no statistically significant differences between patients with and without prosthesis in the latency to the maximum regional blood volume after the task. Conclusively, clenching can be effective for increasing cerebral blood volume; accordingly maintenance of normal chewing might prevent the brain from degenerating.

Candida albicans, Staphylococcus aureus and Streptococcus mutans colonization in patients wearing dental prosthesis.

PubMed

Baena-Monroy, Tania; Moreno-Maldonado, Víctor; Franco-Martínez, Fernando; Aldape-Barrios, Beatriz; Quindós, Guillermo; Sánchez-Vargas, Luis Octavio

2005-04-01

Denture stomatitis is associated to Candida albicans, different bacteria and other co-factors such as an acid pH, a carbohydrate ingestion increase, different systemic illnesses and pharmacological treatments. The aim of this study was to determine Candida albicans, Staphylococcus aureus and Streptococcus mutans prevalence in the mucous membrane and prosthesis of patients with and without atrophic denture stomatitis and its relationship with other potential clinical co-factors. Saliva was collected from 105 patients (62 female and 43 male) wearing dental prosthesis in order to measure their pH. Oral samples of the mucous membrane and the internal surface of dental prosthesis were taken with sterile cotton to proceed with the microbiological study. The identification of the isolated microorganisms was performed using conventional microbiological methods. Diabetes and Hypertension were the most frequent systemic illnesses. High carbohydrate ingestion was observed in numerous patients. Atrophic denture stomatitis was reported in 50 patients and the pH average in saliva was of 5.2. The presence of C albicans, S. aureus and S. mutans in the mucous membrane and prosthesis was of 51.4%, 52.4% and 67.6%, respectively. C. albicans was isolated in 66.7% from the prosthesis, whereas S. aureus and S. mutans were isolated in 49.5% of those same prosthesis. C. albicans was isolated in 86% of the patients with atrophic denture stomatitis and S. aureus was isolated in a similar percentage (84% of patients). The isolation of S. mutans was less frequent, and it was observed in 16% of the oral samples of these patients. C. albicans, S. aureus and S. mutans frequently colonize the oral mucous of patients wearing dental prosthesis. This illness-bearing condition is more frequent in patients with denture stomatitis, even though dental prosthesis colonization is lower than in the oral mucous.

Biocompatible membrane of PDMS for the new chamber prosthesis stapes.

PubMed

Banasik, Katarzyna; Kwacz, Monika

2016-06-30

Stapes protheses are designed for patients with otosclerosis resulting immobilization or significant reduction of the stapes mobility. All currently used prostheses are called - piston prosthesis. However, its use to stimulate the cochlea is still imperfect. New chamber stapes prosthesis allows the perilymph excitation more effective than the piston prothesis. Moreover, the chamber prosthesis eliminates the common causes of piston-stapedotomy failures. The most important element of the new prosthesis is a flexible membrane. The membrane stiffness should be close to the stiffness of normal annular ligament. This work presents the process of selection of the membrane's thickness and its manufacturing technology. Method A 3D model of the chamber stapes prosthesis was build using Autodesk Inventor 2015. The model was imported to Abacus 6.13 computing environment. During numerical simulations, displacements corresponding to applied loads were calculated and the membrane thickness was adjusted so that its stiffness was the same as the ligament stiffness (~ 120 N/m). The compliance ratios calculated from the load-displacement curves for the membrane and the annular ligament were verified using linear regression analysis. After determining the thickness, the manufacturing technology of the membrane was developed. Results The best similarity between the membrane's and annular ligament's stiffness was achieved for PDMS membrane with the 0,15- mm thickness (similarity ratio R2=0,997752). In this work, the technological parameters of spin-coating process for membrane manufacture are also presented. Summary The proper functioning of the chamber stapes prosthesis requires the PDMS membrane with a thickness of 0,15 mm. The 0,15-mm membrane has the tiffness close to the stiffness of the normal annular ligament. Therefore, the chamber stapes prosthesis provides the perilymph stimulation at the level comparable to the healthy ear. New prosthesis is currently under pre-clinical investigation to optimize the shape of the inner chamber's surface.

Kinematic Analysis of a Posterior-stabilized Knee Prosthesis

PubMed Central

Zhao, Zhi-Xin; Wen, Liang; Qu, Tie-Bing; Hou, Li-Li; Xiang, Dong; Bin, Jia

2015-01-01

Background: The goal of total knee arthroplasty (TKA) is to restore knee kinematics. Knee prosthesis design plays a very important role in successful restoration. Here, kinematics models of normal and prosthetic knees were created and validated using previously published data. Methods: Computed tomography and magnetic resonance imaging scans of a healthy, anticorrosive female cadaver were used to establish a model of the entire lower limbs, including the femur, tibia, patella, fibula, distal femur cartilage, and medial and lateral menisci, as well as the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments. The data from the three-dimensional models of the normal knee joint and a posterior-stabilized (PS) knee prosthesis were imported into finite element analysis software to create the final kinematic model of the TKA prosthesis, which was then validated by comparison with a previous study. The displacement of the medial/lateral femur and the internal rotation angle of the tibia were analyzed during 0–135° flexion. Results: Both the output data trends and the measured values derived from the normal knee's kinematics model were very close to the results reported in a previous in vivo study, suggesting that this model can be used for further analyses. The PS knee prosthesis underwent an abnormal forward displacement compared with the normal knee and has insufficient, or insufficiently aggressive, “rollback” compared with the lateral femur of the normal knee. In addition, a certain degree of reverse rotation occurs during flexion of the PS knee prosthesis. Conclusions: There were still several differences between the kinematics of the PS knee prosthesis and a normal knee, suggesting room for improving the design of the PS knee prosthesis. The abnormal kinematics during early flexion shows that the design of the articular surface played a vital role in improving the kinematics of the PS knee prosthesis. PMID:25591565

[Rehabilitation by hollow obturator prosthesis immediately after total maxillectomy for malignant tumor].

PubMed

Li, Xiao-ye; Yan, Ai-hui; Hao, Shuai; Li, Wei; Jiang, Xue-jun; Lu, Li; Qin, Xing-jun; Yan, Hai-xin

2011-05-01

The feasibility and clinical effects of hollow obturator prosthesis for the repair of maxillofacial defect immediately after maxillectomy for cancer were assessed. Thirteen patients with T3-4aN0M0 maxillary neoplasm were treated by the prostheses immediately after maxillectomy. According to the 3D-CT reconstruction of nasal sinus, the 3D stereoscopic prototype was constructed before the surgery. Simulating surgery with Surgicare 5.0 software and then the prosthesis 3D stereoscopic model was shaped. The prosthesis was made quickly and precisely with methacrylate resins according to the model and the print mold before surgery, with supplementary tooth at the bottom of prosthesis. In the surgery, the prosthesis was installed instantly after maxillectomy. The patients were followed up at 1, 3 and 6 month after the surgery, respectively. The facial features and the pronunciation clarity were examined and the questionnaires were carried out in the patients, with comparation by paired t-test. The hollow obturator prosthesis would be replaced by permanent prosthesis made of methacrylate resins at 6 month after the surgery. The hollow obturator prostheses were installed accurately and maxillofacial defects were repaired immediately after maxillectomy in the 13 patients. Postoperative follow-up showed there were significant differences in eyeball sagging (t = 4.67, P < 0.05), mid-facial region collapse (t = 5.67, P < 0.05), and pronunciation clarity (t = 16.38, P < 0.05) between patients with and without prostheses. Questionnaires showed that all the patients were satisfied with the retention of prostheses, the improvement of appearance, the improvement of the symptom of water choking and speech definition. Six months after the surgery, the hollow obturator prostheses were replaced smoothly by permanent prostheses in 11 of the 13 patients. The precise and instant repair of maxillofacial defect by prosthesis after maxillectomy can improve survival quality of patient.

A second prosthesis as a procedural rescue option in trans-apical aortic valve implantation.

PubMed

Kempfert, Jörg; Rastan, Ardawan J; Schuler, Gerhard; Linke, Axel; Holzhey, David; van Linden, Arnaud; Mohr, Friedrich-W; Walther, Thomas

2011-07-01

Trans-apical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved to a routine procedure for selected high-risk elderly patients. In rare cases, misplacement of the SAPIEN™ valve (too low a position), dysfunction of the leaflets or perforation of the interventricular septum (ventricular septal defect, VSD) occurs and requires immediate implantation of a second prosthesis within the first one. Results of this 'bailout' maneuver have not been reported yet. Of 305 TA-AVI procedures, 15 patients required a second prosthesis due to dysfunctional leaflets (n = 6), low position (n = 7), or VSD (n = 2). Mean age was 82.5 ± 1.3 years, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 45.5 ± 5.4, and Society of Thoracic Surgeons (STS) Score was 13.5 ± 1.5. All second SAPIEN™ valves could be implanted successfully within the first one. The second prosthesis solved leaflet dysfunction, sealed the VSD (lower position of the second prosthesis), or corrected the initial misplacement (higher position of the second prosthesis) in all patients. Within 30 days, four patients died (low cardiac output n = 3, all with preoperative ejection fraction (EF) <35%; intestinal ischemia n = 1). Intra-operative echocardiogram and angiogram revealed mild paravalvular leak in three and none/trace in 12 patients. Transvalvular gradients were low despite the implantation of the second valve (P(max)/mean 13.7 ± 4.3/6.4 ± 2.0). Placement of a second SAPIEN™ valve is a valuable 'bailout' technique in case of VSD, dysfunctional leaflets, or too low placement of the first prosthesis. The technique leads to an excellent functional result with low transvalvular gradients. The simple, straight, tubular stent design of the SAPIEN™ prosthesis may be the ideal design for such valve-in-valve procedures. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Designing an Optimized Novel Femoral Stem

PubMed Central

Babaniamansour, Parto; Ebrahimian-Hosseinabadi, Mehdi; Zargar-Kharazi, Anousheh

2017-01-01

Background: After total hip arthroplasty, there would be some problems for the patients. Implant loosening is one of the significant problems which results in thigh pain and even revision surgery. Difference between Young's modulus of bone-metal is the cause of stress shielding, atrophy, and subsequent implant loosening. Materials and Methods: In this paper, femoral stem stiffness is reduced by novel biomechanical and biomaterial design which includes using proper design parameters, coating it with porous surface, and modeling the sketch by the software. Parametric design of femoral stem is done on the basis of clinical reports. Results: Optimized model for femoral stem is proposed. Curved tapered stem with trapezoidal cross-section and particular neck and offset is designed. Fully porous surface is suggested. Moreover, Designed femoral stem analysis showed the Ti6Al4V stem which is covered with layer of 1.5 mm in thickness and 50% of porosity is as stiff as 77 GPa that is 30% less than the stem without any porosity. Porous surface of designed stem makes it fix biologically; thus, prosthesis loosening probability decreases. Conclusion: By optimizing femoral stem geometry (size and shape) and also making a porous surface, which had an intermediate stiffness of bone and implant, a more efficient hip joint prosthesis with more durability fixation was achieved due to better stress transmission from implant to the bone. PMID:28840118

Effect of stump flexion contracture with and without prosthetic alignment intervention towards postural stability among transtibial prosthesis users

NASA Astrophysics Data System (ADS)

Ghazali, M. F.; Razak, N. A. Abd; Abu Osman, N. A.; Gholizadeh, H.

2017-06-01

Knee flexion contracture on a stump side is a phenomenon in which the stump cannot move in normal range of motion (ROM) or cannot be fully extended. This study has been carried out by using Biodex Stability System (BSS) in order to investigate the effect of stump flexion contracture towards the postural stability among the transtibial prosthesis users with the intervention of alignment accommodation. The BSS provides the reading of anterior-posterior stability index (APSI), medial-lateral stability index (MLSI), and overall stability index (OSI). Higher reading of the index indicates lesser stability. Each of the subjects had been tested in three different sessions that were Visit 1 (before contracture improvement), Visit 2 (after contracture improvement without alignment readjustment), and Visit 3 (after contracture improvement with alignment readjustment). The APSI reading was significantly higher during Visit 2 compared to Visit 1 and Visit 3. The OSI during Visit 2 was also found significantly higher compared to Visit 3. In Visit 2, the degree of contracture was significantly improved with 44.1% less than Visit 1. The stability index in anterior-posterior aspect (APSI) was proven to be lower as the prosthetic alignment was adjusted according to the ROM of knee. This finding explained that the alignment set up based on the adaptation with the stump’s ROM can contribute positively in maintaining postural stability.

Rehabilitation regimes based upon psychophysical studies of prosthetic vision

NASA Astrophysics Data System (ADS)

Chen, S. C.; Suaning, G. J.; Morley, J. W.; Lovell, N. H.

2009-06-01

Human trials of prototype visual prostheses have successfully elicited visual percepts (phosphenes) in the visual field of implant recipients blinded through retinitis pigmentosa and age-related macular degeneration. Researchers are progressing rapidly towards a device that utilizes individual phosphenes as the elementary building blocks to compose a visual scene. This form of prosthetic vision is expected, in the near term, to have low resolution, large inter-phosphene gaps, distorted spatial distribution of phosphenes, restricted field of view, an eccentrically located phosphene field and limited number of expressible luminance levels. In order to fully realize the potential of these devices, there needs to be a training and rehabilitation program which aims to assist the prosthesis recipients to understand what they are seeing, and also to adapt their viewing habits to optimize the performance of the device. Based on the literature of psychophysical studies in simulated and real prosthetic vision, this paper proposes a comprehensive, theoretical training regime for a prosthesis recipient: visual search, visual acuity, reading, face/object recognition, hand-eye coordination and navigation. The aim of these tasks is to train the recipients to conduct visual scanning, eccentric viewing and reading, discerning low-contrast visual information, and coordinating bodily actions for visual-guided tasks under prosthetic vision. These skills have been identified as playing an important role in making prosthetic vision functional for the daily activities of their recipients.

[Treatment of periprosthetic femoral fractures after total hip arthroplasty with specially constructed retrograde hollow nails].

PubMed

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.

Calfplasty.

PubMed

Felício, Y

2000-01-01

The author describes a method of calf augmentation by a silicone prosthesis implant for correction of asymmetrical legs or aesthetic problems. Preference is given to the placement of soft silicone implants (Glitzentein implants); they are more natural looking than hard implants. The implants are placed over both heads of the gastrocnemius muscle or beneath the fascia cruris superficialis. Operations were performed from November 1985 to August 1999. One hundred patients were studied: 95 female and 5 male. Two hundred calf implants were performed: 188 soft implants (Glitzenstein), 6 hard implants (Aiache), and 6 together on the same leg (Glitzenstein and Aiache implants). No infection problems, prosthesis rupture, or hematomas occurred. There were four seromas, but they disappeared in 15 days. Four prostheses were removed in two patients who did not like the final result. One prosthesis changed place, to the upper part of the calf. The operation is performed under sedative and local anesthesia, with an incision of approximately 4 to 5 cm in the popliteal pleat, at the same height as the fascia cruris. To date, no functional problem or muscular dysfunction has been provoked by silicone prosthesis implants. The patient walks 8 h after the surgery. We selected 500 patients who received implants in the legs with calf prostheses, fat implants, and prosthesis and fat implant together, during 14 years of follow-up, but the focus of this paper is a calf implant with prosthesis in 100 patients with 200 calf prosthesis implants.

Function of obturator prosthesis after maxillectomy and prosthetic obturator rehabilitation.

PubMed

Chen, Cheng; Ren, Wenhao; Gao, Ling; Cheng, Zheng; Zhang, Linmei; Li, Shaoming; Zhi, Pro Ke-qian

2016-01-01

Maxillary defects are usually rehabilitated by a prosthetic obturator. This study aimed to evaluate the functioning of obturators prosthesis in patients with unilateral defects after maxillectomy. Of 49 patients, 28 underwent to maxillectomy as a result of tumor ablative surgery, and acquired unilateral maxillary defects. Evaluation of the function was performed by applying the Obturator Functional Scale (OFS). From a total of 49 patients, 28 were treated as follows: 9 with a conventional retained obturator prosthesis (COP), 11 (39%) with an enhanced retentive obturator prosthesis with stud attachment (POP) and 8 (28%) with an enhanced retentive obturator prosthesis with magnetic attachment (POM). The mean OFS score was 80. Scores on functions of speech, swallowing and chewing reached statistical significances (p<0.05) among these three subgroups. Comparing COP and MOP groups, the scores of OFS in the domains of "Speech-ability to speak in public" and "Swallowing-leakage with liquids" were significantly higher in AOP group. Comparing COP group, the scores of OFS in "Swallowing-leakage with solid" and "Chewing/eating" domains were increased significantly (p<0.05) both in MOP and AOP groups. Obturator prosthesis improves oral function of patients after maxillary defects; the retention of the obturator prosthesis enhanced by the addition of attachments showed more benefits in oral function. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Percutaneous coronary angioplasty of a left anterior descending artery implanted on a Dacron coronary prosthesis on an aortic conduit.

PubMed

Drobinski, G; Thomas, D; Funck, F; Metzger, J P; Canny, M; Grosgogeat, Y

1986-08-01

Certain surgical techniques may make it difficult to catheterize the coronary ostia and perform percutaneous coronary angioplasty. We report the case of a 48 year old patient who developed unstable angina four years after a Bentall's procedure with reimplantation of the coronary arteries on a Dacron coronary prosthesis. The anginal pain was related to very severe stenosis of the proximal segment of the left anterior descending artery. The difficulties encountered during the dilatation procedure were due to: (a) the ectopic position of the ostium of the prosthesis on the anterior aortic wall; (b) the forces exerted on the aortic prosthesis wall and on the valvular prosthesis during positioning of the guiding catheter which were poorly tolerated and induced a vagal reaction; (c) the direction taken by the distal tip of the guiding catheter, perpendicular to the wall of the aortic prosthesis; (d) the sinuosity of the arterial trajectory: the left coronary segment of the coronary prosthesis was directed towards the left circumflex artery rather than towards the left anterior descending artery. Coronary angioplasty succeeded after relatively complex technical procedures: special guiding catheter, unusual intra-aortic manoeuvres for positioning the guiding catheter, dilatation catheter change on a 3-metre long guide wire in order to cross the stenotic segment; this was performed with a super low-profiled dilatation catheter. There were no complications and anginal pain disappeared.

Bionic ankle–foot prosthesis normalizes walking gait for persons with leg amputation

PubMed Central

Herr, Hugh M.; Grabowski, Alena M.

2012-01-01

Over time, leg prostheses have improved in design, but have been incapable of actively adapting to different walking velocities in a manner comparable to a biological limb. People with a leg amputation using such commercially available passive-elastic prostheses require significantly more metabolic energy to walk at the same velocities, prefer to walk slower and have abnormal biomechanics compared with non-amputees. A bionic prosthesis has been developed that emulates the function of a biological ankle during level-ground walking, specifically providing the net positive work required for a range of walking velocities. We compared metabolic energy costs, preferred velocities and biomechanical patterns of seven people with a unilateral transtibial amputation using the bionic prosthesis and using their own passive-elastic prosthesis to those of seven non-amputees during level-ground walking. Compared with using a passive-elastic prosthesis, using the bionic prosthesis decreased metabolic cost by 8 per cent, increased trailing prosthetic leg mechanical work by 57 per cent and decreased the leading biological leg mechanical work by 10 per cent, on average, across walking velocities of 0.75–1.75 m s−1 and increased preferred walking velocity by 23 per cent. Using the bionic prosthesis resulted in metabolic energy costs, preferred walking velocities and biomechanical patterns that were not significantly different from people without an amputation. PMID:21752817

[Pelvic reconstructions after bone tumor resection].

PubMed

Anract, Philippe; Biau, David; Babinet, Antoine; Tomeno, Bernard

2014-02-01

The three more frequent primitive malignant bone tumour which concerned the iliac bone are chondrosarcoma, following Ewing sarcoma and osteosarcoma. Wide resection remains the most important part of the treatment associated with chemotherapy for osteosarcoma and the Ewing sarcoma. Iliac wing resections and obdurate ring don't required reconstruction. However, acetabular resections and iliac wing resection with disruption of the pelvic ring required reconstruction to provide acceptable functional result. Acetabular reconstruction remains high technical demanding challenge. After isolated acetabular resection or associated to obdurate ring, our usual method of reconstruction is homolateral proximal femoral autograft and total hip prosthesis but it is possible to also used : saddle prosthesis, Mac Minn prosthesis with auto or allograft, modular prosthesis or custom made prosthesis, massive allograft with or without prosthesis and femoro-ilac arthrodesis. After resection of the iliac wing plus acetabulum, reconstruction can be performed by femoro-obturatrice and femora-sacral arthrodesis, homolateral proximal femoral autograft and prosthesis, femoral medialisation, massive allograft and massive allograft. Carcinological results are lesser than resection for distal limb tumor, local recurrence rate range 17 to 45%. Functional results after Iliac wing and obdurate ring are good. However, acetabular reconstruction provide uncertain functional results. The lesser results arrive after hemipelvic or acetabular and iliac wing resection-reconstruction, especially when gluteus muscles were also resected. The most favourable results arrive after isolated acetabular or acetabular plus obturateur ring resection-reconstruction.

Constraining Assertion: An Account of Context-Sensitivity

ERIC Educational Resources Information Center

Villanueva Chigne, Eduardo

2012-01-01

Many philosophers believe that if "S" is an unambiguous, context-sensitive, declarative sentence and "p" is a proposition asserted (without conversational implicatures) by a literal utterance of "S" in a context "c," then "p" is fully determined by the linguistic meaning of "S" in…

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...

Variable Cadence Walking and Ground Adaptive Standing with a Powered Ankle Prosthesis

PubMed Central

Shultz, Amanda H.; Lawson, Brian E.; Goldfarb, Michael

2015-01-01

Abstract This paper describes a control approach that provides walking and standing functionality for a powered ankle prosthesis, and demonstrates the efficacy of the approach in experiments in which a unilateral transtibial amputee subject walks with the prosthesis at variable cadences, and stands on various slopes. Both controllers incorporate a finite-state structure that emulates healthy ankle joint behavior via a series of piecewise passive impedance functions. The walking controller incorporates an algorithm to modify impedance parameters based on estimated cadence, while the standing controller incorporates an algorithm to modulate the ankle equilibrium angle in order to adapt to the ground slope and user posture, and the supervisory controller selects between the walking and standing controllers. The system is shown to reproduce several essential biomechanical features of the healthy joint during walking, particularly relative to a passive prosthesis, and is shown to adapt to variable cadences. The system is also shown to adapt to slopes over a range of ± 15 deg and to provide support to the user in a manner that is biomimetic, as validated by quasi-static stiffness measurements recorded by the prosthesis. Data from standing trials indicate that the user places more weight on the powered prosthesis than on his passive prosthesis when standing on sloped surfaces, particularly at angles of 10 deg or greater. The authors also demonstrated that the prosthesis typically began providing support within 1 s of initial contact with the ground. Further, the supervisory controller was shown to be effective in switching between walking and standing, as well as in determining ground slope just prior to the transition from the standing controller to the walking controller, where the estimated ground slope was within 1.25 deg of the actual ground slope for all trials. PMID:25955789

Clinical Outcome of Medial Pivot Compared With Press-Fit Condylar Sigma Cruciate-Retaining Mobile-Bearing Total Knee Arthroplasty.

PubMed

Kim, Young-Hoo; Park, Jang-Won; Kim, Jun-Shik

2017-10-01

The purpose of this study was to compare the long-term clinical results, radiographic results, range of knee motion, patient satisfaction, and the survival rate of Medial-Pivot posterior cruciate-substituting, knee prosthesis and a press-fit condylar (PFC) Sigma cruciate-retaining mobile-bearing knee prosthesis in the same patients. One hundred eighty-two patients received Medial-Pivot knee prosthesis in one knee and a PFC Sigma knee prosthesis in the contralateral knee. The minimum duration of follow-up was 11 years (range, 11-12.6 years). The knees with a Medial-Pivot knee prosthesis had significantly worse results than those with a PFC Sigma knee prosthesis at the final follow-up with regard to the mean postoperative Knee Society knee scores (90 compared with 95 points), Western Ontario and McMaster Universities Osteoarthritis Index score (25 compared with 18 points), and range of knee motion (117° compared with 128°). Patients were more satisfied with PFC Sigma knee prosthesis (93%) than with Medial-Pivot knee prosthesis (75%). Complication rates were significantly higher in the Medial-Pivot knee group (26%) than those in the PFC Sigma knee group (6.5%). Radiographic results and survival rates (99% compared with 99.5%) were similar between the 2 groups. Although the long-term fixation and survival rate of both Medial-Pivot and PFC Sigma prostheses were similar, we observed a worse knee score, worse range of knee motion, and patient satisfaction was less in the Medial-Pivot knee group than in the PFC Sigma knee group. Furthermore, complication rate was also higher in the Medial-Pivot knee group than the other group. Copyright © 2017 Elsevier Inc. All rights reserved.

[The length of the piston in otosclerosis surgery].

PubMed

Portmann, D; Alcantara, M; Vianna, M

2007-01-01

The measurement of the piston is always described as a significant stage of the surgery but its length is never clearly defined. The goal of this work is to determine the length of the prosthesis. From May 2003 to May 2005, 128 patients with otosclerosis, diagnosed on the basis of their clinical history and their audiogram, were included in this prospective study. Some of them were revision surgeries. The prosthesis generally used was the Portmann piston clip (Medtronic Xomed Inc Portmann Piston Clip Stainless Steel/Fluoroplastic). In stapedectomies, a Teflon piston of 0.6 mm of diameter was used (Pouret Company Fluoroplastic Stapes Prosthesis). These prostheses must be trimmed before their installation. The measurement technique is described. The length of the prosthesis was increased by 0.5 mm to include the thickness of the footplate. The Portmann piston clip was used 116 times (100 initial surgeries and 16 revisions surgeries) and the Teflon prosthesis of 0.6 mm of diameter only 13 times (6 primary stapedectomies and 7 revisions stapedectomies). The length of the prosthesis was between 3,5 mm and 5 mm. In the majority of cases, the length of the prosthesis was 4.75 mm (62 patients, 48.1%), followed by 4.5 mm (29 patients, 22.5%) and 5 mm (27 patients, 20.9%). In eleven cases (8.5%) the prosthesis measured less than 4,5 mm. None of the patients in this study experienced a postoperative sensorineural hearing loss. The measurement of the length of the piston is very significant, and in our study the majority of the pistons were cut at 4.75 mm which indicates an incus-footplate measurement of 4.25 mm.

Predictors of retention and attrition in a study of an advanced upper limb prosthesis: implications for adoption of the DEKA Arm.

PubMed

Resnik, Linda; Cancio, Jill; Klinger, Shana; Latlief, Gail; Sasson, Nicole; Smurr-Walters, Lisa

2018-02-01

The purpose was to identify factors associated with completion of the VA home study of the DEKA Arm. Design and methodological procedures used: Differences between groups were examined using chi-square and t-tests. A multivariable logistic regression model predicting completion was generated and odds ratios (OR) for significant variables calculated. Post-hoc analysis was performed to plot the receiver operating characteristics (ROC) curve. Participants who completed were more likely to be prosthesis users at study onset (p = .03), and less likely to have a history of musculoskeletal problems (p = .047). There were no statistically significant differences between groups who completed and those who did not in gender, race, veteran status, age, body mass index (BMI), weight, height, musculoskeletal pain at baseline, satisfaction with current prosthesis, type of prosthesis, or months of prosthesis use. Two variables, prosthesis use and history of musculoskeletal problems were significant at p < .10. The area under the curve (AUC) accuracy index was 0.78. We considered completion of the home use study a reasonable proxy for participant willingness to adopt the device; and believe that findings can be extrapolated to guide DEKA Arm prescription recommendations. Participants most likely to complete the study were already using a personal prosthesis, and without pre-existing musculoskeletal problems. Implications for rehabilitation Data from the VA Study of the DEKA Arm were analysed to determine which factors were associated with likely successful adoption of the DEKA Arm. Participants most likely to complete the study were those who already using a personal prosthesis, and those without pre-existing chronic or re-occurring musculoskeletal problems. This information may be useful when attempting to identify and target the most appropriate candidates for DEKA Arm prescription.

[Comparison of early clinical effects of two hip prosthesis designs between ceramics to ceramics and metal to polyethylene].

PubMed

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.

Utilization of penile prosthesis and male incontinence prosthetics in Saudi Arabia.

PubMed

Alwaal, Amjad; Al-Sayyad, Ahmad J

2017-01-01

Erectile dysfunction is a prevalent disease affecting over 50% of men between the ages of 40 and 70 years. Penile prosthesis represents the end of the line treatment when other less invasive therapies fail or are contraindicated. Male stress urinary incontinence can significantly diminish quality of life and lead to embarrassment and social withdrawal. Surgical therapies, such as male urethral slings and artificial urinary sphincters (AUS), are considered effective and safe treatments for male stress incontinence. No data exist on the utilization of penile prosthesis or male incontinence surgical treatment in Saudi Arabia. Generally, urological prosthetic surgery is performed either in private hospitals or in government hospitals. Our aim was to assess the trend of penile prosthesis and male incontinence device utilization in Saudi Arabia. We utilized sales' data of penile prosthetics, male slings, and AUS from the only two companies selling these devices in Saudi Arabia (AMS ® and Coloplast ® ), from January 2013 to December 2016. There were 2599 penile prosthesis implantation procedures done in the study period, with 67% of them performed in private institutions. There was a progressively increased use of penile prosthetics which nearly doubled from 2013 to 2016. The main type of prosthesis utilized was the semirigid type 70% versus 11% of the 2-piece inflatable and 17% of the 3-piece inflatable device. Only 10 slings and 31 AUS were inserted during the same study period. There is an increased utilization of penile prosthetics in Saudi Arabia. The private sector performs the majority of penile prosthesis procedures, and most of them are of the semirigid type. The governmental sector is more likely to perform inflatable penile prosthesis and male incontinence device procedures. Male incontinence prosthetics' use is very limited in Saudi Arabia.

[Lysis of the incus long process and incudostapedial rebridging ossiculoplasty: comparative study of titanium-gold angle prosthesis Plester-type versus Martin Incudo prosthesis hydroxylapatite].

PubMed

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.

A laboratory silicone for preclinical training in ear prosthesis.

PubMed

Anand, Vijay; Haribabu; Vimala; Gnanasamband, Vimala

2013-07-01

This article describes an industrial elastic silicone as a material for the laboratory fabrication of ear prosthesis. It has been tested for toxicity in lab animals by the SGS India Pvt. Ltd and approved as a material to pass the parameter of abnormal toxicity. This material therefore can be safely recommended for laboratory exercise to fabricate facial prosthesis. The high cost of the maxillo facial silicone materials prohibits their use for facial prosthesis in pre-clinical training of post-graduate students in maxillofacial prosthodontics. For this reason, pre-clinical laboratory exercise in facial prosthesis is inadequate. A few institutions use polymethyl methacrylate resins which are rigid and do not have elastic characteristics of silicone, which is used for facial defects. This cost-effective industrial silicone material which mimics the elastic and color characteristics of the conventional silicones can be recommended for preclinical exercises.

Aesthetic finger prosthesis with silicone biomaterial

PubMed Central

Raghu, K M; Gururaju, C R; Sundaresh, K J; Mallikarjuna, Rachappa

2013-01-01

The fabrication of finger prosthesis is as much an art as it is science. The ideally constructed prosthesis must duplicate the missing structures so precisely that patients can appear in public without fear of attracting unwanted attraction. A 65-years-old patient reported with loss of his right index finger up to the second phalanx and wanted to get it replaced. An impression of the amputated finger and donor were made. A wax pattern of the prosthesis was fabricated using the donor impression; a trial was performed and flasked. Medical grade silicone was intrinsically stained to match the skin tone, following which it was packed, processed and finished. This clinical report describes a method of attaining retention by selective scoring of the master cast of partially amputated finger to enhance the vacuum effect at par with the proportional distribution of the positive forces on the tissues exerted by the prosthesis. PMID:23975917

A computer simulation of the plasma leakage through a vascular prosthesis made of expanded polytetrafluoroethylene.

PubMed

Tabata, R; Kobayashi, T; Mori, A; Matsuno, S; Watarida, S; Onoe, M; Sugita, T; Shiraisi, S; Nojima, T

1993-04-01

We explored the blood-retaining mechanism of a vascular prosthesis made of expanded polytetrafluoroethylene through analysis of its structure and physicochemical properties. Plasma leakage through this vascular prosthesis was simulated by computer to explore its etiology. These examinations disclosed that leakage is dependent upon the inner pressure and the density of fibers. In other words, the study revealed that the mean distance between fibers constituting the wall of the expanded polytetrafluoroethylene vascular prosthesis is increased by tension (that is, inner pressure), resulting in an increased probability of leakage. It was additionally found that a thin membrane is formed on the polytetrafluoroethylene surface if blood in contact with the surface is dried. This membrane was found to reduce the water-repelling property of polytetrafluoroethylene and to make it impossible to preserve the inter-fiber liquid surface, thus causing leakage through the expanded polytetrafluoroethylene vascular prosthesis.

Short-Term Effect of Prosthesis Transforming Sensory Modalities on Walking in Stroke Patients with Hemiparesis

PubMed Central

Sekiguchi, Yusuke; Honda, Keita; Ishiguro, Akio

2016-01-01

Sensory impairments caused by neurological or physical disorders hamper kinesthesia, making rehabilitation difficult. In order to overcome this problem, we proposed and developed a novel biofeedback prosthesis called Auditory Foot for transforming sensory modalities, in which the sensor prosthesis transforms plantar sensations to auditory feedback signals. This study investigated the short-term effect of the auditory feedback prosthesis on walking in stroke patients with hemiparesis. To evaluate the effect, we compared four conditions of auditory feedback from plantar sensors at the heel and fifth metatarsal. We found significant differences in the maximum hip extension angle and ankle plantar flexor moment on the affected side during the stance phase, between conditions with and without auditory feedback signals. These results indicate that our sensory prosthesis could enhance walking performance in stroke patients with hemiparesis, resulting in effective short-term rehabilitation. PMID:27547456

Customization of stock eye prosthesis for a pediatric patient by a simplified technique.

PubMed

Jurel, Sunit Kumar; Talwar, Naina; Chand, Pooran; Singh, Raghuwar D; Gupta, Durga Shanker

2012-05-01

The unfortunate loss or absence of an eye may be caused by congenital defect , irreparable trauma, tumor or blind eye. The role of the maxillofacial prosthodontist in fabricating an ocular prosthesis to restore facial symmetry and normal appearance for the anophthalmic patient becomes essential. A custom-made ocular prosthesis is an excellent alternative for the people who lose their eye especially in young age. It has acceptable fit, retention and esthetics but is technically difficult to fabricate. On the other hand the stock eye has compromised fit and poor esthetics. Our case report presents a simple technique of customization of stock eye prosthesis to provide accurate fit and acceptable esthetics. How to cite this article: Jurel SK, Talwar N, Chand P, Singh RD, Gupta DS. Customization of Stock Eye Prosthesis for a Pediatric Patient by a Simplified Technique. Int J Clin Pediatr Dent 2012;5(2):155-158.

Customization of Stock Eye Prosthesis for a Pediatric Patient by a Simplified Technique

PubMed Central

Talwar, Naina; Chand, Pooran; Singh, Raghuwar D; Gupta, Durga Shanker

2012-01-01

ABSTRACT The unfortunate loss or absence of an eye may be caused by congenital defect , irreparable trauma, tumor or blind eye. The role of the maxillofacial prosthodontist in fabricating an ocular prosthesis to restore facial symmetry and normal appearance for the anophthalmic patient becomes essential. A custom-made ocular prosthesis is an excellent alternative for the people who lose their eye especially in young age. It has acceptable fit, retention and esthetics but is technically difficult to fabricate. On the other hand the stock eye has compromised fit and poor esthetics. Our case report presents a simple technique of customization of stock eye prosthesis to provide accurate fit and acceptable esthetics. How to cite this article: Jurel SK, Talwar N, Chand P, Singh RD, Gupta DS. Customization of Stock Eye Prosthesis for a Pediatric Patient by a Simplified Technique. Int J Clin Pediatr Dent 2012;5(2):155-158. PMID:25206159

Diameter-Constrained Steiner Tree

NASA Astrophysics Data System (ADS)

Ding, Wei; Lin, Guohui; Xue, Guoliang

Given an edge-weighted undirected graph G = (V,E,c,w), where each edge e ∈ E has a cost c(e) and a weight w(e), a set S ⊆ V of terminals and a positive constant D 0, we seek a minimum cost Steiner tree where all terminals appear as leaves and its diameter is bounded by D 0. Note that the diameter of a tree represents the maximum weight of path connecting two different leaves in the tree. Such problem is called the minimum cost diameter-constrained Steiner tree problem. This problem is NP-hard even when the topology of Steiner tree is fixed. In present paper we focus on this restricted version and present a fully polynomial time approximation scheme (FPTAS) for computing a minimum cost diameter-constrained Steiner tree under a fixed topology.

The complete digital workflow in fixed prosthodontics: a systematic review.

PubMed

Joda, Tim; Zarone, Fernando; Ferrari, Marco

2017-09-19

The continuous development in dental processing ensures new opportunities in the field of fixed prosthodontics in a complete virtual environment without any physical model situations. The aim was to compare fully digitalized workflows to conventional and/or mixed analog-digital workflows for the treatment with tooth-borne or implant-supported fixed reconstructions. A PICO strategy was executed using an electronic (MEDLINE, EMBASE, Google Scholar) plus manual search up to 2016-09-16 focusing on RCTs investigating complete digital workflows in fixed prosthodontics with regard to economics or esthetics or patient-centered outcomes with or without follow-up or survival/success rate analysis as well as complication assessment of at least 1 year under function. The search strategy was assembled from MeSH-Terms and unspecific free-text words: {(("Dental Prosthesis" [MeSH]) OR ("Crowns" [MeSH]) OR ("Dental Prosthesis, Implant-Supported" [MeSH])) OR ((crown) OR (fixed dental prosthesis) OR (fixed reconstruction) OR (dental bridge) OR (implant crown) OR (implant prosthesis) OR (implant restoration) OR (implant reconstruction))} AND {("Computer-Aided Design" [MeSH]) OR ((digital workflow) OR (digital technology) OR (computerized dentistry) OR (intraoral scan) OR (digital impression) OR (scanbody) OR (virtual design) OR (digital design) OR (cad/cam) OR (rapid prototyping) OR (monolithic) OR (full-contour))} AND {("Dental Technology" [MeSH) OR ((conventional workflow) OR (lost-wax-technique) OR (porcelain-fused-to-metal) OR (PFM) OR (implant impression) OR (hand-layering) OR (veneering) OR (framework))} AND {(("Study, Feasibility" [MeSH]) OR ("Survival" [MeSH]) OR ("Success" [MeSH]) OR ("Economics" [MeSH]) OR ("Costs, Cost Analysis" [MeSH]) OR ("Esthetics, Dental" [MeSH]) OR ("Patient Satisfaction" [MeSH])) OR ((feasibility) OR (efficiency) OR (patient-centered outcome))}. Assessment of risk of bias in selected studies was done at a 'trial level' including random sequence generation, allocation concealment, blinding, completeness of outcome data, selective reporting, and other bias using the Cochrane Collaboration tool. A judgment of risk of bias was assigned if one or more key domains had a high or unclear risk of bias. An official registration of the systematic review was not performed. The systematic search identified 67 titles, 32 abstracts thereof were screened, and subsequently, three full-texts included for data extraction. Analysed RCTs were heterogeneous without follow-up. One study demonstrated that fully digitally produced dental crowns revealed the feasibility of the process itself; however, the marginal precision was lower for lithium disilicate (LS2) restorations (113.8 μm) compared to conventional metal-ceramic (92.4 μm) and zirconium dioxide (ZrO2) crowns (68.5 μm) (p < 0.05). Another study showed that leucite-reinforced glass ceramic crowns were esthetically favoured by the patients (8/2 crowns) and clinicians (7/3 crowns) (p < 0.05). The third study investigated implant crowns. The complete digital workflow was more than twofold faster (75.3 min) in comparison to the mixed analog-digital workflow (156.6 min) (p < 0.05). No RCTs could be found investigating multi-unit fixed dental prostheses (FDP). The number of RCTs testing complete digital workflows in fixed prosthodontics is low. Scientifically proven recommendations for clinical routine cannot be given at this time. Research with high-quality trials seems to be slower than the industrial progress of available digital applications. Future research with well-designed RCTs including follow-up observation is compellingly necessary in the field of complete digital processing.

Bionic Running for Unilateral Transtibial Military Amputees

DTIC Science & Technology

2010-01-01

Bellman, R., 2010, “An Active Ankle-Foot Prosthesis With Biomechanical Energy Regeneration”, Transactions of the ASME Journal...Lefeber, D., 2008, “A Biomechanical Transtibial Prosthesis Powered by Pleated Pneumatic Artificial Muscles,” Model Identification and Control, 4, 394- 405. ...Inc., have designed, built, and demonstrated a first of its kind motor powered, single board computer controlled, running prosthesis for military

Encapsulated Ball Bearings for Rotary Micro Machines

DTIC Science & Technology

2007-01-01

maintaining fabrication simplicity and stability. Although ball bearings have been demonstrated in devices such as linear micromotors [6, 7] and rotary... micromotors [8], they have yet to be integrated into the microfabrication process to fully constrain the dynamic element. In the cases of both Modafe et

Implantable multilayer microstrip antenna for retinal prosthesis: antenna testing.

PubMed

Permana, Hans; Fang, Qiang; Rowe, Wayne S T

2012-01-01

Retinal prosthesis has come to a more mature stage and become a very strategic answer to Retinitis Pigmentosa (RP) and Age-related Macular Degeneration (AMD) diseases. In a retinal prosthesis system, wireless link holds a great importance for the continuity of the system. In this paper, an implantable multilayer microstrip antenna was proposed for the retinal prosthesis system. Simulations were performed in High Frequency Structure Simulator (HFSS) with the surrounding material of air and Vitreous Humor fluid. The fabricated antenna was measured for characteristic validation in free space. The results showed that the real antenna possessed similar return loss and radiation pattern, while there was discrepancy with the gain values.

Fabrication of an interim complete removable dental prosthesis with an in-office digital light processing three-dimensional printer: A proof-of-concept technique.

PubMed

Lin, Wei-Shao; Harris, Bryan T; Pellerito, John; Morton, Dean

2018-04-30

This report describes a proof of concept for fabricating an interim complete removable dental prosthesis with a digital light processing 3-dimensional (3D) printer. Although an in-office 3D printer can reduce the overall production cost for an interim complete removable dental prosthesis, the process has not been validated with clinical studies. This report provided a preliminary proof of concept in developing a digital workflow for the in-office additively manufactured interim complete removable dental prosthesis. Copyright © 2018 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Responses evoked by a vestibular implant providing chronic stimulation.

PubMed

Thompson, Lara A; Haburcakova, Csilla; Gong, Wangsong; Lee, Daniel J; Wall, Conrad; Merfeld, Daniel M; Lewis, Richard F

2012-01-01

Patients with bilateral vestibular loss experience dehabilitating visual, perceptual, and postural difficulties, and an implantable vestibular prosthesis that could improve these symptoms would be of great benefit to these patients. In previous work, we have shown that a one-dimensional, unilateral canal prosthesis can improve the vestibulooccular reflex (VOR) in canal-plugged squirrel monkeys. In addition to the VOR, the potential effects of a vestibular prosthesis on more complex, highly integrative behaviors, such as the perception of head orientation and posture have remained unclear. We tested a one-dimensional, unilateral prosthesis in a rhesus monkey with bilateral vestibular loss and found that chronic electrical stimulation partially restored the compensatory VOR and also that percepts of head orientation relative to gravity were improved. However, the one-dimensional prosthetic stimulation had no clear effect on postural stability during quiet stance, but sway evoked by head-turns was modestly reduced. These results suggest that not only can the implementation of a vestibular prosthesis provide partial restitution of VOR but may also improve perception and posture in the presence of bilateral vestibular hypofunction (BVH). In this review, we provide an overview of our previous and current work directed towards the eventual clinical implementation of an implantable vestibular prosthesis.

Chest-wall reconstruction with a customized titanium-alloy prosthesis fabricated by 3D printing and rapid prototyping.

PubMed

Wen, Xiaopeng; Gao, Shan; Feng, Jinteng; Li, Shuo; Gao, Rui; Zhang, Guangjian

2018-01-08

As 3D printing technology emerge, there is increasing demand for a more customizable implant in the repair of chest-wall bony defects. This article aims to present a custom design and fabrication method for repairing bony defects of the chest wall following tumour resection, which utilizes three-dimensional (3D) printing and rapid-prototyping technology. A 3D model of the bony defect was generated after acquiring helical CT data. A customized prosthesis was then designed using computer-aided design (CAD) and mirroring technology, and fabricated using titanium-alloy powder. The mechanical properties of the printed prosthesis were investigated using ANSYS software. The yield strength of the titanium-alloy prosthesis was 950 ± 14 MPa (mean ± SD), and its ultimate strength was 1005 ± 26 MPa. The 3D finite element analyses revealed that the equivalent stress distribution of each prosthesis was unifrom. The symmetry and reconstruction quality contour of the repaired chest wall was satisfactory. No rejection or infection occurred during the 6-month follow-up period. Chest-wall reconstruction with a customized titanium-alloy prosthesis is a reliable technique for repairing bony defects.

Intermanual Transfer Effects in Below-Elbow Myoelectric Prosthesis Users.

PubMed

de Boer, Errit; Romkema, Sietske; Cutti, Andrea G; Brouwers, Michael A; Bongers, Raoul M; van der Sluis, Corry K

2016-11-01

To determine intermanual transfer effects in patients with a below-elbow amputation using a myoelectric prosthesis and to establish whether laterality affects these effects. Case-control. A standardized setting in a rehabilitation clinic. A convenience sample (N=44) of experienced myoelectric prosthesis users (n=22) and matched controls (n=22). Controls were matched on sex, age (±5y), and hand dominance. Both the experienced group and the control group performed several tasks using a prosthesis simulator attached to their nonaffected arm. Movement time, force control, Box and Block test (BBT) scores, and duration of hand opening. Movement times of myoelectric prosthesis users were shorter, and these users had significantly higher BBT scores and shorter hand opening durations than those of controls. No intermanual transfer effects on force control and no laterality effects were found. Intermanual transfer effects were present in experienced myoelectric prosthesis users with a below-elbow amputation, independent of laterality. These findings support the clinical relevance of intermanual transfer training, which may facilitate persons with an upper limb amputation to start training directly after the amputation. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Comparison of mechanical energy profiles of passive and active below-knee prostheses: a case study.

PubMed

Takahashi, Kota Z; Horne, John R; Stanhope, Steven J

2015-04-01

With the recent technological advancements of prosthetic lower limbs, there is currently a great desire to objectively evaluate existing prostheses. Using a novel biomechanical analysis, the purpose of this case study was to compare the mechanical energy profiles of anatomical and two disparate prostheses: a passive prosthesis and an active prosthesis. An individual with a transtibial amputation who customarily wears a passive prosthesis (Elation, Össur) and an active prosthesis (BiOM, iWalk, Inc.) and 11 healthy subjects participated in an instrumented gait analysis. The total mechanical power and work of below-knee structures during stance were quantified using a unified deformable segment power analysis. Active prosthesis generated greater peak power and total positive work than passive prosthesis and healthy anatomical limbs. The case study will enhance future efforts to objectively evaluate prosthetic functions during gait in individuals with transtibial amputations. A prosthetic limb should closely replicate the mechanical energy profiles of anatomical limbs. The unified deformable (UD) analysis may be valuable to facilitate future clinical prescription and guide fine adjustments of prosthetic componentry to optimize gait outcomes. © The International Society for Prosthetics and Orthotics 2014.

Development of a patient-specific temporomandibular joint prosthesis according to the Groningen principle through a cadaver test series.

PubMed

Kraeima, J; Merema, B J; Witjes, M J H; Spijkervet, F K L

2018-05-01

Patients suffering from osteoarthritis, ankylosis (e.g. post-trauma or tumour) in the temporomandibular joint (TMJ) can present with symptoms such as severely restricted mouth opening, pain or other dynamic restrictions of the mandible. To alleviate the symptoms, a total joint prosthesis can be indicated, such as the Groningen TMJ prosthesis. This was developed as a stock device with a lowered centre of rotation for improved translational and opening capacity. This study aimed to improve the design of the prosthesis, and produce a workflow for a customized Groningen TMJ prosthesis, in order to make it more accurate and predictable. The fossa and mandibular components of the Groningen TMJ prosthesis were customized. A series of five human cadavers was operated and bilateral TMJ prostheses were placed using custom cutting and drilling guides. Placement accuracy was evaluated based on post-operative CT data. A total of N = 10 prostheses were placed and analysed. The average Euclidean distance deviation from planned to actual position was 0.81 mm (SD 0.21). All prostheses were placed according to the routine surgical approaches and had an excellent alignment with the bony structures. The newly developed custom Groningen TMJ prosthesis can be placed with great accuracy and is the first step for improving TMJ total joint replacement surgery. Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Engineering platform and experimental protocol for design and evaluation of a neurally-controlled powered transfemoral prosthesis.

PubMed

Zhang, Fan; Liu, Ming; Harper, Stephen; Lee, Michael; Huang, He

2014-07-22

To enable intuitive operation of powered artificial legs, an interface between user and prosthesis that can recognize the user's movement intent is desired. A novel neural-machine interface (NMI) based on neuromuscular-mechanical fusion developed in our previous study has demonstrated a great potential to accurately identify the intended movement of transfemoral amputees. However, this interface has not yet been integrated with a powered prosthetic leg for true neural control. This study aimed to report (1) a flexible platform to implement and optimize neural control of powered lower limb prosthesis and (2) an experimental setup and protocol to evaluate neural prosthesis control on patients with lower limb amputations. First a platform based on a PC and a visual programming environment were developed to implement the prosthesis control algorithms, including NMI training algorithm, NMI online testing algorithm, and intrinsic control algorithm. To demonstrate the function of this platform, in this study the NMI based on neuromuscular-mechanical fusion was hierarchically integrated with intrinsic control of a prototypical transfemoral prosthesis. One patient with a unilateral transfemoral amputation was recruited to evaluate our implemented neural controller when performing activities, such as standing, level-ground walking, ramp ascent, and ramp descent continuously in the laboratory. A novel experimental setup and protocol were developed in order to test the new prosthesis control safely and efficiently. The presented proof-of-concept platform and experimental setup and protocol could aid the future development and application of neurally-controlled powered artificial legs.

Design and fabrication of facial prostheses for cancer patient applying computer aided method and manufacturing (CADCAM)

NASA Astrophysics Data System (ADS)

Din, Tengku Noor Daimah Tengku; Jamayet, Nafij; Rajion, Zainul Ahmad; Luddin, Norhayati; Abdullah, Johari Yap; Abdullah, Abdul Manaf; Yahya, Suzana

2016-12-01

Facial defects are either congenital or caused by trauma or cancer where most of them affect the person appearance. The emotional pressure and low self-esteem are problems commonly related to patient with facial defect. To overcome this problem, silicone prosthesis was designed to cover the defect part. This study describes the techniques in designing and fabrication for facial prosthesis applying computer aided method and manufacturing (CADCAM). The steps of fabricating the facial prosthesis were based on a patient case. The patient was diagnosed for Gorlin Gotz syndrome and came to Hospital Universiti Sains Malaysia (HUSM) for prosthesis. The 3D image of the patient was reconstructed from CT data using MIMICS software. Based on the 3D image, the intercanthal and zygomatic measurements of the patient were compared with available data in the database to find the suitable nose shape. The normal nose shape for the patient was retrieved from the nasal digital library. Mirror imaging technique was used to mirror the facial part. The final design of facial prosthesis including eye, nose and cheek was superimposed to see the result virtually. After the final design was confirmed, the mould design was created. The mould of nasal prosthesis was printed using Objet 3D printer. Silicone casting was done using the 3D print mould. The final prosthesis produced from the computer aided method was acceptable to be used for facial rehabilitation to provide better quality of life.

Should the automatic exposure control system of CT be disabled when scanning patients with endoaortic stents or mechanical heart valves? A phantom study.

PubMed

Di Leo, Giovanni; Spadavecchia, Chiara; Zanardo, Moreno; Secchi, Francesco; Veronese, Ivan; Cantone, Marie Claire; Sardanelli, Francesco

2017-07-01

To estimate the impact of endoaortic stents/mechanical heart valves on the output of an automatic exposure control (AEC) system and CT radiation dose. In this phantom study, seven stents and two valves were scanned with varying tube voltage (80/100/120 kVp), AEC activation (enabled/disabled) and prosthesis (present/absent), for a total of 540 scans. For each prosthesis, the dose-length product (DLP) was compared between scans with the AEC enabled and disabled. Percentage confidence levels for differences due to the prosthesis were calculated. Differences between results with the AEC enabled and disabled were not statistically significant (p ≥ 0.059). In the comparison with and without the prosthesis, DLP was unchanged at 80 kVp and 100 kVp, while a slight increase was observed at 120 kVp. The radiation dose varied from 1.8 mGy to 2.4 mGy without the prosthesis and from 1.8 mGy to 2.5 mGy with the prosthesis (confidence level 37-100%). The effect of the prosthesis on the AEC system was negligible and not clinically relevant. Therefore, disabling the AEC system when scanning these patients is not likely to provide a benefit. • CT-AEC system is not impaired in patients with endoaortic prostheses/heart valves. • Negligible differences may be observed only at 120 kVp. • Disabling the AEC system in these patients is not recommended.

Applications of rapid prototyping technology in maxillofacial prosthetics.

PubMed

Sykes, Leanne M; Parrott, Andrew M; Owen, C Peter; Snaddon, Donald R

2004-01-01

The purpose of this study was to compare the accuracy, required time, and potential advantages of rapid prototyping technology with traditional methods in the manufacture of wax patterns for two facial prostheses. Two clinical situations were investigated: the production of an auricular prosthesis and the duplication of an existing maxillary prosthesis, using a conventional and a rapid prototyping method for each. Conventional wax patterns were created from impressions taken of a patient's remaining ear and an oral prosthesis. For the rapid prototyping method, a cast of the ear and the original maxillary prosthesis were scanned, and rapid prototyping was used to construct the wax patterns. For the auricular prosthesis, both patterns were refined clinically and then flasked and processed in silicone using routine procedures. Twenty-six independent observers evaluated these patterns by comparing them to the cast of the patient's remaining ear. For the duplication procedure, both wax patterns were scanned and compared to scans of the original prosthesis by generating color error maps to highlight volumetric changes. There was a significant difference in opinions for the two auricular prostheses with regard to shape and esthetic appeal, where the hand-carved prosthesis was found to be of poorer quality. The color error maps showed higher errors with the conventional duplication process compared with the rapid prototyping method. The main advantage of rapid prototyping is the ability to produce physical models using digital methods instead of traditional impression techniques. The disadvantage of equipment costs could be overcome by establishing a centralized service.

Towards a Completely Implantable, Light-Sensitive Intraocular Retinal Prosthesis

DTIC Science & Technology

2001-10-25

electronic retinal prosthesis is under development to treat retinitis pigmentosa and age-related macular degeneration, two presently incurable...34Preservation of the inner retina in retinitis pigmentosa . A morphometric analysis," Arch Ophthalmol, vol. 115, no. 4, pp. 511-515, Apr.1997...Towards a completely implantable, light-sensitive intraocular retinal prosthesis. M.S. Humayun, J.D. Weiland, B. Justus1, C. Merrit1, J. Whalen, D

Spring Ankle with Regenerative Kinetics to Build a New Generation of Transtibial Prostheses

DTIC Science & Technology

2008-07-31

form factor that is portable to the wearer. The objective is to build a transtibial prosthesis that will support a Military amputee’s return to...active duty. 15. SUBJECT TERMS Transtibial Prosthesis , regenerative, spring, wearable robot 16. SECURITY CLASSIFICATION OF: 17. LIMITATION...Regenerative Kinetics” to build a new generation of transtibial prostheses Keywords: Transtibial Prosthesis , regenerative, spring, wearable robot

Metabolic cost of level-ground walking with a robotic transtibial prosthesis combining push-off power and nonlinear damping behaviors: preliminary results.

PubMed

Yanggang Feng; Jinying Zhu; Qining Wang

2016-08-01

Recent advances in robotic technology are facilitating the development of robotic prostheses. Our previous studies proposed a lightweight robotic transtibial prosthesis with a damping control strategy. To improve the performance of power assistance, in this paper, we redesign the prosthesis and improve the control strategy by supplying extra push-off power. A male transtibial amputee subject volunteered to participate in the study. Preliminary experimental results show that the proposed prosthesis with push-off control improves energy expenditure by a percentage ranged from 9.72 % to 14.99 % for level-ground walking compared with the one using non-push-off control.

Multidisciplinary approach for in-deep assessment of joint prosthesis failure.

PubMed

Tessarolo, F; Caola, I; Piccoli, F; Dorigotti, P; Demattè, E; Molinari, M; Malavolta, M; Barbareschi, M; Caciagli, P; Nollo, G

2009-01-01

In spite of advancement in biomaterials and biomechanics, in development of new osteo-integrative materials and coatings, and in macro- micro- component design, a non negligible fraction of the implanted prosthesis fails before the expected lifetime. A prospective observational clinical study has been conducted to define and apply a set of experimental techniques to in-deep assess the failure of joint prosthesis. Microbiological, histological and micro-structural techniques were implemented to specifically address phenomena occurring at the tissue-implant interface. Results obtained from 27 cases of prosthetic joint failure are discussed in terms of sensitivity and specificity. A procedural flow-chart is finally proposed for the assessment of joint prosthesis failure.