Sample records for joint prosthesis systems

  1. 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...

  2. 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...

  3. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

  4. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

  5. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

  6. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

  7. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

  8. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

  9. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

  10. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

  11. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

  12. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

  13. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

  14. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

  15. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

  16. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

  17. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

  18. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...

  19. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...

  20. 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.

  1. 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.

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...

  3. 21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...

  4. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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.

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total temporomandibular joint prosthesis. 872.3940 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. The KineSpring® Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis

    PubMed Central

    Clifford, Anton G; Gabriel, Stefan M; O’Connell, Mary; Lowe, David; Miller, Larry E; Block, Jon E

    2013-01-01

    Symptomatic medial compartment knee osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in adults. Therapies intended to unload the medial knee compartment have yielded unsatisfactory results due to low patient compliance with conservative treatments and high complication rates with surgical options. There is no widely available joint-unloading treatment for medial knee OA that offers clinically important symptom alleviation, low complication risk, and high patient acceptance. The KineSpring® Knee Implant System (Moximed, Inc, Hayward, CA, USA) is a first-of-its-kind, implantable, extra-articular, extra-capsular prosthesis intended to alleviate knee OA-related symptoms by reducing medial knee compartment loading while overcoming the limitations of traditional joint-unloading therapies. Preclinical and clinical studies have demonstrated excellent prosthesis durability, substantial reductions in medial compartment and total joint loads, and clinically important improvements in OA-related pain and function. The purpose of this report is to describe the KineSpring System, including implant characteristics, principles of operation, indications for use, patient selection criteria, surgical technique, postoperative care, preclinical testing, and clinical experience. The KineSpring System has potential to bridge the gap between ineffective conservative treatments and irreversible surgical interventions for medial compartment knee OA. PMID:23717052

  18. 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...

  19. 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...

  20. 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...

  1. Wide-awake Anesthesia No Tourniquet Trapeziometacarpal Joint Prosthesis Implantation.

    PubMed

    Müller, Camillo Theo; Christen, Thierry; Heidekruger, Paul I; Lamouille, Jessie; Raffoul, Wassim; McKee, Daniel; Lalonde, Donald H; Durand, Sébastien

    2018-04-01

    Wide awake local anesthesia no tourniquet (WALANT) hand surgery is a rapidly growing in popularity. WALANT has been used by hand surgeons when operating on bones, tendons, ligaments, nerve entrapments. We offer a case report of the first case in the literature describing WALANT technique when performing trapeziometacarpal joint arthroplasty with prosthesis implantation. We offer technical points on how to perform this procedure and the advantages that are associated with using WALANT for prosthesis arthroplasty.

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. A new prosthesis for the metacarpophalangeal joint. Study of materials and biomechanics.

    PubMed

    Petrolati, M; Abbiati, G; Delaria, G; Soffiatti, R; Robotti, P; Guerriero, C

    1999-02-01

    This report discusses the Daphne prosthesis for the metacarpophalangeal joint on the basis of the mechanical, chemical and biological performance of the materials employed. The Daphne prosthesis is a mobile device. The main body is made of a new generation polymethylmetacrylate, while the hinge is made of AISI 316 L stainless steel. Biocompatibility tests were performed on the materials employed. Systemic toxicity, cytotoxicity and contact tests have given favourable results. Mechanical engineering tests have been used to investigate the performances and reliability of the selected materials. The polymethylmetacrylate used in Daphne behaves in a ductile fashion. No mechanical failures were encountered in fatigue tests after 10 million cycles.

  12. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic 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 femoral (hemi-knee) metallic uncemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis. (a) Identification. A knee joint femoral (hemi-knee...

  13. 21 CFR 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing 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) metallic resurfacing... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. (a) Identification. A hip joint femoral (hemi-hip...

  14. 21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint (hemi-hip) acetabular metal cemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. A hip joint (hemi-hip) acetabular...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 21 CFR 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. 888.3400 Section 888.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3400 Hip joint...

  4. 21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint (hemi-hip) acetabular metal cemented prosthesis. 888.3370 Section 888.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint...

  5. 21 CFR 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. 888.3400 Section 888.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3400 Hip joint...

  6. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic 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 femoral (hemi-knee) metallic uncemented prosthesis. 888.3570 Section 888.3570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint...

  7. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic 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 femoral (hemi-knee) metallic uncemented prosthesis. 888.3570 Section 888.3570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint...

  8. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic 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 femoral (hemi-knee) metallic uncemented prosthesis. 888.3570 Section 888.3570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint...

  9. 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...

  10. 21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint (hemi-hip) acetabular metal cemented prosthesis. 888.3370 Section 888.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint...

  11. 21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint (hemi-hip) acetabular metal cemented prosthesis. 888.3370 Section 888.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint...

  12. 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...

  13. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femoral (hemi-knee) metallic uncemented prosthesis. 888.3570 Section 888.3570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint...

  14. 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...

  15. 21 CFR 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. 888.3400 Section 888.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3400 Hip joint...

  16. 21 CFR 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. 888.3400 Section 888.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3400 Hip joint...

  17. Good quality of life outcomes after treatment of prosthetic joint infection with debridement and prosthesis retention.

    PubMed

    Aboltins, Craig; Dowsey, Michelle; Peel, Trish; Lim, Wen K; Choong, Peter

    2016-05-01

    Patients treated for early prosthetic joint infection (PJI) with surgical debridement and prosthesis retention have a rate of successful infection eradication that is similar to patients treated with the traditional approach of prosthesis exchange. It is therefore important to consider other outcomes after prosthetic joint infection treatment that may influence management decisions, such as quality of life (QOL). Our aim was to describe infection cure rates and quality of life for patients with prosthetic joint infection treated with debridement and prosthesis retention and to determine if treatment with this approach was a risk factor for poor quality of life outcomes. Prospectively collected pre and post-arthroplasty data were available for 2,134 patients, of which PJI occurred in 41. For patients treated for prosthetic joint infection, the 2-year survival free of treatment failure was 87% (95%CI 84-89). Prosthetic joint infection cases treated with debridement and retention had a similar improvement from pre-arthroplasty to 12-months post-arthroplasty as patients without PJI in QOL according to the SF-12 survey. Prosthetic joint infection treated with debridement and retention was not a risk factor for poor quality of life on univariate or multivariate analysis. Prosthetic joint infection treated with debridement and prosthesis retention results in good cure rates and quality of life. Further studies are required that directly compare quality of life for different surgical approaches for prosthetic joint infection to better inform management decisions. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:898-902, 2016. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

  18. [A primary application and evaluation of temporomandibular joint replacement with stock prosthesis].

    PubMed

    Zhang, Xiao-hu; Chen, Min-jie; Qiu, Ya-ting; Yang, Chi

    2012-06-01

    To evaluate the effect of total joint replacement in treatment of temporomandibular joint(TMJ) osteoarthropathy with stock prostheses. Six female patients involving 10 joints (2 unilateral and 4 bilateral), with an average age of 59 years old, were involved in this study. Three patients (5 joints) were diagnosed as internal derangement in V stage depending on MRI, 3D-CT findings and clinical characteristics. The other 3 patients (5 joints) had histories of failed temporomandibular joint operation using costochondral graft or temporalis fascial flap. The maximal mouth opening was 1.9 cm on average (range, 1.0 to 2.9cm). All the joints were replaced with Biomet standard prosthesis under general anesthesia. The follow-up period was from 7 to 49 months (average, 17.5 months). All the operations were successfully performed. Heterotopic ossification happened in a bilateral case 1 year postoperatively. One patient with bilateral joint disease complained of severe uncomfortable feeling in the region of the ears and the temples, although there was no significant positive signs according to an ENT examination. Pain relief of the joint and mouth opening improvement were significant in 4 patients. No failure was noted secondary to infection or loosening of the prostheses. The occlusal relationship kept stable postoperatively in all cases. Total TMJ joint replacement with standard prosthesis is a good choice for TMJ reconstruction. It can significantly reduce joint pain and the mouth opening limitation resulted from osteoarthritis. Long-term result remains to be evaluated based on a long-term follow-up.

  19. Finite element analysis of a condylar support prosthesis to replace the temporomandibular joint.

    PubMed

    Abel, Eric W; Hilgers, André; McLoughlin, Philip M

    2015-04-01

    This paper presents a finite element study of a temporomandibular joint (TMJ) prosthesis in which the mandibular component sits on the condyle after removal of only the diseased articular surface and minimal amount of condylar bone. The condylar support prosthesis (CSP) is customised to fit the patient and allows a large part of the joint force to be transmitted through the condyle to the ramus, rather than relying only on transfer of the load by the screws that fix the prosthesis to the ramus. The 3-dimensional structural finite element analysis compared a design of CSP with a standard commercial prosthesis and one that was modified to fit the ramus, to relate the findings to the different designs and geometrical features. The models simulated an incisal bite under high loading. In the CSP and in its fixation screws, the stresses were much lower than those in the other 2 prostheses and the bone strains were at physiological levels. The CSP gives a more physiological form of load transfer than is possible without the condylar contact, and considerably reduces the amount of strain on the bone around the screws. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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.

  15. 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.

  16. 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...

  17. 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...

  18. 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...

  19. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3180...

  20. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3180...

  1. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3180...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3180...

  8. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3180...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing 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 tibial (hemi-knee) metallic resurfacing uncemented prosthesis. 888.3590 Section 888.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3590...

  17. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. 888.3590 Section 888.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3590...

  18. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing 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 tibial (hemi-knee) metallic resurfacing uncemented prosthesis. 888.3590 Section 888.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3590...

  19. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing 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 tibial (hemi-knee) metallic resurfacing uncemented prosthesis. 888.3590 Section 888.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3590...

  20. Development of the transtibial prosthesis controlled pneumatically and electrically by microcomputer system.

    PubMed

    Shimada, Youichi; Terayama, Yukio

    2006-01-01

    This report represents the development of the prototype transtibial prosthesis to assist a smooth and comfortable walking for an unilateral amputee. This prosthesis is composed of two air cylinders, solenoid valves, portable and small air tank for compressed air storage, a multiple sensor system and a microprocessor. Two air cylinders are located around the rods to act as antagonistic and agonistic muscles. The system causes flexion and extension of the foot plate jointed at the ankle with compressed air, injected -or discharged via a solenoid or electromagnetic valves. The valves or solenoids are controlled with a microprocessor (Microchip Technology Inc., PIC16F876), the microprocessor generates control signals to the interface circuits for valve opening and closing consistent with the foot position during the walking phase. The control patterns generated in the microprocessor are modified with feedback from the touch sensor, ankle joint angle sensor and the two dimensional acceleration sensor. The primary walking pattern for an individual amputee should be developed through the gait analysis with video.

  1. Biomechanical Evaluation of a Prototype Foot/Ankle Prosthesis

    PubMed Central

    Quesada, P. M.; Pitkin, M.; Colvin, J.

    2016-01-01

    In this paper, we report on our pilot evaluation of a prototype foot/ankle prosthesis. This prototype has been designed and fabricated with the intention of providing decreased ankle joint stiffness during the middle portion of the stance phase of gait, and increased (i.e., more normal) knee range of motion during stance. Our evaluation involved fitting the existing prototype foot/ankle prosthesis, as well as a traditional solid ankle cushioned heel (SACH) foot, to an otherwise healthy volunteer with a below-knee (BK) amputation. We measured this individual’s lower extremity joint kinematics and kinetics during walking using a video motion analysis system and force platform. These measurements permitted direct comparison of prosthetic ankle joint stiffness and involved side knee joint motion, as well as prosthetic ankle joint moment and power. PMID:10779119

  2. 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

  3. 21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. 888.3390 Section 888.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices...

  4. 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°.

  5. [Inferior hemiarthroplasty of the temporo-mandibular joint with articulated condylar prosthesis type Stryker].

    PubMed

    Bucur, A; Dincă, O; Totan, C; Ghită, V

    2007-01-01

    The optimal reconstruction of the mandible and of the temporo-mandibular joint after mandibular hemi-resection with disarticulation is still controversial in literature. This paperwork presents our experience on four cases in the reconstruction of the mandible together with the inferior arthroplasty of the temporo-mandibular joint, after the resection of extended benign tumors of the mandible, based on fibular free vascularized grafts having attached a Stryker titanium condylar prosthesis reconstructing the inferior segment of the temporo-mandibular joint. Our results for the this technique were excellent, with a functional rehabilitation very close to normal. After reviewing the various techniques and their arguments in literature, with accent on the TMJ reconstruction, we consider this method to be optimal for the reconstruction of mandibular defects in patients with neoplastic conditions.

  6. 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.

  7. 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...

  8. 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...

  9. 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...

  10. 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

  11. 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.

  12. Multibody system of the upper limb including a reverse shoulder prosthesis.

    PubMed

    Quental, C; Folgado, J; Ambrósio, J; Monteiro, J

    2013-11-01

    The reverse shoulder replacement, recommended for the treatment of several shoulder pathologies such as cuff tear arthropathy and fractures in elderly people, changes the biomechanics of the shoulder when compared to the normal anatomy. Although several musculoskeletal models of the upper limb have been presented to study the shoulder joint, only a few of them focus on the biomechanics of the reverse shoulder. This work presents a biomechanical model of the upper limb, including a reverse shoulder prosthesis, to evaluate the impact of the variation of the joint geometry and position on the biomechanical function of the shoulder. The biomechanical model of the reverse shoulder is based on a musculoskeletal model of the upper limb, which is modified to account for the properties of the DELTA® reverse prosthesis. Considering two biomechanical models, which simulate the anatomical and reverse shoulder joints, the changes in muscle lengths, muscle moment arms, and muscle and joint reaction forces are evaluated. The muscle force sharing problem is solved for motions of unloaded abduction in the coronal plane and unloaded anterior flexion in the sagittal plane, acquired using video-imaging, through the minimization of an objective function related to muscle metabolic energy consumption. After the replacement of the shoulder joint, significant changes in the length of the pectoralis major, latissimus dorsi, deltoid, teres major, teres minor, coracobrachialis, and biceps brachii muscles are observed for a reference position considered for the upper limb. The shortening of the teres major and teres minor is the most critical since they become unable to produce active force in this position. Substantial changes of muscle moment arms are also observed, which are consistent with the literature. As expected, there is a significant increase of the deltoid moment arms and more fibers are able to elevate the arm. The solutions to the muscle force sharing problem support the

  13. 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

  14. An Investigation into a Gear-Based Knee Joint Designed for Lower Limb Prosthesis.

    PubMed

    Bhuiyan, M S H; Choudhury, I A; Dahari, M; Nukman, Y; Dawal, S Z

    2017-01-01

    A gear-based knee joint is designed to improve the performance of mechanical-type above-knee prostheses. The gear set with the help of some bracing, and bracket arrangement, is used to enable the prosthesis to follow the residual limb movement. The motion analysis and finite-element analysis (FEA) of knee joint components are carried out to assess the feasibility of the design. The maximum stress of 29.74 MPa and maximum strain of 2.393e-004 are obtained in the gear, whereas the maximum displacement of 7.975 mm occurred in the stopper of the knee arrangement. The factor of safety of 3.5 obtained from the FE analysis indicated no possibility of design failure. The results obtained from the FE analysis are then compared with the real data obtained from the literature for a similar subject. The pattern of motion analysis results has shown a great resemblance with the gait cycle of a healthy biological limb.

  15. An Investigation into a Gear-Based Knee Joint Designed for Lower Limb Prosthesis

    PubMed Central

    2017-01-01

    A gear-based knee joint is designed to improve the performance of mechanical-type above-knee prostheses. The gear set with the help of some bracing, and bracket arrangement, is used to enable the prosthesis to follow the residual limb movement. The motion analysis and finite-element analysis (FEA) of knee joint components are carried out to assess the feasibility of the design. The maximum stress of 29.74 MPa and maximum strain of 2.393e−004 are obtained in the gear, whereas the maximum displacement of 7.975 mm occurred in the stopper of the knee arrangement. The factor of safety of 3.5 obtained from the FE analysis indicated no possibility of design failure. The results obtained from the FE analysis are then compared with the real data obtained from the literature for a similar subject. The pattern of motion analysis results has shown a great resemblance with the gait cycle of a healthy biological limb. PMID:28584518

  16. 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.

  17. Development of an above-knee prosthesis equipped with a microcomputer-controlled knee joint: first test results.

    PubMed

    Aeyels, B; Peeraer, L; Vander Sloten, J; Van der Perre, G

    1992-05-01

    The shortcomings of conventional above-knee prostheses are due to their lack of adaptive control. Implementation of a microcomputer controlling the knee joint in a passive way has been suggested to enhance the patient's gait comfort, safety and cosmesis. This approach was used in the design of a new prosthetic system for the above-knee amputee, and tested on one patient. The knee joint of a conventional, modular prosthesis was replaced by a knee joint mechanism, equipped with a controllable brake on the knee joint axis. Sensors and a microcomputer were added, keeping the system self-contained. The modularity of the design permits the use of an alternative, external, PC-based control unit, emulating the self-contained one, and offering extended data monitoring and storage facilities. For both units an operating environment was written, including sensor/actuator interfacing and the implementation of a real-time interrupt, executing the control algorithm. A double finite state approach was used in the design of the control algorithm. On a higher level, the mode identification algorithm reveals the patient's intent. Within a specific mode (lower level), the relevant mode control algorithm looks for the current phase within the gait cycle. Within a particular phase, a specific simple control action with the brake replaces normal knee muscle activity. Tests were carried out with one prosthetic patient using a basic control algorithm for level walking, allowing controlled knee flexion during stance phase. The technical feasibility of such a concept is illustrated by the test results, even though only flexion during early stance phase was controlled during the trials.(ABSTRACT TRUNCATED AT 250 WORDS)

  18. System training and assessment in simultaneous proportional myoelectric prosthesis control

    PubMed Central

    2014-01-01

    Background Pattern recognition control of prosthetic hands take inputs from one or more myoelectric sensors and controls one or more degrees of freedom. However, most systems created allow only sequential control of one motion class at a time. Additionally, only recently have researchers demonstrated proportional myoelectric control in such systems, an option that is believed to make fine control easier for the user. Recent developments suggest improved reliability if the user follows a so-called prosthesis guided training (PGT) scheme. Methods In this study, a system for simultaneous proportional myoelectric control has been developed for a hand prosthesis with two motor functions (hand open/close, and wrist pro-/supination). The prosthesis has been used with a prosthesis socket equivalent designed for normally-limbed subjects. An extended version of PGT was developed for use with proportional control. The control system’s performance was tested for two subjects in the Clothespin Relocation Task and the Southampton Hand Assessment Procedure (SHAP). Simultaneous proportional control was compared with three other control strategies implemented on the same prosthesis: mutex proportional control (the same system but with simultaneous control disabled), mutex on-off control, and a more traditional, sequential proportional control system with co-contractions for state switching. Results The practical tests indicate that the simultaneous proportional control strategy and the two mutex-based pattern recognition strategies performed equally well, and superiorly to the more traditional sequential strategy according to the chosen outcome measures. Conclusions This is the first simultaneous proportional myoelectric control system demonstrated on a prosthesis affixed to the forearm of a subject. The study illustrates that PGT is a promising system training method for proportional control. Due to the limited number of subjects in this study, no definite conclusions can be

  19. Design and clinical outcome of a novel 3D-printed prosthetic joint replacement for the human temporomandibular joint.

    PubMed

    Ackland, David; Robinson, Dale; Lee, Peter Vee Sin; Dimitroulis, George

    2018-05-11

    Stock prosthetic temporomandibular joint replacements come in limited sizes, and do not always encompass the joint anatomy that presents clinically. The aims of this study were twofold. Firstly, to design a personalized prosthetic total joint replacement for the treatment of a patient's end-stage temporomandibular joint osteoarthritis, to implant the prosthesis into the patient, and assess clinical outcome 12-months post-operatively; and secondly, to evaluate the influence of changes in prosthetic condyle geometry on implant load response during mastication. A 48-year-old female patient with Grade-5 osteoarthritis to the left temporomandibular joint was recruited, and a prosthesis developed to match the native temporomandibular joint anatomy. The prosthesis was 3D printed, sterilized and implanted into the patient, and pain and function measured 12-months post-operatively. The prosthesis load response during a chewing-bite and maximum-force bite was evaluated using a personalized multi-body musculoskeletal model. Simulations were performed after perturbing condyle thickness, neck length and head sphericity. Increases in prosthetic condyle neck length malaligned the mandible and perturbed temporomandibular joint force. Changes in condylar component thickness greatly influenced fixation screw stress response, while a more eccentric condylar head increased prosthetic joint-contact loading. Post-operatively, the prosthetic temporomandibular joint surgery reduced patient pain from 7/10 to 1/10 on a visual analog scale, and increased intercisal opening distance from 22 mm to 38 mm. This study demonstrates effectiveness of a personalized prosthesis that may ultimately be adapted to treat a wide-range of end-stage temporomandibular joint conditions, and highlights sensitivity of prosthesis load response to changes in condylar geometry. Copyright © 2018 Elsevier Ltd. All rights reserved.

  20. Visual prosthesis wireless energy transfer system optimal modeling.

    PubMed

    Li, Xueping; Yang, Yuan; Gao, Yong

    2014-01-16

    Wireless energy transfer system is an effective way to solve the visual prosthesis energy supply problems, theoretical modeling of the system is the prerequisite to do optimal energy transfer system design. On the basis of the ideal model of the wireless energy transfer system, according to visual prosthesis application condition, the system modeling is optimized. During the optimal modeling, taking planar spiral coils as the coupling devices between energy transmitter and receiver, the effect of the parasitic capacitance of the transfer coil is considered, and especially the concept of biological capacitance is proposed to consider the influence of biological tissue on the energy transfer efficiency, resulting in the optimal modeling's more accuracy for the actual application. The simulation data of the optimal model in this paper is compared with that of the previous ideal model, the results show that under high frequency condition, the parasitic capacitance of inductance and biological capacitance considered in the optimal model could have great impact on the wireless energy transfer system. The further comparison with the experimental data verifies the validity and accuracy of the optimal model proposed in this paper. The optimal model proposed in this paper has a higher theoretical guiding significance for the wireless energy transfer system's further research, and provide a more precise model reference for solving the power supply problem in visual prosthesis clinical application.

  1. Standing stability enhancement with an intelligent powered transfemoral prosthesis.

    PubMed

    Lawson, Brian Edward; Varol, Huseyin Atakan; Goldfarb, Michael

    2011-09-01

    The authors have developed a ground-adaptive standing controller for a powered knee and ankle prosthesis which is intended to enhance the standing stability of transfemoral amputees. The finite-state-based controller includes a ground-searching phase, a slope estimation phase, and a joint impedance modulation phase, which together enable the prosthesis to quickly conform to the ground and provide stabilizing assistance to the user. In order to assess the efficacy of the ground-adaptive standing controller, the control approach was implemented on a powered knee and ankle prosthesis, and experimental data were collected on an amputee subject for a variety of standing conditions. Results indicate that the controller can estimate the ground slope within ±1° over a range of ±15°, and that it can provide appropriate joint impedances for standing on slopes within this range.

  2. Do the radial head prosthesis components fit with the anatomical structures of the proximal radioulnar joint?

    PubMed

    Wegmann, Kilian; Hain, Moritz K; Ries, Christian; Neiss, Wolfram F; Müller, Lars P; Burkhart, Klaus J

    2015-09-01

    The fitting accuracy of radial head components has been investigated in the capitulo-radial joint, and reduced contact after prosthetic replacement of the radial head has been observed. The kinematics of the proximal radioulnar joint (PRUJ) are affected by radial head arthroplasty as well, but have not yet been investigated in this regard. The elbow joints of 60 upper extremities of formalin-fixed body donors were disarticulated to obtain a good view of the PRUJ. Each specimen was mounted on the examining table and radial head position in the native PRUJ was assessed in neutral position, full pronation, and full supination. Measurements were repeated after implantation of mono- and bi-polar prostheses. Analysis of the distribution of the joint contacts in the compartments showed significant differences after radial head replacement. In comparison to the native joint, after bipolar and monopolar radial head replacement, the physiological shift of the proximal radius was altered. The physiological shift of the joint contact of the radial head from anterior to posterior during forearm rotation that was found in the native joint in our cadaver model was not observed after prosthetic replacement. With higher conformity and physiological kinematic of radial head prostheses, possibly lower shear forces and lower contact pressures would be generated. The tested radial head prostheses do not replicate the physiological kinematics of the radial head. Further development in the prosthesis design has to be made. The meticulous reconstruction of the annular ligament seems to be of importance to increase joint contact.

  3. Transtibial prosthesis suspension systems: systematic review of literature.

    PubMed

    Gholizadeh, H; Abu Osman, N A; Eshraghi, A; Ali, S; Razak, N A

    2014-01-01

    Today a number of prosthetic suspension systems are available for transtibial amputees. Consideration of an appropriate suspension system can ensure that amputee's functional needs are satisfied. The higher the insight to suspension systems, the easier would be the selection for prosthetists. This review attempted to find scientific evidence pertaining to various transtibial suspension systems to provide selection criteria for clinicians. Databases of PubMed, Web of Science, and ScienceDirect were explored to find related articles. Search terms were as follows: "Transtibial prosthesis (32), prosthetic suspension (48), lower limb prosthesis (54), below-knee prosthesis (58), prosthetic liner (20), transtibial (193), and prosthetic socket (111)". Two reviewers separately examined the papers. Study design (case series of five or more subjects, retrospective or prospective), research instrument, sampling method, outcome measures and protocols were reviewed. Based on the selection criteria, 22 articles (15 prospective studies, and 7 surveys) remained. Sweat control was found to be a major concern with the available suspension liners. Donning and doffing procedures for soft liners are also problematic for some users, particularly those with upper limb weakness. Moreover, the total surface bearing (TSB) socket with pin/lock system is favored by the majority of amputees. In summary, no clinical evidence is available to suggest what kind of suspension system could have an influential effect as a "standard" system for all transtibial amputees. However, among various suspension systems for transtibial amputees, the Iceross system was favored by the majority of users in terms of function and comfort. © 2013. Published by Elsevier Ltd. All rights reserved.

  4. Visual prosthesis wireless energy transfer system optimal modeling

    PubMed Central

    2014-01-01

    Background Wireless energy transfer system is an effective way to solve the visual prosthesis energy supply problems, theoretical modeling of the system is the prerequisite to do optimal energy transfer system design. Methods On the basis of the ideal model of the wireless energy transfer system, according to visual prosthesis application condition, the system modeling is optimized. During the optimal modeling, taking planar spiral coils as the coupling devices between energy transmitter and receiver, the effect of the parasitic capacitance of the transfer coil is considered, and especially the concept of biological capacitance is proposed to consider the influence of biological tissue on the energy transfer efficiency, resulting in the optimal modeling’s more accuracy for the actual application. Results The simulation data of the optimal model in this paper is compared with that of the previous ideal model, the results show that under high frequency condition, the parasitic capacitance of inductance and biological capacitance considered in the optimal model could have great impact on the wireless energy transfer system. The further comparison with the experimental data verifies the validity and accuracy of the optimal model proposed in this paper. Conclusions The optimal model proposed in this paper has a higher theoretical guiding significance for the wireless energy transfer system’s further research, and provide a more precise model reference for solving the power supply problem in visual prosthesis clinical application. PMID:24428906

  5. The Influence of Artificial Cervical Disc Prosthesis Height on the Cervical Biomechanics: A Finite Element Study.

    PubMed

    Yuan, Wei; Zhang, Haiping; Zhou, Xiaoshu; Wu, Weidong; Zhu, Yue

    2018-05-01

    Artificial cervical disc replacement is expected to maintain normal cervical biomechanics. At present, the effect of the Prestige LP prosthesis height on cervical biomechanics has not been thoroughly studied. This finite element study of the cervical biomechanics aims to predict how the parameters, like range of motion (ROM), adjacent intradiscal pressure, facet joint force, and bone-implant interface stress, are affected by different heights of Prestige LP prostheses. The finite element model of intact cervical spine (C3-C7) was obtained from our previous study, and the model was altered to implant Prestige LP prostheses at the C5-C6 level. The effects of the height of 5, 6, and 7 mm prosthesis replacement on ROM, adjacent intradiscal pressure, facet joint force, as well as the distribution of bone-implant interface stress were examined. ROM, adjacent intradiscal pressure, and facet joint force increased with the prosthesis height, whereas ROM and facet joint force decreased at C5-C6. The maximal stress on the inferior surface of the prostheses was greater than that on the superior surface, and the stresses increased with the prosthesis height. The biomechanical changes were slightly affected by the height of 5 and 6 mm prostheses, but were strongly affected by the 7-mm prosthesis. An appropriate height of the Prestige LP prosthesis can preserve normal ROM, adjacent intradiscal pressure, and facet joint force. Prostheses with a height of ≥2 mm than normal can lead to marked changes in the cervical biomechanics and bone-implant interface stress. Copyright © 2018 Elsevier Inc. All rights reserved.

  6. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular...

  7. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular...

  8. Actinomyces gerencseriae hip prosthesis infection: a case report.

    PubMed

    Dubourg, Grégory; Delord, Marion; Gouriet, Frédérique; Fournier, Pierre-Edouard; Drancourt, Michel

    2015-09-28

    Actinomyces bacteria are part of the human oropharyngeal microbiota. They have been associated with abdominal, cervicofacial and thoracic infections and a few cases of joint infections have also been described. In particular, Actinomyces gerencseriae, formerly described as Actinomyces israelii serovar II, has rarely been associated with human infections, mostly involving cervicofacial lesions and periodontal diseases. Here, we report one case of hip prosthesis infection due to A. gerencseriae. A 72-year-old Caucasian male developed an inflammatory collection on the outside of the right thigh where a hip prosthesis had been implanted for 11 years. Culturing a fluid sample from the collection puncture found Staphylococcus hominis and a Gram-positive bacillus unidentified by matrix-assisted laser desorption ionization time-of-flight mass-spectrometry (MALDI-TOF). Sequencing the 16S rRNA gene amplified from both the specimen and the isolate identified A. gerencseriae. Treatment adjusted with amoxicillin and trimethropim-sulfamethoxazole cured the infection. The recently described A. gerencseriae has rarely been involved in human infections. We report the first case of A. gerencseriae joint infection in a hip prosthesis.

  9. [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.

  10. Design, analysis and verification of a knee joint oncological prosthesis finite element model.

    PubMed

    Zach, Lukáš; Kunčická, Lenka; Růžička, Pavel; Kocich, Radim

    2014-11-01

    The aim of this paper was to design a finite element model for a hinged PROSPON oncological knee endoprosthesis and to verify the model by comparison with ankle flexion angle using knee-bending experimental data obtained previously. Visible Human Project CT scans were used to create a general lower extremity bones model and to compose a 3D CAD knee joint model to which muscles and ligaments were added. Into the assembly the designed finite element PROSPON prosthesis model was integrated and an analysis focused on the PEEK-OPTIMA hinge pin bushing stress state was carried out. To confirm the stress state analysis results, contact pressure was investigated. The analysis was performed in the knee-bending position within 15.4-69.4° hip joint flexion range. The results showed that the maximum stress achieved during the analysis (46.6 MPa) did not exceed the yield strength of the material (90 MPa); the condition of plastic stability was therefore met. The stress state analysis results were confirmed by the distribution of contact pressure during knee-bending. The applicability of our designed finite element model for the real implant behaviour prediction was proven on the basis of good correlation of the analytical and experimental ankle flexion angle data. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. 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.

  12. [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.

  13. Early prosthetic hip joint infection treated with debridement, prosthesis retention and biofilm-active antibiotics: functional outcomes, quality of life and complications.

    PubMed

    Aboltins, C; Dowsey, M M; Peel, T; Lim, W K; Parikh, S; Stanley, P; Choong, P F

    2013-07-01

    Patients treated for early prosthetic joint infection (PJI) with surgical debridement, prosthesis retention and biofilm-active antibiotics, such as rifampicin or fluoroquinolones have a rate of successful infection eradication that is similar to patients treated with the traditional approach of prosthesis exchange. It is therefore important to consider other outcomes after PJI treatment that may influence management decisions, such as function, quality of life (QOL) and treatment-associated complications. To describe rates of successful treatment for patients with PJI undergoing surgical debridement, prosthesis retention and biofilm-active antibiotics and compare their functional outcomes, QOL and complication rates to patients without PJI. Nineteen patients treated for PJI after hip arthroplasty with debridement, prosthesis retention and biofilm-active antibiotics were matched to 76 controls who underwent hip arthroplasty with no infection. Cumulative survival free from treatment failure at 2 years was 88% (95% confidence interval, 59-97%). PJI cases had significant improvement from pre-arthroplasty to 12-months post-arthroplasty in function according to Harris Hip Score and QOL according to the 12-item Short Form Health Survey Physical Component Summary. There was no significant difference in the improvement between controls and cases. PJI was not a risk factor for poor function or QOL. Medical complications occurred more frequently in cases (6/19 (32%)) than controls (9/76 (12%); P = 0.04), with this difference being accounted for by drug reactions. Surgical complications were the same in the two groups. Treatment of PJI with debridement, prosthesis retention and biofilm-active antibiotics is successful, well tolerated and results in significant improvements in function and QOL, which are similar to patients without PJI. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

  14. A Canadian Electric-Arm Prosthesis for Children

    PubMed Central

    Nicholls, Peter B.; Stevenson, David A.; Sherman, E. David; Lippay, Andrew L.; Gingras, Gustave

    1967-01-01

    The thalidomide tragedy in Canada initiated new efforts to produce functional prosthetic appliances for very young amputees. In 1962, the Rehabilitation Institute of Montreal began to fit 36 babies with adapted conventional and gas-operated devices. Practical experience with the Soviet prosthesis proved the feasibility of myoelectric control, and indicated the possibility of using skin electrodes over an active muscle for control purposes in children. We obtained assistance from the Northern Electric Company, whose research laboratories produced the prototype arms described in this report. An all-electric prosthetic system was developed which carries out four different movements driven by a single motor. Function is effected by switches, but a myoelectric control system could be readily adapted without major changes. In the description of our needs for the proposed arm, we asked for modular construction and a minimum service life of one year between major repairs. Details of design and performance are outlined in this report. Initial clinical experience indicates that the prosthesis is completely accepted by the young patient, in spite of its excessive weight and inconvenient control. Four powered joints give the child greater functional freedom. In future we plan to fit an older child and will study more bilateral installations in the next 14 months. After further use, study and improvement, this device will become a useful prosthesis. ImagesFig. 1Fig. 2Fig. 3Fig. 4Fig. 5 PMID:6021562

  15. 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.

  16. 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.

  17. A personalized 3D-printed prosthetic joint replacement for the human temporomandibular joint: From implant design to implantation.

    PubMed

    Ackland, David C; Robinson, Dale; Redhead, Michael; Lee, Peter Vee Sin; Moskaljuk, Adrian; Dimitroulis, George

    2017-05-01

    Personalized prosthetic joint replacements have important applications in cases of complex bone and joint conditions where the shape and size of off-the-shelf components may not be adequate. The objective of this study was to design, test and fabricate a personalized 3D-printed prosthesis for a patient requiring total joint replacement surgery of the temporomandibular joint (TMJ). The new 'Melbourne' prosthetic TMJ design featured a condylar component sized specifically to the patient and fixation screw positions that avoid potential intra-operative damage to the mandibular nerve. The Melbourne prosthetic TMJ was developed for a 58-year-old female recipient with end-stage osteoarthritis of the TMJ. The load response of the prosthesis during chewing and a maximum-force bite was quantified using a personalized musculoskeletal model of the patient's masticatory system developed using medical images. The simulations were then repeated after implantation of the Biomet Microfixation prosthetic TMJ, an established stock device. The maximum condylar stresses, screw stress and mandibular stress at the screw-bone interface were lower in the Melbourne prosthetic TMJ (259.6MPa, 312.9MPa and 198.4MPa, respectively) than those in the Biomet Microfixation device (284.0MPa, 416.0MPa and 262.2MPa, respectively) during the maximum-force bite, with similar trends also observed during the chewing bite. After trialing surgical placement and evaluating prosthetic TMJ stability using cadaveric specimens, the prosthesis was fabricated using 3D printing, sterilized, and implanted into the female recipient. Six months post-operatively, the prosthesis recipient had a normal jaw opening distance (40.0 mm), with no complications identified. The new design features and immediate load response of the Melbourne prosthetic TMJ suggests that it may provide improved clinical and biomechanical joint function compared to a commonly used stock device, and reduce risk of intra-operative nerve damage

  18. 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

  19. Control of dental prosthesis system with microcontroller.

    PubMed

    Kapidere, M; Müldür, S; Güler, I

    2000-04-01

    In this study, a microcontroller-based electronic circuit was designed and implemented for dental prosthesis curing system. Heater, compressor and valve were controlled by 8-bit PIC16C64 microcontroller which is programmed using MPASM package. The temperature and time were controlled automatically by preset values which were inputted from keyboard while the pressure was kept constant. Calibration was controlled and the working range was tested. The test results showed that the system provided a good performance.

  20. An implantable myoelectric sensor based prosthesis control system.

    PubMed

    DeMichele, Glenn A; Troyk, Philip R; Kerns, Douglas A; Weir, Richard

    2006-01-01

    We present progress on the design and testing of an upper-extremity prosthesis control system based on implantable myoelectric sensors. The implant consists of a single silicon chip packaged with transmit and receive coils. Forward control telemetry to, and reverse EMG data telemetry from multiple implants has been demonstrated.

  1. A proposed intracortical visual prosthesis image processing system.

    PubMed

    Srivastava, N R; Troyk, P

    2005-01-01

    It has been a goal of neuroprosthesis researchers to develop a system, which could provide artifical vision to a large population of individuals with blindness. It has been demonstrated by earlier researches that stimulating the visual cortex area electrically can evoke spatial visual percepts, i.e. phosphenes. The goal of visual cortex prosthesis is to stimulate the visual cortex area and generate a visual perception in real time to restore vision. Even though the normal working of the visual system is not been completely understood, the existing knowledge has inspired research groups to develop strategies to develop visual cortex prosthesis which can help blind patients in their daily activities. A major limitation in this work is the development of an image proceessing system for converting an electronic image, as captured by a camera, into a real-time data stream for stimulation of the implanted electrodes. This paper proposes a system, which will capture the image using a camera and use a dedicated hardware real time image processor to deliver electrical pulses to intracortical electrodes. This system has to be flexible enough to adapt to individual patients and to various strategies of image reconstruction. Here we consider a preliminary architecture for this system.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. Optimal design and control of an electromechanical transfemoral prosthesis with energy regeneration.

    PubMed

    Rohani, Farbod; Richter, Hanz; van den Bogert, Antonie J

    2017-01-01

    In this paper, we present the design of an electromechanical above-knee active prosthesis with energy storage and regeneration. The system consists of geared knee and ankle motors, parallel springs for each motor, an ultracapacitor, and controllable four-quadrant power converters. The goal is to maximize the performance of the system by finding optimal controls and design parameters. A model of the system dynamics was developed, and used to solve a combined trajectory and design optimization problem. The objectives of the optimization were to minimize tracking error relative to human joint motions, as well as energy use. The optimization problem was solved by the method of direct collocation, based on joint torque and joint angle data from ten subjects walking at three speeds. After optimization of controls and design parameters, the simulated system could operate at zero energy cost while still closely emulating able-bodied gait. This was achieved by controlled energy transfer between knee and ankle, and by controlled storage and release of energy throughout the gait cycle. Optimal gear ratios and spring parameters were similar across subjects and walking speeds.

  9. Uncemented three-dimensional-printed prosthetic replacement for giant cell tumor of distal radius: a new design of prosthesis and surgical techniques.

    PubMed

    Lu, Minxun; Min, Li; Xiao, Cong; Li, Yongjiang; Luo, Yi; Zhou, Yong; Zhang, Wenli; Tu, Chongqi

    2018-01-01

    Currently, it is challenging to treat giant cell tumor (GCT) of distal radius. For Campanacci grade III or recurrent GCTs, en bloc resection has been accepted as a better treatment option. Although numerous methods are available for reconstruction, all of them have some limitations in joint function and complications. In this study, our aims were to treat the GCT of distal radius with uncemented three-dimensional (3D)-printed prosthesis and to present and evaluate the surgical techniques and short-term outcomes. Between September 2015 and March 2017, 11 patients with distal radius GCTs were treated with personalized uncemented 3D-printed prosthesis. The preoperative/postoperative pain, range of motion, and grip strengths of all patients were evaluated. Oncological results, complications, and degenerative changes in the wrist joint were evaluated. Functional outcomes were assessed according to the disabilities of the arm, shoulder, and hand (DASH) questionnaire and Mayo wrist scoring systems. The average follow-up was 14.45 months (range, 8-18 months). There was a significant decrease in the mean postoperative visual analog scale score (2.33) compared with the preoperative score (5.22; p <0.001). The mean DASH score and Mayo wrist score of the wrist joint function were 18.7 and 72, respectively. There was no local recurrence or lung metastasis. No complication associated with prosthesis was observed, including aseptic loosening, subluxation, and breakage. Joint space narrowing, or disuse osteoporosis, was also not found in all cases. En bloc resection and reconstruction with a personalized uncemented 3D-printed prosthesis can be alternative options to treat Campanacci grade III or recurrent GCTs of distal radius and can result in short-term oncologic salvage, good postoperative function, and low complication rate. However, a long-term follow-up is required to determine the outcome.

  10. Simultaneous, proportional, multi-axis prosthesis control using multichannel surface EMG.

    PubMed

    Yatsenko, Dimitri; McDonnall, Daniel; Guillory, K Shane

    2007-01-01

    Most upper limb prosthesis controllers only allow the individual selection and control of single joints of the limb. The main limiting factor for simultaneous multi-joint control is usually the availability of reliable independent control signals that can intuitively be used. In this paper, a novel method is presented for extraction of individual muscle source signals from surface EMG array recordings, based on EMG energy orthonormalization along principle movement vectors. In cases where independently-controllable muscles are present in residual limbs, this method can be used to provide simultaneous, multi-axis, proportional control of prosthetic systems. Initial results are presented for simultaneous control of wrist rotation, wrist flexion/extension, and grip open/close for two intact subjects under both isometric and non-isometric conditions and for one subject with transradial amputation.

  11. Alloplastic temporomandibular joint replacement systems: a systematic review of their history.

    PubMed

    De Meurechy, N; Mommaerts, M Y

    2018-06-01

    This systematic review provides an overview of the historical evolution of the prosthetic temporomandibular joint and addresses the challenges and complications faced by engineers and surgeons, in an effort to shed light on why only a few systems remain available. A better understanding of the history of temporomandibular joint prostheses might also provide insights into the origin of the negative public opinion of the prosthesis, which is based on outdated information. A computerized search using the PubMed Central, ScienceDirect, Wiley Online, Ovid, and Cochrane Library databases was performed following the PRISMA guidelines. Out of 7122 articles identified, 41 met the inclusion criteria for this systematic review. Although several historical reviews have been published previously, none has covered such an extensive time period or has described all designs. Furthermore, besides providing a historical overview, this review discusses the rationale behind the evolution in design and biomaterials, which have largely contributed to the outcomes of the prosthetic systems. Copyright © 2018 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  12. Torsion and bending imposed on a new anterior cruciate ligament prosthesis during knee flexion: an evaluation method.

    PubMed

    Gely, P; Drouin, G; Thiry, P S; Tremblay, G R

    1984-11-01

    A new composite prosthesis was recently proposed for the anterior cruciate ligament. It is implanted in the femur and the tibia through two anchoring channels. Its intra-articular portion, composed of a fiber mesh sheath wrapped around a silicone rubber cylindrical core, reproduces satisfactorily the ligament response in tension. However, the prosthesis does not only undergo elongation. In addition, it is submitted to torsion in its intra-articular portion and bending at its ends. This paper presents a new method to evaluate these two types of deformations throughout a knee flexion by means of a geometric model of the implanted prosthesis. Input data originate from two sources: (i) a three-dimensional anatomic topology of the knee joint in full extension, providing the localization of the prosthesis anchoring channels, and ii) a kinematic model of the knee describing the motion of these anchoring channels during a physiological flexion of the knee joint. The evaluation method is independent of the way input data are obtained. This method, applied to a right cadaveric knee, shows that the orientation of the anchoring channels has a large effect on the extent of torsion and bending applied to the implanted prosthesis throughout a knee flexion, especially on the femoral side. The study suggests also the best choice for the anchoring channel axes orientation.

  13. First metatarsophalangeal joint replacement with modular three-component press-fit implant. Preliminary report.

    PubMed

    Kolodziej, L; Bohatyrewicz, A; Zietek, P

    2013-01-01

    The aim of this retrospective study was to assess functional and radiographic results of the first metatarsophalangeal joint replacement with use of unconstrained, modular, three components, porous titanium and hydroxyapatite coated, press-fit METIS® prosthesis. According to author's knowledge, results of that type of prosthesis have never been published before. 25 prosthesis were implanted in 24 patients between February 2009 and May 2011. American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal scoring system (AOFAS-HMI) was used to assess functional results. Patients were also asked if they would undergo procedure again or recommend it to other people. Weight bearing radiographs ware made at final follow up and analyzed for presence of osteolysis and radiolucencies. In 8 patients total joint replacement was introduced as a salvage after failure of previous surgery like Keller resection arthroplasty, failed arthrodesis, avascular necrosis and postoperative arthritis. In 11 patients the reason for prosthetic replacement were hallux rigidus, in 4 cases rheumatoid arthritis and gout in one patient. In two patients additional procedures like Akin phalangeal osteotomy and in one case fifth metatarsal osteotomy, was performed. There were 20 females and 4 males in presented group. The mean age at the operation was 56 years. The average follow up period was 18 months (from 12 to 36 months). The median postoperative value of AOFAS-HMI scores was 88 points (from 75 to 95 points). First metatarsophalangeal joint motion (dorsiflexion plus plantarflexion) was classified according to AOFAS-HMI ranges as: moderately restricted (between 30 to 70 degrees) in 19 patients 80% (20 prosthesis) and severely restricted (less then 30 degrees) in 5 patients (20%). 15 (64%) patients were completely satisfied, 5 (20%) reported moderate satisfaction and (16%) 4 were totally disappointed and would not undergo this procedure again. A limited hallux dorsiflexion

  14. 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.

  15. 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.

  16. 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...

  17. 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...

  18. 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…

  19. MR safety and compatibility of a noninvasively expandable total-joint endoprosthesis.

    PubMed

    Ogg, Robert J; McDaniel, C Brian; Wallace, Donald; Pitot, Pierre; Neel, Michael D; Kaste, Sue C

    2005-09-01

    A noninvasively expandable total-joint endoprosthesis is now available for pediatric patients; the prosthesis can be lengthened by external application of a magnetic field. We investigated the risks of unintentional heating or lengthening of the prosthesis during MR imaging and evaluated the effect of the device on the diagnostic efficacy of MR imaging of surrounding tissues. We performed MR imaging at 1.5 T by using standard pulse sequences and pulse sequences with high-gradient and high-radiofrequency duty cycle. MR imaging caused no measurable change in prosthesis length, and the temperature of the prosthesis increased by less than 1 degrees C during repeated 14-min exposures. Despite significant signal loss and image distortion around the prosthetic joint, clinically useful images were obtained as close as 12 cm from the ends of the prosthetic stems, measured toward the body of the device. Thus, the prosthesis can be safely exposed to MR imaging pulse sequences at 1.5 T, and the visualization of some tissue surrounding the device is clinically useful.

  20. Position of the prosthesis and the incidence of dislocation following total hip replacement.

    PubMed

    He, Rong-xin; Yan, Shi-gui; Wu, Li-dong; Wang, Xiang-hua; Dai, Xue-song

    2007-07-05

    Dislocation is the second most common complication of hip replacement surgery, and impact of the prosthesis is believed to be the fundamental reason. The present study employed Solidworks 2003 and MSC-Nastran software to analyze the three dimensional variables in order to investigate how to prevent dislocation following hip replacement surgery. Computed tomography (CT) imaging was used to collect femoral outline data and Solidworks 2003 software was used to construct the cup model with variabilities. Nastran software was used to evaluate dislocation at different prosthesis positions and different geometrical shapes. Three dimensional movement and results from finite element method were analyzed and the values of dislocation resistance index (DRI), range of motion to impingement (ROM-I), range of motion to dislocation (ROM-D) and peak resisting moment (PRM) were determined. Computer simulation was used to evaluate the range of motion of the hip joint at different prosthesis positions. Finite element analysis showed: (1) Increasing the ratio of head/neck increased the ROM-I values and moderately increased ROM-D and PRM values. Increasing the head size significantly increased PRM and to some extent ROM-I and ROM-D values, which suggested that there would be a greater likelihood of dislocation. (2) Increasing the anteversion angle increased the ROM-I, ROM-D, PRM, energy required for dislocation (ENERGY-D) and DRI values, which would increase the stability of the joint. (3) As the chamber angle was increased, ROM-I, ROM-D, PRM, Energy-D and DRI values were increased, resulting in improved joint stability. Chamber angles exceeding 55 degrees resulted in increases in ROM-I and ROM-D values, but decreases in PRM, Energy-D, and DRI values, which, in turn, increased the likelihood of dislocation. (4) The cup, which was reduced posteriorly, reduced ROM-I values (2.1 -- 5.3 degrees ) and increased the DRI value (0.073). This suggested that the posterior high side had the

  1. 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.

  2. [The spectrum of histomorphological findings related to joint endoprosthetics].

    PubMed

    Morawietz, L; Krenn, V

    2014-11-01

    Approximately 230,000 total hip and 170,000 knee joint endoprostheses are implanted in Germany annually of which approximately 10% (i.e. 40,000 interventions per year) are cases of revision surgery. These interventions involve removal of a previously implanted prosthesis which has resulted in complaints and replacement with a new prosthesis. There are manifold reasons for revision surgery, the most common indication being so-called endoprosthesis loosening, which is subdivided into septic and aseptic loosening. Histomorphological studies revealed that periprosthetic tissue from endoprosthesis loosening can be classified into four types (I) wear-particle induced type, (II) infectious type, (III) combined type and (IV) fibrous type. Types I and IV represent aseptic loosening and types II and III septic loosening. Recently, the topic of implant allergy has emerged. The detection of cellular, mostly perivascular lymphocytic infiltrates is discussed as being a sign of an allergic tissue reaction. It has most frequently been observed in type I periprosthetic membranes with a dense load of metal wear, which occurs with metal-on-metal bearings. Apart from endoprosthesis loosening, arthrofibrosis is another complication of joint endoprosthetics and can cause pain and impaired function. Histopathologically, arthrofibrosis can be evaluated by a three-tiered grading system. Furthermore, bone pathologies, such as ossification, osteopenia or osteomyelitis can occur as complications of joint endoprosthetics. This review gives an overview of the whole spectrum of pathological findings in joint endoprosthetics and offers a comprehensive and standardized classification system for routine histopathological diagnostics.

  3. On the analysis of using 3-coil wireless power transfer system in retinal prosthesis.

    PubMed

    Bai, Shun; Skafidas, Stan

    2014-01-01

    Designing a wireless power transmission system(WPTS) using inductive coupling has been investigated extensively in the last decade. Depending on the different configurations of the coupling system, there have been various designing methods to optimise the power transmission efficiency based on the tuning circuitry, quality factor optimisation and geometrical configuration. Recently, a 3-coil WPTS was introduced in retinal prosthesis to overcome the low power transferring efficiency due to low coupling coefficient. Here we present a method to analyse this 3-coil WPTS using the S-parameters to directly obtain maximum achievable power transferring efficiency. Through electromagnetic simulation, we brought a question on the condition of improvement using 3-coil WPTS in powering retinal prosthesis.

  4. Robotic cadaver testing of a new total ankle prosthesis model (German Ankle System).

    PubMed

    Richter, Martinus; Zech, Stefan; Westphal, Ralf; Klimesch, Yvone; Gosling, Thomas

    2007-12-01

    An investigation was carried out into possible increased forces, torques, and altered motions during load-bearing ankle motion after implantation of two different total ankle prostheses. We hypothesized that the parameters investigated would not differ in relation to the two implants compared. We included two different ankle prostheses (Hintegra, Newdeal, Vienne, France; German Ankle System, R-Innovation, Coburg, Germany). The prostheses were implanted in seven paired cadaver specimens. The specimens were mounted on an industrial robot that enables complex motion under predefined conditions (RX 90, Stäubli, Bayreuth, Germany). The robot detected the load-bearing (30 kg) motion of the 100(th) cycle of the specimens without prostheses as the baseline for the later testing, and mimicked that exact motion during 100 cycles after the prostheses were implanted. The resulting forces, torques, and bone motions were recorded and the differences between the prostheses compared. The Hintegra and German Ankle System, significantly increased the forces and torques in relation to the specimen without a prosthesis with one exception (one-sample-t-test, each p < or = 0.01; exception, parameter lateral force measured with the German Ankle System, p = 0.34). The force, torque, and motion differences between the specimens before and after implantation of the prostheses were lower with the German Ankle System than with the Hintegra (unpaired t-test, each p < or = 0.05). The German Ankle System prosthesis had less of an effect on resulting forces and torques during partial weightbearing passive ankle motion than the Hintegra prosthesis. This might improve function and minimize loosening during the clinical use.

  5. Prosthetic joint infection caused by Granulicatella adiacens: a case series and review of literature.

    PubMed

    Quénard, Fanny; Seng, Piseth; Lagier, Jean-Christophe; Fenollar, Florence; Stein, Andreas

    2017-06-23

    Bone and joint infection involving Granulicatella adiacens is rare, and mainly involved in cases of bacteremia and infectious endocarditis. Here we report three cases of prosthetic joint infection involving G. adiacens that were successfully treated with surgery and prolonged antimicrobial treatment. We also review the two cases of prosthetic joint infection involving G. adiacens that are reported in the literature. Not all five cases of prosthetic joint infection caused by G. adiacens were associated with bacteremia or infectious endocarditis. Dental care before the onset of infection was observed in two cases. The median time delay between arthroplasty implantation and the onset of infection was of 4 years (ranging between 2 and 10 years). One of our cases was identified with 16srRNA gene sequencing, one case with MALDI-TOF mass spectrometry, and one case with both techniques. Two literature cases were diagnosed by 16srRNA gene sequencing. All five cases were cured after surgery including a two-stage prosthesis exchange in three cases, a one-stage prosthesis exchange in one case, and debridement, antibiotics, irrigation, and retention of the prosthesis in one case, and prolonged antimicrobial treatment. Prosthetic joint infection involving G. adiacens is probably often dismissed due to difficult culture or misdiagnosis, in particular in the cases of polymicrobial infection. Debridement, antibiotics, irrigation, and retention of the prosthesis associated with prolonged antimicrobial treatment (≥ 8 weeks) should be considered as a treatment strategy for prosthetic joint infection involving G. adiacens.

  6. 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.

  7. 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.

  8. The effect of changing the inertia of a trans-tibial dynamic elastic response prosthesis on the kinematics and ground reaction force patterns.

    PubMed

    Hillery, S C; Wallace, E S; McIlhagger, R; Watson, P

    1997-08-01

    The aim of this study was to assess, by means of gait analysis, the effect on the gait of a trans-tibial amputee of altering the mass and the moment of inertia of a dynamic elastic response prosthesis. One male amputee was analysed for four to five walking trials at normal and fast cadences, using the VICON system of motion analysis and an AMTI force plate. The kinematic variables of cadence, swing time, single support time and joint angles for the knee and hip on the affected and intact sides were analysed. The ground reaction force was also analysed. The sample size was limited to one as an example to indicate the changes which are possible through simply changing the inertial characteristics. Descriptive statistics are used to demonstrate these changes. Three mass conditions for the prosthesis were analysed m1: 1080g; m2: 1080 + 530g; m3: 1080 + 1460g. The m1 condition is the mass of the prosthesis with no added weight while m2 and m3 were attachments of the same geometrical shape but were made from different materials. It was felt that the large mass range would highlight biomechanical adjustments as a result of its alteration. The effect on selected temporal characteristics were that as the speed increased the cadence changed and the affected side single support times as a percentage of the gait cycle were altered. The effect on the joint angles was also apparent at the hip and knee of both sides. The ground reaction force patterns were similar for all three mass conditions, though the impact peak which was evident in the intact limb was missing, indicating a shock absorbing property in the prosthesis. Clearly, changing the mass and moment of inertia has an effect on the kinematic variables of gait and should be considered when designing a prosthesis.

  9. 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 .

  10. [Distal fixation prosthesis for unstable intertrochanteric fractures in elderly patients: a mid-term follow-up study].

    PubMed

    Zhang, Zhan-feng; Min, Ji-kang; Zhong, Jian-ming; Wang, Dan

    2016-06-01

    To explore mid-term follow up results of distal fixation prosthesis in treating unstable intertrochanteric fractures in elderly patients. From May 2008 to March 2014,58 elderly patients with unstable intertrochanteric were treated with distal fixation prosthesis, among them, there were 15 males and 43 females aged from 75 to 87 years old with an average of 83.2 years old. Fracture were classified according to Evans classification, 39 cases were type I c and 19 cases were type I d. Surgical risk was evaluated before operation, 9 patients were performed total hip arthroplasty and 49 patients were performed prosthetic replacement hip joint function of patients with different age period, Evans classificaton, prothesis type, fixation method were evaluated respectively by using Harris score. Fifty-six patients were followed up from 13 to 36 months with an average of 21.6 months. Harris score was 83.51 ± 6.40, 5 cases got excellent results, 38 cases good and 13 cases moderate. Harris score of patients aged from 75 to 80 years old was 88.64 ± 2.35, 81.64 ± 6.40 in patients aged more than 80 years old, and had significant differences between two groups; Harris score in patients with type Evans I c was 83.64 ± 6.53, and 83.11 ± 6.08 in type Evans I d, while there was no significant differences between two groups. There was no obvious meaning in Harris score between patients with tension band (83.63 ± 6.15) and without tension band (82.41 ± 6.57). There was no significant meaning in Harris score between patients with normal distal fixation prosthesis (83.34 ± 6.43) and femoral moment reconstruction distal fixation prosthesis (83.92 ± 6.51). There was 1 patient occurred hip joint dislocation on the operative side and re-dislocation after manual reduction, then received open reduction. Two patients occurred femoral osteolysis without clinical symptoms, and treated conservative treatment. Artificial joint replacement for unstable intertrochanteric fractures in elderly

  11. Added value of 18F-FDG PET/CT in diagnosing infected hip prosthesis.

    PubMed

    Kwee, Robert M; Broos, Wouter Am; Brans, Boudewijn; Walenkamp, Geert Him; Geurts, Jan; Weijers, René E

    2018-05-01

    Background The diagnosis of infected hip prosthesis is frequently not straightforward yet very important as it changes treatment. Purpose To retrospectively investigate the added value of 18F-FDG PET/CT to conventional tests including radiography, erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP) testing, and joint aspiration, in diagnosing infected hip prosthesis. Material and Methods Seventy-eight hip prostheses of 78 patients (55% men; mean age = 66.5 years; age range = 30-85 years) with non-specific clinical presentation, i.e. no abscess or sinus tract communicating with the joint space at clinical examination, were analyzed. Cultures of intra-articular fluid and peri-implant tissues after revision surgery or clinical follow-up ≥6 months served as gold standard. Areas under the receiver operating characteristic curves (AUCs) of radiography, ESR/CRP testing, aspiration culture, and white blood cell (WBC) count without and with the addition of 18F-FDG PET/CT were compared. Results The addition of 18F-FDG PET/CT increased AUCs: for radiography with 0.212, P = 0.001; for ESR/CRP testing with 0.076, P = 0.072; for aspiration culture with 0.126, P = 0.032; and for aspiration WBC count with 0.191, P = 0.035. Conclusion This study shows that 18F-FDG PET/CT adds to individual conventional tests in diagnosing infected hip prosthesis. It may improve the preoperative planning and should therefore be considered in the diagnostic work-up. Future studies should define the exact place of 18F-FDG PET/CT in the diagnostic work-up of periprosthetic joint infection.

  12. 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.

  13. [Total hip replacement with isoelastic prosthesis in animals (author's transl)].

    PubMed

    Muhr, O; Stockhusen, H; Müller, O

    1976-10-08

    Uncemented fixation and low-fraction materials are the basis of this experiment. Plastics with an elasticity similar to the bone ("isoelasticity") show very propitious material qualities. The direct cementless incorporation of test bodies must be checked. In 63 sheep isoelastic total hip joints were implanted. After 2 till 51 weeks the animals were sacrificed and 44 specimen of hips and organs were explored macroscopically, radiologically, spherimetrically and histologically. The result was: 1. Plastic hip prosthesis are incorporated in the bone, but the boundary layer is built by a collagenous fiber tissue. 2. Loosening brings resoption of the bone and expansion of the structural changed soft tissue. 3. The transformation of the femoral cortex to osteoporosis is considered possibly as the consequence of an insufficient biological transfer of the weight. 4. Fractures of the femoral prosthesis-stem could not be observed. 5. The radiology allows at the pelvis prosthesis a concret statement concerning stability, on the femoral part a probable one. 6. The abrasion is minimal, the tissue reaction to abrasion products is unessential. 7. Small abrasion particles are carried of by the lymph tract and stored in the first regional gland. A more distant spreading is not demonstrable.

  14. Reading Visual Braille with a Retinal Prosthesis

    PubMed Central

    Lauritzen, Thomas Z.; Harris, Jordan; Mohand-Said, Saddek; Sahel, Jose A.; Dorn, Jessy D.; McClure, Kelly; Greenberg, Robert J.

    2012-01-01

    Retinal prostheses, which restore partial vision to patients blinded by outer retinal degeneration, are currently in clinical trial. The Argus II retinal prosthesis system was recently awarded CE approval for commercial use in Europe. While retinal prosthesis users have achieved remarkable visual improvement to the point of reading letters and short sentences, the reading process is still fairly cumbersome. This study investigates the possibility of using an epiretinal prosthesis to stimulate visual braille as a sensory substitution for reading written letters and words. The Argus II retinal prosthesis system, used in this study, includes a 10 × 6 electrode array implanted epiretinally, a tiny video camera mounted on a pair of glasses, and a wearable computer that processes the video and determines the stimulation current of each electrode in real time. In the braille reading system, individual letters are created by a subset of dots from a 3 by 2 array of six dots. For the visual braille experiment, a grid of six electrodes was chosen out of the 10 × 6 Argus II array. Groups of these electrodes were then directly stimulated (bypassing the camera) to create visual percepts of individual braille letters. Experiments were performed in a single subject. Single letters were stimulated in an alternative forced choice (AFC) paradigm, and short 2–4-letter words were stimulated (one letter at a time) in an open-choice reading paradigm. The subject correctly identified 89% of single letters, 80% of 2-letter, 60% of 3-letter, and 70% of 4-letter words. This work suggests that text can successfully be stimulated and read as visual braille in retinal prosthesis patients. PMID:23189036

  15. Reading visual braille with a retinal prosthesis.

    PubMed

    Lauritzen, Thomas Z; Harris, Jordan; Mohand-Said, Saddek; Sahel, Jose A; Dorn, Jessy D; McClure, Kelly; Greenberg, Robert J

    2012-01-01

    Retinal prostheses, which restore partial vision to patients blinded by outer retinal degeneration, are currently in clinical trial. The Argus II retinal prosthesis system was recently awarded CE approval for commercial use in Europe. While retinal prosthesis users have achieved remarkable visual improvement to the point of reading letters and short sentences, the reading process is still fairly cumbersome. This study investigates the possibility of using an epiretinal prosthesis to stimulate visual braille as a sensory substitution for reading written letters and words. The Argus II retinal prosthesis system, used in this study, includes a 10 × 6 electrode array implanted epiretinally, a tiny video camera mounted on a pair of glasses, and a wearable computer that processes the video and determines the stimulation current of each electrode in real time. In the braille reading system, individual letters are created by a subset of dots from a 3 by 2 array of six dots. For the visual braille experiment, a grid of six electrodes was chosen out of the 10 × 6 Argus II array. Groups of these electrodes were then directly stimulated (bypassing the camera) to create visual percepts of individual braille letters. Experiments were performed in a single subject. Single letters were stimulated in an alternative forced choice (AFC) paradigm, and short 2-4-letter words were stimulated (one letter at a time) in an open-choice reading paradigm. The subject correctly identified 89% of single letters, 80% of 2-letter, 60% of 3-letter, and 70% of 4-letter words. This work suggests that text can successfully be stimulated and read as visual braille in retinal prosthesis patients.

  16. [CLINICAL APPLICATION OF OXFORD MOBILE-BEARING BIPOLAR PROSTHESIS UNICOMPARTMENTAL KNEE ARTHROPLASTY FOR SINGLE COMPARTMENTAL KNEE OSTEOARTHRITIS].

    PubMed

    Wang, Shangzeng; Cheng, Shao; Wang, Yisheng

    2016-01-01

    To evaluate the effectiveness of Oxford mobile-bearing bipolar prosthesis unicompartmental knee arthroplasty (UKA) in the treatment of single compartmental knee osteoarthritis. Between June 2011 and July 2013, 22 cases of single compartmental knee osteoarthritis were treated by Oxford mobile-bearing bipolar prosthesis UKA. Of 22 cases, 8 were male and 14 were female with an average age of 65 years (range, 45-80 years); the left knee was involved in 12 cases, and the right knee in 10 cases, with a mean disease duration of 32.5 months (range, 8-90 months). The mean weight was 55.2 kg (range, 50-65 kg), and the mean body mass index was 20.8 kg/m2 (range, 17-25 kg/m2). Osteoarthritis involved in the single knee medial compartment in all patients. Knee society score (KSS) and range of motion (ROM) were measured to evaluate the knee joint function. Primary healing of incision was obtained in all patients, and there was no complication of infection, bedsore, or deep venous thrombosis. Postoperative follow-up was 2-4 years (mean, 3.2 years). The X-ray films showed good position of prosthesis, no prosthesis dislocation, or periprosthetic infection during follow-up. Knee ROM, KSS function score, and KSS clinical score were significantly improved at 1 week after operation and at last follow-up when compared with preoperative ones (P < 0.05), but no significant difference was shown between at 1 week and at last follow-up (P > 0.05). Oxford mobile-bearing bipolar prosthesis UKA is an effective method to treat single compartmental knee osteoarthritis, with the advantages of less trauma, earlier rehabilitation exercise, near physiological state in joint function, and less risk of complications.

  17. Acinetobacter Prosthetic Joint Infection Treated with Debridement and High-Dose Tigecycline.

    PubMed

    Vila, Andrea; Pagella, Hugo; Amadio, Claudio; Leiva, Alejandro

    2016-12-01

    Prosthesis retention is not recommended for multidrug-resistant Acinetobacter prosthetic joint infection due to its high failure rate. Nevertheless, replacing the prosthesis implies high morbidity and prolonged hospitalization. Although tigecycline is not approved for the treatment of prosthetic joint infection due to multidrug resistant Acinetobacter baumannii, its appropriate use may preclude prosthesis exchange. Since the area under the curve divided by the minimum inhibitory concentration is the best pharmacodynamic predictor of its efficacy, we used tigecycline at high dose, in order to optimize its efficacy and achieve implant retention in 3 patients who refused prosthesis exchange. All patients with prosthetic joint infections treated at our Institution are prospectively registered in a database. Three patients with early prosthetic joint infection of total hip arthroplasty due to multidrug resistant A. baumannii were treated with debridement, antibiotics and implant retention, using a high maintenance dose of tigecycline (100 mg every 12 hours). The cases were retrospectively reviewed. All patients signed informed consent for receiving off-label use of tigecycline. Tigecycline was well tolerated, allowing its administration at high maintenance dose for a median of 40 days (range 30-60). Two patients were then switched to minocycline at standard doses for a median of 3.3 months in order to complete treatment. Currently, none of the patients showed relapse. Increasing the dose of tigecycline could be considered as a means to better attain pharmacodynamic targets in patients with severe or difficult-to-treat infections. Tigecycline at high maintenance dose might be useful when retention of the implant is attempted for treatment for prosthetic joint infections due to multidrug resistant Acinetobacter. Although this approach might be promising, off-label use of tigecycline should be interpreted cautiously until prospective data are available. Tigecycline is

  18. [The endo-exo prosthesis treatment concept : Improvement in quality of life after limb amputation].

    PubMed

    Hoffmeister, T; Schwarze, F; Aschoff, H H

    2017-05-01

    Osseointegrated, percutaneous implants as the force bearer for exoprosthetics after limb amputation have been used in individual cases for clinical rehabilitation of amputees during the past years. Most experience in this field in Germany has been accumulated at the Sana Klinik in Lübeck with the so-called endo-exo prosthesis (EEP) system. The two-step implantation procedure can now be considered as reliable. Following a well-documented learning curve initial soft tissue problems concerning the cutaneous stoma can now be regarded as exceptions. The retrospective examination of the results concerning by now more than 100 patients provided with an endo-exo femoral prosthesis (EEFP) showed a very satisfying outcome concerning objective as well as subjective values, such as duration of daily use and wearing comfort of the exoprosthesis. Regaining the ability of osseoperception due to the intraosseous fixation is described by the patients as a great advantage. The step from a socket prosthesis to an EEP is felt to be a big increase in quality of life by nearly all patients included into the follow-up. Nearly all of the patients questioned would choose an endo-exo prosthesis again. Meanwhile, the success of the EEP resulted in the broadening of indications from above-knee amputations to transtibial as well as transhumeral amputations. The results are likewise encouraging. The use of EEP for the upper limbs leads to substantial improvement in the range of motion of the shoulder joint with the intramedullary anchored percutaneous implant. Furthermore, new pathbreaking possibilities in the fixation of myoelectrically controlled arm prostheses may arise from the EEP technique.

  19. Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment

    PubMed Central

    Lee, Christine; Tu, Hong Anh; Weir, Mark; Holubowich, Corinne

    2016-01-01

    Background Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system. Methods We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients’ lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another. Results One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life

  20. Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment.

    PubMed

    2016-01-01

    Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system. We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients' lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another. One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life-year. The 5-year budget

  1. 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.

  2. The transport of wear particles in the prosthetic hip joint: a computational fluid dynamics investigation.

    PubMed

    Hölzer, Andreas; Schröder, Christian; Woiczinski, Matthias; Sadoghi, Patrick; Müller, Peter E; Jansson, Volkmar

    2012-02-02

    The joint fluid mechanics and transport of wear particles in the prosthetic hip joint were analyzed for subluxation and flexion motion using computational fluid dynamics (CFD). The entire joint space including a moving capsule boundary was considered. It was found that particles suspended in the joint space are drawn into the joint gap between prosthesis cup and head during subluxation, which was also documented by Lundberg et al. (2007; Journal of Biomechanics 40, 1676-1685), however, wear particles remain in the joint gap. Wear particles leave the joint gap during flexion and can finally migrate to the proximal boundaries including the acetabular bone, where the particle deposition can cause osteolysis according to the established literature. Thus, the present study supports the theory of polyethylene wear particle induced osteolysis of the acetabular bone as a major factor in the loosening of hip prosthesis cups. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. [The development of research in tribology of artificial joints].

    PubMed

    Dai, Zhendong; Gong, Juanqing

    2006-06-01

    Aseptic loosening of the prosthesis is a major form for the failure of artificial joints, which results in the conglomeration of wear particles at the bone-implant interface. This paper briefly reviews the recent development of tribology of artificial joints preserving good lubrication, enhancing the wear resistance of materials for the joints, reducing the generation of sensitive-size particles and depressing the debris-tissue reactions. Suggestion for improvement in the design of artificial joints is presented.

  4. Total Hip Joint Replacement Biotelemetry System

    NASA Technical Reports Server (NTRS)

    Boreham, J. F.; Postal, R. B.; Luntz, R. A.

    1981-01-01

    The development of a biotelemetry system that is hermetically sealed within a total hip replacement implant is reported. The telemetry system transmits six channels of stress data to reconstruct the major forces acting on the neck of the prosthesis and uses an induction power coupling technique to eliminate the need for internal batteries. The activities associated with the telemetry microminiaturization, data recovery console, hardware fabrications, power induction systems, electrical and mechanical testing and hermetic sealing test results are discussed.

  5. [Viscosity determination of synovial fluids from the canine hip and elbow joint as well as the human knee joint].

    PubMed

    Helms, Gabriele; Rittmann, Pia; Wefstaedt, Patrick; Windhagen, Henning; Pressel, Thomas; Behrens, Bernd-Arno; Nolte, Ingo

    2008-01-01

    The development of pathological changes in both human and canine hip joints is mainly caused by a lack of synovial fluid lubrication. This results in an increased joint abrasion. Even after implantation of joint prosthesis, inadequate lubrication can lead to abrasion in the tribological pair. This can finally result in aseptic loosening of the prosthesis. In spite of the enormous number of studies that have been performed on human, only little knowledge about the tribological properties of the joints in dogs is available in the literature. For this reason the viscosities of synovial fluid, derived from physiological and pathologically changed canine elbow joints were measured. The viscosities were determined by the use of a cone-plate viscometer at different temperatures and shear rates. The obtained values were compared with the viscosity values of pathologically changed synovial fluids from human knee joints as well as with pathological samples from the canine hip joint. The results show that the viscosity values vary within a series of measurements and are inversely proportional to the temperature of the sample and the shear rate. The differences between the average viscosities of canine and human synovial fluids taken from pathologically changed joints are below 4% (22.5 s(-1) at theta1 = 25 degrees C). The findings of this study are being implemented in a FE-Model for the computation of actual forces in the hip joint during different movements. This would represent a contribution to an improved prosthetic treatment of canine and human hips.

  6. 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.

  7. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report.

    PubMed

    Shankaran, Gayatri; Deogade, Suryakant Chhagan; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography.

  8. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report

    PubMed Central

    Shankaran, Gayatri; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography. PMID:27536331

  9. Transtibial prosthesis suspension failure during skydiving freefall: a case report.

    PubMed

    Gordon, Assaf T; Land, Rebekah M

    2009-01-01

    This report describes the unusual case of an everyday-use prosthesis suspension system failure during the freefall phase of a skydiving jump. The case individual was a 53-year-old male with a left transtibial amputation secondary to trauma. He used his everyday prosthesis, a transtibial endoskeleton with push-button, plunger-releasing, pin-locking silicon liner suction suspension and a neoprene knee suspension sleeve, for a standard recreational tandem skydive. Within seconds of exiting the plane, the suspension systems failed, resulting in the complete prosthesis floating away. Several factors may have led to suspension system failure, including an inadequate seal and material design of the knee suspension sleeve and liner, lack of auxiliary suspension mechanisms, and lack of a safety cover overlying the push-button release mechanism. This is the first report, to our knowledge, to discuss prosthetic issues specifically related to skydiving. While amputees are to be encouraged to participate in this extreme sport, special modifications to everyday components may be necessary to reduce the possibility of prosthesis failure during freefall, parachute deployment, and landing.

  10. 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

  11. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    FAB/CAM, a subsidiary of the Harshberger Prosthetic and Orthotic Center, Inc., approached Marshall for help in replacing the heavy, fragile plaster they used to produce master molds for prosthetics. Concurrently, Marshall and Martin Marietta were creating a commercial derivative of the foam insulation used to protect the Space Shuttle External Tank from excessive heat. FAB/CAM found the foam blanks to be lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the consumer. Martin Marietta markets the foam system, MARCORE, for the prosthesis market. The system also has commercial potential in high temperature insulation and structural applications.

  12. Joint registries as continuous surveillance systems: the experience of the Catalan Arthroplasty Register (RACat).

    PubMed

    Allepuz, Alejandro; Martínez, Olga; Tebé, Cristian; Nardi, Joan; Portabella, Frederic; Espallargues, Mireia

    2014-03-01

    The aim was to present results on prosthesis performance in Catalonia for the period 2005-2010. All publicly funded hospitals submit in an electronic format data on hip and knee arthroplasties: patients' insurance identification number, hospital, joint (hip/knee), type of arthroplasty (primary/revision), side (right/left), date of surgery and prosthesis (manufacturer name and catalogue number). A standard survival analysis based on Kaplan-Meier estimation was carried out. Fifty-two hospitals have sent information to the RACat which has data on 36,951 knee and 26,477 hip arthroplasties. Cumulative prostheses revision risks at 3 years were 3.3% (95% CI: 3.1-3.6) for knee, 2.9% (95% CI: 2.5-3.3) for total hip and 2.5% (95% CI: 2.0-3.1) for partial hip. When compared to other registries a higher risk of revision was observed. © 2013.

  13. 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.

  14. Effects of a powered ankle-foot prosthesis on kinetic loading of the unaffected leg during level-ground walking

    PubMed Central

    2013-01-01

    Background People with a lower-extremity amputation that use conventional passive-elastic ankle-foot prostheses encounter a series of stress-related challenges during walking such as greater forces on their unaffected leg, and may thus be predisposed to secondary musculoskeletal injuries such as chronic joint disorders. Specifically, people with a unilateral transtibial amputation have an increased susceptibility to knee osteoarthritis, especially in their unaffected leg. Previous studies have hypothesized that the development of this disorder is linked to the abnormally high peak knee external adduction moments encountered during walking. An ankle-foot prosthesis that supplies biomimetic power could potentially mitigate the forces and knee adduction moments applied to the unaffected leg of a person with a transtibial amputation, which could, in turn, reduce the risk of knee osteoarthritis. We hypothesized that compared to using a passive-elastic prosthesis, people with a transtibial amputation using a powered ankle-foot prosthesis would have lower peak resultant ground reaction forces, peak external knee adduction moments, and corresponding loading rates applied to their unaffected leg during walking over a wide range of speeds. Methods We analyzed ground reaction forces and knee joint kinetics of the unaffected leg of seven participants with a unilateral transtibial amputation and seven age-, height- and weight-matched non-amputees during level-ground walking at 0.75, 1.00, 1.25, 1.50, and 1.75 m/s. Subjects with an amputation walked while using their own passive-elastic prosthesis and a powered ankle-foot prosthesis capable of providing net positive mechanical work and powered ankle plantar flexion during late stance. Results Use of the powered prosthesis significantly decreased unaffected leg peak resultant forces by 2-11% at 0.75-1.50 m/s, and first peak knee external adduction moments by 21 and 12% at 1.50 and 1.75 m/s, respectively. Loading rates were not

  15. Analysis of a retrieved delta III total shoulder prosthesis.

    PubMed

    Nyffeler, R W; Werner, C M L; Simmen, B R; Gerber, C

    2004-11-01

    A reversed Delta III total shoulder prosthesis was retrieved post-mortem, eight months after implantation. A significant notch was evident at the inferior pole of the scapular neck which extended beyond the inferior fixation screw. This bone loss was associated with a corresponding, erosive defect of the polyethylene cup. Histological examination revealed a chronic foreign-body reaction in the joint capsule. There were, however, no histological signs of loosening of the glenoid base plate and the stability of the prosthetic articulation was only slightly reduced by the eroded rim of the cup.

  16. Identification of overlengthening after replacement of the radial head with a bipolar prosthesis.

    PubMed

    Wegmann, K; Lamsfuss, J; Ries, C; Neiss, W F; Franklin, J; Müller, L P; Burkhart, K J

    2015-12-01

    Overlengthening of the radial column leads to insufficient functionality and increased capitellar wear. Methods to detect or prevent overlengthening have been described for monopolar prostheses. The aim of this study was to evaluate whether one such method described by Athwal et al. is also applicable for a bipolar prosthesis. The radial heads of six fresh frozen upper extremities were resected. A bipolar radial head prosthesis was implanted in each, and the effects of sequential overlengthening on the alignment of the radiocapitellar and ulnohumeral joint line were recorded by fluoroscopic images. Digital image analysis and estimation of overlengthening followed according to the method described by Athwal et al. Statistical analysis of the estimated and actual differences between the native state and bipolar replacement of the radial head with stepwise overlengthening of 1.5, 3, 4.5, and 6 mm showed a specificity of 86 % but consistently underestimated the amount of overlengthening with a sensitivity of only 61 %. The method described by Athwal et al. for the identification of overlengthening by a monopolar prosthesis was not found to be reliable for ruling out or quantifying overlengthening of the tested bipolar prosthesis. However, the use of the method to detect (rule in) overlengthening may be acceptable in certain circumstances. A reliable method for postoperative quantification of overlengthening by bipolar prostheses has still to be found.

  17. "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.

  18. 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

  19. MEMS-based system and image processing strategy for epiretinal prosthesis.

    PubMed

    Xia, Peng; Hu, Jie; Qi, Jin; Gu, Chaochen; Peng, Yinghong

    2015-01-01

    Retinal prostheses have the potential to restore some level of visual function to the patients suffering from retinal degeneration. In this paper, an epiretinal approach with active stimulation devices is presented. The MEMS-based processing system consists of an external micro-camera, an information processor, an implanted electrical stimulator and a microelectrode array. The image processing strategy combining image clustering and enhancement techniques was proposed and evaluated by psychophysical experiments. The results indicated that the image processing strategy improved the visual performance compared with direct merging pixels to low resolution. The image processing methods assist epiretinal prosthesis for vision restoration.

  20. A Stereophotogrammetric System For The Detection Of Prosthesis Loosening In Total Hip Arthroplasty

    NASA Astrophysics Data System (ADS)

    Baumrind, Sheldon; Genant, Harry K.; Hunter, John; Miller, David; Moffitt, Francis; Murray, William R.; Ross, Steven E.

    1980-07-01

    Loosening of the prosthetic device occurs in about 5% of cases following placement of total hip prostheses (THP). Early detection of loosening is much desired but is difficult to achieve using conventional methods. Due to errors of projection, it is quite possible to fail to detect mobility of even as much as 5 mm on single x-ray films. We are attempting to develop a simplified photogrammetric system suitable for general hospital use which could detect loosening of 0.8 mm at the 95 % level of confidence without use of complex stereoplotting equipment. Metal reference markers are placed in the shaft of the femur and in the acetabular region of the pelvis at the time of surgery. The distances between these reference markers and certain unambiguous points on the prostheses are computed analytically using an X-Y acoustical digitizer (accuracy ± 0.1 mm) and software developed previously for craniofacial measurement. Separate stereopairs of the joint region are taken under weight-bearing and nonweight-bearing conditions. Differences in the measured distances between the bo-ne markers and the prosthetic components on the two stereopairs are taken as indicators of prosthesis loosening. Measurements on a phantom using ten different x-ray stereopairs taken from as many different perspectives have established that true linear distances between reference points and prostheses can be measured at the desired reliability with the present low precision system. Preliminary in vivo measurements indicate that the main unresolved problem is the movement of the subject between the two exposures of each single stereopair. Two possible solutions to this problem are discussed.

  1. 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...

  2. Patient and implant survival following joint replacement because of metastatic bone disease

    PubMed Central

    2013-01-01

    Background Patients suffering from a pathological fracture or painful bony lesion because of metastatic bone disease often benefit from a total joint replacement. However, these are large operations in patients who are often weak. We examined the patient survival and complication rates after total joint replacement as the treatment for bone metastasis or hematological diseases of the extremities. Patients and methods 130 patients (mean age 64 (30–85) years, 76 females) received 140 joint replacements due to skeletal metastases (n = 114) or hematological disease (n = 16) during the period 2003–2008. 21 replaced joints were located in the upper extremities and 119 in the lower extremities. Clinical and survival data were extracted from patient files and various registers. Results The probability of patient survival was 51% (95% CI: 42–59) after 6 months, 39% (CI: 31–48) after 12 months, and 29% (CI: 21–37) after 24 months. The following surgical complications were seen (8 of which led to additional surgery): 2–5 hip dislocations (n = 8), deep infection (n = 3), peroneal palsy (n = 2), a shoulder prosthesis penetrating the skin (n = 1), and disassembly of an elbow prosthesis (n = 1). The probability of avoiding all kinds of surgery related to the implanted prosthesis was 94% (CI: 89–99) after 1 year and 92% (CI: 85–98) after 2 years. Conclusion Joint replacement operations because of metastatic bone disease do not appear to have given a poorer rate of patient survival than other types of surgical treatment, and the reoperation rate was low. PMID:23530874

  3. 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.

  4. Thirteen-year outcomes in the Anatomique Benoist Girard II hip prosthesis.

    PubMed

    Catanach, Michael J M; Sorial, Rami M; Eslick, Guy D

    2015-04-01

    The Stryker Anatomique Benoist Girard (ABG) hip implant system was a commonly used cementless prosthesis in the early 2000s, which fell from favour after several studies emerged implicating the prosthesis in high rates of revision. This retrospective, single-surgeon clinical study examines the fracture rate, revision rate and reasons for revision in 500 consecutive ABG II primary total conventional hip replacements. Follow-up was conducted by audit of patient notes, patient mailout survey, patient phone contact and audit of the Australian National Joint Replacement Registry (NJRR) database to find instances of fracture and revision. End points were periprosthetic fracture and revision for any reason. Follow-up was 1.2-13.8 years with a mean of 6.58 years. Of the 500 hips, 17 (3.4%) had undergone a revision. Of these, 13 were due to periprosthetic fracture. Four further fractures occurred that were not revised. Eight of these periprosthetic fractures occurred within 1 year post-operatively. There were four revisions for recurrent dislocations. Kaplan-Meier survival curve demonstrates a 93.7% survivorship at 6.58 years for revision for any reason. Multivariate analysis showed the only statistically significant factor for increased risk of revision was smaller stem size. Our results were consistent with the literature in that the ABG II system has good medium-term results but is prone to periprosthetic fractures, especially in the early post-operative period. When used as a primary total hip arthroplasty, the ABG II system has an 8-year revision rate of 5.6% compared with the 4.9% of all primary total hip arthroplasties. © 2014 Royal Australasian College of Surgeons.

  5. Prosthesis for blepharospasm.

    PubMed

    Moss, H L

    1983-12-01

    Following several years of experience with a newly designed spectacle-supported ptosis crutch for ptosis and blepharospasm, the author has developed a new approach to these conditions. In mild to moderate blepharospasm cases, the spectacle-supported prosthesis can still produce satisfactory results. However, in moderate to severe blepharospasm, the force of the spasm moves the entire device forward and downward, making it ineffective or too uncomfortable to wear. To create greater stability and a more effective counterforce to the blepharospasm, the author has developed a simple headband-supported device which does not use a spectacle frame for support. This new prosthesis is constructed of varying diameters of spring tempered diamond drawn stainless steel orthodontic wire, partially or completely covered by Teflon tubing. A silicon rubber cylinder is placed over the center which becomes a bridge and the main support for the device. An elastic head band completes the prosthesis.

  6. 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.

  7. 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.

  8. 21 CFR 888.3380 - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...

  9. 21 CFR 888.3380 - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...

  10. 21 CFR 888.3380 - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...

  11. 21 CFR 888.3380 - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...

  12. 21 CFR 888.3380 - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a... head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888...

  13. [Multicentre study of infection incidence in knee prosthesis].

    PubMed

    Jaén, F; Sanz-Gallardo, M I; Arrazola, M P; García de Codes, A; de Juanes, A; Resines, C

    2012-01-01

    To determine the incidence of surgical site infection in knee prosthesis surgical procedure for a follow-up period of one year in twelve hospitals in Madrid region. A prospective study was carried out from January to December 2009 using a national surveillance system called Indicadores Clínicos de Mejora Continua de Calidad. Primary and revision knee joint replacements in patients operated on in the previous year were included. Criteria used to define surgical site infection and patient risk index categories were those established by the Centers for Disease Control and Prevention and National Nosocomial Infections Surveillance. The incidence rates were worked out crude and adjusted by hazard ratio. 2,088 knee prosthesis procedures were analyzed. The overall incidence of surgical site infection was 2.1%. Sixty-five percent of the infections were organ/space. Sixty percent of the infections were identified in the early postoperative period. Of all surgical site infections, 41.9% were microbiologically confirmed. Antibiotic prophylaxis was implemented correctly in 63.3% of the cases. The most important cause of inappropriate prophylaxis was an unsuitable duration in 85.7% of the cases. The presurgical preparation was carried out correctly in 50.3% of surgical operations. The incidence of knee arthroplasty infection was twice as high as in the National Healthcare Safety Network and similar to national rates. In this study, the incidence of infection was within the range of infection rates in other published European studies. Surveillance and control strategies of health care for associated infections allow us to assess trends and the impact of preventive measures. Copyright © 2011 SECOT. Published by Elsevier Espana. All rights reserved.

  14. TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS.

    PubMed

    Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan

    2010-01-01

    Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years.

  15. TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS

    PubMed Central

    Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan

    2015-01-01

    Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years. PMID:27022527

  16. Optoelectronic retinal prosthesis: system design and performance

    NASA Astrophysics Data System (ADS)

    Loudin, J. D.; Simanovskii, D. M.; Vijayraghavan, K.; Sramek, C. K.; Butterwick, A. F.; Huie, P.; McLean, G. Y.; Palanker, D. V.

    2007-03-01

    The design of high-resolution retinal prostheses presents many unique engineering and biological challenges. Ever smaller electrodes must inject enough charge to stimulate nerve cells, within electrochemically safe voltage limits. Stimulation sites should be placed within an electrode diameter from the target cells to prevent 'blurring' and minimize current. Signals must be delivered wirelessly from an external source to a large number of electrodes, and visual information should, ideally, maintain its natural link to eye movements. Finally, a good system must have a wide range of stimulation currents, external control of image processing and the option of either anodic-first or cathodic-first pulses. This paper discusses these challenges and presents solutions to them for a system based on a photodiode array implant. Video frames are processed and imaged onto the retinal implant by a head-mounted near-to-eye projection system operating at near-infrared wavelengths. Photodiodes convert light into pulsed electric current, with charge injection maximized by applying a common biphasic bias waveform. The resulting prosthesis will provide stimulation with a frame rate of up to 50 Hz in a central 10° visual field, with a full 30° field accessible via eye movements. Pixel sizes are scalable from 100 to 25 µm, corresponding to 640-10 000 pixels on an implant 3 mm in diameter.

  17. A universal ankle-foot prosthesis emulator for human locomotion experiments.

    PubMed

    Caputo, Joshua M; Collins, Steven H

    2014-03-01

    Robotic prostheses have the potential to significantly improve mobility for people with lower-limb amputation. Humans exhibit complex responses to mechanical interactions with these devices, however, and computational models are not yet able to predict such responses meaningfully. Experiments therefore play a critical role in development, but have been limited by the use of product-like prototypes, each requiring years of development and specialized for a narrow range of functions. Here we describe a robotic ankle-foot prosthesis system that enables rapid exploration of a wide range of dynamical behaviors in experiments with human subjects. This emulator comprises powerful off-board motor and control hardware, a flexible Bowden cable tether, and a lightweight instrumented prosthesis, resulting in a combination of low mass worn by the human (0.96 kg) and high mechatronic performance compared to prior platforms. Benchtop tests demonstrated closed-loop torque bandwidth of 17 Hz, peak torque of 175 Nm, and peak power of 1.0 kW. Tests with an anthropomorphic pendulum "leg" demonstrated low interference from the tether, less than 1 Nm about the hip. This combination of low worn mass, high bandwidth, high torque, and unrestricted movement makes the platform exceptionally versatile. To demonstrate suitability for human experiments, we performed preliminary tests in which a subject with unilateral transtibial amputation walked on a treadmill at 1.25 ms-1 while the prosthesis behaved in various ways. These tests revealed low torque tracking error (RMS error of 2.8 Nm) and the capacity to systematically vary work production or absorption across a broad range (from -5 to 21 J per step). These results support the use of robotic emulators during early stage assessment of proposed device functionalities and for scientific study of fundamental aspects of human-robot interaction. The design of simple, alternate end-effectors would enable studies at other joints or with

  18. 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...

  19. Tribological characterisation of UHMWPE used in dual mobility total hip prosthesis

    NASA Astrophysics Data System (ADS)

    Essefi, I.; Hakkouna, H.; Ouenzerfi, G.; Mollon, G.; Hamza, S.; Renault, E.; Berthier, Y.; Trunfio-Sfarghiu, A.-M.

    2016-08-01

    Total hip arthroplasty represents an effective solution for bone and joint diseases. Nevertheless, the hip prosthesis has a limited lifetime, in the average around fifteen years. Their improvement, especially their dual mobility is the objective of this study. Therefore, our strategy is focused on improving the material by comparing three types of polyethylene to determine the best one from a friction mechanism and wear rate minimization standpoint. A dual mobility hip prosthesis, containing a two-sided steel and cobalt chrome cup, was tested with a TORNIER hip joint simulator in calf serum. The rubbed surfaces were characterized using scanning electron microscopy (SEM), contact angle measurements, atomic force microscopy (AFM) and confocal fluorescence microscopy. All these multiscale characterization techniques (from nanoscale to millimeter and micro- scale) showed that the velocity accommodation mechanism is different from one type of polyethylene to another. The wear in the case of standard polyethylene was noticeable and the particles were large and scattered between the surface of polyethylene, the surface of the cup and in the calf serum. For the crosslinked polyethylene, the particles coming from the wear, were not as large, but they were spread the same way as the first case. Even though it shares the same accommodation principle on the detachment of the material with the crosslinked polyethylene the wear particles for the crosslinked vitaminized polyethylene were large and they were only found on the surface of the polyethylene.

  20. 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...

  1. 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...

  2. Differences in the stress distribution in the distal femur between patellofemoral joint replacement and total knee replacement: a finite element study

    PubMed Central

    2012-01-01

    Background Patellofemoral joint replacement is a successful treatment option for isolated patellofemoral osteoarthritis. However, results of later conversion to total knee replacement may be compromised by periprosthetic bone loss. Previous clinical studies have demonstrated a decrease in distal femoral bone mineral density after patellofemoral joint replacement. It is unclear whether this is due to periprosthetic stress shielding. The main objective of the current study was to evaluate the stress shielding effect of prosthetic replacement with 2 different patellofemoral prosthetic designs and with a total knee prosthesis. Methods We developed a finite element model of an intact patellofemoral joint, and finite element models of patellofemoral joint replacement with a Journey PFJ prosthesis, a Richards II prosthesis, and a Genesis II total knee prosthesis. For each of these 4 finite element models, the average Von Mises stress in 2 clinically relevant regions of interest were evaluated during a simulated squatting movement until 120 degrees of flexion. Results During deep knee flexion, in the anterior region of interest, the average Von Mises stress with the Journey PFJ design was comparable to the physiological knee, while reduced by almost 25% for both the Richards II design and the Genesis II total knee joint replacement design. The average Von Mises stress in the supracondylar region of interest was similar for both patellofemoral prosthetic designs and the physiological model, with slightly lower stress for the Genesis II design. Conclusions Patellofemoral joint replacement results in periprosthetic stress-shielding, although to a smaller degree than in total knee replacement. Specific patellofemoral prosthetic design properties may result in differences in femoral stress shielding. PMID:22704638

  3. Above-knee prosthesis design based on fatigue life using finite element method and design of experiment.

    PubMed

    Phanphet, Suwattanarwong; Dechjarern, Surangsee; Jomjanyong, Sermkiat

    2017-05-01

    The main objective of this work is to improve the standard of the existing design of knee prosthesis developed by Thailand's Prostheses Foundation of Her Royal Highness The Princess Mother. The experimental structural tests, based on the ISO 10328, of the existing design showed that a few components failed due to fatigue under normal cyclic loading below the required number of cycles. The finite element (FE) simulations of structural tests on the knee prosthesis were carried out. Fatigue life predictions of knee component materials were modeled based on the Morrow's approach. The fatigue life prediction based on the FE model result was validated with the corresponding structural test and the results agreed well. The new designs of the failed components were studied using the design of experimental approach and finite element analysis of the ISO 10328 structural test of knee prostheses under two separated loading cases. Under ultimate loading, knee prosthesis peak von Mises stress must be less than the yield strength of knee component's material and the total knee deflection must be lower than 2.5mm. The fatigue life prediction of all knee components must be higher than 3,000,000 cycles under normal cyclic loading. The design parameters are the thickness of joint bars, the diameter of lower connector and the thickness of absorber-stopper. The optimized knee prosthesis design meeting all the requirements was recommended. Experimental ISO 10328 structural test of the fabricated knee prosthesis based on the optimized design confirmed the finite element prediction. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

  4. 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.

  5. 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.

  6. 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.

  7. Experimental and failure analysis of the prosthetic finger joint implants

    NASA Astrophysics Data System (ADS)

    Naidu, Sanjiv H.

    Small joint replacement arthroplasty of the hand is a well accepted surgical procedure to restore function and cosmesis in an individual with a crippled hand. Silicone elastomers have been used as prosthetic material in various small hand joints for well over three decades. Although the clinical science aspects of silicone elastomer failure are well known, the physical science aspects of prosthetic failure are scant and vague. In the following thesis, using both an animal model, and actual retrieved specimens which have failed in human service, experimental and failure analysis of silicone finger joints are presented. Fractured surfaces of retrieved silicone trapezial implants, and silicone finger joint implants were studied with both FESEM and SEM; the mode of failure for silicone trapezium is by wear polishing, whereas the finger joint implants failed either by fatigue fracture or tearing of the elastomer, or a combination of both. Thermal analysis revealed that the retrieved elastomer implants maintained its viscoelastic properties throughout the service period. In order to provide for a more functional and physiologic arthroplasty a novel finger joint (Rolamite prosthesis) is proposed using more recently developed thermoplastic polymers. The following thesis also addresses the outcome of the experimental studies of the Rolamite prosthesis in a rabbit animal model, in addition to the failure analysis of the thermoplastic polymers while in service in an in vivo synovial environment. Results of retrieved Rolamite specimens suggest that the use for thermoplastic elastomers such as block copolymer based elastomers in a synovial environment such as a mammalian joint may very well be limited.

  8. 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.

  9. Long-term outcome of acute prosthetic joint infections due to gram-negative bacilli treated with retention of prosthesis.

    PubMed

    Jaén, N; Martínez-Pastor, J C; Muñoz-Mahamud, E; García-Ramiro, S; Bosch, J; Mensa, J; Soriano, A

    2012-09-01

    To update the clinical information of the 47 patients with a prosthetic joint infection due to Gram-negative bacilli included in a previous study and to reassess the predictors of failure after a longer follow-up. Using the electronic files of our hospital, all the information regarding readmissions to the hospital, new surgical procedures and the reason for the new surgery (infection, aseptic loosening), and the last visit in the hospital were registered. The medical chart of the 35 patients that were considered in remission in the previous publication was reviewed. In 30 patients no clinical evidence of failure was detected and no additional surgery on the previously infected prosthesis was necessary and they were considered in long-term remission. In 5 cases a late complication was identified. One case had a reinfection due to coagulase-negative staphylococci after 22 months from the open debridement and required a 2-stage revision surgery. The other 4 cases developed an aseptic loosening and it was necessary to perform a 1-stage exchange. Receiving a fluoroquinolone when all the Gram-negatives involved in the infection were susceptible to fluoroquinolones was the only factor associated with remission in the univariate analysis (p=0.002). After a long-term follow-up, our results support the importance of using fluoroquinolones in acute PJI due to Gram-negative bacilli.

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. Technical note: validation of a motion analysis system for measuring the relative motion of the intermediate component of a tripolar total hip arthroplasty prosthesis.

    PubMed

    Chen, Qingshan; Lazennec, Jean Yves; Guyen, Olivier; Kinbrum, Amy; Berry, Daniel J; An, Kai-Nan

    2005-07-01

    Tripolar total hip arthroplasty (THA) prosthesis had been suggested as a method to reduce the occurrence of hip dislocation and microseparation. Precisely measuring the motion of the intermediate component in vitro would provide fundamental knowledge for understanding its mechanism. The present study validates the accuracy and repeatability of a three-dimensional motion analysis system to quantitatively measure the relative motion of the intermediate component of tripolar total hip arthroplasty prostheses. Static and dynamic validations of the system were made by comparing the measurement to that of a potentiometer. Differences between the mean system-calculated angle and the angle measured by the potentiometer were within +/-1 degrees . The mean within-trial variability was less than 1 degrees . The mean slope was 0.9-1.02 for different angular velocities. The dynamic noise was within 1 degrees . The system was then applied to measure the relative motion of an eccentric THA prosthesis. The study shows that this motion analysis system provides an accurate and practical method for measuring the relative motion of the tripolar THA prosthesis in vitro, a necessary first step towards the understanding of its in vivo kinematics.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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

  2. Joint Polar Satellite System

    NASA Technical Reports Server (NTRS)

    Trenkle, Timothy; Driggers, Phillip

    2011-01-01

    The Joint Polar Satellite System (JPSS) is a joint NOAA/NASA mission comprised of a series of polar orbiting weather and climate monitoring satellites which will fly in a sun-synchronous orbit, with a 1330 equatorial crossing time. JPSS resulted from the decision to reconstitute the National Polar-orbiting Operational Environmental Satellite System (NPOESS) into two separate programs, one to be run by the Department of Defense (DOD) and the other by NOAA. This decision was reached in early 2010, after numerous development issues caused a series of unacceptable delays in launching the NPOESS system.

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. Differential bacterial load on components of total knee prosthesis in patients with prosthetic joint infection.

    PubMed

    Holinka, Johannes; Pilz, Magdalena; Hirschl, Alexander M; Graninger, Wolfgang; Windhager, Reinhard; Presterl, Elisabeth

    2012-10-01

    The purpose of our study was to evaluate and quantify the bacterial adherence on different components of total knee prosthesis with the sonication culture method. Explanted components of all patients with presumptive prosthetic or implant infection were treated by sonication separately in sterile containers to dislodge the adherent bacteria from the surfaces and cultured. The bacterial load of the different knee components (femur, tibia, PE-inlay and patella) was evaluated by counting of colony-forming units (CFU) dislodged from the components surfaces using the sonication culture method. Overall, 27 patients had positive sonication cultures of explanted total knee prostheses. Microorganisms were detected from 88 of 100 explanted components. Twenty femoral components were culture positive and 7 negative, 23 tibial components as well as 23 polyethylene (PE) platforms had positive microorganism detection from the surface. Staphylococcus epidermidis adhered to the highest number of components whereas Staphylococcus aureus yielded the highest load of CFU in the sonication cultures. Although not significant, PE-inlays and tibial components were most often affected. The highest CFU count was detected in polyethylene components. The sonication culture method is a reliable method to detect bacteria from the components. Additionally, the results demonstrate that bacterial adherence is not affecting a single component of knee prosthesis only. Thus, in septic revision surgery partial prosthetic exchange or exchange of single polyethylene components alone may be not sufficient.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. Experimental measurement of flexion-extension movement in normal and corpse prosthetic elbow joint.

    PubMed

    TarniŢă, Daniela; TarniŢă, DănuŢ Nicolae

    2016-01-01

    This paper presents a comparative experimental study of flexion-extension movement in healthy elbow and in the prosthetic elbow joint fixed on an original experimental bench. Measurements were carried out in order to validate the functional morphology and a new elbow prosthesis type ball head. The three-dimensional (3D) model and the physical prototype of our experimental bench used to test elbow endoprosthesis at flexion-extension and pronation-supination movements is presented. The measurements were carried out on a group of nine healthy subjects and on the prosthetic corpse elbow, the experimental data being obtained for flexion-extension movement cycles. Experimental data for the two different flexion-extension tests for the nine subjects and for the corpse prosthetic elbow were acquired using SimiMotion video system. Experimental data were processed statistically. The corresponding graphs were obtained for all subjects in the experimental group, and for corpse prosthetic elbow for both flexion-extension tests. The statistical analysis has proved that the flexion angles of healthy elbows were significantly close to the values measured at the prosthetic elbow fixed on the experimental bench. The studied elbow prosthesis manages to re-establish the mobility for the elbow joint as close to the normal one.

  1. Arthroscopic Management of Scaphoid-Trapezium-Trapezoid Joint Arthritis.

    PubMed

    Pegoli, Loris; Pozzi, Alessandro

    2017-11-01

    Scaphoid-trapezium-trapezoid (STT) joint arthritis is a common condition consisting of pain on the radial side of the wrist and base of the thumb, swelling, and tenderness over the STT joint. Common symptoms are loss of grip strength and thumb function. There are several treatments, from symptomatic conservative treatment to surgical solutions, such as arthrodesis, arthroplasties, and prosthesis implant. The role of arthroscopy has grown and is probably the best treatment of this condition. Advantages of arthroscopic management of STT arthritis are faster recovery, better view of the joint during surgery, and possibility of creating less damage to the capsular and ligamentous structures. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Impact of a stance phase microprocessor-controlled knee prosthesis on level walking in lower functioning individuals with a transfemoral amputation.

    PubMed

    Eberly, Valerie J; Mulroy, Sara J; Gronley, JoAnne K; Perry, Jacquelin; Yule, William J; Burnfield, Judith M

    2014-12-01

    For individuals with transfemoral amputation, walking with a prosthesis presents challenges to stability and increases the demand on the hip of the prosthetic limb. Increasing age or comorbidities magnify these challenges. Computerized prosthetic knee joints improve stability and efficiency of gait, but are seldom prescribed for less physically capable walkers who may benefit from them. To compare level walking function while wearing a microprocessor-controlled knee (C-Leg Compact) prosthesis to a traditionally prescribed non-microprocessor-controlled knee prosthesis for Medicare Functional Classification Level K-2 walkers. Crossover. Stride characteristics, kinematics, kinetics, and electromyographic activity were recorded in 10 participants while walking with non-microprocessor-controlled knee and Compact prostheses. Walking with the Compact produced significant increase in velocity, cadence, stride length, single-limb support, and heel-rise timing compared to walking with the non-microprocessor-controlled knee prosthesis. Hip and thigh extension during late stance improved bilaterally. Ankle dorsiflexion, knee extension, and hip flexion moments of the prosthetic limb were significantly improved. Improvements in walking function and stability on the prosthetic limb were demonstrated by the K-2 level walkers when using the C-Leg Compact prosthesis. Understanding the impact of new prosthetic designs on gait mechanics is essential to improve prescription guidelines for deconditioned or older persons with transfemoral amputation. Prosthetic designs that improve stability for safety and walking function have the potential to improve community participation and quality of life. © The International Society for Prosthetics and Orthotics 2013.

  3. The "caviar" madreporic knee prosthesis.

    PubMed

    Kenesi, C

    1979-01-01

    The madreporic ("caviar") prosthesis is a hinged knee prosthesis that can be inserted without the use of cement. The surfaces of the intramedullary stems are constructed with contiguous spheres one mm in diameter. These spaces are filled by bone trabeculae and haversian bone, providing permanent biologic fixation. Experimental madreporic knee arthroplasties in dogs show that bone probes these surfaces and produces solid attachments. Histologically, the trabeculae remain separated from the metal by a fine layer of fibrous tissue. The method of insertion of the prosthesis is simple. Preparing the epiphyses before any bone resection avoids the possibility of rotational positioning errors. The form of the intramedullary stems offers good positioning in the frontal plane. The analysis of an initial series of 15 cases shows results that are far from outstanding. The 2 deaths, the 2 cases of sepsis, and the recuperation of only mediocre motion can be explained, at least in part, by the advanced age of the patients and the poor bone quality of the rheumatoid patients. Nevertheless, this type of prosthesis has 2 important advantages. It avoids the complications from the use of acrylic cement and allows for a revision operation for cases of failed surface replacement designs. Obviously further experimentation with noncemented designs will continue and definitive studies will be reported later.

  4. 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

  5. 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

  6. Operative tactics and results of treatment of patients with coxarthrosis secondary to congenital high luxation of hip joints.

    PubMed

    Król, Roman; Rojewski, Marek; Kamiński, Adam; Popławski, Tomasz

    2007-01-01

    Treatment of the sequelae of congenital high luxation of the hip joint is a major challenge in prosthetic surgery, demanding from the operator thorough familiarity with the problem and experience in hop reconstructive surgery. The results of 4 years observation, of the treatment of 14 woman in the average age of 38 years old with 18 hip joints with congenital high luxation are presented. In all cases cementless total hip arthroplasty was made. Acetabular component of the prosthesis was implanted correctly and stable in its physiological placement. Femur was shortened average 4 cm and stabilized by cementless press-fit stem of prosthesis. The place of femur osteotomy was covered with autogenic spongy bone from resected caput of femur. The union was achieved after average 10 weeks. In clinical assessment there were obtained 10 very good, 5 good and 3 satisfactory clinical results. There were no superficial or deep infections, no neurological disorders and no loosening of components of implanted prostheses observed. 1. Careful planning and carrying out the operative procedures allow to insert the acetabular component of the prosthesis in its physiological place and achieve good results. 2. Shortening of femur and repositioning of components of prosthesis in 90 degrees knee flexion and also position on broken bed after operative procedure allowed to avoid neurological disorders. 3. Cementless and hydroxyapatite-covered femoral component of the prosthesis correctly stabilize place of femur osteotomy.

  7. 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.

  8. 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.

  9. 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.

  10. Regulation of step frequency in transtibial amputee endurance athletes using a running-specific prosthesis.

    PubMed

    Oudenhoven, Laura M; Boes, Judith M; Hak, Laura; Faber, Gert S; Houdijk, Han

    2017-01-25

    Running specific prostheses (RSP) are designed to replicate the spring-like behaviour of the human leg during running, by incorporating a real physical spring in the prosthesis. Leg stiffness is an important parameter in running as it is strongly related to step frequency and running economy. To be able to select a prosthesis that contributes to the required leg stiffness of the athlete, it needs to be known to what extent the behaviour of the prosthetic leg during running is dominated by the stiffness of the prosthesis or whether it can be regulated by adaptations of the residual joints. The aim of this study was to investigate whether and how athletes with an RSP could regulate leg stiffness during distance running at different step frequencies. Seven endurance runners with an unilateral transtibial amputation performed five running trials on a treadmill at a fixed speed, while different step frequencies were imposed (preferred step frequency (PSF) and -15%, -7.5%, +7.5% and +15% of PSF). Among others, step time, ground contact time, flight time, leg stiffness and joint kinetics were measured for both legs. In the intact leg, increasing step frequency was accompanied by a decrease in both contact and flight time, while in the prosthetic leg contact time remained constant and only flight time decreased. In accordance, leg stiffness increased in the intact leg, but not in the prosthetic leg. Although a substantial contribution of the residual leg to total leg stiffness was observed, this contribution did not change considerably with changing step frequency. Amputee athletes do not seem to be able to alter prosthetic leg stiffness to regulate step frequency during running. This invariant behaviour indicates that RSP stiffness has a large effect on total leg stiffness and therefore can have an important influence on running performance. Nevertheless, since prosthetic leg stiffness was considerably lower than stiffness of the RSP, compliance of the residual leg should

  11. Kinematic analysis of total knee prosthesis designed for Asian population.

    PubMed

    Low, F H; Khoo, L P; Chua, C K; Lo, N N

    2000-01-01

    In designing a total knee replacement (TKR) prosthesis catering for the Asian population, 62 sets of femur were harvested and analyzed. The morphometrical data obtained were found to be in good agreement with dimensions typical of the Asian knee and has reaffirmed the fact that Caucasian knees are generally larger than Asian knees. Subsequently, these data when treated using a multivariate statistical technique resulted in the establishment of major design parameters for six different sizes of femoral implants. An extra-small implant size with established dimensions and geometrical shape has surfaced from the study. The differences between the Asian knees and the Caucasian knees are discussed. Employing the established femoral dimensions and motion path of the knee joint, the articulating tibia profile was generated. All the sizes of implants were modeled using a computer-aided software package. Thereupon, these models that accurately fits the local Asian knee were transported into a dynamic and kinematic analysis software package. The tibiofemoral joint was modeled successfully as a slide curve joint to study intuitively the motion of the femur when articulating on the tibia surface. An optimal tibia profile could be synthesized to mimic the natural knee path motion. Details of the analysis are presented and discussed.

  12. The Argus(®) II Retinal Prosthesis System.

    PubMed

    Luo, Yvonne Hsu-Lin; da Cruz, Lyndon

    2016-01-01

    The Argus(®) II Retinal Prosthesis System (Second Sight Medical Products) is the first prosthetic vision device to obtain regulatory approval in both Europe and the USA. As such it has entered the commercial market as a treatment for patients with profound vision loss from end-stage outer retinal disease, predominantly retinitis pigmentosa. To date, over 100 devices have been implanted worldwide, representing the largest group of patients currently treated with visual prostheses. The system works by direct stimulation of the relatively preserved inner retina via epiretinal microelectrodes, thereby replacing the function of the degenerated photoreceptors. Visual information from a glasses-mounted video camera is converted to a pixelated image by an external processor, before being transmitted to the microelectrode array at the macula. Elicited retinal responses are then relayed via the normal optic nerve to the cortex for interpretation. We reviewed the animal and human studies that led to the development of the Argus(®) II device. A sufficiently robust safety profile was demonstrated in the phase I/II clinical trial of 30 patients. Improvement of function in terms of orientation and mobility, target localisation, shape and object recognition, and reading of letters and short unrehearsed words have also been shown. There remains a wide variability in the functional outcomes amongst the patients and the factors contributing to these performance differences are still unclear. Future developments in terms of both software and hardware aimed at improving visual function have been proposed. Further experience in clinical outcomes is being acquired due to increasing implantation. Copyright © 2015. Published by Elsevier Ltd.

  13. An analysis of observer‐rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years

    PubMed Central

    Richards, Thomas P; Arditi, Aries; da Cruz, Lyndon; Dagnelie, Gislin; Dorn, Jessy D; Duncan, Jacque L; Ho, Allen C; Olmos de Koo, Lisa C; Sahel, José‐Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J

    2016-01-01

    Abstract Objective The purpose of this analysis was to compare observer‐rated tasks in patients implanted with the Argus II Retinal Prosthesis System, when the device is ON versus OFF. Methods The Functional Low‐Vision Observer Rated Assessment (FLORA) instrument was administered to 26 blind patients implanted with the Argus II Retinal Prosthesis System at a mean follow‐up of 36 months. FLORA is a multi‐component instrument that consists in part of observer‐rated assessment of 35 tasks completed with the device ON versus OFF. The ease with which a patient completes a task is scored using a four‐point scale, ranging from easy (score of 1) to impossible (score of 4). The tasks are evaluated individually and organised into four discrete domains, including ‘Visual orientation’, ‘Visual mobility’, ‘Daily life and ‘Interaction with others’. Results Twenty‐six patients completed each of the 35 tasks. Overall, 24 out of 35 tasks (69 per cent) were statistically significantly easier to achieve with the device ON versus OFF. In each of the four domains, patients’ performances were significantly better (p < 0.05) with the device ON versus OFF, ranging from 19 to 38 per cent improvement. Conclusion Patients with an Argus II Retinal Prosthesis implanted for 18 to 44 months (mean 36 months), demonstrated significantly improved completion of vision‐related tasks with the device ON versus OFF. PMID:26804484

  14. Effect of prosthesis endplate lordosis angles on L5-S1 kinematics after disc arthroplasty.

    PubMed

    Tsitsopoulos, Parmenion P; Wojewnik, Bartosz; Voronov, Leonard I; Havey, Robert M; Renner, Susan M; Zelenakova, Julia; McIntosh, Braden; Carandang, Gerard; Abjornson, Celeste; Patwardhan, Avinash G

    2012-06-01

    We hypothesized that L5-S1 kinematics will not be affected by the lordosis distribution between the prosthesis endplates. Twelve cadaveric lumbosacral spines (51.3 ± 9.8 years) were implanted with 6° or 11° prostheses (ProDisc-L) with four combinations of superior/inferior lordosis (6°/0°, 3°/3°, 11°/0°, 3°/8°). Specimens were tested intact and after prostheses implantation with different lordosis distributions. Center of rotation (COR) and range of motion (ROM) were quantified. Six-degree lordosis prostheses (n = 7) showed no difference in flexion-extension ROM, regardless of design (6°/0° or 3°/3°) (p > 0.05). In lateral bending (LB), both designs reduced ROM (p < 0.05). In axial rotation, only the 3°/3° design reduced ROM (p < 0.05). Eleven-degree lordosis prostheses (n = 5) showed no difference in flexion-extension ROM for either design (p > 0.05). LB ROM decreased with distributed lordosis prostheses (3°/8°) (p < 0.05). Overall, L5-S1 range of motion was not markedly influenced by lordosis distribution among the two prosthesis endplates. The ProDisc-L prosthesis design where all lordosis is concentrated in the superior endplate yielded COR locations that were anterior and caudal to intact controls. The prosthesis with lordosis distributed between the two endplates yielded a COR that tended to be closer to intact. Further clinical and biomechanical studies are needed to assess the long-term impact of lordosis angle distribution on the fate of the facet joints.

  15. Stair ascent with an innovative microprocessor-controlled exoprosthetic knee joint.

    PubMed

    Bellmann, Malte; Schmalz, Thomas; Ludwigs, Eva; Blumentritt, Siegmar

    2012-12-01

    Climbing stairs can pose a major challenge for above-knee amputees as a result of compromised motor performance and limitations to prosthetic design. A new, innovative microprocessor-controlled prosthetic knee joint, the Genium, incorporates a function that allows an above-knee amputee to climb stairs step over step. To execute this function, a number of different sensors and complex switching algorithms were integrated into the prosthetic knee joint. The function is intuitive for the user. A biomechanical study was conducted to assess objective gait measurements and calculate joint kinematics and kinetics as subjects ascended stairs. Results demonstrated that climbing stairs step over step is more biomechanically efficient for an amputee using the Genium prosthetic knee than the previously possible conventional method where the extended prosthesis is trailed as the amputee executes one or two steps at a time. There is a natural amount of stress on the residual musculoskeletal system, and it has been shown that the healthy contralateral side supports the movements of the amputated side. The mechanical power that the healthy contralateral knee joint needs to generate during the extension phase is also reduced. Similarly, there is near normal loading of the hip joint on the amputated side.

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. Hearing results using the SMart piston prosthesis.

    PubMed

    Fayad, Jose N; Semaan, Maroun T; Meier, Josh C; House, John W

    2009-12-01

    SMart, a newly introduced piston prosthesis for stapedotomy, is a nitinol-based, heat-activated, self-crimping prosthesis. We review our hearing results and postoperative complications using this self-crimped piston prosthesis and compare them with those obtained using stainless steel or platinum piston prostheses. Audiometric results using the SMart piston are identical to those obtained using a conventional piston prosthesis. Retrospective chart review. Private neurotologic tertiary referral center. The 416 ears reviewed included 306 with a SMart prosthesis and 110 conventional prostheses. 61% were women. Mean follow-up time was 5.6 (standard deviation [SD], 6.3 mo) and 6.9 months (SD, 7.0 mo) for the 2 groups, respectively. Stapedotomy using the SMart or a conventional (non-SMart) prosthesis. Audiometric hearing results, including pure-tone average (PTA) and air-bone gap (ABG), and prevalence of postoperative complications. Mean postoperative PTA was 32.6 (SD, 16.8) dB for the SMart group and 29.4 (SD, 13.5) dB for the non-SMart group, with ABGs of 7.6 (SD, 8.9) and 6.0 (SD, 5.2) dB, respectively. Mean change (decrease) in ABG was 18.7 (SD, 13.1) dB for the SMart group and 19.9 (SD, 10.3) dB for the non-SMart group. High-frequency bone PTAs showed overclosure of 2.0 (SD, 7.9) dB for the SMart group and 3.6 (SD, 8.6) dB for the non-SMart group. Postoperative vertigo and tinnitus were infrequent. No significant differences in these audiometric outcomes or complication rates were noted between groups. There was no significant difference in rate of gap closure to within 10 dB (78.3 versus 84.2%, SMart and non-SMart, respectively) or 20 dB (94.2 and 98.0%). Compared with conventional stapes prostheses, the nitinol-based SMart is a safe and reliable stapes prosthesis that eliminates manual crimping without significantly altering the audiometric outcome. Complications are rare, but longer follow-up is needed before establishing long-term stability.

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. Game-Based Rehabilitation for Myoelectric Prosthesis Control.

    PubMed

    Prahm, Cosima; Vujaklija, Ivan; Kayali, Fares; Purgathofer, Peter; Aszmann, Oskar C

    2017-02-09

    A high number of upper extremity myoelectric prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train in absence of a physiotherapist. Virtual training systems, in the form of video games, provide patients with an entertaining and intuitive method for improved muscle coordination and improved overall control. Complementary to established rehabilitation protocols, it is highly beneficial for this virtual training process to start even before receiving the final prosthesis, and to be continued at home for as long as needed. The aim of this study is to evaluate (1) the short-term effects of a commercially available electromyographic (EMG) system on controllability after a simple video game-based rehabilitation protocol, and (2) different input methods, control mechanisms, and games. Eleven able-bodied participants with no prior experience in EMG control took part in this study. Participants were asked to perform a surface EMG test evaluating their provisional maximum muscle contraction, fine accuracy and isolation of electrode activation, and endurance control over at least 300 seconds. These assessments were carried out (1) in a Pregaming session before interacting with three EMG-controlled computer games, (2) in a Postgaming session after playing the games, and (3) in a Follow-Up session two days after the gaming protocol to evaluate short-term retention rate. After each game, participants were given a user evaluation survey for the assessment of the games and their input mechanisms. Participants also received a questionnaire regarding their intrinsic motivation (Intrinsic Motivation Inventory) at the end of the last game. Results showed a significant improvement in fine accuracy electrode activation (P<.01), electrode separation (P=.02), and endurance control (P<.01) from Pregaming EMG assessments to the Follow-Up measurement. The deviation around the EMG goal value diminished and the opposing electrode was

  8. Game-Based Rehabilitation for Myoelectric Prosthesis Control

    PubMed Central

    Vujaklija, Ivan; Kayali, Fares; Purgathofer, Peter; Aszmann, Oskar C

    2017-01-01

    Background A high number of upper extremity myoelectric prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train in absence of a physiotherapist. Virtual training systems, in the form of video games, provide patients with an entertaining and intuitive method for improved muscle coordination and improved overall control. Complementary to established rehabilitation protocols, it is highly beneficial for this virtual training process to start even before receiving the final prosthesis, and to be continued at home for as long as needed. Objective The aim of this study is to evaluate (1) the short-term effects of a commercially available electromyographic (EMG) system on controllability after a simple video game-based rehabilitation protocol, and (2) different input methods, control mechanisms, and games. Methods Eleven able-bodied participants with no prior experience in EMG control took part in this study. Participants were asked to perform a surface EMG test evaluating their provisional maximum muscle contraction, fine accuracy and isolation of electrode activation, and endurance control over at least 300 seconds. These assessments were carried out (1) in a Pregaming session before interacting with three EMG-controlled computer games, (2) in a Postgaming session after playing the games, and (3) in a Follow-Up session two days after the gaming protocol to evaluate short-term retention rate. After each game, participants were given a user evaluation survey for the assessment of the games and their input mechanisms. Participants also received a questionnaire regarding their intrinsic motivation (Intrinsic Motivation Inventory) at the end of the last game. Results Results showed a significant improvement in fine accuracy electrode activation (P<.01), electrode separation (P=.02), and endurance control (P<.01) from Pregaming EMG assessments to the Follow-Up measurement. The deviation around the EMG goal value

  9. Experimental effective shape control of a powered transfemoral prosthesis.

    PubMed

    Gregg, Robert D; Lenzi, Tommaso; Fey, Nicholas P; Hargrove, Levi J; Sensinger, Jonathon W

    2013-06-01

    This paper presents the design and experimental implementation of a novel feedback control strategy that regulates effective shape on a powered transfemoral prosthesis. The human effective shape is the effective geometry to which the biological leg conforms--through movement of ground reaction forces and leg joints--during the stance period of gait. Able-bodied humans regulate effective shapes to be invariant across conditions such as heel height, walking speed, and body weight, so this measure has proven to be a very useful tool for the alignment and design of passive prostheses. However, leg joints must be actively controlled to assume different effective shapes that are unique to tasks such as standing, walking, and stair climbing. Using our previous simulation studies as a starting point, we model and control the effective shape as a virtual kinematic constraint on the powered Vanderbilt prosthetic leg with a custom instrumented foot. An able-bodied subject used a by-pass adapter to walk on the controlled leg over ground and over a treadmill. These preliminary experiments demonstrate, for the first time, that effective shape (or virtual constraints in general) can be used to control a powered prosthetic leg.

  10. Evaluation of pipe-type cable joint restraint systems

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

    Silver, D.A.; Seman, G.W.

    1990-03-01

    the purpose of this project was to evaluate two systems for restraining the movement of 345kV high-pressure oil-filled (HPOF) cable joints during load cycling. Problems with joints and adjacent cables due to thermomechanical bending (TMB) experienced by the Consolidated Edison Company of New York and Public Service Electric Gas Company of New Jersey are reviewed. Some approaches to reducing or preventing TMB induced damage to HPOF pipe type cable joints are discussed. The design and operation of a special test apparatus for simulating TMB effects under laboratory conditions is described. One of the two joint restraint systems evaluated under thismore » project was developed by PSE G and employed wedging devices, which could be retrofitted into existing installations, that limited the longitudinal movement of the joints during load cycling. The other system developed by Pirelli Cable Corporation applied the restraining force to the cylindrical portion of the hand applied joint insulation by means of support spiders and steel rods attached to the reducer faces. The test results show that the PSE G restraint system can effectively limit joint longitudinal movement while causing a minimal amount of mechanical disturbance to the joint stress cones. The test results obtained with the PCC system are inconclusive and indicate that further refinement and testing are required to demonstrate the effectiveness of this promising joint restraint system.« less

  11. 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.

  12. 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.

  13. An analysis of observer-rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years.

    PubMed

    Geruschat, Duane R; Richards, Thomas P; Arditi, Aries; da Cruz, Lyndon; Dagnelie, Gislin; Dorn, Jessy D; Duncan, Jacque L; Ho, Allen C; Olmos de Koo, Lisa C; Sahel, José-Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J

    2016-05-01

    The purpose of this analysis was to compare observer-rated tasks in patients implanted with the Argus II Retinal Prosthesis System, when the device is ON versus OFF. The Functional Low-Vision Observer Rated Assessment (FLORA) instrument was administered to 26 blind patients implanted with the Argus II Retinal Prosthesis System at a mean follow-up of 36 months. FLORA is a multi-component instrument that consists in part of observer-rated assessment of 35 tasks completed with the device ON versus OFF. The ease with which a patient completes a task is scored using a four-point scale, ranging from easy (score of 1) to impossible (score of 4). The tasks are evaluated individually and organised into four discrete domains, including 'Visual orientation', 'Visual mobility', 'Daily life and 'Interaction with others'. Twenty-six patients completed each of the 35 tasks. Overall, 24 out of 35 tasks (69 per cent) were statistically significantly easier to achieve with the device ON versus OFF. In each of the four domains, patients' performances were significantly better (p < 0.05) with the device ON versus OFF, ranging from 19 to 38 per cent improvement. Patients with an Argus II Retinal Prosthesis implanted for 18 to 44 months (mean 36 months), demonstrated significantly improved completion of vision-related tasks with the device ON versus OFF. © 2016 The Authors Clinical and Experimental Optometry published by John Wiley & Sons Australia, Ltd on behalf of Optometry Australia.

  14. Joint Online Thesis and Research System (JOTARS)

    DTIC Science & Technology

    2006-09-01

    NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution is unlimited JOINT ONLINE ...September 2006 3. REPORT TYPE AND DATES COVERED Master’s Thesis 4. TITLE AND SUBTITLE: Joint Online Thesis and Research System (JOTARS) 6. AUTHOR...prototype website is the Joint Online Thesis and Research System (JOTARS). The specific functional objectives of JOTARS are to establish standard

  15. Radial Head Prosthesis Removal: a Retrospective Case Series of 14 Patients

    PubMed Central

    Neuhaus, Valentin; Christoforou, Dimitrios C.; Kachooei, Amir Reza; Jupiter, Jesse B.; Ring, David C.; Mudgal, Chaitanya S.

    2015-01-01

    Background: The purpose of this study was to report the preoperative complaints and postoperative outcome of patients after removal of the radial head prosthesis. Methods: This is a retrospective review of 14 adult patients (6 females and 8 males) from 2007 to 2011, who underwent radial head prosthesis removal by three surgeons. The average time between implantation and removal was 23 months (range from 2 weeks to 12 years, median 12 months). Results: The leading reported complaints before removal were restricted mobility of the elbow (active range of motion of less than 100 degrees) in 6, pain in 3, and pain together with restricted mobility in 4 patients. The objective findings before removal were restricted mobility of the elbow in 10 (71%), capitellar cartilage wear, loose implants, and heterotopic ossification each in 8 (57%), subluxation of the radio-capitellar joint or malpositioning of the stem in 5 (36%), and chronic infection in 2 (14%) patients. All patients with pain had wear of the capitellar cartilage on radiographs. The ulnar nerve was decompressed in four patients at the time of removal. Four patients underwent a subsequent operation for postoperative ulnar nerve symptoms 5 to 21 months after removal. Four patients were still complaining about persistent pain at the last follow-up visit. Except two patients, the total range of motion improved with a mean of 34 degrees (range 5 to 70) after a mean follow-up of 11 months. Conclusions: Removal of radial head prosthesis improved function and lessened pain in our case series. The reoperation rate was yet nearly 30% due to ulnar neuritis. Selective ulnar nerve decompression at the time of removal must be evaluated, especially in patients with expected large gain in range of motion after removal. PMID:26110173

  16. Development of a prosthesis shoulder mechanism for upper limb amputees: application of an original design methodology to optimize functionality and wearability.

    PubMed

    Troncossi, Marco; Borghi, Corrado; Chiossi, Marco; Davalli, Angelo; Parenti-Castelli, Vincenzo

    2009-05-01

    The application of a design methodology for the determination of the optimal prosthesis architecture for a given upper limb amputee is presented in this paper along with the discussion of its results. In particular, a novel procedure was used to provide the main guidelines for the design of an actuated shoulder articulation for externally powered prostheses. The topology and the geometry of the new articulation were determined as the optimal compromise between wearability (for the ease of use and the patient's comfort) and functionality of the device (in terms of mobility, velocity, payload, etc.). This choice was based on kinematic and kinetostatic analyses of different upper limb prosthesis models and on purpose-built indices that were set up to evaluate the models from different viewpoints. Only 12 of the 31 simulated prostheses proved a sufficient level of functionality: among these, the optimal solution was an articulation having two actuated revolute joints with orthogonal axes for the elevation of the upper arm in any vertical plane and a frictional joint for the passive adjustment of the humeral intra-extra rotation. A prototype of the mechanism is at the clinical test stage.

  17. 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.

  18. 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

  19. Classification of EMG signals using artificial neural networks for virtual hand prosthesis control.

    PubMed

    Mattioli, Fernando E R; Lamounier, Edgard A; Cardoso, Alexandre; Soares, Alcimar B; Andrade, Adriano O

    2011-01-01

    Computer-based training systems have been widely studied in the field of human rehabilitation. In health applications, Virtual Reality presents itself as an appropriate tool to simulate training environments without exposing the patients to risks. In particular, virtual prosthetic devices have been used to reduce the great mental effort needed by patients fitted with myoelectric prosthesis, during the training stage. In this paper, the application of Virtual Reality in a hand prosthesis training system is presented. To achieve this, the possibility of exploring Neural Networks in a real-time classification system is discussed. The classification technique used in this work resulted in a 95% success rate when discriminating 4 different hand movements.

  20. Numerical simulation of artificial hip joint motion based on human age factor

    NASA Astrophysics Data System (ADS)

    Ramdhani, Safarudin; Saputra, Eko; Jamari, J.

    2018-05-01

    Artificial hip joint is a prosthesis (synthetic body part) which usually consists of two or more components. Replacement of the hip joint due to the occurrence of arthritis, ordinarily patients aged or older. Numerical simulation models are used to observe the range of motion in the artificial hip joint, the range of motion of joints used as the basis of human age. Finite- element analysis (FEA) is used to calculate stress von mises in motion and observes a probability of prosthetic impingement. FEA uses a three-dimensional nonlinear model and considers the position variation of acetabular liner cups. The result of numerical simulation shows that FEA method can be used to analyze the performance calculation of the artificial hip joint at this time more accurate than conventional method.

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. Selection of contact bearing couple materials for hip prosthesis using finite element analysis under static conditions

    NASA Astrophysics Data System (ADS)

    Arirajan, K. A.; Chockalingam, K.; Vignesh, C.

    2018-04-01

    Implants are the artificial parts to replace the missing bones or joints in human anatomy to give mechanical support. Hip joint replacement is an important issue in orthopaedic surgery. The main concern limiting the long-run success of the total hip replacement is the limited service life. Hip replacement technique is widely used in replacing the femur head and acetabular cup by materials that are highly biocompatible. The success of the artificial hip replacement depends upon proper material selection, structure, and shape of the hip prosthesis. Many orthopaedic analyses have been tried with different materials, but ended with partial success on the application side. It is a critical task for selecting the best material pair in the hip prosthesis design. This work develops the finite element analysis of an artificial hip implant to study highest von Mises stress, contact pressure and elastic strain occurs for the dissimilar material combination. The different bearing couple considered for the analysis are Metal on Metal, Metal on Plastic, Metal on Ceramic, Ceramic on Plastic, Ceramic on Ceramic combinations. The analysis is carried out at different static positions of a human (i.e) standing, sitting. The results reveals that the combination with metal in contact with plastic (i.e) Titanium femoral head paired with Ultra High Molecular Weight Poly Ethylene acetabular cup reduces maximum von Mises stress and also it gives lowest contact pressure than other combination of bearing couples.

  7. 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.

  8. 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.

  9. Friction in Total Hip Joint Prosthesis Measured In Vivo during Walking

    PubMed Central

    Damm, Philipp; Dymke, Joern; Ackermann, Robert; Bender, Alwina; Graichen, Friedmar; Halder, Andreas; Beier, Alexander; Bergmann, Georg

    2013-01-01

    Friction-induced moments and subsequent cup loosening can be the reason for total hip joint replacement failure. The aim of this study was to measure the in vivo contact forces and friction moments during walking. Instrumented hip implants with Al2O3 ceramic head and an XPE inlay were used. In vivo measurements were taken 3 months post operatively in 8 subjects. The coefficient of friction was calculated in 3D throughout the whole gait cycle, and average values of the friction-induced power dissipation in the joint were determined. On average, peak contact forces of 248% of the bodyweight and peak friction moments of 0.26% bodyweight times meter were determined. However, contact forces and friction moments varied greatly between individuals. The friction moment increased during the extension phase of the joint. The average coefficient of friction also increased during this period, from 0.04 (0.03 to 0.06) at contralateral toe off to 0.06 (0.04 to 0.08) at contralateral heel strike. During the flexion phase, the coefficient of friction increased further to 0.14 (0.09 to 0.23) at toe off. The average friction-induced power throughout the whole gait cycle was 2.3 W (1.4 W to 3.8 W). Although more parameters than only the synovia determine the friction, the wide ranges of friction coefficients and power dissipation indicate that the lubricating properties of synovia are individually very different. However, such differences may also exist in natural joints and may influence the progression of arthrosis. Furthermore, subjects with very high power dissipation may be at risk of thermally induced implant loosening. The large increase of the friction coefficient during each step could be caused by the synovia being squeezed out under load. PMID:24260114

  10. Friction in total hip joint prosthesis measured in vivo during walking.

    PubMed

    Damm, Philipp; Dymke, Joern; Ackermann, Robert; Bender, Alwina; Graichen, Friedmar; Halder, Andreas; Beier, Alexander; Bergmann, Georg

    2013-01-01

    Friction-induced moments and subsequent cup loosening can be the reason for total hip joint replacement failure. The aim of this study was to measure the in vivo contact forces and friction moments during walking. Instrumented hip implants with Al2O3 ceramic head and an XPE inlay were used. In vivo measurements were taken 3 months post operatively in 8 subjects. The coefficient of friction was calculated in 3D throughout the whole gait cycle, and average values of the friction-induced power dissipation in the joint were determined. On average, peak contact forces of 248% of the bodyweight and peak friction moments of 0.26% bodyweight times meter were determined. However, contact forces and friction moments varied greatly between individuals. The friction moment increased during the extension phase of the joint. The average coefficient of friction also increased during this period, from 0.04 (0.03 to 0.06) at contralateral toe off to 0.06 (0.04 to 0.08) at contralateral heel strike. During the flexion phase, the coefficient of friction increased further to 0.14 (0.09 to 0.23) at toe off. The average friction-induced power throughout the whole gait cycle was 2.3 W (1.4 W to 3.8 W). Although more parameters than only the synovia determine the friction, the wide ranges of friction coefficients and power dissipation indicate that the lubricating properties of synovia are individually very different. However, such differences may also exist in natural joints and may influence the progression of arthrosis. Furthermore, subjects with very high power dissipation may be at risk of thermally induced implant loosening. The large increase of the friction coefficient during each step could be caused by the synovia being squeezed out under load.

  11. The Effect of Gap Angle on Tensile Strength of Preceramic Base Metal Solder Joints.

    PubMed

    Fattahi, Farnaz; Hashemi Ardakani, Zahra; Hashemi Ardakani, Maryam

    2015-12-01

    Soldering is a process commonly used in fabricating dental prosthesis. Since most soldered prosthesis fail at the solder joints; the joint strength is of utmost importance. The purpose of this study was to evaluate the effect of gap angle on the tensile strength of base metal solder joints. A total number of 40 Ni-Cr samples were fabricated according to ADA/ISO 9693 specifications for tensile test. Samples were cut at the midpoint of the bar, and were placed at the considered angles by employing an explicitly designed device. They were divided into 4 groups regarding the gap angle; Group C (control group) with parallel gap on steady distance of 0.2mm, Group 1: 10°, Group 2: 20°, and Group3: 30° gap angles. When soldered, the specimens were all tested for tensile strength using a universal testing machine at a cross-head speed of 0.5 mm/min with a preload of 10N. Kruskal-Wallis H test was used to compare tensile strength among the groups (p< 0.05). The mean tensile strength values obtained from the study groups were respectively 307.84, 391.50, 365.18, and 368.86 MPa. The tensile strength was not statistically different among the four groups in general (p≤ 0.490). Making the gap angular at the solder joints and the subsequent unsteady increase of the gap distance would not change the tensile strength of the joint.

  12. Economic Analysis of 4221 Revisions Due to Periprosthetic Joint Infection in Poland.

    PubMed

    Babiak, Ireneusz; Pędzisz, Piotr; Janowicz, Jakub; Kulig, Mateusz; Małdyk, Paweł

    2017-01-26

    Periprosthetic joint infection (PJI) is one of the most severe complications of total hip (THA) and total knee (TKA) arthroplasty. The aim of the study is to determine the number and type of hip and knee prosthesis revisions in Poland performed due to infection and reimbursement of the cost of septic revisions and to compare the costs of septic and aseptic revisions in Poland and other countries. The data published for the period 2009-2013 by the National Health Fund (NHF) were analysed and the average cost of septic and aseptic revisions was calculated. In the years 2009-2013, a total of 260,030 hip and knee arthroplasties including 23,027 revisions (incl. 4,221 septic) were performed in Poland. In 2013, septic revisions accounted for 1.38% of all hip replacement procedures, 2.56% of all knee replacement procedures and 14.67% of all hip revisions and 30.23% of all knee revisions. In 2013, the difference between the average cost incurred by the hospital and the NHF refund for septic revision due to PJI was at least €238 and the cost-refund gap for the entire year was €219198. 1. The system of reporting periprostheticjoint infections currently in use in Poland does not adequately reflect the current classification of PJI and reimbursement for septic revision of joint prosthesis does not match the actual costs. 2. The Polish DRG system does not distinguish between early and late PJI and fails to acknowledge basic guidelines for infection treatment currently followed in Poland and worldwide. 3. According to the DRG system, patients requiring different treatment are placed in one category. 4. Until the year 2013, the less expensive treatment of early infections had been reimbursed on the same basis as the more costly two-stage revision procedures.

  13. 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.

  14. 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

  15. Comparison of hearing results of nitinol SMART stapes piston prosthesis with conventional piston prostheses: postoperative results of nitinol stapes prosthesis.

    PubMed

    Harris, Jeffrey P; Gong, Shusheng

    2007-08-01

    Recently, a new stapedotomy piston prosthesis, which is a composite metal alloy of nickel and titanium known as nitinol, has been introduced into medical use. This biocompatible alloy has the unique property of shape-memory, which permits tight self-crimping when heat is applied to the wire. To substantiate the favorable initial observations with the SMART piston, this study was undertaken to compare these results (n=26) with those obtained using conventional stainless steel or platinum ribbon prostheses (n=28). Prospective consecutive case review: consecutive cases performed by the same surgeon were analyzed. Tertiary referral center. Fifty-four healthy patients with otosclerosis. Stapedotomy using either SMART prosthesis or conventional prosthesis. Hearing outcomes by audiological assessment. The postoperative hearing mean pure-tone average was 24.81+/-16.20 dBHL for Group 1 (SMART prosthesis) and 27.46+/-15.57 dBHL for Group 2 (conventional prosthesis). Postoperative mean air-bone gap was 7.07+/-8.14 dBHL for Group 1 and 6.38+/-7.54 dBHL for Group 2 using 0.5-, 1-, 2-, and 4-kHz frequencies. When analyzed according to the American Academy of Otolaryngology-Head & Neck Surgery reporting criteria using an estimate of 3 kHz as a mean of the 2-and 4-kHz values, the postoperative mean air-bone gap was 5.42+/-5.4 dBHL for Group 1 SMART and 5.98+/-5.47 dBHL for Group 2 conventional prostheses. Postoperative speech discrimination scores were 96%+/-8.64% and 97%+/-5.9%, respectively. These differences were not shown to be statistically different. Results demonstrate that experienced surgeons may achieve comparable results with both prostheses; however, the ease of self-crimping and the tightness of the crimp may provide advantages that may have long-term benefits. The potential issue of nickel allergy is important when considering patients for this prosthesis.

  16. 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

  17. IMU-Based Joint Angle Measurement for Gait Analysis

    PubMed Central

    Seel, Thomas; Raisch, Jorg; Schauer, Thomas

    2014-01-01

    This contribution is concerned with joint angle calculation based on inertial measurement data in the context of human motion analysis. Unlike most robotic devices, the human body lacks even surfaces and right angles. Therefore, we focus on methods that avoid assuming certain orientations in which the sensors are mounted with respect to the body segments. After a review of available methods that may cope with this challenge, we present a set of new methods for: (1) joint axis and position identification; and (2) flexion/extension joint angle measurement. In particular, we propose methods that use only gyroscopes and accelerometers and, therefore, do not rely on a homogeneous magnetic field. We provide results from gait trials of a transfemoral amputee in which we compare the inertial measurement unit (IMU)-based methods to an optical 3D motion capture system. Unlike most authors, we place the optical markers on anatomical landmarks instead of attaching them to the IMUs. Root mean square errors of the knee flexion/extension angles are found to be less than 1° on the prosthesis and about 3° on the human leg. For the plantar/dorsiflexion of the ankle, both deviations are about 1°. PMID:24743160

  18. Tracheostomy cannulas and voice prosthesis

    PubMed Central

    Kramp, Burkhard; Dommerich, Steffen

    2011-01-01

    Cannulas and voice prostheses are mechanical aids for patients who had to undergo tracheotomy or laryngectomy for different reasons. For better understanding of the function of those artificial devices, first the indications and particularities of the previous surgical intervention are described in the context of this review. Despite the established procedure of percutaneous dilatation tracheotomy e.g. in intensive care units, the application of epithelised tracheostomas has its own position, especially when airway obstruction is persistent (e.g. caused by traumata, inflammations, or tumors) and a longer artificial ventilation or special care of the patient are required. In order to keep the airways open after tracheotomy, tracheostomy cannulas of different materials with different functions are available. For each patient the most appropriate type of cannula must be found. Voice prostheses are meanwhile the device of choice for rapid and efficient voice rehabilitation after laryngectomy. Individual sizes and materials allow adaptation of the voice prostheses to the individual anatomical situation of the patients. The combined application of voice prostheses with HME (Head and Moisture Exchanger) allows a good vocal as well as pulmonary rehabilitation. Precondition for efficient voice prosthesis is the observation of certain surgical principles during laryngectomy. The duration of the prosthesis mainly depends on material properties and biofilms, mostly consisting of funguses and bacteries. The quality of voice with valve prosthesis is clearly superior to esophagus prosthesis or electro-laryngeal voice. Whenever possible, tracheostoma valves for free-hand speech should be applied. Physicians taking care of patients with speech prostheses after laryngectomy should know exactly what to do in case the device fails or gets lost. PMID:22073098

  19. Tracheostomy cannulas and voice prosthesis.

    PubMed

    Kramp, Burkhard; Dommerich, Steffen

    2009-01-01

    Cannulas and voice prostheses are mechanical aids for patients who had to undergo tracheotomy or laryngectomy for different reasons. For better understanding of the function of those artificial devices, first the indications and particularities of the previous surgical intervention are described in the context of this review. Despite the established procedure of percutaneous dilatation tracheotomy e.g. in intensive care units, the application of epithelised tracheostomas has its own position, especially when airway obstruction is persistent (e.g. caused by traumata, inflammations, or tumors) and a longer artificial ventilation or special care of the patient are required. In order to keep the airways open after tracheotomy, tracheostomy cannulas of different materials with different functions are available. For each patient the most appropriate type of cannula must be found. Voice prostheses are meanwhile the device of choice for rapid and efficient voice rehabilitation after laryngectomy. Individual sizes and materials allow adaptation of the voice prostheses to the individual anatomical situation of the patients. The combined application of voice prostheses with HME (Head and Moisture Exchanger) allows a good vocal as well as pulmonary rehabilitation. Precondition for efficient voice prosthesis is the observation of certain surgical principles during laryngectomy. The duration of the prosthesis mainly depends on material properties and biofilms, mostly consisting of funguses and bacteries. The quality of voice with valve prosthesis is clearly superior to esophagus prosthesis or electro-laryngeal voice. Whenever possible, tracheostoma valves for free-hand speech should be applied. Physicians taking care of patients with speech prostheses after laryngectomy should know exactly what to do in case the device fails or gets lost.

  20. Changes in performance over time while learning to use a myoelectric prosthesis

    PubMed Central

    2014-01-01

    Background Training increases the functional use of an upper limb prosthesis, but little is known about how people learn to use their prosthesis. The aim of this study was to describe the changes in performance with an upper limb myoelectric prosthesis during practice. The results provide a basis to develop an evidence-based training program. Methods Thirty-one able-bodied participants took part in an experiment as well as thirty-one age- and gender-matched controls. Participants in the experimental condition, randomly assigned to one of four groups, practiced with a myoelectric simulator for five sessions in a two-weeks period. Group 1 practiced direct grasping, Group 2 practiced indirect grasping, Group 3 practiced fixating, and Group 4 practiced a combination of all three tasks. The Southampton Hand Assessment Procedure (SHAP) was assessed in a pretest, posttest, and two retention tests. Participants in the control condition performed SHAP two times, two weeks apart with no practice in between. Compressible objects were used in the grasping tasks. Changes in end-point kinematics, joint angles, and grip force control, the latter measured by magnitude of object compression, were examined. Results The experimental groups improved more on SHAP than the control group. Interestingly, the fixation group improved comparable to the other training groups on the SHAP. Improvement in global position of the prosthesis leveled off after three practice sessions, whereas learning to control grip force required more time. The indirect grasping group had the smallest object compression in the beginning and this did not change over time, whereas the direct grasping and the combination group had a decrease in compression over time. Moreover, the indirect grasping group had the smallest grasping time that did not vary over object rigidity, while for the other two groups the grasping time decreased with an increase in object rigidity. Conclusions A training program should spend more

  1. 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

  2. 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.

  3. New synthetic prosthesis for peripheral nerve injuries: an experimental pilot study.

    PubMed

    Uranüs, Selman; Bretthauer, Georg; Nagele-Moser, Doris; Saliba, Sarah; Tomasch, Gordana; Rafolt, Dietmar; Justich, Ivo; Waldert, Jörg; Berghold, Andrea; Kleinert, Reinhold; Becker, Heinz; Voges, Udo; Wiederstein-Grasser, Iris; Koch, Horst

    2013-04-01

    Even the most modern technology has failed to induce satisfactory functional regeneration of traumatically severed peripheral nerves. Delayed neural regeneration and in consequence, slower neural conduction seriously limit muscle function in the area supplied by the injured nerve. This study aimed to compare a new nerve coaptation system involving an innovative prosthesis with the classical clinical method of sutured nerve coaptation. Besides the time and degree of nerve regeneration, the influence of electrostimulation was also tested. The sciatic nerve was severed in 14 female Göttingen minipigs with an average weight of 40.4 kg. The animals were randomized into 2 groups: One group received the new prosthesis and the other underwent microsurgical coaptation. In each group, according to the randomization a part of the animals received postoperative electrostimulation. Postoperative monitoring and the stimulation schedule covered a period of 9 months, during which axonal budding was evaluated monthly. The data from the pilot study indicate that results with the nerve prosthesis were comparable with those of conventional coaptation. The results indicate that implantation of the nerve prosthesis allows for good and effective neural regeneration. This new and simple treatment option for peripheral nerve injuries can be performed in any hospital with surgical facilities as it does not involve the demanding microsurgical suture technique that can only be performed in specialized centers.

  4. 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.

  5. 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

  6. Literature Review on Needs of Upper Limb Prosthesis Users.

    PubMed

    Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

    2016-01-01

    The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses.

  7. Literature Review on Needs of Upper Limb Prosthesis Users

    PubMed Central

    Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

    2016-01-01

    The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses. PMID:27242413

  8. 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.

  9. Treatment of acute periprosthetic infections with prosthesis retention: Review of current concepts.

    PubMed

    Kuiper, Jesse Wp; Willink, Robin Tjeenk; Moojen, Dirk Jan F; van den Bekerom, Michel Pj; Colen, Sascha

    2014-11-18

    Periprosthetic joint infection (PJI) is a devastating complication after total joint arthroplasty, occurring in approximately 1%-2% of all cases. With growing populations and increasing age, PJI will have a growing effect on health care costs. Many risk factors have been identified that increase the risk of developing PJI, including obesity, immune system deficiencies, malignancy, previous surgery of the same joint and longer operating time. Acute PJI occurs either postoperatively (4 wk to 3 mo after initial arthroplasty, depending on the classification system), or via hematogenous spreading after a period in which the prosthesis had functioned properly. Diagnosis and the choice of treatment are the cornerstones to success. Although different definitions for PJI have been used in the past, most are more or less similar and include the presence of a sinus tract, blood infection values, synovial white blood cell count, signs of infection on histopathological analysis and one or more positive culture results. Debridement, antibiotics and implant retention (DAIR) is the primary treatment for acute PJI, and should be performed as soon as possible after the development of symptoms. Success rates differ, but most studies report success rates of around 60%-80%. Whether single or multiple debridement procedures are more successful remains unclear. The use of local antibiotics in addition to the administration of systemic antibiotic agents is also subject to debate, and its pro's and con's should be carefully considered. Systemic treatment, based on culture results, is of importance for all PJI treatments. Additionally, rifampin should be given in Staphylococcal PJIs, unless all foreign material is removed. The most important factors contributing to treatment failure are longer duration of symptoms, a longer time after initial arthroplasty, the need for more debridement procedures, the retention of exchangeable components, and PJI caused by Staphylococcus (aureus or

  10. 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

  11. 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.

  12. 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.

  13. Minimally invasive arthrodesis for chronic sacroiliac joint dysfunction using the SImmetry SI Joint Fusion system.

    PubMed

    Miller, Larry E; Block, Jon E

    2014-01-01

    Chronic sacroiliac (SI) joint-related low back pain (LBP) is a common, yet under-diagnosed and undertreated condition due to difficulties in accurate diagnosis and highly variable treatment practices. In patients with debilitating SI-related LBP for at least 6 months duration who have failed conservative management, arthrodesis is a viable option. The SImmetry(®) SI Joint Fusion System is a novel therapy for SI joint fusion, not just fixation, which utilizes a minimally invasive surgical approach, instrumented fixation for immediate stability, and joint preparation with bone grafting for a secure construct in the long term. The purpose of this report is to describe the minimally invasive SI Joint Fusion System, including patient selection criteria, implant characteristics, surgical technique, postoperative recovery, and biomechanical testing results. Advantages and limitations of this system will be discussed.

  14. 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.

  15. Development of a shape memory alloy actuator for a robotic eye prosthesis

    NASA Astrophysics Data System (ADS)

    Bunton, T. B. Wolfe; Faulkner, M. G.; Wolfaardt, J.

    2005-08-01

    The quality of life of patients who wear an orbital prosthesis would be vastly improved if their prostheses were also able to execute vertical and horizontal motion. This requires appropriate actuation and control systems to create an intelligent prosthesis. A method of actuation that meets the demanding design criteria is currently not available. The present work considers an activation system that follows a design philosophy of biomimicry, simplicity and space optimization. While several methods of actuation were considered, shape memory alloys were chosen for their high power density, high actuation forces and high displacements. The behaviour of specific shape memory alloys as an actuator was investigated to determine the force obtained, the transformation temperatures and details of the material processing. In addition, a large-scale prototype was constructed to validate the response of the proposed system.

  16. 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...

  17. Survey of upper limb prosthesis users in Sweden, the United Kingdom and Canada.

    PubMed

    Kyberd, Peter J; Hill, Wendy

    2011-06-01

    As part of the process of improving prosthetic arms, it is important to obtain the opinions of the user population. To identify factors that should be focused on to improve prosthesis provision. Postal questionnaire. The questionnaire was sent to 292 adults (aged 18 to 70 years) with upper-limb loss or absence at five centres (four in Europe) Participants were identified as regular attendees of the centres. This questionnaire received a response from 180 users (response rate 62%) of different types of prosthetic devices. Responses showed that the type of prosthesis generally used was associated with gender, level of loss and use for work (Pearson chi-square, p-values below 0.05). The type of prosthesis was not associated with cause, side, usage (length per day, sports or driving) or reported problems. The findings did not identify any single factor requiring focus for the improvement of prostheses or prosthetic provision. Every part of the process of fitting a prosthesis can be improved, which will have an effect for some of the population who use their devices regularly. There is, however, no single factor that would bring greater improvement to all users. Based on information gained from a broad range of prosthesis users, no single aspect of prosthetic provision will have a greater impact on the use of upper limb prostheses than any other. Efforts to improve the designs of prosthetic systems can cover any aspect of provision.

  18. [Tracheobronchial prosthesis in Mounier-Kuhn syndrome: New perspectives].

    PubMed

    Sauvage, M; Tiffet, O; Vergnon, J-M

    2015-05-01

    Mounier-Kuhn syndrome or tracheobronchomegaly is a rare congenital condition, the management of which is complex. We report the case of a patient who was treated with interventional endoscopy. We describe the case of a 74-year-old man with a diagnosis of tracheobronchomegaly who was admitted in 2003 with a background of deteriorating respiratory status and the occurrence of postural syncope. He initially received a tracheobronchial silicone Y prosthesis, extended with metal prostheses at the tracheal and bronchial level. This arrangement remained stable until 2011. He then began to develop episodes of asphyxia related to posterior dislocation of the tracheobronchial prosthesis, after breakage of the metallic mesh tracheal prosthesis. A new tracheobronchial prosthesis Y was then placed, custom-made from a 3D model of the airways. This was clinically and functionally effective. This case describes the management of a patient with Mounier-Kuhn syndrome by interventional bronchoscopy, with the adaptation of prosthetic materials, on an individual basis, to the anatomy of the patient's airway. Copyright © 2015 SPLF. Published by Elsevier Masson SAS. All rights reserved.

  19. Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment Update

    PubMed Central

    Lee, Christine; Tu, Hong Anh; Wells, David; Holubowich, Corinne

    2017-01-01

    Background Retinitis pigmentosa is a group of inherited disorders characterized by the degeneration of the photoreceptors in the retina, resulting in progressive vision loss. The Argus II system is designed to restore partial functional vision in patients with profound vision loss from advanced retinitis pigmentosa. At present, it is the only treatment option approved by Health Canada for this patient population. In June 2016, Health Quality Ontario published a health technology assessment of the Argus II retinal prosthesis system for patients with advanced retinitis pigmentosa. Based on that assessment, the Ontario Health Technology Advisory Committee recommended against publicly funding the Argus II system for this population. It also recommended that Health Quality Ontario re-evaluate the evidence in 1 year. The objective of this report was to examine new evidence published since the 2016 health technology assessment. Methods We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences related to the Argus II system. We performed a systematic literature search for studies published since the 2016 Argus II health technology assessment. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care, and we calculated incremental cost-effectiveness ratios over a 20-year time horizon. We also conducted a five-year budget impact analysis. Finally, we interviewed people with retinitis pigmentosa about their lived experience with vision loss, and with the Argus II system. Results Four publications from one multicentre international study were included in the clinical review. Patients showed significant improvements in visual function and functional outcomes with the Argus II system, and these outcomes were sustained up to a 5-year follow-up (moderate quality of evidence). The safety profile was generally acceptable. In

  20. Minimally invasive arthrodesis for chronic sacroiliac joint dysfunction using the SImmetry SI Joint Fusion system

    PubMed Central

    Miller, Larry E; Block, Jon E

    2014-01-01

    Chronic sacroiliac (SI) joint-related low back pain (LBP) is a common, yet under-diagnosed and undertreated condition due to difficulties in accurate diagnosis and highly variable treatment practices. In patients with debilitating SI-related LBP for at least 6 months duration who have failed conservative management, arthrodesis is a viable option. The SImmetry® SI Joint Fusion System is a novel therapy for SI joint fusion, not just fixation, which utilizes a minimally invasive surgical approach, instrumented fixation for immediate stability, and joint preparation with bone grafting for a secure construct in the long term. The purpose of this report is to describe the minimally invasive SI Joint Fusion System, including patient selection criteria, implant characteristics, surgical technique, postoperative recovery, and biomechanical testing results. Advantages and limitations of this system will be discussed. PMID:24851059

  1. 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.

  2. Customized Knee Prosthesis in Treatment of Giant Cell Tumors of the Proximal Tibia: Application of 3-Dimensional Printing Technology in Surgical Design.

    PubMed

    Luo, Wenbin; Huang, Lanfeng; Liu, He; Qu, Wenrui; Zhao, Xin; Wang, Chenyu; Li, Chen; Yu, Tao; Han, Qing; Wang, Jincheng; Qin, Yanguo

    2017-04-07

    BACKGROUND We explored the application of 3-dimensional (3D) printing technology in treating giant cell tumors (GCT) of the proximal tibia. A tibia block was designed and produced through 3D printing technology. We expected that this 3D-printed block would fill the bone defect after en-bloc resection. Importantly, the block, combined with a standard knee joint prosthesis, provided attachments for collateral ligaments of the knee, which can maintain knee stability. MATERIAL AND METHODS A computed tomography (CT) scan was taken of both knee joints in 4 patients with GCT of the proximal tibia. We developed a novel technique - the real-size 3D-printed proximal tibia model - to design preoperative treatment plans. Hence, with the application of 3D printing technology, a customized proximal tibia block could be designed for each patient individually, which fixed the bone defect, combined with standard knee prosthesis. RESULTS In all 4 cases, the 3D-printed block fitted the bone defect precisely. The motion range of the affected knee was 90 degrees on average, and the soft tissue balance and stability of the knee were good. After an average 7-month follow-up, the MSTS score was 19 on average. No sign of prosthesis fracture, loosening, or other relevant complications were detected. CONCLUSIONS This technique can be used to treat GCT of the proximal tibia when it is hard to achieve soft tissue balance after tumor resection. 3D printing technology simplified the design and manufacturing progress of custom-made orthopedic medical instruments. This new surgical technique could be much more widely applied because of 3D printing technology.

  3. [Total Joint Replacement and Return to Sports].

    PubMed

    Oehler, N; Schmidt, T; Niemeier, A

    2016-12-01

    Background: An increasing number of physically active patients not only need to know if they will basically be able to engage in sports after undergoing arthroplasty. They also would like to know whether or not they will be able to resume their preoperative activity levels. This article aims to provide an overview of recent data regarding the following questions on hip, knee and shoulder arthroplasty: (1) What is the impact of physical activity on an endoprosthesis? (2) What level of sports can be achieved after an arthroplasty procedure? (3) What types of sport are recommended for patients with an endoprosthesis? Methods: PubMed-based review of the literature. Narrative review focusing on current data from the years 2010 to 2016. Results: The commonly known recommendation to exercise low-impact sports such as hiking, swimming, cycling or golf at a moderate intensity remains valid for all types of prostheses in all joints. There is broad consensus that the benefits of these sports outweigh the negative effects. Having undergone total hip or knee arthroplasty, most patients with a high preoperative activity level return to sports after 3-6 months, albeit with a clear tendency to lower intensity and a shift from high-impact to low-impact sports. Some key questions have to be answered regarding the effects of low-impact sports that are exercised with high intensity, the effects resulting from high-impact sports, effects specific to different types of sport, and possibilities provided by different prosthesis types. In this context, a lot remains to be done to investigate the limits between positive and negative effects resulting from physical activity of varying intensity. New data suggests that generally a higher physical performance level may be achieved than has been traditionally recommended. Early results of unicondylar knee prostheses are far better than those achieved with bicondylar prostheses. In contrast to expert recommendations, shoulder endoprostheses show

  4. 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.

  5. Thermal Protection System with Staggered Joints

    NASA Technical Reports Server (NTRS)

    Simon, Xavier D. (Inventor); Robinson, Michael J. (Inventor); Andrews, Thomas L. (Inventor)

    2014-01-01

    The thermal protection system disclosed herein is suitable for use with a spacecraft such as a reentry module or vehicle, where the spacecraft has a convex surface to be protected. An embodiment of the thermal protection system includes a plurality of heat resistant panels, each having an outer surface configured for exposure to atmosphere, an inner surface opposite the outer surface and configured for attachment to the convex surface of the spacecraft, and a joint edge defined between the outer surface and the inner surface. The joint edges of adjacent ones of the heat resistant panels are configured to mate with each other to form staggered joints that run between the peak of the convex surface and the base section of the convex surface.

  6. The Effect of Gap Angle on Tensile Strength of Preceramic Base Metal Solder Joints

    PubMed Central

    Fattahi, Farnaz; Hashemi Ardakani, Zahra; Hashemi Ardakani, Maryam

    2015-01-01

    Statement of the Problem Soldering is a process commonly used in fabricating dental prosthesis. Since most soldered prosthesis fail at the solder joints; the joint strength is of utmost importance. Purpose The purpose of this study was to evaluate the effect of gap angle on the tensile strength of base metal solder joints. Materials and Method A total number of 40 Ni-Cr samples were fabricated according to ADA/ISO 9693 specifications for tensile test. Samples were cut at the midpoint of the bar, and were placed at the considered angles by employing an explicitly designed device. They were divided into 4 groups regarding the gap angle; Group C (control group) with parallel gap on steady distance of 0.2mm, Group 1: 10°, Group 2: 20°, and Group3: 30° gap angles. When soldered, the specimens were all tested for tensile strength using a universal testing machine at a cross-head speed of 0.5 mm/min with a preload of 10N. Kruskal-Wallis H test was used to compare tensile strength among the groups (p< 0.05). Results The mean tensile strength values obtained from the study groups were respectively 307.84, 391.50, 365.18, and 368.86 MPa. The tensile strength was not statistically different among the four groups in general (p≤ 0.490). Conclusion Making the gap angular at the solder joints and the subsequent unsteady increase of the gap distance would not change the tensile strength of the joint. PMID:26636118

  7. Wear-screening and joint simulation studies vs. materials selection and prosthesis design.

    PubMed

    Clarke, I C

    1982-01-01

    Satisfactory friction and wear performance of orthomedic biomaterials is an essential criterion for both hemiarthroplasty and total joint replacements. This report will chart the clinical historical experience of candidate biomaterials with their wear resistance and compare/contrast these data to experimental test predictions. The latter review will encompass publications dealing with both joint simulators and the more basic friction and wear screening devices. Special consideration will be given to the adequacy of the test protocol, the design of the experimental machines, and the accuracy of the measurement techniques. The discussion will then center on clinical reality vs. experimental adequacy and summarize current developments.

  8. Locomotion mode identification for lower limbs using neuromuscular and joint kinematic signals.

    PubMed

    Afzal, Taimoor; White, Gannon; Wright, Andrew B; Iqbal, Kamran

    2014-01-01

    Recent development in lower limb prosthetics has seen an emergence of powered prosthesis that have the capability to operate in different locomotion modes. However, these devices cannot transition seamlessly between modes such as level walking, stair ascent and descent and up slope and down slope walking. They require some form of user input that defines the human intent. The purpose of this study was to develop a locomotion mode detection system and evaluate its performance for different sensor configurations and to study the effect of locomotion mode detection with and without electromyography (EMG) signals while using kinematic data from hip joint of non-dominant/impaired limb and an accelerometer. Data was collected from four able bodied subjects that completed two circuits that contained standing, level-walking, ramp ascent and descent and stair ascent and descent. By using only the kinematic data from the hip joint and accelerometer data the system was able to identify the transitions, stance and swing phases with similar performance as compared to using only EMG and accelerometer data. However, significant improvement in classification error was observed when EMG, kinematic and accelerometer data were used together to identify the locomotion modes. The higher recognition rates when using the kinematic data along with EMG shows that the joint kinematics could be beneficial in intent recognition systems of locomotion modes.

  9. QM-8 field joint protection system, volume 7

    NASA Technical Reports Server (NTRS)

    Hale, Elgie

    1989-01-01

    The pre-launch functioning data of the Field Joint Protection System (JPS) used on QM-8 are presented. Also included is the post fire condition of the JPS components following the test firing of the motor. The JPS components are: field joint heaters; field joint sensors; field joint moisture seal; moisture seal kevlar retaining straps; field joint external extruded cork insulation; vent valve; power cables; and igniter heater.

  10. 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

  11. 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.

  12. Prosthesis Prescription Protocol of the Arm (PPP-Arm): The implementation of a national prosthesis prescription protocol.

    PubMed

    Wijdenes, Paula; Brouwers, Michael; van der Sluis, Corry K

    2018-02-01

    In order to create more uniformity in the prescription of upper limb prostheses by Dutch rehabilitation teams, the development and implementation of a Prosthesis Prescription Protocol of the upper limb (PPP-Arm) was initiated. The aim was to create a national digital protocol to structure, underpin, and evaluate the prescription of upper limb prostheses for clients with acquired or congenital arm defects. Prosthesis Prescription Protocol of the Arm (PPP-Arm) was developed on the basis of the International Classification of Functioning and consisted of several layers. All stakeholders (rehabilitation teams, orthopedic workshops, patients, and insurance companies) were involved in development and implementation. A national project coordinator and knowledge brokers in each team were essential for the project. PPP-Arm was successfully developed and implemented in nine Dutch rehabilitation teams. The protocol improved team collaboration, structure, and completeness of prosthesis prescriptions and treatment uniformity and might be interesting for other countries as well. Clinical relevance A national protocol to prescribe upper limb prostheses can be helpful to create uniformity in treatment of patients with upper limb defects. Such a protocol improves quality of care for all patients in the country.

  13. Comparison of Diagnostic Accuracy of Periprosthetic Tissue Culture in Blood Culture Bottles to That of Prosthesis Sonication Fluid Culture for Diagnosis of Prosthetic Joint Infection (PJI) by Use of Bayesian Latent Class Modeling and IDSA PJI Criteria for Classification.

    PubMed

    Yan, Qun; Karau, Melissa J; Greenwood-Quaintance, Kerryl E; Mandrekar, Jayawant N; Osmon, Douglas R; Abdel, Matthew P; Patel, Robin

    2018-06-01

    We have previously demonstrated that culturing periprosthetic tissue in blood culture bottles (BCBs) improves sensitivity compared to conventional agar and broth culture methods for diagnosis of prosthetic joint infection (PJI). We have also shown that prosthesis sonication culture improves sensitivity compared to periprosthetic tissue culture using conventional agar and broth methods. The purpose of this study was to compare the diagnostic accuracy of tissue culture in BCBs (subsequently referred to as tissue culture) to prosthesis sonication culture (subsequently referred to as sonicate fluid culture). We studied 229 subjects who underwent arthroplasty revision or resection surgery between March 2016 and October 2017 at Mayo Clinic in Rochester, Minnesota. Using the Infectious Diseases Society of America (IDSA) PJI diagnostic criteria (omitting culture criteria) as the gold standard, the sensitivity of tissue culture was similar to that of the sonicate fluid culture (66.4% versus 73.1%, P = 0.07) but was significantly lower than that of the two tests combined (66.4% versus 76.9%, P < 0.001). Using Bayesian latent class modeling, which assumes no gold standard for PJI diagnosis, the sensitivity of tissue culture was slightly lower than that of sonicate fluid culture (86.3% versus 88.7%) and much lower than that of the two tests combined (86.3% versus 99.1%). In conclusion, tissue culture in BCBs reached sensitivity similar to that of prosthesis sonicate fluid culture for diagnosis of PJI, but the two tests combined had the highest sensitivity without compromising specificity. The combination of tissue culture in BCBs and sonicate fluid culture is recommended to achieve the highest level of microbiological diagnosis of PJI. Copyright © 2018 American Society for Microbiology.

  14. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    2004-01-01

    In this photograph, Amputee Amie Bradly uses a NASA-developed prosthesis to paint her fingernails. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  15. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    In this photograph, James Carden uses a NASA-developed prosthesis to moved planks around his home. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  16. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    In this photograph, Sandra Rossi user her NASA-developed prosthesis for the first time. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  17. Application of the rapid prototyping technique to design a customized temporomandibular joint used to treat temporomandibular ankylosis

    PubMed Central

    Chaware, Suresh M.; Bagaria, Vaibhav; Kuthe, Abhay

    2009-01-01

    Anthropometric variations in humans make it difficult to replace a temporomandibular joint (TMJ), successfully using a standard “one-size-fits-all” prosthesis. The case report presents a unique concept of total TMJ replacement with customized and modified TMJ prosthesis, which is cost-effective and provides the best fit for the patient. The process involved in designing and modifications over the existing prosthesis are also described. A 12-year- old female who presented for treatment of left unilateral TMJ ankylosis underwent the surgery for total TMJ replacement. A three-dimensional computed tomography (CT) scan suggested features of bony ankylosis of left TMJ. CT images were converted to a sterolithographic model using CAD software and a rapid prototyping machine. A process of rapid manufacturing was then used to manufacture the customized prosthesis. Postoperative recovery was uneventful, with an improvement in mouth opening of 3.5 cm and painless jaw movements. Three years postsurgery, the patient is pain-free, has a mouth opening of about 4.0 cm and enjoys a normal diet. The postoperative radiographs concur with the excellent clinical results. The use of CAD/CAM technique to design the custom-made prosthesis, using orthopaedically proven structural materials, significantly improves the predictability and success rates of TMJ replacement surgery. PMID:19881026

  18. Sensor fusion and computer vision for context-aware control of a multi degree-of-freedom prosthesis.

    PubMed

    Markovic, Marko; Dosen, Strahinja; Popovic, Dejan; Graimann, Bernhard; Farina, Dario

    2015-12-01

    Myoelectric activity volitionally generated by the user is often used for controlling hand prostheses in order to replicate the synergistic actions of muscles in healthy humans during grasping. Muscle synergies in healthy humans are based on the integration of visual perception, heuristics and proprioception. Here, we demonstrate how sensor fusion that combines artificial vision and proprioceptive information with the high-level processing characteristics of biological systems can be effectively used in transradial prosthesis control. We developed a novel context- and user-aware prosthesis (CASP) controller integrating computer vision and inertial sensing with myoelectric activity in order to achieve semi-autonomous and reactive control of a prosthetic hand. The presented method semi-automatically provides simultaneous and proportional control of multiple degrees-of-freedom (DOFs), thus decreasing overall physical effort while retaining full user control. The system was compared against the major commercial state-of-the art myoelectric control system in ten able-bodied and one amputee subject. All subjects used transradial prosthesis with an active wrist to grasp objects typically associated with activities of daily living. The CASP significantly outperformed the myoelectric interface when controlling all of the prosthesis DOF. However, when tested with less complex prosthetic system (smaller number of DOF), the CASP was slower but resulted with reaching motions that contained less compensatory movements. Another important finding is that the CASP system required minimal user adaptation and training. The CASP constitutes a substantial improvement for the control of multi-DOF prostheses. The application of the CASP will have a significant impact when translated to real-life scenarious, particularly with respect to improving the usability and acceptance of highly complex systems (e.g., full prosthetic arms) by amputees.

  19. Development of a Mandibular Motion Simulator for Total Joint Replacement

    PubMed Central

    Celebi, Nukhet; Rohner, E. Carlos; Gateno, Jaime; Noble, Philip C.; Ismaily, Sabir K.; Teichgraeber, John F.; Xia, James J.

    2015-01-01

    Purpose The purpose of this study was to develop a motion simulator capable of recreating and recording the full range of mandibular motions in a cadaveric preparation for an intact temporomandibular joint (TMJ) and after total joint replacement. Material and Methods A human cadaver head was used. Two sets of tracking balls were attached to the forehead and mandible, respectively. Computed tomographic (CT) scan was performed and 3-dimensional CT models of the skull were generated. The cadaver head was then dissected to attach the muscle activation cables and mounted onto the TMJ simulator. Realistic jaw motions were generated through the application of the following muscle forces: lateral pterygoid muscle, suprahyoid depressors (geniohyoid, mylohyoid, and digastric muscles), and elevator muscles. To simulate muscle contraction, cables were inserted into the mandible at the center area of each muscle's attachment. To provide a minimum mouth closing force at the initial position, the elevator muscles were combined at the anterior mandible. During mandibular movement, each motion was recorded using a high-resolution laser scanner. The right TMJ of the same head was reconstructed with a total TMJ prosthesis. The same forces were applied and the jaw motions were recorded again. CT scan was performed and 3-dimensional CT models of the skull with TMJ prosthesis were generated. Results Mandibular motions, before and after TMJ replacement, with and without lateral pterygoid muscle reattachment, were re-created in a cadaveric preparation. The laser-scanned data during the mandibular motion were used to drive 3-dimensional CT models. A movie for each mandibular motion was subsequently created for motion path analysis. Compared with mandibular motion before TMJ replacement, mandibular lateral and protrusive motions after TMJ replacement, with and without lateral pterygoid muscle reattachment, were greatly limited. The jaw motion recorded before total joint replacement was

  20. Modeling joint restoration strategies for interdependent infrastructure systems

    PubMed Central

    Simonovic, Slobodan P.

    2018-01-01

    Life in the modern world depends on multiple critical services provided by infrastructure systems which are interdependent at multiple levels. To effectively respond to infrastructure failures, this paper proposes a model for developing optimal joint restoration strategy for interdependent infrastructure systems following a disruptive event. First, models for (i) describing structure of interdependent infrastructure system and (ii) their interaction process, are presented. Both models are considering the failure types, infrastructure operating rules and interdependencies among systems. Second, an optimization model for determining an optimal joint restoration strategy at infrastructure component level by minimizing the economic loss from the infrastructure failures, is proposed. The utility of the model is illustrated using a case study of electric-water systems. Results show that a small number of failed infrastructure components can trigger high level failures in interdependent systems; the optimal joint restoration strategy varies with failure occurrence time. The proposed models can help decision makers to understand the mechanisms of infrastructure interactions and search for optimal joint restoration strategy, which can significantly enhance safety of infrastructure systems. PMID:29649300

  1. Modeling joint restoration strategies for interdependent infrastructure systems.

    PubMed

    Zhang, Chao; Kong, Jingjing; Simonovic, Slobodan P

    2018-01-01

    Life in the modern world depends on multiple critical services provided by infrastructure systems which are interdependent at multiple levels. To effectively respond to infrastructure failures, this paper proposes a model for developing optimal joint restoration strategy for interdependent infrastructure systems following a disruptive event. First, models for (i) describing structure of interdependent infrastructure system and (ii) their interaction process, are presented. Both models are considering the failure types, infrastructure operating rules and interdependencies among systems. Second, an optimization model for determining an optimal joint restoration strategy at infrastructure component level by minimizing the economic loss from the infrastructure failures, is proposed. The utility of the model is illustrated using a case study of electric-water systems. Results show that a small number of failed infrastructure components can trigger high level failures in interdependent systems; the optimal joint restoration strategy varies with failure occurrence time. The proposed models can help decision makers to understand the mechanisms of infrastructure interactions and search for optimal joint restoration strategy, which can significantly enhance safety of infrastructure systems.

  2. Context-Dependent Upper Limb Prosthesis Control for Natural and Robust Use.

    PubMed

    Amsuess, Sebastian; Vujaklija, Ivan; Goebel, Peter; Roche, Aidan D; Graimann, Bernhard; Aszmann, Oskar C; Farina, Dario

    2016-07-01

    Pattern recognition and regression methods applied to the surface EMG have been used for estimating the user intended motor tasks across multiple degrees of freedom (DOF), for prosthetic control. While these methods are effective in several conditions, they are still characterized by some shortcomings. In this study we propose a methodology that combines these two approaches for mutually alleviating their limitations. This resulted in a control method capable of context-dependent movement estimation that switched automatically between sequential (one DOF at a time) or simultaneous (multiple DOF) prosthesis control, based on an online estimation of signal dimensionality. The proposed method was evaluated in scenarios close to real-life situations, with the control of a physical prosthesis in applied tasks of varying difficulties. Test prostheses were individually manufactured for both able-bodied and transradial amputee subjects. With these prostheses, two amputees performed the Southampton Hand Assessment Procedure test with scores of 58 and 71 points. The five able-bodied individuals performed standardized tests, such as the box&block and clothes pin test, reducing the completion times by up to 30%, with respect to using a state-of-the-art pure sequential control algorithm. Apart from facilitating fast simultaneous movements, the proposed control scheme was also more intuitive to use, since human movements are predominated by simultaneous activations across joints. The proposed method thus represents a significant step towards intelligent, intuitive and natural control of upper limb prostheses.

  3. Fabrication and characterization of DLC coated microdimples on hip prosthesis heads.

    PubMed

    Choudhury, Dipankar; Ay Ching, Hee; Mamat, Azuddin Bin; Cizek, Jan; Abu Osman, Noor Azuan; Vrbka, Martin; Hartl, Martin; Krupka, Ivan

    2015-07-01

    Diamond like carbon (DLC) is applied as a thin film onto substrates to obtain desired surface properties such as increased hardness and corrosion resistance, and decreased friction and wear rate. Microdimple is an advanced surface modification technique enhancing the tribological performance. In this study, DLC coated microdimples were fabricated on hip prosthesis heads and their mechanical, material and surface properties were characterized. An Electro discharge machining (EDM) oriented microdrilling was utilized to fabricate a defined microdimple array (diameter of 300 µm, depth of 70 µm, and pitch of 900 µm) on stainless steel (SS) hip prosthesis heads. The dimpled surfaces were then coated by hydrogenated amorphous carbon (a-C:H) and tetrahedral amorphous carbon (Ta-C) layers by using a magnetron sputtering technology. A preliminary tribology test was conducted on these fabricated surfaces against a ceramic ball in simulated hip joint conditions. It was found that the fabricated dimples were perpendicular to the spherical surfaces and no cutting-tools wear debris was detected inside the individual dimples. The a-C:H and Ta-C coatings increased the hardness at both the dimple edges and the nondimpled region. The tribology test showed a significant reduction in friction coefficient for coated surfaces regardless of microdimple arrays: the lowest friction coefficient was found for the a-C:H samples (µ = 0.084), followed by Ta-C (µ = 0.119), as compared to the SS surface (µ = 0.248). © 2014 Wiley Periodicals, Inc.

  4. [Revision hip arthroplasty by Waldemar Link custom-made total hip prosthesis].

    PubMed

    Medenica, Ivica; Luković, Milan; Radoicić, Dragan

    2010-02-01

    The number of patients undergoing hip arthroplasty revision is constantly growing. Especially, complex problem is extensive loss of bone stock and pelvic discontinuity that requires reconstruction. The paper presented a 50-year old patient, who ten years ago underwent a total cement artrhroplasty of the left hip. A year after the primary operation the patient had difficulties in walking without crutches. Problems intensified in the last five years, the patient had severe pain, totally limited movement in the left hip and could not walk at all. Radiographically, we found loose femoral component, massive loss of bone stock of proximal femur, acetabular protrusion and a consequent pelvic discontinuity. Clinically, a completely disfunctional left hip joint was registered (Harris hip score--7.1). We performed total rearthroplasty by a custom-made Waldemar Link total hip prosthesis with acetabular antiprotrusio cage and compensation of bone defects with a graft from the bone bank. A year after the operation, we found clinically an extreme improvement in Harris hip score--87.8. Radiographically, we found stability of implanted components, a complete graft integration and bone bridging across the site of pelvic discontinuity. Pelvic discontinuity and massive loss of proximal femoral bone stock is a challenging and complex entity. Conventional prostheses cannot provide an adequate fixation and stability of the hip. Application of custom-made prosthesis (measured specificaly for a patient) and additional alografting bone defects is a good method in revision surgery after unsuccessful hip arthroplasty with extensive bone defects.

  5. 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.

  6. Cranioplasty prosthesis manufacturing based on reverse engineering technology

    PubMed Central

    Chrzan, Robert; Urbanik, Andrzej; Karbowski, Krzysztof; Moskała, Marek; Polak, Jarosław; Pyrich, Marek

    2012-01-01

    Summary Background Most patients with large focal skull bone loss after craniectomy are referred for cranioplasty. Reverse engineering is a technology which creates a computer-aided design (CAD) model of a real structure. Rapid prototyping is a technology which produces physical objects from virtual CAD models. The aim of this study was to assess the clinical usefulness of these technologies in cranioplasty prosthesis manufacturing. Material/Methods CT was performed on 19 patients with focal skull bone loss after craniectomy, using a dedicated protocol. A material model of skull deficit was produced using computer numerical control (CNC) milling, and individually pre-operatively adjusted polypropylene-polyester prosthesis was prepared. In a control group of 20 patients a prosthesis was manually adjusted to each patient by a neurosurgeon during surgery, without using CT-based reverse engineering/rapid prototyping. In each case, the prosthesis was implanted into the patient. The mean operating times in both groups were compared. Results In the group of patients with reverse engineering/rapid prototyping-based cranioplasty, the mean operating time was shorter (120.3 min) compared to that in the control group (136.5 min). The neurosurgeons found the new technology particularly useful in more complicated bone deficits with different curvatures in various planes. Conclusions Reverse engineering and rapid prototyping may reduce the time needed for cranioplasty neurosurgery and improve the prosthesis fitting. Such technologies may utilize data obtained by commonly used spiral CT scanners. The manufacturing of individually adjusted prostheses should be commonly used in patients planned for cranioplasty with synthetic material. PMID:22207125

  7. 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.

  8. Wear Distribution Detection of Knee Joint Prostheses by Means of 3D Optical Scanners

    PubMed Central

    Affatato, Saverio; Valigi, Maria Cristina; Logozzo, Silvia

    2017-01-01

    The objective of this study was to examine total knee polyethylene inserts from in vitro simulation to evaluate and display—using a 3D optical scanner—wear patterns and wear rates of inserts exposed to wear by means of simulators. Various sets of tibial inserts have been reconstructed by using optical scanners. With this in mind, the wear behavior of fixed and mobile bearing polyethylene knee configurations was investigated using a knee wear joint simulator. After the completion of the wear test, the polyethylene menisci were analyzed by an innovative 3D optical scanners in order to evaluate the 3D wear distribution on the prosthesis surface. This study implemented a new procedure for evaluating polyethylene bearings of joint prostheses obtained after in vitro wear tests and the proposed new approach allowed quantification of the contact zone on the geometry of total knee prostheses. The results of the present study showed that mobile TKPs (total knee prosthesis) have lower wear resistance with respect to fixed TKPs. PMID:28772725

  9. Total knee arthroplasty for the management of joint destruction in tuberculous arthritis.

    PubMed

    Oztürkmen, Yusuf; Uzümcügil, Onat; Karamehmetoğlu, Mahmut; Leblebici, Cem; Caniklioğlu, Mustafa

    2014-05-01

    The purpose of this study was to evaluate our experience to clarify the suggestion that there should be a significant disease-free interval before total knee arthroplasty (TKA) and to determine the correct timing of surgery for reconstruction of the joint destruction in patients suffering from tuberculous arthritis. Twelve patients with advanced joint destruction and tuberculous arthritis of the knee with recent onset were reviewed in this study. The time interval from our diagnosis of active infection to arthroplasty averaged 4 ± 1.5 months. Histopathology of the biopsy specimens revealing granulomatous lesions, including epithelioid histiocytes surrounded by lymphocytes, confirmed the diagnosis of each patient. A primary knee prosthesis was performed in seven knees. In five knees, there was severe bone loss after the extensive debridement of the entire joint, and thereafter, revision prosthesis was preferred to preserve the joint line. Patients were given post-operative antituberculous treatment for a total of 1 year, whereas for three patients, whose erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values remained above normal by the sixth month, the chemotherapy was continued for up to 18 months. The Knee Society TKA roentgenographic evaluation and scoring system was used for radiological evaluation of the knees. Clinical evaluation of the knees was done preoperatively and at the time of the most recent follow-up using the American Knee Society Scoring System. Within the average follow-up period of 6.1 ± 1.8 years, no reactivation of tuberculous infection was found in any of the patients. ESR was normal, less than 20 mm/h, after a mean time of 5.5 ± 2.0 months. The CRP was normal, less than 0.8 mg/dl, after a mean time of 4.6 ± 1.3 months. At the most recent follow-up, the average knee score improved from 32.4 ± 19.4 to 83.4 ± 14.0 points (p < 0.05), and the average function score improved from 33.3 ± 11.9 to 86

  10. 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.

  11. Mechanical end joint system for structural column elements

    NASA Technical Reports Server (NTRS)

    Bush, H. G.; Wallsom, R. E. (Inventor)

    1982-01-01

    A mechanical end joint system, useful for the transverse connection of strut elements to a common node, comprises a node joint half with a semicircular tongue and groove, and a strut joint half with a semicircular tongue and groove. The two joint halves are engaged transversely and the connection is made secure by the inherent physical property characteristics of locking latches and/or by a spring-actioned shaft. A quick release mechanism provides rapid disengagement of the joint halves.

  12. 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.

  13. From medical data to simple virtual mock-up of scapulo-humeral joint

    NASA Astrophysics Data System (ADS)

    Atmani, H.; Merienne, F.; Fofi, D.; Trouilloud, P.

    2007-01-01

    The surgical operations of shoulder joint are guided by various principles: osteosynthesis in the case of fracture, osteotomy in order to correct a deformation or to modify the functioning of the joint, or implementation of articular prosthesis. At the end of the twentieth century, many innovations in the domains of biomechanics and orthopedic surgery have been performed. Nevertheless, theoretical and practical problems may appear during the operation (visual field of surgeon is very limited, quality and shape of the bone is variable depending on the patient). Biomechanical criteria of success are defined for each intervention. For example, the installation with success of prosthetic implant will be estimated according to the degree of mobility of the new articulation, the movements of this articulation being function of the shape of the prosthesis and of its position on its osseous support. It is not always easy to optimize the preparation of the surgical operation for every patient, and a preliminary computer simulation would allow helping the surgeon in its choices and its preparation of the intervention. The techniques of virtual reality allow a high degree of immersion and allow envisaging the development of a navigation device during the operating act.

  14. Candida periprosthetic joint infection: A rare and difficult-to-treat infection.

    PubMed

    Escolà-Vergé, Laura; Rodríguez-Pardo, Dolors; Lora-Tamayo, Jaime; Morata, Laura; Murillo, Oscar; Vilchez, Helem; Sorli, Luisa; Carrión, Laura Guío; Barbero, José Mª; Palomino-Nicás, Julián; Bahamonde, Alberto; Jover-Sáenz, Alfredo; Benito, Natividad; Escudero, Rosa; Sampedro, Marta Fernandez; Vidal, Rafael Pérez; Gómez, Lucía; Corona, Pablo S; Almirante, Benito; Ariza, Javier; Pigrau, Carles

    2018-05-08

    Candida periprosthetic joint infection (CPJI) is a rare, difficult-to-treat disease. The purpose of this study was to evaluate the clinical characteristics and outcomes of CPJI treated with various surgical and antifungal strategies. We conducted a multicenter retrospective study of all CPJI diagnosed between 2003 and 2015 in 16 Spanish hospitals. Forty-three patients included: median age, 75 years, and median Charlson Comorbidity Index score, 4. Thirty-four (79.1%) patients had ≥1 risk factor for Candida infection. Most common causative species were C. albicans and C. parapsilosis. Thirty-five patients were evaluable for outcome: overall, treatment succeeded in 17 (48.6%) and failed in 18 (51.4%). Success was 13/20 (67%) in patients with prosthesis removal and 4/15 (27%) with debridement and prosthesis retention (p = 0.041). All 3 patients who received an amphotericin B-impregnated cement spacer cured. In the prosthesis removal group, success was 5/6 (83%) with an antibiofilm regimen and 8/13 (62%) with azoles (p = 0.605). In the debridement and prosthesis retention group, success was 3/10 (30%) with azoles and 1/5 (20%) with antibiofilm agents. Therapeutic failure was due to relapse in 9 patients, need for suppressive treatment in 5, persistent infection in 2, and CPJI-related death in 2; overall attributable mortality was 6%. CPJI is usually a chronic disease in patients with comorbidities and risk factors for Candida infection. Treatment success is low, and prosthesis removal improves outcome. Although there is insufficient evidence that use of antifungals with antibiofilm activity has additional benefits, our experience indicates it may be recommendable. Copyright © 2018 Elsevier Ltd. All rights reserved.

  15. 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.

  16. 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.

  17. Results of arthroscopic joint debridement in different stages of chondromalacia of the knee joint.

    PubMed

    Krüger, T; Wohlrab, D; Birke, A; Hein, W

    2000-01-01

    A retrospective study was performed of 161 patients who had undergone arthroscopic operation for chondromalacia of the knee joint. After an average follow-up period of 40 (range 10-72) months, patients with severe articular cartilage lesions who had undergone articular lavage alone showed significantly poorer results (P < 0.001). With the same stage of chondromalacia and having undergone the same surgical procedure, younger patients showed better results than older patients. The more effective interruption of the circulus vitiosus during the development of degenerative joint diseases is the primary cause for better results achieved by mechanical debridement of the joint for patients suffering from grade 2 or higher. According to the literature, aggressive subchondral abrasion in severely degenerated knees does not show any benefits. Apparently, the success of the therapy depends to a great extent on the inferiority of the potential degenerative regenerate (lack of capacity of intrinsic regeneration of the hyaline cartilage) as well as on the grade and the progression of chondromalacia. Almost every second patient suffering from grade 4 chondromalacia complained of recurrent pain 1 year postoperatively. One of every 6 patients received a knee joint prosthesis within the 1st year. Therefore, the patients' preoperative expectations have to be clearly objectified. The surgical procedure as an operation with a low complication risk can also be justified as a temporary alternative to total knee arthroplasty in patients suffering from a high-grade degeneration of the joint.

  18. Evaluation of longitudinal joint tie bar system.

    DOT National Transportation Integrated Search

    2011-09-01

    "An adequate longitudinal joint tie bar system is essential in the overall performance of concrete pavement. Excessive : longitudinal joint openings are believed to be caused by either inadequate tie bar size or spacing or improper tie bar : installa...

  19. Elevated sacroilac joint uptake ratios in systemic lupus erythematosus

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

    De Smet, A.A.; Mahmood, T.; Robinson, R.G.

    1984-08-01

    Sacroiliac joint radiographs and radionuclide sacroiliac joint uptake ratios were obtained on 14 patients with active systemic lupus erythematosus. Elevated joint ratios were found unilaterally in two patients and bilaterally in seven patients when their lupus was active. In patients whose disease became quiescent, the uptake ratios returned to normal. Two patients had persistently elevated ratios with continued clinical and laboratory evidence of active lupus. Mild sacroiliac joint sclerosis and erosions were detected on pelvic radiographs in these same two patients. Elevated quantitative sacroiliac joint uptake ratios may occur as a manifestation of active systemic lupus erythematosus.

  20. Simplified technique for orbital prosthesis fabrication: a clinical report.

    PubMed

    Veerareddy, Chandrika; Nair, K Chandrasekharan; Reddy, G Ramaswamy

    2012-10-01

    Loss of orbital content can cause functional impairment, disfigurement of the face, and psychological distress. Rehabilitation of an orbital defect is a complex task, and if reconstruction by plastic surgery is not possible or not desired by the patient, the defect can be rehabilitated by an orbital prosthesis. The prosthetic rehabilitation in such cases depends on the precisely retained, user-friendly removable maxillofacial prosthesis. Many times, making an impression of the orbital area with an accurate record of surface details can be a difficult procedure. The critical areas are making a facial moulage, mold preparation, and attaching the retention device, particularly when eyeglass frames are used. This case focuses on these hindrance factors. A simple basket was used for the impression tray to obtain the facial moulage. A putty mold was used, and attachment of the prosthesis to a retention device was accomplished with positional distance. This method proves to be an economical and simple way of making an orbital prosthesis. © 2012 by the American College of Prosthodontists.

Some links on this page may take you to non-federal websites. Their policies may differ from this site.