Sample records for comparing joint prosthesis

  1. 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.

  2. 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.

  3. 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.

  4. 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...

  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 888.3230 - 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  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 888.3780 - 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. Multi-Axis Prosthetic Knee Resembles Alpine Skiing Movements of an Intact Leg

    PubMed Central

    Demšar, Ivan; Duhovnik, Jože; Lešnik, Blaž; Supej, Matej

    2015-01-01

    The purpose of the study was to analyse the flexion angles of the ski boot, ankle and knee joints of an above-knee prosthesis and to compare them with an intact leg and a control group of skiers. One subject with an above-knee amputation of the right leg and eight healthy subjects simulated the movement of a skiing turn by performing two-leg squats in laboratory conditions. By adding additional loads in proportion to body weight (BW; +1/3 BW, +2/3 BW, +3/3 BW), various skiing regimes were simulated. Change of Flexion Angle (CoFA) and Range of Motion (RoM) in the ski boot, ankle and knee joints were calculated and compared. An average RoM in the skiing boot on the side of prosthesis (4.4 ± 1.1°) was significantly lower compared to an intact leg (5.9 ± 1.8°) and the control group (6.5 ± 2.3°). In the ankle joint, the average RoM was determined to be 13.2±2.9° in the prosthesis, 12.7 ± 2.8° in an intact leg and 14.8±3.6 in the control group. However, the RoM of the knee joint in the prosthesis (42.2 ± 4.2°) was significantly larger than that of the intact leg (34.7 ± 4.4°). The average RoM of the knee joint in the control group was 47.8 ± 5.4°. The influences of additional loads on the kinematics of the lower extremities were different on the side of the prosthesis and on the intact leg. In contrast, additional loads did not produce any significant differences in the control group. Although different CoFAs in the ski boot, ankle and knee joints were used, an above-knee prosthesis with a built-in multi-axis prosthetic knee enables comparable leg kinematics in simulated alpine skiing. Key points The RoM in the ski boot on the side of the prosthetic leg was smaller than the RoM of the intact leg and the control group of healthy subjects. The RoM in the ankle joint of prosthetic leg was comparable to that of the intact leg and the control group of healthy subjects. The RoM in the prosthetic knee joint was greater than the RoM in the knee joint of the intact leg and smaller than that of the control group. The total knee flexions in the laboratory measurements were comparable with field measurements. Additional load affects the RoM of the ski boot, ankle and knee joints for the amputated skier in both legs. No significant influence from the additional load was found on the RoM in the control group of healthy subjects. The above-knee prosthesis with a multiple-axis prosthetic knee reproduces the alpine skiing kinematics of an intact leg. PMID:26664282

  4. 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.

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  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 888.3770 - 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. [Patellofemoral arthroplasty].

    PubMed

    Cotic, M; Forkel, P; Imhoff, A B

    2017-02-01

    Isolated resurfacing of the trochlea using an inlay prosthesis without changing the complex kinematics of the patellofemoral joint. Symptomatic, isolated patellofemoral osteoarthritis or isolated osteochondral lesions, failed conservative and cartilage regeneration procedures. No or concurrently corrected ligament instability, tibiofemoral and patellofemoral malalignment. Symptomatic patellofemoral osteoarthritis, inflammatory joint disease, chondrocalcinosis, chronic pain syndromes, active infections or knee ankylosis. Following a medial arthrotomy, coronal and sagittal curvatures of the trochlea are measured. Based on these measurements, corresponding surface reamers create an implant bed by removing damaged cartilage of the trochlea. A central fixation screw is placed to the desired depth and the inlay prosthesis is tapped carefully onto it. Final placement of the prosthesis is targeted slightly recessed to the surrounding joint surface. Free passive range of motion exercises of the knee joint are recommended starting on postoperative day 1. Depending on symptoms (e.g., pain and joint effusion), partial weight-bearing of 20 kg is allowed during postoperative weeks 1 and 2, which is increased by 20 kg/week thereafter. In a prospective study of 29 patients (mean age: 42 years) treated with inlay arthroplasty, 2‑year follow-up results showed significant improvements (p < 0.05) in WOMAC, IKDC and VAS (pain) scores when compared to baseline. Compared to onlay PF arthroplasty modern inlay prosthetic placement showed a better preservation of the tibiofemoral joint without progression of tibiofemoral degeneration. This may be due to possible avoidance of patellofemoral overstuffing using a more physiological placement of the inlay prosthesis.

  14. 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.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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.

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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.

  4. 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.

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

    PubMed

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

    2018-02-01

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

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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.

  11. 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.

  12. 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.

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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

  1. 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

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. [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.

  15. 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.

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  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 888.3200 - 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  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. 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.

  3. [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.

  4. 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.

  5. A general model for estimating lower extremity inertial properties of individuals with transtibial amputation.

    PubMed

    Ferris, Abbie E; Smith, Jeremy D; Heise, Gary D; Hinrichs, Richard N; Martin, Philip E

    2017-03-21

    Lower extremity joint moment magnitudes during swing are dependent on the inertial properties of the prosthesis and residual limb of individuals with transtibial amputation (TTA). Often, intact limb inertial properties (INTACT) are used for prosthetic limb values in an inverse dynamics model even though these values overestimate the amputated limb's inertial properties. The purpose of this study was to use subject-specific (SPECIFIC) measures of prosthesis inertial properties to generate a general model (GENERAL) for estimating TTA prosthesis inertial properties. Subject-specific mass, center of mass, and moment of inertia were determined for the shank and foot segments of the prosthesis (n=11) using an oscillation technique and reaction board. The GENERAL model was derived from the means of the SPECIFIC model. Mass and segment lengths are required GENERAL model inputs. Comparisons of segment inertial properties and joint moments during walking were made using three inertial models (unique sample; n=9): (1) SPECIFIC, (2) GENERAL, and (3) INTACT. Prosthetic shank inertial properties were significantly smaller with the SPECIFIC and GENERAL model than the INTACT model, but the SPECIFIC and GENERAL model did not statistically differ. Peak knee and hip joint moments during swing were significantly smaller for the SPECIFIC and GENERAL model compared with the INTACT model and were not significantly different between SPECIFIC and GENERAL models. When subject-specific measures are unavailable, using the GENERAL model produces a better estimate of prosthetic side inertial properties resulting in more accurate joint moment measurements for individuals with TTA than the INTACT model. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. 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.

  7. 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.

  8. 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 during placement. The framework presented may be useful for designing and testing customized devices for the treatment of debilitating bone and joint conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.

  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. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

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

    PubMed

    Szalay, G; Meyer, C; Mika, J; Schnettler, R; Thormann, U

    2014-12-01

    Treatment of periprosthetic fractures by implantation of a specially constructed, retrograde hollow nail which fits over the tip of the prosthesis and becomes locked on it. Periprosthetic femoral fractures with firmly anchored prosthesis shaft after total hip arthroplasty of types B1 and C according to the Vancouver classification. Loosened prosthesis (type B2/B3) and trochanteric fractures (type A). Broken or damaged prosthesis, florid inflammation and soft tissue injuries in the operation field, contracted knee joint, advanced deformation in the knee joint and distal femur, enclosed prosthesis and general contraindications. In a supine position the periprosthetic fracture is exposed via a lateral access. For cemented prostheses the cement is removed around the tip of the prosthesis (at least 2-3 cm) and medullary cavity. Arthrotomy with flexion of the knee joint and marking of the nail entry point. Drill the medullary cavity, retrograde introduction of the nail, visually fit the nail over the tip of the prosthesis and lock the nail with the prosthesis. If necessary use additional spongiosaplasty or also placement of additional cerclages depending on fracture type and size of the defect zone. Lock the nail distally. Use intraoperative radiological imaging to control correct positioning and length of the nail. Close the wound layer by layer with placement of suction drainage devices and dressing. Partial loading for 6 weeks with a subsequent pain-adapted loading gradient until full loading is possible. If selective partial loading is not possible, a decision must be made in individual cases as to whether the intraoperative findings allow immediate full loading. From 2004 to 2011 a total of 25 periprosthetic femoral fractures in 25 patients were treated in 2 locations using specially constructed slotted hollow nails. Within the framework of a retrospective study 20 of these patients (16 female and 4 male; average age 77.2 [72-84] years) were clinically and radiologically re-examined on average 19.3 (7-31) months postoperatively. No postoperative bleeding, wound healing disorders and infections. In all patients there was a loading stable consolidation of the fracture in the correct femoral axis, length and rotation with no evidence for radiological signs of loosening of the prosthesis or dislocation of the nails. In one case there was loosening of the prosthesis which had obviously occurred during the operative procedure. After consolidation of the fracture it was necessary to exchange the prosthesis for a long shafted prosthesis. A comparable situation to the preoperative degree of mobility was found in 12 out of the 20 patients, a moderate deterioration in 5 patients, a substantial residual impairment in 2 patients and an improvement of the situation in 1 patient.

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

    PubMed Central

    Highsmith, M. Jason; Kahle, Jason T.; Miro, Rebecca M.; Mengelkoch, Larry J.

    2016-01-01

    Transfemoral amputation (TFA) patients require considerably more energy to walk and run than non-amputees. The purpose of this study was to examine potential bioenergetic differences (oxygen uptake (VO2), heart rate (HR), and ratings of perceived exertion (RPE)) for TFA patients utilizing a conventional running prosthesis with an articulating knee mechanism versus a running prosthesis with a non-articulating knee joint. Four trained TFA runners (n = 4) were accommodated to and tested with both conditions. VO2 and HR were significantly lower (p ≤ 0.05) in five of eight fixed walking and running speeds for the prosthesis with an articulating knee mechanism. TFA demonstrated a trend for lower RPE at six of eight walking speeds using the prosthesis with the articulated knee condition. A trend was observed for self-selected walking speed, self-selected running speed, and maximal speed to be faster for TFA subjects using the prosthesis with the articulated knee condition. Finally, all four TFA participants subjectively preferred running with the prosthesis with the articulated knee condition. These findings suggest that, for trained TFA runners, a running prosthesis with an articulating knee prosthesis reduces ambulatory energy costs and enhances subjective perceptive measures compared to using a non-articulating knee prosthesis. PMID:28066524

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. Comparison of patellofemoral outcomes after TKA using two prostheses with different patellofemoral design features.

    PubMed

    Bae, Dae Kyung; Baek, Jong Hun; Yoon, Kyung Tack; Son, Hyuck Sung; Song, Sang Jun

    2017-12-01

    The purpose of the present study was to compare the clinical and radiographic results after TKA using two prostheses with different sagittal patellofemoral design features, including outcomes related to compatibility of the patellofemoral joint. The clinical and radiographic results of 81 patients (100 knees) who underwent TKA using the specific prosthesis (group A) were compared with those in a control group who underwent TKA using the other prosthesis (group B). The presence of anterior knee joint pain, patellar crepitation, and patellar clunk syndrome was also checked. The function score and maximum flexion angle at the last follow-up were slightly better in group A than those in group B (92.0 ± 2.3 vs. 90.6 ± 4.2) (133.6° ± 8.4° vs. 129.6° ± 11.4°). Anterior knee pain was observed in 6 knees and patellar crepitation in four knees in group A. In group B, these symptoms were observed in 22 knees and 18 knees, respectively. There was no patellar clunk syndrome in either group. The alignment was corrected with satisfactory positioning of components. The patellar height remained unchanged after TKA in the two groups. The differences between preoperative and postoperative patellar tilt angle and patellar translation were small. When comparing the clinical and radiographic results after TKA using two prostheses with different sagittal patellofemoral design features, TKA using the specific prosthesis provided satisfactory results with less clinical symptoms related to the patellofemoral kinematics with TKA using the other prosthesis. III.

  19. 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...

  20. 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...

  1. 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...

  2. 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.

  3. A novel tribological study on DLC-coated micro-dimpled orthopedics implant interface.

    PubMed

    Choudhury, Dipankar; Urban, Filip; Vrbka, Martin; Hartl, Martin; Krupka, Ivan

    2015-05-01

    This study investigates a tribological performance of diamond like carbon (DLC) coated micro dimpled prosthesis heads against ceramic cups in a novel pendulum hip joint simulator. The simulator enables determining friction coefficient and viscous effects of a concave shaped specimen interface (conformal contact). Two types of DLC such as hydrogenated amorphous carbon (a-C:H) and tetrahedral amorphous carbon (Ta-C) and one set of micro dimple (diameter of 300µm, depth of 70µm, and pitch of 900µm) were fabricated on metallic prosthesis heads. The experiment results reveal a significant friction coefficient reduction to the 'dimpled a-C:H/ceramic' prosthesis compared to a 'Metal (CoCr)/ceramic' prosthesis because of their improved material and surface properties and viscous effect. The post-experiment surface analysis displays that the dimpled a-C:H yielded a minor change in the surface roughness, and generated a larger sizes of wear debris (40-200nm sized, equivalent diameter), a size which could be certainly stored in the dimple, thus likely to reducing their possible third body abrasive wear rate. Thus, dimpled a:C-H can be used as a 'metal on ceramic hip joint interface', whereas the simulator can be utilized as an advanced bio-tribometer. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Evaluation of a noninvasive command scheme for upper-limb prostheses in a virtual reality reach and grasp task.

    PubMed

    Kaliki, Rahul R; Davoodi, Rahman; Loeb, Gerald E

    2013-03-01

    C5/C6 tetraplegic patients and transhumeral amputees may be able to use voluntary shoulder motion as command signals for a functional electrical stimulation system or transhumeral prosthesis. Stereotyped relationships, termed "postural synergies," among the shoulder, forearm, and wrist joints emerge during goal-oriented reaching and transport movements as performed by able-bodied subjects. Thus, the posture of the shoulder can potentially be used to infer the desired posture of the elbow and forearm joints during reaching and transporting movements. We investigated how well able-bodied subjects could learn to use a noninvasive command scheme based on inferences from these postural synergies to control a simulated transhumeral prosthesis in a virtual reality task. We compared the performance of subjects using the inferential command scheme (ICS) with subjects operating the simulated prosthesis in virtual reality according to complete motion tracking of their actual arm and hand movements. Initially, subjects performed poorly with the ICS but improved rapidly with modest amounts of practice, eventually achieving performance only slightly less than subjects using complete motion tracking. Thus, inferring the desired movement of distal joints from voluntary shoulder movements appears to be an intuitive and noninvasive approach for obtaining command signals for prostheses to restore reaching and grasping functions.

  5. 21 CFR 888.6 - Degree of constraint.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  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. 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.

  8. [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.

  9. 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.

  10. 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

  11. 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.

  12. 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...

  13. 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...

  14. 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.

  15. The biomechanical response of persons with transfemoral amputation to variations in prosthetic knee alignment during level walking.

    PubMed

    Koehler-McNicholas, Sara R; Lipschutz, Robert D; Gard, Steven A

    2016-01-01

    Prosthetic alignment is an important factor in the overall fit and performance of a lower-limb prosthesis. However, the association between prosthetic alignment and control strategies used by persons with transfemoral amputation to coordinate the movement of a passive prosthetic knee is poorly understood. This study investigated the biomechanical response of persons with transfemoral amputation to systematic perturbations in knee joint alignment during a level walking task. Quantitative gait data were collected for three alignment conditions: bench alignment, 2 cm anterior knee translation (ANT), and 2 cm posterior knee translation (POST). In response to a destabilizing alignment perturbation (i.e., the ANT condition), participants significantly increased their early-stance hip extension moment, confirming that persons with transfemoral amputation rely on a hip extensor strategy to maintain knee joint stability. However, participants also decreased the rate at which they loaded their prosthesis, decreased their affected-side step length, increased their trunk flexion, and maintained their prosthesis in a more vertical posture at the time of opposite toe off. Collectively, these results suggest that persons with transfemoral amputation rely on a combination of strategies to coordinate stance-phase knee flexion. Further, comparatively few significant changes were observed in response to the POST condition, suggesting that a bias toward posterior alignment may have fewer implications in terms of stance-phase, knee joint control.

  16. 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.

  17. 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.

  18. [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.

  19. 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.

  20. Changes in In Vivo Knee Loading with a Variable-Stiffness Intervention Shoe Correlate with Changes in the Knee Adduction Moment

    PubMed Central

    Erhart, Jennifer C.; Dyrby, Chris O.; D'Lima, Darryl D.; Colwell, Clifford W.; Andriacchi, Thomas P.

    2010-01-01

    External knee adduction moment can be reduced using footwear interventions, but the exact changes in in vivo medial joint loading remain unknown. An instrumented knee replacement was used to assess changes in in vivo medial joint loading in a single patient walking with a variable-stiffness intervention shoe. We hypothesized that during walking with a load modifying variable-stiffness shoe intervention: (1) the first peak knee adduction moment will be reduced compared to a subject's personal shoes; (2) the first peak in vivo medial contact force will be reduced compared to personal shoes; and (3) the reduction in knee adduction moment will be correlated with the reduction in medial contact force. The instrumentation included a motion capture system, force plate, and the instrumented knee prosthesis. The intervention shoe reduced the first peak knee adduction moment (13.3%, p=0.011) and medial compartment joint contact force (22%; p=0.008) compared to the personal shoe. The change in first peak knee adduction moment was significantly correlated with the change in first peak medial contact force (R2=0.67, p=0.007). Thus, for a single subject with a total knee prosthesis the variable-stiffness shoe reduces loading on the affected compartment of the joint. The reductions in the external knee adduction moment are indicative of reductions in in vivo medial compressive force with this intervention. PMID:20973058

  1. 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.

  2. [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.

  3. Movement quality of conventional prostheses and the DEKA Arm during everyday tasks

    PubMed Central

    Cowley, Jeffrey; Resnik, Linda; Wilken, Jason; Walters, Lisa Smurr; Gates, Deanna

    2017-01-01

    Background Conventional prosthetic devices fail to restore the function and characteristic movement quality of the upper limb. The DEKA Arm is a new, advanced prosthesis featuring a compound, powered wrist and multiple grip configurations. Objectives The purpose of this study was to determine if the DEKA Arm improved the movement quality of upper limb prosthesis users compared to conventional prostheses. Study design Case series. Methods Three people with transradial amputation completed tasks of daily life with their conventional prosthesis and with the DEKA Arm. A total of 10 healthy controls completed the same tasks. The trajectory of the wrist joint center was analyzed to determine how different prostheses affected movement duration, speed, smoothness, and curvature compared to patients’ own intact limbs and controls. Results Movement quality decreased with the DEKA Arm for two participants, and increased for the third. Prosthesis users made slower, less smooth, more curved movements with the prosthetic limb compared to the intact limb and controls, particularly when grasping and manipulating objects. Conclusion The effects of one month of training with the DEKA Arm on movement quality varied with participants’ skill and experience with conventional prostheses. Future studies should examine changes in movement quality after long-term use of advanced prostheses. PMID:26932980

  4. 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.

  5. Measurement of installation deformation of the acetabulum during prosthetic replacement of a hip joint using digital image correlation

    NASA Astrophysics Data System (ADS)

    Lei, Dong; Bai, Pengxiang; Zhu, Feipeng

    2018-01-01

    Nowadays, acetabulum prosthesis replacement is widely used in clinical medicine. However, there is no efficient way to evaluate the implantation effect of the prosthesis. Based on a modern photomechanics technique called digital image correlation (DIC), the evaluation method of the installation effect of the acetabulum was established during a prosthetic replacement of a hip joint. The DIC method determines strain field by comparing the speckle images between the undeformed sample and the deformed counterpart. Three groups of experiments were carried out to verify the feasibility of the DIC method on the acetabulum installation deformation test. Experimental results indicate that the installation deformation of acetabulum generally includes elastic deformation (corresponding to the principal strain of about 1.2%) and plastic deformation. When the installation angle is ideal, the plastic deformation can be effectively reduced, which could prolong the service life of acetabulum prostheses.

  6. 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 biomechanical advantages attributed to the reverse shoulder design and show an increase in activity from the deltoid, teres minor, and coracobrachialis muscles. The glenohumeral joint reaction forces estimated for the reverse shoulder are up to 15% lower than those in the normal shoulder anatomy. The data presented here complements previous publications, which, all together, allow researchers to build a biomechanical model of the upper limb including a reverse shoulder prosthesis.

  7. 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 significantly different between prosthetic feet. Conclusions Use of a biomimetic powered ankle-foot prosthesis decreased peak resultant force at slow and moderate speeds and knee external adduction moment at moderate and fast speeds on the unaffected leg of people with a transtibial amputation during level-ground walking. Thus, use of an ankle-foot prosthesis that provides net positive mechanical work could reduce the risk of comorbidities such as knee osteoarthritis. PMID:23758860

  8. 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

  9. 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 probably under-dosed for the treatment of implant and biofilm associated infections.

  10. Alcohol Devitalization and Replantation for Primary Malignant Bone Tumors of the Knee Joint

    PubMed Central

    ZHANG, Xihai; CHEN, Ge; WANG, Jun; TANG, Lian; YIN, Yiran

    2017-01-01

    Background: This paper is aimed at studying the therapeutic effects of in situ replantation of alcohol-devitalized bone segments to treat malignant bone tumors of the knee joint. Methods: We retrospectively analyzed clinical data for 45 patients from January 2013 to January 2016 who underwent replantation following alcohol-devitalization of bone segments and 40 who underwent prosthesis implantation. The two groups were comparable in basal clinical biometric data, including gender, age, tumor type and location, Enneking staging, and maximum tumor diameter. Radical tumor resection was combined with neoadjuvant chemotherapy following the two-implantation procedures. Results: The median follow-up time was 25 months, and the outcomes were compared. We found no differences in the length of bone lesions, surgery time, intraoperative blood loss, amount of postoperative drainage, and perioperative complications, which were just three for each method. We also found no significant differences in limb function scores, internal fixation imaging scores, tumor-free survival rate, and overall survival rate between the two groups. Replantation following alcohol-devitalization of tumor-bearing bone segment demonstrated similar clinical outcomes compared with prosthesis implantation in the treatment of primary malignant bone tumors of the knee joint. Conclusion: Both therapies enjoy good application safety and effectiveness. Because alcohol devitalization is inexpensive and easy to apply in the clinic, it should be considered a preferred method in the treatment of bone tumors. PMID:29308374

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. [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.

  16. 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.

  17. 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.

  18. 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 was the main dissatisfaction reason. Partial radiolucent line was seen in one patient (4%). Authors noticed two serious complications. In one patient, with rheumatoid arthritis, deep infection occurred 12 months after prosthesis implantation. In second case phalangeal implant was revised due to misalignment. METIS® metatarsophalangeal joint replacement allows alleviate of pain relating to hallux rigidus and partial restoration of joint movement, even in patients after failures of primary metatarsophalangeal joint surgery. AOFAS-HMI results are better than previously reported in the literature in assessment of the first metatarsophalangeal joint replacement. Radiographic results imply satisfactory bone ingrowth into the cementless implants.

  19. 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...

  20. 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...

  1. 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

  2. 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.

  3. 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.

  4. 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...

  5. Efficacy of Antibiotic Suppressive Therapy in Patients with a Prosthetic Joint Infection.

    PubMed

    Wouthuyzen-Bakker, Marjan; Nijman, Jasperina M; Kampinga, Greetje A; van Assen, Sander; Jutte, Paul C

    2017-01-01

    Introduction: For chronic prosthetic joint infections (PJI), complete removal of the infected prosthesis is necessary in order to cure the infection. Unfortunately, a subgroup of patients is not able to undergo a revision surgery due to high surgical risk. Alternatively, these patients can be treated with antibiotic suppressive therapy (AST) to suppress the infection. Aim: To evaluate the efficacy and tolerability of AST. Methods: We retrospectively collected data (period 2009-2015) from patients with a PJI (of hip, knee or shoulder) who were treated with AST at the University Medical Center Groningen, the Netherlands. AST was defined as antibiotic treatment for PJI that was started after the usual 3 months of antibiotic treatment. The time of follow-up was defined from the time point AST was started. Treatment was considered as failed, when the patient still experienced joint pain, when surgical intervention (debridement, removal, arthrodesis or amputation) was needed to control the infection and/or when death occurred due to the infection. Results: We included 21 patients with a median age of 67 years (range 21 - 88) and with a median follow-up of 21 months (range 3 - 81). Coagulase negative staphylococci (CNS) (n=6), S. aureus (n=6) and polymicrobial flora (n=4) were the most frequently found causative pathogens. Most patients with CNS and S. aureus were treated with minocycline (67%) and clindamycin (83%) as AST, respectively. Overall, treatment was successful in 67% of patients. Failure was due to persistent joint pain (n=1), surgical intervention because of an uncontrolled infection (n=3), and death due the infection (n=3). We observed a treatment success of 90% in patients with a 'standard' prosthesis (n=11), compared to only 50% in patients with a tumor-prosthesis (n=10). Also, treatment was successful in 83% of patients with a CNS as causative microorganism for the infection, compared to 50% in patients with a S. aureus . Patients who failed on AST had a higher ESR in comparison to patients with a successful treatment (mean 73 ± 25SD versus 32 ± 19SD mm/hour (p = 0.007), respectively. 43% of patients experienced side effects and led to a switch of antibiotic treatment or a dose adjustment in almost all of these patients. Conclusions: Removal of the implant remains first choice in patients with chronic PJI. However, AST is a reasonable alternative treatment option in a subgroup of patients with a PJI who are no candidate for revision surgery, in particular in patients with a 'standard' prosthesis and/or CNS as the causative micro-organism.

  6. Comparison of biomechanical function at ideal and varied surgical placement for two lumbar artificial disc implant designs: mobile-core versus fixed-core.

    PubMed

    Moumene, Missoum; Geisler, Fred H

    2007-08-01

    Finite element model. To estimate the effect of lumbar mobile-core and fixed-core artificial disc design and placement on the loading of the facet joints, and stresses on the polyethylene core. Although both mobile-core and fixed-core lumbar artificial disc designs have been used clinically, the effect of their design and the effect of placement within the disc space on the structural element loading, and in particular the facets and the implant itself, have not been investigated. A 3D nonlinear finite element model of an intact ligamentous L4-L5 motion segment was developed and validated in all 6 df based on previous experiments conducted on human cadavers. Facet loading of a mobile-core TDR and a fixed-core TDR were estimated with 4 different prosthesis placements for 3 different ranges of motion. Placing the mobile-core TDR anywhere within the disc space reduced facet loading by more than 50%, while the fixed-core TDR increased facet loading by more than 10% when compared with the intact disc in axial rotation. For central (ideal) placement, the mobile- and fixed-core implants were subjected to compressive stresses on the order of 3 MPa and 24 MPa, respectively. The mobile-core stresses were not affected by implant placement, while the fixed-core stresses increased by up to 40%. A mobile-core artificial disc design is less sensitive to placement, and unloads the facet joints, compared with a fixed-core design. The decreased core stress may result in a reduced potential for wear in a mobile-core prosthesis compared with a fixed-core prosthesis, which may increase the functional longevity of the device.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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 effect of 10 degrees anteversion angle. Increasing the head/neck ratio increases joint stability. Posterior high side reduced the range of motion of the joint but increased joint stability; Increasing the anteversion angle increases DRI values and thus improve joint stability; Increasing the chamber angle increases DRI values and improves joint stability. However, at angles exceeding 55 degrees , further increases in the chamber angle result in decreased DRI values and reduce the stability of the joint.

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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

  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. 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.

  19. Walking speed related joint kinetic alterations in trans-tibial amputees: impact of hydraulic 'ankle' damping.

    PubMed

    De Asha, Alan R; Munjal, Ramesh; Kulkarni, Jai; Buckley, John G

    2013-10-17

    Passive prosthetic devices are set up to provide optimal function at customary walking speed and thus may function less effectively at other speeds. This partly explains why joint kinetic adaptations become more apparent in lower-limb amputees when walking at speeds other than customary. The present study determined whether a trans-tibial prosthesis incorporating a dynamic-response foot that was attached to the shank via an articulating hydraulic device (hyA-F) lessened speed-related adaptations in joint kinetics compared to when the foot was attached via a rigid, non-articulating attachment (rigF). Eight active unilateral trans-tibial amputees completed walking trials at their customary walking speed, and at speeds they deemed to be slow-comfortable and fast-comfortable whilst using each type of foot attachment. Moments and powers at the distal end of the prosthetic shank and at the intact joints of both limbs were compared between attachment conditions. There was no change in the amount of intact-limb ankle work across speed or attachment conditions. As speed level increased there was an increase on both limbs in the amount of hip and knee joint work done, and increases on the prosthetic side were greater when using the hyA-F. However, because all walking speed levels were higher when using the hyA-F, the intact-limb ankle and combined joints work per meter travelled were significantly lower; particularly so at the customary speed level. This was the case despite the hyA-F dissipating more energy during stance. In addition, the amount of eccentric work done per meter travelled became increased at the residual knee when using the hyA-F, with increases again greatest at customary speed. Findings indicate that a trans-tibial prosthesis incorporating a dynamic-response foot reduced speed-related changes in compensatory intact-limb joint kinetics when the foot was attached via an articulating hydraulic device compared to rigid attachment. As differences between attachment conditions were greatest at customary speed, findings indicate a hydraulic ankle-foot device is most effectual at the speed it is set-up for.

  20. 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°.

  1. Ultrasonographic assessment of the quadriceps muscle and femoral cartilage in transtibial amputees using different prostheses.

    PubMed

    Şahin Onat, Şule; Malas, Fevziye Ünsal; Öztürk, Gökhan Tuna; Akkaya, Nuray; Kara, Murat; Özçakar, Levent

    2016-08-01

    In patients with lower limb amputations, gait alteration, increased loading on the intact extremity, and use of prosthesis may lead to joint degeneration. To explore the effects of prosthesis type on quadriceps muscle and distal femoral cartilage thicknesses in transtibial amputees. A cross-sectional study. A total of 38 below-knee amputees were enrolled in the study, of which 13 patients were using vacuum system type prosthesis and 25 patients were using silicon liner pin system prosthesis. Patients' femoral cartilage and quadriceps muscle thickness measurements were performed using musculoskeletal ultrasound. When compared with the intact sides, cartilage and rectus femoris, vastus intermedius, and vastus medialis muscle thickness values were significantly decreased on the amputee sides (all p < 0.05). Clinical characteristics and ultrasound measurements were similar between the two groups except the lateral and medial femoral condyle thicknesses, thinner in the silicon liner pin system users (both p < 0.05). The distal femoral cartilage and quadriceps muscle thicknesses were found to be decreased on the amputated sides, and the negative impact on the cartilage seemed to be worse in the silicon liner pin system users. This study might provide another argument as regards the preference of vacuum system type prosthesis to prevent possible knee osteoarthritis due to cartilage thinning in adult transtibial amputees. © The International Society for Prosthetics and Orthotics 2015.

  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. [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 patients, hip joint function in patients aged more than 80 years old is worse, while there was no obvious market effect in fracture classification, whether to use tension band and type of distal fixation prosthesis, moreover, proximal femoral osteolysis should be focused on.

  4. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...

  5. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...

  6. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...

  7. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...

  8. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra...

  9. Biomechanics of the ankle-foot system during stair ambulation: implications for design of advanced ankle-foot prostheses.

    PubMed

    Sinitski, Emily H; Hansen, Andrew H; Wilken, Jason M

    2012-02-02

    Unilateral lower limb prosthesis users display temporal, kinematic, and kinetic asymmetries between limbs while ascending and descending stairs. These asymmetries are due, in part, to the inability of current prosthetic devices to effectively mimic normal ankle function. The purpose of this study was to provide a comprehensive set of biomechanical data for able-bodied and unilateral transtibial amputee (TTA) ankle-foot systems for level-ground (LG), stair ascent (SA), and stair descent (SD), and to characterize deviations from normal performance associated with prosthesis use. Ankle joint kinematics, kinetics, torque-angle curves, and effective shapes were calculated for twelve able-bodied individuals and twelve individuals with TTA. The data from this study demonstrated the prosthetic limb can more effectively mimic the range of motion and power output of a normal ankle-foot during LG compared to SA and SD. There were larger differences between the prosthetic and able-bodied limbs during SA and SD, most evident in the torque-angle curves and effective shapes. These data can be used by persons designing ankle-foot prostheses and provide comparative data for assessment of future ankle-foot prosthesis designs. Published by Elsevier Ltd.

  10. Design and characterization of a biologically inspired quasi-passive prosthetic ankle-foot.

    PubMed

    Mooney, Luke M; Lai, Cara H; Rouse, Elliott J

    2014-01-01

    By design, commonly worn energy storage and release (ESR) prosthetic feet cannot provide biologically realistic ankle joint torque and angle profiles during walking. Additionally, their anthropomorphic, cantilever architecture causes their mechanical stiffness to decrease throughout the stance phase of walking, opposing the known trend of the biological ankle. In this study, the design of a quasi-passive pneumatic ankle-foot prosthesis is detailed that is able to replicate the biological ankle's torque and angle profiles during walking. The prosthetic ankle is comprised of a pneumatic piston, bending spring and solenoid valve. The mechanical properties of the pneumatic ankle prosthesis are characterized using a materials testing machine and the properties are compared to those from a common, passive ESR prosthetic foot. The characterization spanned a range of ankle equilibrium pressures and testing locations beneath the foot, analogous to the location of center of pressure within the stance phase of walking. The pneumatic ankle prosthesis was shown to provide biologically appropriate trends and magnitudes of torque, angle and stiffness behavior, when compared to the passive ESR prosthetic foot. Future work will focus on the development of a control system for the quasi-passive device and clinical testing of the pneumatic ankle to demonstrate efficacy.

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. [Comparative clinical study of 2 surgical techniques for trapeziometacarpal osteoarthritis].

    PubMed

    Martínez-Martínez, F; García-Hortelano, S; García-Paños, J P; Moreno-Fernández, J M; Martín-Ferrero, M Á

    2016-01-01

    In trapeziometacarpal osteoarthritis (or rhizarthrosis), there is great controversy over the surgical technique to choose: simple trapeziectomy, resection-interposition arthroplasty, interposition arthroplasty suspension-or arthroplasty with implant or prosthesis. These latter 2 are the most used without consensus in the literature on the technique to choose and without sufficient comparative studies. The objective is to compare the 2 techniques most used today: suspension-interposition arthroplasty and arthroplasty with prosthesis. A prospective study was conducted on 15 patients diagnosed with grade 2-3 rhizarthrosis treated with interposition arthroplasty-suspension (group 1) and 15 with prosthesis (group 2) showing clinical outcomes, advantages and disadvantages of each. The study variables were the visual analogue scale (VAS), the DASH questionnaire, the grip strength, the strength of end to end and end-lateral clamp, the joint balance adduction-abduction and preemption-retropositioning, and the opposition. The 2 groups are from 2 different hospitals operated on by a hand surgeon from the Hand Unit. The follow-up time for all patients included in the study was 12 months. The VAS, DASH and grip strength at 12 months did not show significant differences. As regards the strength of end to end and end-lateral clamp, group 2 showed the highest values in all follow-up periods with statistically significant differences. Patient selection and surgical experience is essential, given the satisfactory results of both techniques. Arthroplasty prosthesis is reserved for grades 2 and 3, middle-aged patients, good trapezium architecture, and experienced surgeons. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.

  17. Motor adaptation to prosthetic cycling in people with trans-tibial amputation

    PubMed Central

    Childers, W. Lee; Prilutsky, Boris I.; Gregor, Robert J.

    2014-01-01

    The neuromusculoskeletal system interacts with the external environment via end-segments, e.g. feet. A person with trans-tibial amputation (TTAmp) has lost a foot and ankle; hence the residuum with prosthesis becomes the new end-segment. We investigated changes in kinetics and muscle activity in TTAmps during cycling with this altered interface with the environment. Nine unilateral TTAmps and nine subjects without amputation (NoAmp) pedaled at a constant torque of 15Nm and a constant cadence of 90rpm (~150watts). Pedal forces and limb kinematics were used to calculate resultant joint moments. Electromyographic activity was recorded to determine its magnitude and timing. Biomechanical and EMG variables of the amputated limb were compared to those of the TTAmp sound limb and to the dominant limb in the NoAmp group using a one-way ANOVA. Results showed maximum angular displacement between the residuum and prosthesis was 4.8 ± 1.8deg. The amputated limb compared to sound limb and NoAmp group produced lower extensor moments averaged over the cycle about the ankle (13 ± 2.3, 20 ± 5.7, and 19 ± 5.3Nm, respectfully) and knee (8.4 ± 5.0, 15 ± 4.5, and 12.7 ± 5.9Nm, respectfully) (p<0.05). Gastrocnemius and rectus femoris peak activity in the TTAmps shifted to later in the crank cycle (by 36° and 75°, respectfully; p<0.05). These data suggest gastrocnemius was utilized as a one-joint knee flexor in combination with rectus femoris for prosthetic socket control and highlight prosthetic control as an interaction between the residuum, prosthesis and external environment. PMID:24818794

  18. Overcoming boundaries of worldwide joint arthroplasty registers: the European Arthroplasty Register minimal dataset.

    PubMed

    Sadoghi, Patrick; Leithner, Andreas; Labek, Gerold

    2013-09-01

    Worldwide joint arthroplasty registers are instrumental to screen for complications or implant failures. In order to achieve comparable results a similar classification dataset is essential. The authors therefore present the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) European Arthroplasty Register (EAR) minimal dataset for primary and revision joint arthroplasty. Main parameters include the following: date of operation, country, hospital ID-code, patient's name and prename, birthday, identification code of the implant, gender, diagnosis, preoperations, type of prosthesis (partial, total), side, cementation technique, use of antibiotics in the cement, surgical approach, and others specifically related to the affected joint. The authors believe that using this minimal dataset will improve the chance for a worldwide comparison of arthroplasty registers and ask future countries for implementation. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Gait and balance of transfemoral amputees using passive mechanical and microprocessor-controlled prosthetic knees.

    PubMed

    Kaufman, K R; Levine, J A; Brey, R H; Iverson, B K; McCrady, S K; Padgett, D J; Joyner, M J

    2007-10-01

    Microprocessor-controlled knee joints appeared on the market a decade ago. These joints are more sophisticated and more expensive than mechanical ones. The literature is contradictory regarding changes in gait and balance when using these sophisticated devices. This study employed a crossover design to assess the comparative performance of a passive mechanical knee prosthesis compared to a microprocessor-controlled knee joint in 15 subjects with an above-knee amputation. Objective measurements of gait and balance were obtained. Subjects demonstrated significantly improved gait characteristics after receiving the microprocessor-controlled prosthetic knee joint (p<0.01). Improvements in gait were a transition from a hyperextended knee to a flexed knee during loading response which resulted in a change from an internal knee flexor moment to a knee extensor moment. The participants' balance also improved (p<0.01). All conditions of the Sensory Organization Test (SOT) demonstrated improvements in equilibrium score. The composite score also increased. Transfemoral amputees using a microprocessor-controlled knee have significant improvements in gait and balance.

  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. [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.

  2. The Influence Of Component Alignment On The Life Of Total Knee Prostheses

    NASA Astrophysics Data System (ADS)

    Bugariu, Delia; Bereteu, Liviu

    2012-12-01

    An arthritic knee affects the patient's life by causing pain and limiting movement. If the cartilage and the bone surfaces are severely affected, the natural joint is replaced with an artificial joint. The procedure is called total knee arthroplasty (TKA). Lately, the numbers of implanted total knee prostheses grow steadily. An important factor in TKA is the perfect alignment of the total knee prosthesis (TKP) components. Component misalignment can lead to the prosthesis loss by producing wear particles. The paper proposes a study on mechanical behaviors of a TKP based on numerical analysis, using ANSYS software. The numerical analysis is based on both the normal and the changed angle of the components alignment.

  3. 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 .

  4. 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.

  5. 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

  6. 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.

  7. CAD - CAM Procedures Used for Rapid Prototyping of Prosthetic Hip Joint Bone

    NASA Astrophysics Data System (ADS)

    Popa, Luminita I.; Popa, Vasile N.

    2016-11-01

    The article addresses the issue of rapid prototyping CAD/ CAM procedures, based on CT imaging, for custom implants dedicated to hip arthroplasty and the correlation study to be achieved between femoral canal shape, valued by modern imaging methods, and the prosthesis form. A set of CT images is transformed into a digital model using one of several software packages available for conversion. The purpose of research is to obtain prosthesis with compatible characteristics as close to the physiological, with an optimal adjustment of the prosthesis to the bone in which it is implanted, allowing the recovery of the patient physically, mentally and socially.

  8. Rapid Molecular Microbiologic Diagnosis of Prosthetic Joint Infection

    PubMed Central

    Cazanave, Charles; Greenwood-Quaintance, Kerryl E.; Hanssen, Arlen D.; Karau, Melissa J.; Schmidt, Suzannah M.; Gomez Urena, Eric O.; Mandrekar, Jayawant N.; Osmon, Douglas R.; Lough, Lindsay E.; Pritt, Bobbi S.; Steckelberg, James M.

    2013-01-01

    We previously showed that culture of samples obtained by prosthesis vortexing and sonication was more sensitive than tissue culture for prosthetic joint infection (PJI) diagnosis. Despite improved sensitivity, culture-negative cases remained; furthermore, culture has a long turnaround time. We designed a genus-/group-specific rapid PCR assay panel targeting PJI bacteria and applied it to samples obtained by vortexing and sonicating explanted hip and knee prostheses, and we compared the results to those with sonicate fluid and periprosthetic tissue culture obtained at revision or resection arthroplasty. We studied 434 subjects with knee (n = 272) or hip (n = 162) prostheses; using a standardized definition, 144 had PJI. Sensitivities of tissue culture, of sonicate fluid culture, and of PCR were 70.1, 72.9, and 77.1%, respectively. Specificities were 97.9, 98.3, and 97.9%, respectively. Sonicate fluid PCR was more sensitive than tissue culture (P = 0.04). PCR of prosthesis sonication samples is more sensitive than tissue culture for the microbiologic diagnosis of prosthetic hip and knee infection and provides same-day PJI diagnosis with definition of microbiology. The high assay specificity suggests that typical PJI bacteria may not cause aseptic implant failure. PMID:23658273

  9. Gait asymmetry of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees.

    PubMed

    Kaufman, Kenton R; Frittoli, Serena; Frigo, Carlo A

    2012-06-01

    Amputees walk with an asymmetrical gait, which may lead to future musculoskeletal degenerative changes. The purpose of this study was to compare the gait asymmetry of active transfemoral amputees while using a passive mechanical knee joint or a microprocessor-controlled knee joint. Objective 3D gait measurements were obtained in 15 subjects (12 men and 3 women; age 42, range 26-57). Research participants were longtime users of a mechanical prosthesis (mean 20 years, range 3-36 years). Joint symmetry was calculated using a novel method that includes the entire waveform throughout the gait cycle. There was no significant difference in hip, knee and ankle kinematics symmetry when using the different knee prostheses. In contrast, the results demonstrated a significant improvement in lower extremity joint kinetics symmetry when using the microprocessor-controlled knee. Use of the microprocessor-controlled knee joint resulted in improved gait symmetry. These improvements may lead to a reduction in the degenerative musculoskeletal changes often experienced by amputees. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. Design and control of a prosthetic leg for above-knee amputees operated in semi-active and active modes

    NASA Astrophysics Data System (ADS)

    Park, Jinhyuk; Yoon, Gun-Ha; Kang, Je-Won; Choi, Seung-Bok

    2016-08-01

    This paper proposes a new prosthesis operated in two different modes; the semi-active and active modes. The semi-active mode is achieved from a flow mode magneto-rheological (MR) damper, while the active mode is obtained from an electronically commutated (EC) motor. The knee joint part of the above knee prosthesis is equipped with the MR damper and EC motor. The MR damper generates reaction force by controlling the field-dependent yield stress of the MR fluid, while the EC motor actively controls the knee joint angle during gait cycle. In this work, the MR damper is designed as a two-end type flow mode mechanism without air chamber for compact size. On other hand, in order to predict desired knee joint angle to be controlled by EC motor, a polynomial prediction function using a statistical method is used. A nonlinear proportional-derivative controller integrated with the computed torque method is then designed and applied to both MR damper and EC motor to control the knee joint angle. It is demonstrated that the desired knee joint angle is well achieved in different walking velocities on the ground ground.

  11. Sensitivity of biomechanical outcomes to independent variations of hindfoot and forefoot stiffness in foot prostheses.

    PubMed

    Adamczyk, Peter Gabriel; Roland, Michelle; Hahn, Michael E

    2017-08-01

    Many studies have reported the effects of different foot prostheses on gait, but most results cannot be generalized because the prostheses' properties are seldom reported. We varied hindfoot and forefoot stiffness in an experimental foot prosthesis, in increments of 15N/mm, and tested the parametric effects of these variations on treadmill walking in unilateral transtibial amputees, at speeds from 0.7 to 1.5m/s. We computed outcomes such as prosthesis energy return, center of mass (COM) mechanics, ground reaction forces, and joint mechanics, and computed their sensitivity to component stiffness. A stiffer hindfoot led to reduced prosthesis energy return, increased ground reaction force (GRF) loading rate, and greater stance-phase knee flexion and knee extensor moment. A stiffer forefoot resulted in reduced prosthetic-side ankle push-off and COM push-off work, and increased knee extension and knee flexor moment in late stance. The sensitivity parameters obtained from these tests may be useful in clinical prescription and further research into compensatory mechanisms of joint function. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... type of device is designed to achieve biological fixation to bone without the use of bone cement. This... bearing is rigidly secured to the metal tibial base plate. (b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint...

  13. 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 applied to the mandibular and prostheses models after total TMJ replacement. The condylar component was observed sinking into the fossa during jaw motion. Conclusion A motion simulator capable of re-creating and recording full range of mandibular motions in a cadaveric preparation has been developed. It can be used to simulate mandibular motions for the intact TMJ and total joint prosthesis, and to re-create and record their full range of mandibular motions. In addition, the full range of the recorded motion can be re-created as motion images in a computer. These images can be used for motion path analysis and to study the causation of limited range of motion after total joint replacement and strategies for improvement. PMID:21050636

  14. Ceramic debris in hip prosthesis: correlation between synovial fluid and joint capsule.

    PubMed

    De Pasquale, Dalila; Stea, Susanna; Beraudi, Alina; Montesi, Monica; Squarzoni, Stefano; Toni, Aldo

    2013-05-01

    Detection of ceramic particles in synovial fluids allows early diagnosis of ceramic damage, but there is no evidence of a relationship between ceramic debris in the articular space and in the joint capsule. The aim of the present study is to verify if the particles isolated in the synovial fluid are comparable with those stored in the capsular tissue. Twenty-one patients were enrolled. Both synovial fluid and capsular samples were collected during revision surgery and ceramic particles were isolated and analyzed by scanning electron microscopy and energy-dispersive X-ray microanalysis. It resulted a significant correlation between the samples couples (18 out of 21). This study confirms that the synovial fluid analysis can give a clear definition of the presence of particles in the joint capsule. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. [In vitro analysis of the continuous active patellofemoral kinematics of the normal and prosthetic knee].

    PubMed

    Jenny, J-Y; Lefèbvre, Y; Vernizeau, M; Lavaste, F; Skalli, W

    2002-12-01

    In vitro experiments are particularly useful for studying kinematic changes from the normal knee to experimental conditions simulating different disease states. We developed an experimental protocol allowing a kinematic analysis of the femorotibial and femoropatellar joints in the healthy knee and after implantation of a knee prosthesis, according to the central pivot during simulated active loaded movement from the standing to sitting position. An experimental device was designed to apply force to the femur of a cadaveric specimen including the femur, the patella and the tibia. The tibia was angled in the sagittal plane and the femur was free to move in space in response to the geometric movement of the knee joint, the capsuloligamentary structures, the quadriceps tendon and gravity. Variation in the length of the quadriceps tendon controlled the flexion-extension movement. The experimental setup included computer-controlled activation allowing continuous coordinated movement of the femur relative to the tibia and of the tibia relative to the ground. Standard activations simulated movement from the standing to the sitting position. Five pairs of fresh-frozen cadaver specimens including the entire femur, patella, tibia and fibula, the capsuloligamentary and intra-articular structures of the knee, the superior and inferior tibiofibular ligaments and the quadriceps tendon were studied. The quadriceps tendon was connected to the computer-guided activation device. Reflectors were fixed onto the anterior aspect of the femur, the superior tibial epiphysis and the center of the patella. Anatomic landmarks on the femur, the tibia, and the patella were identified to determine the plane of movement of each bone in the three rotation axes and the three translation directions. Three infrared cameras recorded movements of the reflectors fixed on the bony segments and, by mathematical transformation, the movement of the corresponding bony segment, displayed in time-course curves. The patella moved in continuous fashion over the femur, directly following the angle of knee flexion with a ratio of about 60%, which was constant for all knees studied and for all configurations. The patella of healthy knees and knees implanted with a unicompartmental prosthesis exhibited medial rotation during the first 30 degrees of flexion, with a movement of about of 10 degrees, then a lateral rotation of about 10 degrees to 20 degrees when the flexion reached 90 degrees; implantation of a total knee prosthesis led to a medial rotation which was continuous from 5 degrees to 15 degrees. There was a trend towards continuous abduction of about 10 degrees. The patella exhibited a continuous anterior translation of 10 to 20 mm from the tibia with increasing knee flexion, in both normal and prosthetic knees (unicompartmental prosthesis); knees implanted with a total knee prosthesis exhibited 5 to 10 mm anterior translation from 0 degrees to 50 degrees flexion, then an equivalent posterior translation for 50 degrees to 90 degrees flexion. The patella made a continuous 5 to 10 mm medial translation movement over the tibia in both normal and prosthetic (unicompartmental) knees; knees implanted with a total knee prosthesis exhibited 0 to 5 mm lateral translation starting after 50 degrees flexion. The patella also exhibited a continuous distal translation over the tibia of about 20 to 30 mm, for all configurations. The experimental set up enables a comparison of the kinetics of a normal knee with the kinetics observed after implantation of a prosthesis on the same knee. Implantation of a unicompartmental medial prosthesis, leaving the posterior cruciate ligament intact and irrespective of the status of the anterior cruciate ligament, did not, in these experimental conditions, exhibit any significant difference in the femorotibial or femoropatellar kinetics compared with the same normal knee. Implantation of a total knee prosthesis had a significant effect on the femoropatellar kinematics, compared with the same knee before implantation. The main anomalies were related to the medial-lateral rotation of the patella which exhibited an abnormal lateral rotation, possibly favorable for subluxation; these changes were directly related to femorotibial rotation after implantation of the total prosthesis and appeared to be related to the symmetry of the femoral condyles of the prosthesis model studied, perturbing the normal automatic rotation of the knee. There is thus a strong relationship between femorotibial and femoropatellar kinetics in the total knee prosthesis.

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

    PubMed

    Jiang, Ling; Liu, Yan-Qing; Cui, Li-Gang; Meng, Ying; Tian, Hua; Zhang, Ke; Wang, Jin-Rui

    2016-10-10

    Objective To explore the feasibility and clinical value of ultrasonography in evaluating the morphology and function of medial collateral ligaments (MCL) after total knee arthroplasty (TKA). Methods Totally 38 patients undergoing routine KTA (group A) and 22 patients undergoing constrained condylar knee arthroplasty KTA with MCL injury (group B) were included. Long axis views of MCL were taken and the MCL thickness was measured on femur side and tibial side 1 cm away from the joint line, respectively. The thicknesses were compared between the two groups. Subsequently, the gap between the metal part of the femoral prosthesis and the spacer after dynamic valgus stress was measured. The distribution and composition of the gap between the two groups were compared. Results High-frequency ultrasound clearly showed the prosthesis and MCL after TKA. MCL fiber structures of both groups were intact. The MCL thickness on the tibial side in group B was (0.25±0.06)cm, which was significantly thinner than group A [(0.32±0.14)cm] (t=2.12, P=0.040).For the femur side, there was no significant difference (t=1.65, P=0.110) between these two groups [(0.37±0.09) cm in group B versus (0.42±0.12)cm in group A]. Under the condition of valgus stress, the gaps between the metal part of the femoral prosthesis and the spacer could be found in 11 cases in group B but only in 1 case in group A. The proportion of gaps in group B was significantly higher than that in group A (Fisher's exact test, P=0.000). Conclusions High-frequency ultrasound can clearly show the prosthesis and MCL after TKA. The injured MCL can be well joined but the thickness is thinner. Under the condition of valgus stress of the knee, the stability of the TKA can be evaluated according to the gap between the prosthesis and the spacer.

  17. 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.

  18. Reconstruction with 3D-printed pelvic endoprostheses after resection of a pelvic tumour.

    PubMed

    Liang, H; Ji, T; Zhang, Y; Wang, Y; Guo, W

    2017-02-01

    The aims of this retrospective study were to report the feasibility of using 3D-printing technology for patients with a pelvic tumour who underwent reconstruction. A total of 35 patients underwent resection of a pelvic tumour and reconstruction using 3D-printed endoprostheses between September 2013 and December 2015. According to Enneking's classification of bone defects, there were three Type I lesions, 12 Type II+III lesions, five Type I+II lesions, two Type I+II+III lesions, ten type I+II+IV lesions and three type I+II+III+IV lesions. A total of three patients underwent reconstruction using an iliac prosthesis, 12 using a standard hemipelvic prosthesis and 20 using a screw-rod connected hemipelvic prosthesis. All patients had an en bloc resection. Margins were wide in 15 patients, marginal in 14 and intralesional in six. After a mean follow-up of 20.5 months (6 to 30), 25 patients survived without evidence of disease, five were alive with disease and five had died from metastatic disease. Complications included seven patients with delayed wound healing and two with a dislocation of the hip. None had a deep infection. For the 30 surviving patients, the mean Musculoskeletal Society 93 score was 22.7 (20 to 25) for patients with an iliac prosthesis, 19.8 (15 to 26) for those with a standard prosthesis, and 17.7 (9 to 25) for those with a screw-rod connected prosthesis. The application of 3D-printing technology can facilitate the precise matching and osseointegration between implants and the host bone. We found that the use of 3D-printed pelvic prostheses for reconstruction of the bony defect after resection of a pelvic tumour was safe, without additional complications, and gave good short-term functional results. Cite this article: Bone Joint J 2017;99-B:267-75. ©2017 The British Editorial Society of Bone & Joint Surgery.

  19. 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.

  20. 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

  1. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices... Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90... device intended to be implanted to replace part of a knee joint in the treatment of primary...

  2. 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.

  3. [The clinical value of cartilaginous surface and corresponding osseous contour of patellofemoral joint].

    PubMed

    Zhang, Jian-Bing; Chen, Bai-Cheng; Zhang, Jing; Wang, Zhi-Qiang; Yan, Chang-Bao

    2010-11-15

    to investigate if the cartilaginous surface and corresponding osseous contour of the patellofemoral joint match in the axial plane for providing theoretical basis with evaluating alignment of patellofemoral joint and designing the part of patellofemoral joint in knee prosthesis. from January 2009 to March 2010, 9 human cadaver knees were prepared, which chandra of patellofemoral joint didn't degenerate. Each specimen was sectioned in the axial plane at 20° to 30° knee flax. The cross-sections revealed characteristics in the bony anatomy and corresponding articular surface geometry of the patellofemoral joint in the axial plane. Evaluating parameters included osseous patella congruence angle (OPCA), chondral patella congruence angle (CPCA), patella chondral convex point parameter (PCCPP), patella subchondral osseous convex point parameter (PSOCPP), the parameters of the deepest (chondral or osseous) point of the intercondylar sulcus. After that, the osseous and cartilaginous contours and subchondral osseous contours of the patella in the axial plane were analyzed through MRI data of 11 patients who didn't degenerate in patellofemoral joint cartilage. Parameters as same as cadaver knees were compared. data from specimens of OPCA was (-4.5 ± 1.1)°, CPCA was (0.5 ± 0.8)°, PCCPP was 1.13 ± 0.11, PSOCPP was 1.67 ± 0.14, PCDPIS was 1.35 ± 0.28, PODPIS was 1.38 ± 0.33. Date from MRI of OPCA was (-3.8 ± 1.4)°, CPCA was (0.7 ± 1.0)°, PCCPP was 1.05 ± 0.21, PSOCPP was 1.73 ± 0.18, PCDPIS was 1.41 ± 0.21, PODPIS was 1.37 ± 0.27. The patella exhibited significant differences in the bony vs. chondral anatomy (P < 0.05), but the intercondylar sulcus nearly match in the bony vs. chondral anatomy. the cartilaginous surface and corresponding osseous contour of the patella don't match in the patellofemoral joint axial plane, but that of the trochlea nearly matches. This is very important for accurately evaluating alignment of patellofemoral joint because the normal osseous alignment of patellofemoral joint don't represent the normal alignment and helpful for designing the part of patellofemoral joint in knee prosthesis.

  4. Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

    ClinicalTrials.gov

    2018-06-07

    Surgical Wound; Revision Total Knee Arthroplasty; Wounds and Injuries; Joint Disease; Musculoskeletal Disease; Prosthesis-Related Infections; Infection; Postoperative Complications; Pathologic Processes

  5. 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.

  6. Estimation of continuous multi-DOF finger joint kinematics from surface EMG using a multi-output Gaussian Process.

    PubMed

    Ngeo, Jimson; Tamei, Tomoya; Shibata, Tomohiro

    2014-01-01

    Surface electromyographic (EMG) signals have often been used in estimating upper and lower limb dynamics and kinematics for the purpose of controlling robotic devices such as robot prosthesis and finger exoskeletons. However, in estimating multiple and a high number of degrees-of-freedom (DOF) kinematics from EMG, output DOFs are usually estimated independently. In this study, we estimate finger joint kinematics from EMG signals using a multi-output convolved Gaussian Process (Multi-output Full GP) that considers dependencies between outputs. We show that estimation of finger joints from muscle activation inputs can be improved by using a regression model that considers inherent coupling or correlation within the hand and finger joints. We also provide a comparison of estimation performance between different regression methods, such as Artificial Neural Networks (ANN) which is used by many of the related studies. We show that using a multi-output GP gives improved estimation compared to multi-output ANN and even dedicated or independent regression models.

  7. 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.

  8. Uncemented three-dimensional-printed prosthetic reconstruction for massive bone defects of the proximal tibia.

    PubMed

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

    2018-03-06

    Currently, it is challenging to treat massive bone defects of proximal tibia. Although numerous methods are available for reconstruction with epiphysis preservation, limitations in knee function and complications are noted with these methods. Our paper describes our attempt to reconstruct a marked defect in the proximal tibia with an uncemented three-dimensional (3D)-printed prosthesis and to evaluate the prosthesis design and short-term outcomes. A 15-year-old boy with metaphyseal osteosarcoma of the tibia underwent intercalary allograft reconstruction following wide tumour resection with epiphysis preservation. However, chronic allograft rejection and/or infection occurred after the surgery and a sinus tract was formed. The rejection and/or infection process was successfully stopped by the removal of the graft and implantation of an antibiotic-loaded cement spacer; however, the limb function was poor. Because of the irregular shape of the defect and the excessively short length of the residual proximal tibia, we used the 3D printing technology to design and fabricate a personalised prosthesis to reconstruct the defect, with the preservation of the knee joint. At the last follow-up at 26 months, the patient had satisfactory limb function. The 3D-printed prosthesis may be a feasible option in the reconstruction of tibial metaphyseal defects with the preservation of the knee joint. Moreover, it can result in good postoperative function and low complication rates. However, a long-term follow-up is required to clarify its long-term outcomes.

  9. Combining two open source tools for neural computation (BioPatRec and Netlab) improves movement classification for prosthetic control.

    PubMed

    Prahm, Cosima; Eckstein, Korbinian; Ortiz-Catalan, Max; Dorffner, Georg; Kaniusas, Eugenijus; Aszmann, Oskar C

    2016-08-31

    Controlling a myoelectric prosthesis for upper limbs is increasingly challenging for the user as more electrodes and joints become available. Motion classification based on pattern recognition with a multi-electrode array allows multiple joints to be controlled simultaneously. Previous pattern recognition studies are difficult to compare, because individual research groups use their own data sets. To resolve this shortcoming and to facilitate comparisons, open access data sets were analysed using components of BioPatRec and Netlab pattern recognition models. Performances of the artificial neural networks, linear models, and training program components were compared. Evaluation took place within the BioPatRec environment, a Matlab-based open source platform that provides feature extraction, processing and motion classification algorithms for prosthetic control. The algorithms were applied to myoelectric signals for individual and simultaneous classification of movements, with the aim of finding the best performing algorithm and network model. Evaluation criteria included classification accuracy and training time. Results in both the linear and the artificial neural network models demonstrated that Netlab's implementation using scaled conjugate training algorithm reached significantly higher accuracies than BioPatRec. It is concluded that the best movement classification performance would be achieved through integrating Netlab training algorithms in the BioPatRec environment so that future prosthesis training can be shortened and control made more reliable. Netlab was therefore included into the newest release of BioPatRec (v4.0).

  10. [Osteoarthritis of the trapeziometacarpal joint in men: different stakes. Results of three surgical techniques].

    PubMed

    Gallinet, D; Gasse, N; Blanchet, N; Tropet, Y; Obert, L

    2011-02-01

    Basal thumb arthritis is less common in men, but the functional implication is different in this manual worker or active retired population. The objective was to analyse the results of three surgical procedure in an exclusively men's population. Twenty-eight patients (19 partial trapeziectomy with interposition of a chondrocostal autograft, seven total trapeziectomy and two prosthesis), with a mean age of 69 years old, were reviewed at a mean follow-up of 71 months. Mobility and pain were similar in the three populations. But the strength and Dash scores were better in the cartilage group. Radiologically the length of the thumb ray was greater in the cartilage group and no signs of loosening were observed in the prosthesis group. The surgery of reference in this population is the arthrodesis of the trapeziometacarpal joint. But the lack of mobility is disabling, the strength is questionable and painlessness varies due to high rates of non-union. Only one study compared four surgical procedures in an exclusively male population and total trapeziectomy seemed to give the best results. But this technique carries risk of shortening of the thumb ray. Even if the comparison is difficult, the association of partial trapeziectomy with interposition of costal cartilage graft seems to give better stability to the thumb column by preserving length as well as greater strength compared to total trapeziectomy. We advocate this procedure for basal thumb arthritis in men. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  11. [Endoprostheses in geriatric traumatology].

    PubMed

    Buecking, B; Eschbach, D; Bliemel, C; Knobe, M; Aigner, R; Ruchholtz, S

    2017-01-01

    Geriatric traumatology is increasing in importance due to the demographic transition. In cases of fractures close to large joints it is questionable whether primary joint replacement is advantageous compared to joint-preserving internal fixation. The aim of this study was to describe the importance of prosthetic joint replacement in the treatment of geriatric patients suffering from frequent periarticular fractures in comparison to osteosynthetic joint reconstruction and conservative methods. A selective search of the literature was carried out to identify studies and recommendations concerned with primary arthroplasty of fractures in the region of the various joints (hip, shoulder, elbow and knee). The importance of primary arthroplasty in geriatric traumatology differs greatly between the various joints. Implantation of a prosthesis has now become the gold standard for displaced fractures of the femoral neck. In addition, reverse shoulder arthroplasty has become an established alternative option to osteosynthesis in the treatment of complex proximal humeral fractures. Due to a lack of large studies definitive recommendations cannot yet be given for fractures around the elbow and the knee. Nowadays, joint replacement for these fractures is recommended only if reconstruction of the joint surface is not possible. The importance of primary joint replacement for geriatric fractures will probably increase in the future. Further studies with larger patient numbers must be conducted to achieve more confidence in decision making between joint replacement and internal fixation especially for shoulder, elbow and knee joints.

  12. 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.

  13. Whole-body angular momentum during stair walking using passive and powered lower-limb prostheses.

    PubMed

    Pickle, Nathaniel T; Wilken, Jason M; Aldridge, Jennifer M; Neptune, Richard R; Silverman, Anne K

    2014-10-17

    Individuals with a unilateral transtibial amputation have a greater risk of falling compared to able-bodied individuals, and falling on stairs can lead to serious injuries. Individuals with transtibial amputations have lost ankle plantarflexor muscle function, which is critical for regulating whole-body angular momentum to maintain dynamic balance. Recently, powered prostheses have been designed to provide active ankle power generation with the goal of restoring biological ankle function. However, the effects of using a powered prosthesis on the regulation of whole-body angular momentum are unknown. The purpose of this study was to use angular momentum to evaluate dynamic balance in individuals with a transtibial amputation using powered and passive prostheses relative to able-bodied individuals during stair ascent and descent. Ground reaction forces, external moment arms, and joint powers were also investigated to interpret the angular momentum results. A key result was that individuals with an amputation had a larger range of sagittal-plane angular momentum during prosthetic limb stance compared to able-bodied individuals during stair ascent. There were no significant differences in the frontal, transverse, or sagittal-plane ranges of angular momentum or maximum magnitude of the angular momentum vector between the passive and powered prostheses during stair ascent or descent. These results indicate that individuals with an amputation have altered angular momentum trajectories during stair walking compared to able-bodied individuals, which may contribute to an increased fall risk. The results also suggest that a powered prosthesis provides no distinct advantage over a passive prosthesis in maintaining dynamic balance during stair walking. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. A review of extra-articular prosthetic stabilization of the cranial cruciate ligament-deficient stifle.

    PubMed

    Tonks, C A; Lewis, D D; Pozzi, A

    2011-01-01

    Extra-articular prosthetic stabilization techniques have been used as a method of stabilization of the cranial cruciate ligament (CrCL)-deficient stifle for decades. During extra-articular prosthetic stabilization, the prosthesis is anchored to the femur and tibia, and tensioned in the attempt to resolve femorotibial instability. The position of the anchor points of the prosthesis is crucial for restoring a normal range of joint motion and mitigating alterations in prosthesis tension during motion. Recently developed techniques offer several innovations with potential advantages such as bone-to-bone fixation, prosthetic materials with better mechanical properties, and improved isometry of the anchor points. Whether these innovations provide clinically superior results to the traditional techniques such as lateral circumfabellar-tibial suture techniques has yet to be determined.

  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. 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.

  17. The effect of segmental weight of prosthesis on hemodynamic responses and energy expenditure of lower extremity amputees

    PubMed Central

    Mutlu, Akmer; Kharooty, Mohammad Dawood; Yakut, Yavuz

    2017-01-01

    [Purpose] The aim of this study was to investigate the effect of segmental weight of the prosthesis on hemodynamic responses and energy expenditure in lower extremity amputees. [Subjects and Methods] Thirteen patients with a mean age of 44 ± 15.84 years and with unilateral transtibial, transfemoral and Syme’s amputation were included to the study. The difference between the lightest and the heaviest prosthesis, 250 g used as the weight. All the patients completed the measurements first without weight and then with 250 g weight on the ankle joint. The blood pressure and heart rate of the patients were recorded before and after Six Minute Walk Test (6MWT) and 10 stairs up & down stairs test. Physiological Cost Index was used to calculate the energy expenditure. [Results] Heart rate and energy expenditure increased significantly when without weight and with weight results compared. [Conclusion] We conclude that the segmental weight of the prosthetic limb has a significant effect on the heart rate and energy expenditure but has no effect on the systolic and diastolic blood pressure of lower limb amputees. In order to generalize our results to lower limb amputees, more patients need to be included in future studies. PMID:28533599

  18. Staged Reimplantation of a Total Hip Prosthesis After Co-infection with Candida tropicalis and Staphylococcus haemolyticus: A Case Report.

    PubMed

    Sebastian, Sujeesh; Malhotra, Rajesh; Pande, Ashish; Gautam, Deepak; Xess, Immaculata; Dhawan, Benu

    2018-06-01

    Fungal prosthetic joint infection is a rare complication in total joint arthroplasty. There are no established guidelines for management of these infections. We present a case of a 53-year-old male with a hip joint prosthesis co-infected with Candida tropicalis and Staphylococcus haemolyticus. A two-stage exchange arthroplasty was performed. The patient underwent implant removal, debridement, irrigation with saline solution and application of cement spacer impregnated with vancomycin followed by aggressive antimicrobial treatment in first stage. Complete eradication of infection was demonstrated by negative culture of sonicated cement spacer fluid and negative 16S rRNA and 18S rRNA gene PCR of sonicate fluid, synovial fluid and periprosthetic tissue samples. He underwent second-stage revision hip arthroplasty after 9 months of the first stage. At the latest follow-up, there was no evidence of recurrence of infection. This case illustrates the utility of sonication of biomaterials and molecular techniques for microbiological confirmation of absence of infection in staged surgeries which is required for a successful outcome.

  19. 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.

  20. 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.

  1. Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review

    PubMed Central

    2013-01-01

    Background The effectiveness of microprocessor-controlled prosthetic knee joints (MPKs) has been assessed using a variety of outcome measures in a variety of health and health-related domains. However, if the patient is to receive a prosthetic knee joint that enables him to function optimally in daily life, it is vital that the clinician has adequate information about the effects of that particular component on all aspects of persons’ functioning. Especially information concerning activities and participation is of high importance, as this component of functioning closely describes the person’s ability to function with the prosthesis in daily life. The present study aimed to review the outcome measures that have been utilized to assess the effects of microprocessor-controlled prosthetic knee joints (MPK), in comparison with mechanically controlled prosthetic knee joints, and aimed to classify these measures according to the components and categories of functioning defined by the International Classification of Functioning, Disability and Health (ICF). Subsequently, the gaps in the scientific evidence regarding the effectiveness of MPKs were determined. Methods A systematic literature search in 6 databases (i.e. PubMed, CINAHL, Cochrane Library, Embase, Medline and PsychInfo) identified scientific studies that compared the effects of using MPKs with mechanically controlled prosthetic knee joints on persons’ functioning. The outcome measures that have been utilized in those studies were extracted and categorized according to the ICF framework. Also, a descriptive analysis regarding all studies has been performed. Results A total of 37 studies and 72 outcome measures have been identified. The majority (67%) of the outcome measures that described the effects of using an MPK on persons’ actual performance with the prosthesis covered the ICF body functions component. Only 31% of the measures on persons’ actual performance investigated how an MPK may affect performance in daily life. Research also typically focused on young, fit and active persons. Conclusions Scientifically valid evidence regarding the performance of persons with an MPK in everyday life is limited. Future research should specifically focus on activities and participation to increase the understanding of the possible functional added value of MPKs. PMID:24279314

  2. Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review.

    PubMed

    Theeven, Patrick J R; Hemmen, Bea; Brink, Peter R G; Smeets, Rob J E M; Seelen, Henk A M

    2013-11-27

    The effectiveness of microprocessor-controlled prosthetic knee joints (MPKs) has been assessed using a variety of outcome measures in a variety of health and health-related domains. However, if the patient is to receive a prosthetic knee joint that enables him to function optimally in daily life, it is vital that the clinician has adequate information about the effects of that particular component on all aspects of persons' functioning. Especially information concerning activities and participation is of high importance, as this component of functioning closely describes the person's ability to function with the prosthesis in daily life. The present study aimed to review the outcome measures that have been utilized to assess the effects of microprocessor-controlled prosthetic knee joints (MPK), in comparison with mechanically controlled prosthetic knee joints, and aimed to classify these measures according to the components and categories of functioning defined by the International Classification of Functioning, Disability and Health (ICF). Subsequently, the gaps in the scientific evidence regarding the effectiveness of MPKs were determined. A systematic literature search in 6 databases (i.e. PubMed, CINAHL, Cochrane Library, Embase, Medline and PsychInfo) identified scientific studies that compared the effects of using MPKs with mechanically controlled prosthetic knee joints on persons' functioning. The outcome measures that have been utilized in those studies were extracted and categorized according to the ICF framework. Also, a descriptive analysis regarding all studies has been performed. A total of 37 studies and 72 outcome measures have been identified. The majority (67%) of the outcome measures that described the effects of using an MPK on persons' actual performance with the prosthesis covered the ICF body functions component. Only 31% of the measures on persons' actual performance investigated how an MPK may affect performance in daily life. Research also typically focused on young, fit and active persons. Scientifically valid evidence regarding the performance of persons with an MPK in everyday life is limited. Future research should specifically focus on activities and participation to increase the understanding of the possible functional added value of MPKs.

  3. [Total hip endoprosthesis following resection arthroplasty].

    PubMed

    Engelbrecht, E; Siegel, A; Kappus, M

    1995-08-01

    From 1976 to December 1994, a total of 347 patients underwent implantation of a hip prosthesis at the ENDO-Klinik for treatment of an unsatisfactory condition following resection arthroplasty. From 1976 to 1987, 143 patients were treated and in 1989 the results obtained in these patients were analysed: 99 of them were available for a follow-up examination in 1989, and 64 for a further examination in 1995. In 130 cases infection had been the reason for joint resection. At the time of the prosthesis operation (1-20 years later) intraoperative biopsy revealed that infection was still present in 41 cases (31.5%). Only 15 of these infections had been detected preoperatively by joint aspiration. This shows that the value of resection arthroplasty as a method of treating periprosthetic infection is limited and lends support to the one-stage exchange operation, which is the method we prefer in cases of infected hip prostheses. The operative technique and preparation for implantation of the prosthesis are described, as are septic and aseptic complications and the measures that can be taken to treat them. In spite of the patients' generally poor initial condition and with due consideration for the further revision operations, the medium-term results finally obtained are poor in only 9%.

  4. Cost analysis of debridement and retention for management of prosthetic joint infection.

    PubMed

    Peel, T N; Dowsey, M M; Buising, K L; Liew, D; Choong, P F M

    2013-02-01

    Prosthetic joint infection remains one of the most devastating complications of arthroplasty. Debridement and retention of the prosthesis is an attractive management option in carefully selected patients. Despite this, there are no data investigating the cost of this management modality for prosthetic joint infections. The aim of this case-control study was to calculate the cost associated with debridement and retention for management of prosthetic joint infection compared with primary joint replacement surgery without prosthetic joint infection. From 1 January 2008 to 30 June 2010, there were 21 prosthetic joint infections matched to 42 control patients. Controls were matched to cases according to the arthroplasty site, age and sex. Cases had a greater number of unplanned readmissions (100% vs. 7.1%; p <0.001), more additional surgery (3.3 vs. 0.07; p <0.001) and longer total bed days (31.6 vs. 7.9 days; p <0.001). In addition they had more inpatient, outpatient and emergency department visits (p <0.001, respectively). For patients with prosthetic joint infection the total cost, including index operation and costs of management of the prosthetic joint infection, was 3.1 times the cost of primary arthoplasty; the mean cost for cases was Australian dollars (AUD) $69,414 (±29,869) compared with $22,085 (±8147) (p <0.001). The demand for arthroplasty continues to grow and with that, the number of prosthetic joint infections will also increase, placing significant burden on the health system. Our study adds significantly to the growing body of evidence highlighting the substantial costs associated with prosthetic joint infection. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.

  5. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... degenerative and posttraumatic patellar arthritis. (2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis. (c) Date PMA or notice of completion of a PDP is required. A...

  6. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... degenerative and posttraumatic patellar arthritis. (2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis. (c) Date PMA or notice of completion of a PDP is required. A...

  7. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... degenerative and posttraumatic patellar arthritis. (2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis. (c) Date PMA or notice of completion of a PDP is required. A...

  8. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... degenerative and posttraumatic patellar arthritis. (2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis. (c) Date PMA or notice of completion of a PDP is required. A...

  9. Patient-specific musculoskeletal modeling of the hip joint for preoperative planning of total hip arthroplasty: A validation study based on in vivo measurements

    PubMed Central

    Schick, Fabian; Asseln, Malte; Damm, Philipp; Radermacher, Klaus

    2018-01-01

    Validation of musculoskeletal models for application in preoperative planning is still a challenging task. Ideally, the simulation results of a patient-specific musculoskeletal model are compared to corresponding in vivo measurements. Currently, the only possibility to measure in vivo joint forces is to implant an instrumented prosthesis in patients undergoing a total joint replacement. In this study, a musculoskeletal model of the AnyBody Modeling System was adapted patient-specifically and validated against the in vivo hip joint force measurements of ten subjects performing one-leg stance and level walking. The impact of four model parameters was evaluated; hip joint width, muscle strength, muscle recruitment, and type of muscle model. The smallest difference between simulated and in vivo hip joint force was achieved by using the hip joint width measured in computed tomography images, a muscle strength of 90 N/cm2, a third order polynomial muscle recruitment, and a simple muscle model. This parameter combination reached mean deviations between simulation and in vivo measurement during the peak force phase of 12% ± 14% in magnitude and 11° ± 5° in orientation for one-leg stance and 8% ± 6% in magnitude and 10° ± 5° in orientation for level walking. PMID:29649235

  10. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide...

  11. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide...

  12. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide...

  13. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide...

  14. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide...

  15. 21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...

  16. 21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...

  17. 21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...

  18. Ankle mechanics during sidestep cutting implicates need for 2-degrees of freedom powered ankle-foot prostheses.

    PubMed

    Ficanha, Evandro M; Rastgaar, Mohammad; Kaufman, Kenton R

    2015-01-01

    The ankle joint of currently available powered prostheses is capable of controlling one degree of freedom (DOF), focusing on improved mobility in the sagittal plane. To increase agility, the requirements of turning in prosthesis design need to be considered. Ankle kinematics and kinetics were studied during sidestep cutting and straight walking. There were no significant differences between the ankle sagittal plane mechanics when comparing sidestep cutting and straight walking; however, significant differences were observed in ankle frontal plane mechanics. During straight walking, the inversion-eversion (IE) angles were smaller than with sidestep cutting. The ankle that initiated the sidestep cutting showed progressively increasing inversion from 2 to 13 degrees while the following contralateral step showed progressively decreasing inversion from 8 to -4 degrees during normal walking speed. The changes in IE kinematics were the most significant during sidestep cutting compared with straight walking. The IE moments of the step that initiated the sidestep cutting were always in eversion, acting as a braking moment opposing the inverting motion. This suggests that an ankle-foot prosthesis with active DOFs in the sagittal and frontal planes will increase the agility of gait for patients with limb loss.

  19. Can We Achieve Intuitive Prosthetic Elbow Control Based on Healthy Upper Limb Motor Strategies?

    PubMed Central

    Merad, Manelle; de Montalivet, Étienne; Touillet, Amélie; Martinet, Noël; Roby-Brami, Agnès; Jarrassé, Nathanaël

    2018-01-01

    Most transhumeral amputees report that their prosthetic device lacks functionality, citing the control strategy as a major limitation. Indeed, they are required to control several degrees of freedom with muscle groups primarily used for elbow actuation. As a result, most of them choose to have a one-degree-of-freedom myoelectric hand for grasping objects, a myoelectric wrist for pronation/supination, and a body-powered elbow. Unlike healthy upper limb movements, the prosthetic elbow joint angle, adjusted prior to the motion, is not involved in the overall upper limb movements, causing the rest of the body to compensate for the lack of mobility of the prosthesis. A promising solution to improve upper limb prosthesis control exploits the residual limb mobility: like in healthy movements, shoulder and prosthetic elbow motions are coupled using inter-joint coordination models. The present study aims to test this approach. A transhumeral amputated individual used a prosthesis with a residual limb motion-driven elbow to point at targets. The prosthetic elbow motion was derived from IMU-based shoulder measurements and a generic model of inter-joint coordinations built from healthy individuals data. For comparison, the participant also performed the task while the prosthetic elbow was implemented with his own myoelectric control strategy. The results show that although the transhumeral amputated participant achieved the pointing task with a better precision when the elbow was myoelectrically-controlled, he had to develop large compensatory trunk movements. Automatic elbow control reduced trunk displacements, and enabled a more natural body behavior with synchronous shoulder and elbow motions. However, due to socket impairments, the residual limb amplitudes were not as large as those of healthy shoulder movements. Therefore, this work also investigates if a control strategy whereby prosthetic joints are automatized according to healthy individuals' coordination models can lead to an intuitive and natural prosthetic control. PMID:29456499

  20. Microbial biofilms on facial prostheses.

    PubMed

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

    2012-01-01

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

  1. 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.

  2. 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.

  3. Temporary arthrodesis using fixator rods in two-stage revision of septic knee prothesis with severe bone and tissue defects.

    PubMed

    Röhner, Eric; Pfitzner, Tilman; Preininger, Bernd; Zippelius, Timo; Perka, Carsten

    2016-01-01

    The present study describes a new temporary arthrodesis procedure, which aims for septic knee prosthesis replacement, in particular for larger bone and soft tissue defects. Our technique offers high stability and full weight-bearing capacity of the knee joint. The study included 16 patients with major bone defects (AORI type IIb or greater) after receiving a radical debridement and a septic two-stage revision total knee arthroplasty. After removing the infected prosthesis and debridement, two AO fixator rods were positioned into the intramedullary space of the femur and tibia. Subsequently, both rods were joined tube-to-tube and adjusted in the center of the knee joint. Finally, the whole cavity of the knee joint was filled with PMMA. The number of previous surgeries, bacterial spectrum, risk factors for further infection and reinfection rates was recorded. Immediately after the temporary arthrodesis, radiographs of the knee with the enclosed spacers were taken in order to compare to previous radiographs and avoiding to miss possible spacer loosening. Nine of sixteen patients underwent more than two revision surgeries before receiving our new arthrodesis technique. No cases of spacer loosening were observed in all 16 patients; further, there were no peri-implant fractures, and four persistent infections were noted. Temporary arthrodesis using AO fixator rods offers a high stability without loosening. Its potential to replace conventional augmentation techniques should be taken into account, particularly in the case of larger bone and tissue defects. In clinical practice, the cemented spacer using AO fixator rods could be an alternative technique for temporary knee arthrodesis after septic debridement. Retrospective case series, Level IV.

  4. Restoration of the joint geometry and outcome after stemless TESS shoulder arthroplasty

    PubMed Central

    von Engelhardt, Lars V; Manzke, Michael; Breil-Wirth, Andreas; Filler, Timm J; Jerosch, Joerg

    2017-01-01

    AIM To evaluate the joint geometry and the clinical outcome of stemless, anatomical shoulder arthroplasty with the TESS system. METHODS Twenty-one shoulders with a mean follow-up 18 of months were included. On scaled digital radiographs the premorbid center of rotation (CoR) was assessed and compared to the CoR of the prosthesis by using the MediCAD® software. Additionally, the pre- and post-operative geometry of the CoR was assessed in relation to the glenoid, the acromion as well as to the proximal humerus. Radiological changes, such as radiolucencies, were also assessed. Clinical outcome was assessed with the Constant and DASH score. RESULTS Both, the Constant and DASH scores improved significantly from 11% to 75% and from 70 to 30 points, P < 0.01 respectively. There were no significant differences regarding age, etiology, cemented or metal-backed glenoids, etc. (P > 0.05). The pre- and postoperative humeral offset, the lateral glenohumeral offset, the height of the CoR, the acromiohumeral distance as well as neck-shaft angle showed no significant changes (P > 0.05). The mean deviation of the CoR of the prosthesis from the anatomic center was 1.0 ± 2.8 mm. Three cases showed a medial deviation of more than 3 mm. These deviations of 5.1, 5.7 and 7.6 mm and were caused by an inaccurate humeral neck cut. These 3 patients showed a relatively poor outcome scoring. CONCLUSION TESS arthroplasty allows an anatomical joint reconstruction with a very good outcome. Outliers described in this study sensitize the surgeon for an accurate humeral neck cut. PMID:29094010

  5. Outcome of prosthesis matched and unmatched patella components in primary and revision total knee replacement.

    PubMed

    Lewis, Peter L; Gamboa, Ai E; Campbell, David G; Lorimer, Michelle

    2017-10-01

    Although knee replacements have specifically designed patella prostheses that correspond to the geometry of their femoral components, a patella prosthesis that is unmatched to the femoral component may occasionally be inserted. In revision total knee arthroplasty (TKA), an originally resurfaced patella may be left, but the femoral component revised to one that does not match the patella. Few studies have compared the outcome of matched and unmatched patella components in TKA. This study compared the primary or revision TKA outcome of procedures where patella components matched to their femoral counterparts were inserted, with procedures using patella and femoral components that were unmatched. Data on all primary and revision TKA procedures without a patella component or a matched or an unmatched patella component were obtained from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Revision surgery was the outcome measure. Cumulative percent revised (CPR) were calculated and Hazard ratios with p values were used to test statistical significance. In primary TKA, there were higher rates of revision where unmatched patella components were used, regardless of implant design. There was no difference in the second revision rates of unmatched versus matched patella component groups. This was evident where delayed resurfacing was carried out, and where the patella prosthesis was left alone but the femoral component was changed. All primary TKA procedures require a patella component corresponding to the femoral component if the patella is resurfaced. Conversely, revision knee arthroplasties are not affected by the use of dissimilar patella and femoral components. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. 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.

  7. [Knee arthrodesis using a customized intramedullary nail: 14 cases].

    PubMed

    Volpi, R; Dehoux, E; Touchard, P; Mensa, C; Segal, P

    2004-02-01

    We report our experience with knee arthrodesis using a customized intramedullary nail implanted in 14 patients. Indications for knee arthrodesis were: recurrent prosthesis infection (n=11), post-traumatic septic arthritis (n=1), aseptic loosening of a hinge prosthesis (n=1), and nonunion (n=1). A two-stage procedure was used for the 12 patients with infected joints. Mean follow-up was 19 months. Weight bearing began during the first week after arthrodesis in 13 patients. First intention bone healing was achieved in 13 patients. Mean time to healing was three months. All patients rapidly recovered full independence. Complications were: one misinsertion of the tibial stem, one nonunion which fused after repeated grafting, and two recurrent infections (controlled chronic fistulae) which required skin flaps for cover. We have found that this customized nail is a useful method for achieving bone fusion in patients with difficult indications for arthrodesis, particularly recurrent prosthesis infection.

  8. 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.

  9. Soft-Tissue Reconstruction of the Complicated Knee Arthroplasty: Principles and Predictors of Salvage.

    PubMed

    Colen, David L; Carney, Martin J; Shubinets, Valeriy; Lanni, Michael A; Liu, Tiffany; Levin, L Scott; Lee, Gwo-Chin; Kovach, Stephen J

    2018-04-01

    Total knee arthroplasty is a common orthopedic procedure in the United States and complications can be devastating. Soft-tissue compromise or joint infection may cause failure of prosthesis requiring knee fusion or amputation. The role of a plastic surgeon in total knee arthroplasty is critical for cases requiring optimization of the soft-tissue envelope. The purpose of this study was to elucidate factors associated with total knee arthroplasty salvage following complications and clarify principles of reconstruction to optimize outcomes. A retrospective review of patients requiring soft-tissue reconstruction performed by the senior author after total knee arthroplasty over 8 years was completed. Logistic regression and Fisher's exact tests determined factors associated with the primary outcome, prosthesis salvage versus knee fusion or amputation. Seventy-three knees in 71 patients required soft-tissue reconstruction (mean follow-up, 1.8 years), with a salvage rate of 61.1 percent, mostly using medial gastrocnemius flaps. Patients referred to our institution with complicated periprosthetic wounds were significantly more likely to lose their knee prosthesis than patients treated only within our system. Patients with multiple prior knee operations before definitive soft-tissue reconstruction had significantly decreased rates of prosthesis salvage and an increased risk of amputation. Knee salvage significantly decreased with positive joint cultures (Gram-negative greater than Gram-positive organisms) and particularly at the time of definitive reconstruction, which also trended toward an increased risk of amputation. In revision total knee arthroplasty, prompt soft-tissue reconstruction improves the likelihood of success, and protracted surgical courses and contamination increase failure and amputations. The authors show a benefit to involving plastic surgeons early in the course of total knee arthroplasty complications to optimize genicular soft tissues. Therapeutic, III.

  10. [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.

  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. 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.

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

    PubMed

    Fottner, Andreas; Schmid, Markus; Birkenmaier, Christof; Mazoochian, Farhad; Plitz, Wolfgang; Volkmar, Jansson

    2009-06-01

    Stemless and short-stemmed hip prostheses have been developed to preserve femoral bone stock. While all these prostheses claim a more or less physiological load transfer, clinical long-term results are only available for the stemless thrust plate prosthesis. In this study, the in vitro primary stability of the thrust plate prosthesis was compared to two types of short-stemmed prostheses. In addition to the well-established Mayo prosthesis, the modular Metha prosthesis was tested using cone adapters with 130 degrees and 140 degrees neck-shaft-angles. The prostheses were implanted in composite femurs and loaded dynamically (300-1700 N). Three-dimensional micromotions at the bone-prosthesis interface were measured. In addition, the three-dimensional deformations at the surface of the composite femur were measured to gain data on the strain distribution. For all tested prostheses, the micromotions did not exceed 150 microm, the critical value for osteointegration. The thrust plate prosthesis revealed similar motions as the short-stemmed prostheses. The short-stemmed prosthesis with the 130 degrees cone tended to have the highest micromotions of all tested short-stemmed prostheses. The thrust plate prosthesis revealed the lowest alteration of bone surface deformation after implantation. The comparably low micromotions of the thrust plate prosthesis and the short-stemmed prostheses should be conducive to osseous integration. The higher alteration of load transmission after implantation reveals a higher risk of stress shielding for the short-stemmed prostheses.

  14. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  15. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  16. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  17. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  18. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  19. Sound side joint contact forces in below knee amputee gait with an ESAR prosthetic foot.

    PubMed

    Karimi, Mohammad Taghi; Salami, Firooz; Esrafilian, Amir; Heitzmann, Daniel W W; Alimusaj, Merkur; Putz, Cornelia; Wolf, Sebastian I

    2017-10-01

    The incidence of knee and hip joint osteoarthritis in subjects with below knee amputation (BK) appears significantly higher compared to unimpaired subjects, especially in the intact side. However, it is controversial if constant higher loads on the sound side are one of the major factors for an increased osteoarthritis (OA) incidence in subjects with BK, beside other risk factors, e.g. with respect to metabolism. The aim wasto investigate joint contact forces (JCF) calculated by a musculoskeletal model in the intact side and to compare it with those of unimpaired subjects and to further elucidate in how far increased knee JCF are associated with increased frontal plane knee moments. A group of seven subjects with BK amputation and a group of ten unimpaired subjects were recruited for this study. Gait data were measured by 3D motion capture and force plates. OpenSim software was applied to calculate JCF. Maximum joint angles, ground reaction forces, and moments as well as time distance parameters were determined and compared between groups showing no significant differences, with some JCF components of knee and hip even being slightly smaller in subjects with BK compared to the reference group. This positive finding may be due to the selected ESAR foot. However, other beneficial factors may also have influenced this positive result such as the general good health status of the subjects or the thorough and proper fitting and alignment of the prosthesis. Copyright © 2017 Elsevier B.V. All rights reserved.

  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. Effects of Design Variants in Lower-Limb Prostheses on Gait Synergy

    PubMed Central

    Pitkin, Mark R.

    2016-01-01

    A lower-limb prosthesis is the mechanical device with which an amputee’s residual limb interacts with the walking surface. The pressure and shear forces that affect the residuum due to prosthesis use are the sources of pain, residual-limb skin problems and gait deviations. Direct approaches to reducing these problems include improving fit, alignment technique and socket design as well as increasing cushioning with socket liners. A summary of typical malalignments and their consequences is presented. The malalignments are considered sources of excessive moments applied to the residuum, which simplifies the analysis of a patient’s gait. A better design of prosthetic joints could improve prosthetic gait. This article addresses the key mechanical parameter of prosthetic joints, namely the dependence “moment of resistance/angle of deflection.” A mathematical model has been developed that links stresses on the residuum in transtibial amputees with the moment of resistance in the prosthetic ankle at the critical gait phases. Analysis of the model yields a substantial decrease in stresses on the residuum during the most demanding, load-bearing phase of stance if the moment of resistance in the ankle is similar to that seen in the biological ankle joint. Gait study shows use of the experimental rolling-joint prosthetic foot more closely simulates normal gait synergy than the SACH foot. PMID:27087763

  2. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

  3. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

  4. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

  5. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

  6. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

  7. Prosthetic joint infection caused by Pasteurella multocida: a case series and review of literature.

    PubMed

    Honnorat, Estelle; Seng, Piseth; Savini, Hélène; Pinelli, Pierre-Olivier; Simon, Fabrice; Stein, Andreas

    2016-08-20

    Pasteurella multocida is a well-recognized zoonotic agent following dog or cat bites or scratches. Nevertheless, prosthetic joint infection caused by P. multocida are rarely reported. We report here a series of six cases of prosthetic joint infection caused by P. multocida managed at a referral centre for the treatment of bone and joint infection in southern France. We also reviewed the 26 cases reported in literature. The mean age of our cases was 74 years [±8.2, range 63-85]. In majority of our cases (5 cases) were associated with knee prostheses and one case with a hip prosthesis. Most of cases occurred after cat or dog scratches or licks or contact. Diagnoses of prosthetic joint infection caused by P. multocida were made by positive cultures of surgical biopsies or needle aspiration. Mean time delay between prosthetic joint implantation and infection onset was 7.6 years (±5.12 years, range 2-17). Local inflammation, which occurred in all six cases, was the most frequent clinical symptom, followed by pain in five cases, fever and swollen joints in four cases, and a fistula with purulent discharge inside the wound in two cases. The mean time of antibiotic therapy was 8 months. Surgical treatment with prosthesis removal was performed in three cases. Six of our cases were in remission without apparent relapse at 3 years after end of treatment. Prosthetic joint infections caused by P. multocida usually occur after animal scratches or bites, but can occasionally occur after a short animal lick. These infections are usually resulting from a contiguous infection and localized in the knee. An early antibiotic therapy after surgical debridement could avoid prosthetic withdrawal, notably in elderly patients. Patients with prosthetic joints should be warned that animals are potential sources of serious infection and urgent medical advice should be sought if they are bitten or scratched.

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

    PubMed

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

    2017-10-01

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

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

    PubMed

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

    2010-06-01

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

  10. 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.

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

    PubMed

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

    2018-06-07

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

  12. Operating theatre ventilation systems and microbial air contamination in total joint replacement surgery: results of the GISIO-ISChIA study.

    PubMed

    Agodi, A; Auxilia, F; Barchitta, M; Cristina, M L; D'Alessandro, D; Mura, I; Nobile, M; Pasquarella, C

    2015-07-01

    Recent studies have shown a higher rate of surgical site infections in hip prosthesis implantation using unidirectional airflow ventilation compared with turbulent ventilation. However, these studies did not measure the air microbial quality of operating theatres (OTs), and assumed it to be compliant with the recommended standards for this ventilation technique. To evaluate airborne microbial contamination in OTs during hip and knee replacement surgery, and compare the findings with values recommended for joint replacement surgery. Air samplings were performed in 28 OTs supplied with unidirectional, turbulent and mixed airflow ventilation. Samples were collected using passive sampling to determine the index of microbial air contamination (IMA). Active sampling was also performed in some of the OTs. The average number of people in the OT and the number of door openings during the sampling period were recorded. In total, 1228 elective prosthesis procedures (60.1% hip and 39.9% knee) were included in this study. Of passive samplings performed during surgical activity in unidirectional airflow ventilation OTs (U-OTs) and mixed airflow OTs (M-OTs), 58.9% and 87.6% had IMA values >2, respectively. Of samplings performed during surgical activity in turbulent airflow OTs (T-OTs) and in turbulent airflow OTs with the surgical team wearing Steri-Shield Turbo Helmets (TH-OTs), 8.6% and 60% had IMA values ≤ 2, respectively. Positive correlation was found between IMA values and the number of people in the OT and the number of door openings (P < 0.001). In addition, correlation was found between active and passive sampling (P < 0.001). These findings challenge the belief that unidirectional systems always provide acceptable airborne bacterial counts. Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  13. 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.

  14. [Principles of management of periprosthetic fractures].

    PubMed

    Röderer, G; Gebhard, F; Scola, A

    2016-03-01

    The increasing numbers of primary total hip and knee replacements have subsequently led to growing rates of periprosthetic fractures. In many cases geriatric patients with osteopenia or osteoporotic bone quality are affected. The goal of treatment is the retention or reconstruction of joint function using open reduction and internal fixation or a revision prosthesis. The aim of this article is a description of the basic principles of treatment of periprosthetic fractures of the lower extremities. An exact description of the fracture using current classification systems with imaging diagnostics is mandatory. This also includes an assessment of the stability of the prosthesis. In the case of a stable prosthesis and a good bone stock open reduction and internal fixation should be performed. In these cases locking plates are standard procedure. If fracture reduction is possible minimally invasive procedures can be performed which help to reduce the surgical trauma and accelerate rehabilitation. If the prosthesis is loose it has to be exchanged for a revision implant. If vast bony defects result they can be augmented using wedges. Conservative treatment plays only a subordinate role in selected cases. Periprosthetic fractures show an increasing incidence and occur more frequently in the geriatric patient population. Due to comorbidities and poor bone quality surgical treatment is a challenge. The fracture must be exactly classified using the appropriate classification system in order to clarify if the prosthesis can be retained or if it has to be exchanged.

  15. [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.

  16. 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.

  17. The accuracy and precision of radiostereometric analysis in upper limb arthroplasty.

    PubMed

    Ten Brinke, Bart; Beumer, Annechien; Koenraadt, Koen L M; Eygendaal, Denise; Kraan, Gerald A; Mathijssen, Nina M C

    2017-06-01

    Background and purpose - Radiostereometric analysis (RSA) is an accurate method for measurement of early migration of implants. Since a relation has been shown between early migration and future loosening of total knee and hip prostheses, RSA plays an important role in the development and evaluation of prostheses. However, there have been few RSA studies of the upper limb, and the value of RSA of the upper limb is not yet clear. We therefore performed a systematic review to investigate the accuracy and precision of RSA of the upper limb. Patients and methods - PRISMA guidelines were followed and the protocol for this review was published online at PROSPERO under registration number CRD42016042014. A systematic search of the literature was performed in the databases Embase, Medline, Cochrane, Web of Science, Scopus, Cinahl, and Google Scholar on April 25, 2015 based on the keywords radiostereometric analysis, shoulder prosthesis, elbow prosthesis, wrist prosthesis, trapeziometacarpal joint prosthesis, humerus, ulna, radius, carpus. Articles concerning RSA for the analysis of early migration of prostheses of the upper limb were included. Quality assessment was performed using the MINORS score, Downs and Black checklist, and the ISO RSA Results - 23 studies were included. Precision values were in the 0.06-0.88 mm and 0.05-10.7° range for the shoulder, the 0.05-0.34 mm and 0.16-0.76° range for the elbow, and the 0.16-1.83 mm and 11-124° range for the TMC joint. Accuracy data from marker- and model-based RSA were not reported in the studies included. Interpretation - RSA is a highly precise method for measurement of early migration of orthopedic implants in the upper limb. However, the precision of rotation measurement is poor in some components. Challenges with RSA in the upper limb include the symmetrical shape of prostheses and the limited size of surrounding bone, leading to over-projection of the markers by the prosthesis. We recommend higher adherence to RSA guidelines and encourage investigators to publish long-term follow-up RSA studies.

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

    PubMed

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

    2015-07-01

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

  19. 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

  20. Synovial fluid multiplex PCR is superior to culture for detection of low-virulent pathogens causing periprosthetic joint infection.

    PubMed

    Morgenstern, Christian; Cabric, Sabrina; Perka, Carsten; Trampuz, Andrej; Renz, Nora

    2018-02-01

    Analysis of joint aspirate is the standard preoperative investigation for diagnosis of periprosthetic joint infection (PJI). We compared the diagnostic performance of culture and multiplex polymerase chain reaction (PCR) of synovial fluid for diagnosis of PJI. Patients in whom aspiration of the prosthetic hip or knee joint was performed before revision arthroplasty were prospectively included. The performance of synovial fluid culture and multiplex PCR was compared by McNemar's chi-squared test. A total of 142 patients were included, 82 with knee and 60 with hip prosthesis. PJI was diagnosed in 77 patients (54%) and aseptic failure in 65 patients (46%). The sensitivity of synovial fluid culture and PCR was 52% and 60%, respectively, showing concordant results in 116 patients (82%). In patients with PJI, PCR missed 6 high-virulent pathogens (S. aureus, streptococci, E. faecalis, E. coli) which grew in synovial fluid culture, whereas synovial fluid culture missed 12 pathogens detected by multiplex PCR, predominantly low-virulent pathogens (Cutibacterium acnes and coagulase-negative staphylococci). In patients with aseptic failure, PCR detected 6 low-virulent organisms (predominantly C. acnes). While the overall performance of synovial fluid PCR was comparable to culture, PCR was superior for detection of low-virulent bacteria such as Cutibacterium spp. and coagulase-negative staphylococci. In addition, synovial fluid culture required several days for growth, whereas multiplex PCR provided results within 5hours in an automated manner. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    PubMed Central

    Herr, Hugh M.; Grabowski, Alena M.

    2012-01-01

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

  2. Management of the patient with a total joint replacement: the primary care practitioner's role.

    PubMed

    Palmer, L M

    1999-01-01

    The primary care practitioner assumes chief responsibility for patients with arthritis. More than 40 million Americans experience some form of arthritis. Management of the patient with arthritis may include a referral to an orthopedic surgeon for surgical intervention. As estimated, up to 500,000 total joint replacement procedures are performed by orthopedic surgeons each year in the United States. Presurgical evaluation for a total joint replacement is imperative to ensure that the patient can safely undergo this surgical procedure. Postsurgical care of a patient with total joint replacement involves coordinating care with the physical therapist and orthopedic surgeon to ensure adequate follow-through with the recommended rehabilitation program, prophylactic antibiotic coverage, and observation for any complications including infection, deep-vein thrombosis, or loosening of the total-joint prosthesis.

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

    PubMed Central

    Rosenberg, Nahum; Neumann, Lars; Modi, Amit; Mersich, Istvan J; Wallace, Angus W

    2007-01-01

    Background The uncemented Nottingham Total Shoulder Replacement prosthesis system (Nottingham TSR) was developed from the previous BioModular® shoulder prosthesis taking into consideration the causes of the initial implant's failure. We investigated the impact of changes in the design of Nottingham TSR prosthesis on its survivorship rate. Methods Survivorship analyses of three types of uncemented total shoulder arthroplasty prostheses (BioModular®, initial Nottingham TSR and current Nottingham TSR systems with 11, 8 and 4 year survivorship data respectively) were compared. All these prostheses were implanted for the treatment of disabling pain in the shoulder due to primary and secondary osteoarthritis or rheumatoid arthritis. Each type of the prosthesis studied was implanted in consecutive group of patients – 90 patients with BioModular® system, 103 with the initial Nottingham TSR and 34 patients with the current Nottingham TSR system. The comparison of the annual cumulative survivorship values in the compatible time range between the three groups was done according to the paired t test. Results The 8-year and 11-year survivorship rates for the initially used modified BioModular® uncemented prosthesis were relatively low (75.6% and 71.7% respectively) comparing to the reported survivorship of the conventional cemented implants. The 8-year survivorship for the uncemented Nottingham TSR prosthesis was significantly higher (81.8%), but still not in the desired range of above 90%, that is found in other cemented designs. Glenoid component loosening was the main factor of prosthesis failure in both prostheses and mainly occurred in the first 4 postoperative years. The 4-year survivorship of the currently re-designed Nottingham TSR prosthesis, with hydroxylapatite coating of the glenoid baseplate, was significantly higher, 93.1% as compared to 85.1% of the previous Nottingham TSR. Conclusion The initial Nottingham shoulder prosthesis showed significantly higher survivorship than the BioModular® uncemented prosthesis, but lower than expected. Subsequently re-designed Nottingham TSR system presented a high short term survivorship rate that encourages its ongoing use PMID:17683577

  4. Insufficient sensitivity of joint aspiration during the two-stage exchange of the hip with spacers.

    PubMed

    Boelch, Sebastian Philipp; Weissenberger, Manuel; Spohn, Frederik; Rudert, Maximilian; Luedemann, Martin

    2018-01-10

    Evaluation of infection persistence during the two-stage exchange of the hip is challenging. Joint aspiration before reconstruction is supposed to rule out infection persistence. Sensitivity and specificity of synovial fluid culture and synovial leucocyte count for detecting infection persistence during the two-stage exchange of the hip were evaluated. Ninety-two aspirations before planned joint reconstruction during the two-stage exchange with spacers of the hip were retrospectively analyzed. The sensitivity and specificity of synovial fluid culture was 4.6 and 94.3%. The sensitivity and specificity of synovial leucocyte count at a cut-off value of 2000 cells/μl was 25.0 and 96.9%. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) values were significantly higher before prosthesis removal and reconstruction or spacer exchange (p = 0.00; p = 0.013 and p = 0.039; p = 0.002) in the infection persistence group. Receiver operating characteristic area under the curve values before prosthesis removal and reconstruction or spacer exchange for ESR were lower (0.516 and 0.635) than for CRP (0.720 and 0.671). Synovial fluid culture and leucocyte count cannot rule out infection persistence during the two-stage exchange of the hip.

  5. 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.

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

    PubMed

    Horehledova, Barbora; Mihl, Casper; Hendriks, Babs M F; Eijsvoogel, Nienke G; Vainer, Jindrich; Veenstra, Leo F; Wildberger, Joachim E; Das, Marco

    2018-06-16

    Incorrect prosthesis size has direct impact on patient outcome after transcatheter aortic valve implantation (TAVI) procedure. Currently, annular diameter, area or perimeter may be used for prosthesis size selection. The aim was to evaluate whether the use different annular dimensions would result in the selection of different prosthesis sizes, when assessed in the same TAVI-candidate during the same phase of a cardiac cycle. Fifty consecutive TAVI-candidates underwent retrospectively ECG-gated computed tomography angiography (CTA). Aortic root dimensions were assessed in the 20% phase of the R-R interval. Annular short diameter, perimeter and area were used to select the prosthesis size, based on the industry recommendations for a self-expandable (Medtronic CoreValve; MCV) and balloon-expandable (Edwards Sapien XT Valve; ESV) valve. Complete agreement on selected prosthesis size amongst all three annular dimensions was observed in 62% (31/50; ESV) and 30% (15/50; MCV). Short aortic annulus measurement resulted in a smaller prosthesis size in 20% (10/50; ESV) and in 60% of cases (30/50; MCV) compared to the size suggested by both annular perimeter and area. In 18% (9/50; ESV) and 10% of cases (5/50; MCV) a larger prosthesis would have been selected based on annular perimeter compared to annular diameter and area. Prosthesis size derived from area was always in agreement with at least one other parameter in all cases. Aortic annulus area appears to be the most robust parameter for TAVI-prosthesis size selection, regardless of the specific prosthesis size. Short aortic annulus diameter may underestimate the prosthesis size, while use of annular perimeter may lead to size overestimation in some cases.

  7. 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.

  8. [Joint endoprosthesis pathology. Histopathological diagnostics and classification].

    PubMed

    Krenn, V; Morawietz, L; Jakobs, M; Kienapfel, H; Ascherl, R; Bause, L; Kuhn, H; Matziolis, G; Skutek, M; Gehrke, T

    2011-05-01

    Prosthesis durability has steadily increased with high 10-year rates of 88-95%. However, four pathogenetic groups of diseases can decrease prosthesis durability: (1) periprosthetic wear particle disease (aseptic loosening) (2) bacterial infection (septic loosening) (3) periprosthetic ossification, and (4) arthrofibrosis. The histopathological "extended consensus classification of periprosthetic membranes" includes four types of membranes, arthrofibrosis, and osseous diseases of endoprosthetics: The four types of neosynovia are: wear particle-induced type (type I), mean prosthesis durability (MPD) in years 12.0; infectious type (type II), MPD 2.5; combined type (type III) MPD 4.2; and indeterminate type (type IV), MPD 5.5. Arthrofibrosis can be determined in three grades: grade 1 needs clinical information to be differentiated from a type IV membrane, and grades 2 & 3 can be diagnosed histopathologically. Periprosthetic ossification, osteopenia-induced fractures, and aseptic osteonecrosis can be histopathologically diagnosed safely with clinical information. The extended consensus classification of periprosthetic membranes may be a diagnostic groundwork for a future national endoprosthesis register.

  9. Assessing physical function in adult acquired major upper-limb amputees by combining the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Questionnaire and clinical examination.

    PubMed

    Ostlie, Kristin; Franklin, Rosemary J; Skjeldal, Ola H; Skrondal, Anders; Magnus, Per

    2011-10-01

    To describe physical function in adult acquired major upper-limb amputees (ULAs) by combining self-assessed arm function and physical measures obtained by clinical examinations; to estimate associations between background factors and self-assessed arm function in ULAs; and to assess whether clinical examination findings may be used to detect reduced arm function in unilateral ULAs. postal questionnaires and clinical examinations. Norwegian ULA population. Clinical examinations performed at 3 clinics. Questionnaires: population-based sample (n=224; 57.4% response rate). Clinical examinations: combined referred sample and convenience sample of questionnaire responders (n=70; 83.3% of those invited). SURVEY inclusion criteria: adult acquired major upper-limb amputation, resident in Norway, mastering of spoken and written Norwegian. Not applicable. The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Questionnaire, and clinical examination of joint motion and muscle strength with and without prostheses. Mean DASH score was 22.7 (95% confidence interval [CI], 20.3-25.0); in bilateral amputees, 35.7 (95% CI, 23.0-48.4); and in unilateral amputees, 22.1 (95% CI, 19.8-24.5). A lower unilateral DASH score (better function) was associated with paid employment (vs not in paid employment: adjusted regression coefficient [aB]=-5.40, P=.033; vs students: aB=-13.88, P=.022), increasing postamputation time (aB=-.27, P=.001), and Norwegian ethnicity (aB=-14.45, P<.001). At clinical examination, we found a high frequency of impaired neck mobility and varying frequencies of impaired joint motion and strength at the shoulder, elbow, and forearm level. Prosthesis wear was associated with impaired joint motion in all upper-limb joints (P<.006) and with reduced shoulder abduction strength (P=.002). Impaired without-prosthesis joint motion in shoulder flexion (ipsilateral: aB=12.19, P=.001) and shoulder abduction (ipsilateral: aB=12.01, P=.005; contralateral: aB=28.82, P=.004) was associated with increased DASH scores. Upper-limb loss clearly affects physical function. DASH score limitation profiles may be useful in individual clinical assessments. Targeted clinical examination may indicate patients with extra rehabilitational needs. Such examinations may be of special importance in relation to prosthesis function. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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

    PubMed

    Zollinger, Paul E; Unal, Halil; Ellis, Maarten L; Tuinebreijer, Wim E

    2010-02-17

    Complex regional pain syndrome (CRPS) type I may occur as complication after any type of surgery for basal joint arthritis of the thumb. We investigated prospectively in an ongoing study our results after a fully standardized treatment with a total joint prosthesis under vitamin C prophylaxis.Patients with trapeziometacarpal arthritis stage II or III according to Dell, and no benefit from conservative treatment, were selected to undergo joint replacement with a semi-constrained hydroxyapatite coated prosthesis.First web opening and visual analogue scale (VAS) scores for pain, activities of daily living (ADL) and satisfaction were taken pre and postoperatively. Vitamin C 500 mg daily was started two days prior to surgery during 50 days as prevention for CRPS. Post-operative treatment was functional.We performed 40 implantations for trapeziometacarpal arthritis in 34 patients (mean age 60.8 years; 27 females, 7 males) with a mean follow-up of 44 months. Operations were performed in day care under regional (or general) anesthesia.First web opening increased with 15.4 degrees and there was a significant improvement for pain, ADL and satisfaction as well (p = 0.000). Patient satisfaction was strongly associated with the amount of pain reduction. According to the Veldman and IASP criteria, there were no cases of CRPS.The overall complication rate for this procedure is high. Literature reports 5 cases of CRPS after 38 operations with the same implant (13%). We advise vitamin C as prophylaxis against CRPS in trapeziometacarpal joint replacement.

  11. 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.

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

    PubMed

    Polat, Beldan; Orhan, Kadir Serkan; Kesimli, Mustafa Caner; Gorgulu, Yasemin; Ulusan, Murat; Deger, Kemal

    2015-11-01

    This study aims to evaluate the effects of voice rehabilitation with indwelling voice prosthesis on quality of life, depression, anxiety, self-esteem, and sexual functions in laryngectomy patients. Provox-1 was applied to 30 patients who underwent total laryngectomy by opening a tracheoesophageal fistula. WHO Quality of Life-BREF, Beck Depression Inventory, Beck Anxiety Inventory, Rosenberg Self-Esteem Scale, Arizona Sexual Experience Scale forms were asked to be filled out by the patients before voice prosthesis application. These tests were asked to be filled out again 3 months later after the voice prosthesis application. Paired samples and Wilcoxon tests were used to compare before and after operation values. Indwelling voice prosthesis was found to improve quality of life, self-esteem, and sexual function (p < 0.05). Additionally, symptoms of depression and anxiety were regressed (p < 0.05). Indwelling voice prosthesis was found to especially increase the quality of life and decrease depression (p < 0.05). This study is an uncontrolled single-arm study comparing patients' psychosocial statuses pre- and post-voice prosthesis.

  13. 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 time on learning fine control aspects of the prosthetic hand during rehabilitation. Moreover, training should start with the indirect grasping task that has the best performance, which is probably due to the higher amount of useful information available from the sound hand. PMID:24568148

  14. [Surgical technique and clinical results of total knee arthroplasty in treating endstage gonarthrosis combined with valgus knee deformity].

    PubMed

    Wang, Xingshan; Weng, Xisheng; Lin, Jin; Jin, Jin; Qian, Wenwei

    2012-05-01

    To investigate the surgical technique and the clinical results of total knee arthroplasty (TKA) in treating end-stage gonarthrosis combined with valgus knee deformity. Between November 1998 and October 2010, 64 patients (72 knees) with end-stage gonarthrosis combined with valgus knee deformity underwent TKA by a medial parapatellar approach. Of the 64 patients, 18 were male and 46 were female with an average age of 62.5 years (range, 23-82 years), including 44 cases (49 knees) of osteoarthritis, 17 cases (20 knees) of rheumatoid arthritis, 2 cases (2 knees) of haemophilic arthritis, and 1 case (1 knee) of post-traumatic arthritis. Bilateral knees were involved in 8 cases, and single knee in 56 cases. The flexion and extension range of motion (ROM) of the knee joint was (82.2 +/- 28.7) degrees; the femur-tibia angle (FTA) was (18.0 +/- 5.8) degrees; according to Knee Society Score (KSS) criterion, the preoperative clinical score was 31.2 +/- 10.1 and functional score was 37.3 +/- 9.0. According to Krackow's classification, there were 65 knees of type I and 7 knees of type II. By medial parapatellar approach, conventional osteotomy and Ranawat soft tissue release were performed in all cases. Prosthesis of preserved posterior cruciate ligament were used in 7 cases (7 knees), posterior stabilize prosthesis in 54 cases (60 knees), constrained prosthesis in 4 cases (5 knees). Incisions healed by first intention in all cases. Peroneal nerve palsy occurred in 1 patient with haemophilic arthritis, severe valgus deformity (FTA was 41 degrees), and flexion contracture (20 degrees), which was cured after 1 year of conservative treatment. Revison surgery was performed in 1 case of deep infection at 2 years after surgery. All the patients were followed up 4.9 years on average (range, 1-13 years). At last follow-up, the FTA was (7.0 +/- 2.5) degrees, showing significant difference when compared with preoperative value (t = 15.502, P = 0.000). The KSS clinical score was 83.0 +/- 6.6 and functional score was 85.1 +/- 10.5, the flexion and extension ROM of the knee joint was (106.1 +/- 17.0) degrees, all showing significant differences when compared with preoperative values (P < 0.05). Five patients had 12-15 degrees valgus knee deformity, but the function of the affect knees were good. TKA is an effective way for the patients with end-stage gonarthrosis combined with valgus knee deformity by medial parapatellar approach combined with conventional osteotomy and Ranawat soft tissue release. The correction of deformity and improvement of joint function can be achieved significantly. The clinical result is satisfactory.

  15. 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.

  16. Applications of rapid prototyping technology in maxillofacial prosthetics.

    PubMed

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

    2004-01-01

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

  17. 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.

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

    PubMed

    Green, J Douglas; McElveen, John T

    2017-04-01

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

  19. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  20. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  1. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  2. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  3. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

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

    PubMed

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

    2015-03-24

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

  5. Constructing a simple parametric model of shoulder from medical images

    NASA Astrophysics Data System (ADS)

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

    2006-02-01

    The modelling of the shoulder joint is an important step to set a Computer-Aided Surgery System for shoulder prosthesis placement. Our approach mainly concerns the bones structures of the scapulo-humeral joint. Our goal is to develop a tool that allows the surgeon to extract morphological data from medical images in order to interpret the biomechanical behaviour of a prosthesised shoulder for preoperative and peroperative virtual surgery. To provide a light and easy-handling representation of the shoulder, a geometrical model composed of quadrics, planes and other simple forms is proposed.

  6. Tribology and total hip joint replacement: current concepts in mechanical simulation.

    PubMed

    Affatato, S; Spinelli, M; Zavalloni, M; Mazzega-Fabbro, C; Viceconti, M

    2008-12-01

    Interest in the rheology and effects of interacting surfaces is as ancient as man. This subject can be represented by a recently coined word: tribology. This term is derived from the Greek word "tribos" and means the "science of rubbing". Friction, lubrication, and wear mechanism in the common English language means the precise field of interest of tribology. Wear of total hip prosthesis is a significant clinical problem that involves, nowadays, a too high a number of patients. In order to acquire further knowledge on the tribological phenomena that involve hip prosthesis wear tests are conducted on employed materials to extend lifetime of orthopaedic implants. The most basic type of test device is the material wear machine, however, a more advanced one may more accurately reproduce some of the in vivo conditions. Typically, these apparatus are called simulators, and, while there is no absolute definition of a joint simulator, its description as a mechanical rig used to test a joint replacement, under conditions approximating those occurring in the human body, is acceptable. Simulator tests, moreover, can be used to conduct accelerated protocols that replicate/simulate particularly extreme conditions, thus establishing the limits of performance for the material. Simulators vary in their level of sophistication and the international literature reveals many interpretations of the design of machines used for joint replacement testing. This paper aims to review the current state of the art of the hip joint simulators worldwide. This is specified through a schematic overview by describing, in particular, constructive solutions adopted to reproduce in vivo conditions. An exhaustive commentary on the evolution and actually existing simulation standards is proposed by the authors. The need of a shared protocol among research laboratories all over the world could lead to a consensus conference.

  7. Staged lengthening arthroplasty for pediatric osteosarcoma around the knee.

    PubMed

    Kong, Chang-Bae; Lee, Soo-Yong; Jeon, Dae-Geun

    2010-06-01

    Orthopaedic oncologists often must address leg-length discrepancy after resection of tumors in growing patients with osteosarcoma. There are various alternatives to address this problem. We describe a three-stage procedure: (1) temporary arthrodesis, (2) lengthening by Ilizarov apparatus, and (3) tumor prosthesis. We asked (1) to what extent are affected limbs actually lengthened; (2) how many of the patients who undergo a lengthening procedure eventually achieve joint arthroplasty; and (3) can the three-stage procedure give patients a functioning joint with equalization of limb length? We reviewed 56 patients (younger than 14 years) with osteosarcoma who had staged lengthening arthroplasty between 1991 and 2004. Thirty-five of the 56 patients (63%) underwent soft tissue lengthening, and of these 35, 28 (50% of the original group of 56) had implantation of a mobile joint. Three of the 28 prostheses were later removed owing to infection after arthroplasty. The overall average length gained was 7.8 cm (range, 4-14 cm), and 25 (71%) of the 35 patients had a mobile joint at final followup. The average Musculoskeletal Tumor Society functional score was 23.2 (range, 15-28) and limb-length discrepancy at final followup was 2.6 cm (range, 0-6.5 cm). Although most mobile joints had an acceptable ROM (average, 74.2 degrees ; range, 35 degrees -110 degrees ), extension lag was frequent. Our approach is one option for skeletally immature patients, especially in situations where an expandable prosthesis is not available. However, this technique requires multiple stages and would be inappropriate for patients who cannot accept prolonged functional deficit owing to a limited lifespan or other reasons. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

  8. 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)

  9. A Mobile Motion Analysis System Using Intertial Sensors for Analysis of Lower Limb Prosthetics

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

    Mueller, John Kyle P; Ericson, Milton Nance; Farquhar, Ethan

    Soldiers returning from the global war on terror requiring lower leg prosthetics generally have different concerns and requirements than the typical lower leg amputee. These subjects are usually young, wish to remain active and often desire to return to active military duty. As such, they demand higher performance from their prosthetics, but are at risk for chronic injury and joint conditions in their unaffected limb. Motion analysis is a valuable tool in assessing the performance of new and existing prosthetic technologies as well as the methods in fitting these devices to both maximize performance and minimize risk of injury formore » the individual soldier. We are developing a mobile, low-cost motion analysis system using inertial measurement units (IMUs) and two custom force sensors that detect ground reaction forces and moments on both the unaffected limb and prosthesis. IMUs were tested on a robot programmed to simulate human gait motion. An algorithm which uses a kinematic model of the robot and an extended Kalman filter (EKF) was used to convert the rates and accelerations from the gyro and accelerometer into joint angles. Compared to encoder data from the robot, which was considered the ground truth in this experiment, the inertial measurement system had a RMSE of <1.0 degree. Collecting kinematic and kinetic data without the restrictions and expense of a motion analysis lab could help researchers, designers and prosthetists advance prosthesis technology and customize devices for individuals. Ultimately, these improvements will result in better prosthetic performance for the military population.« less

  10. Molecularly specific detection of bacterial lipoteichoic acid for diagnosis of prosthetic joint infection of the bone.

    PubMed

    Pickett, Julie E; Thompson, John M; Sadowska, Agnieszka; Tkaczyk, Christine; Sellman, Bret R; Minola, Andrea; Corti, Davide; Lanzavecchia, Antonio; Miller, Lloyd S; Thorek, Daniel Lj

    2018-01-01

    Discriminating sterile inflammation from infection, especially in cases of aseptic loosening versus an actual prosthetic joint infection, is challenging and has significant treatment implications. Our goal was to evaluate a novel human monoclonal antibody (mAb) probe directed against the Gram-positive bacterial surface molecule lipoteichoic acid (LTA). Specificity and affinity were assessed in vitro. We then radiolabeled the anti-LTA mAb and evaluated its effectiveness as a diagnostic imaging tool for detecting infection via immunoPET imaging in an in vivo mouse model of prosthetic joint infection (PJI). In vitro and ex vivo binding of the anti-LTA mAb to pathogenic bacteria was measured with Octet, ELISA, and flow cytometry. The in vivo PJI mouse model was assessed using traditional imaging modalities, including positron emission tomography (PET) with [ 18 F]FDG and [ 18 F]NaF as well as X-ray computed tomography (CT), before being evaluated with the zirconium-89-labeled antibody specific for LTA ([ 89 Zr]SAC55). The anti-LTA mAb exhibited specific binding in vitro to LTA-expressing bacteria. Results from imaging showed that our model could reliably simulate infection at the surgical site by bioluminescent imaging, conventional PET tracer imaging, and bone morphological changes by CT. One day following injection of both the radiolabeled anti-LTA and isotype control antibodies, the anti-LTA antibody demonstrated significantly greater ( P  < 0.05) uptake at S . aureus -infected prosthesis sites over either the same antibody at sterile prosthesis sites or of control non-specific antibody at infected prosthesis sites. Taken together, the radiolabeled anti-LTA mAb, [ 89 Zr]SAC55, may serve as a valuable diagnostic molecular imaging probe to help distinguish between sterile inflammation and infection in the setting of PJI. Future studies are needed to determine whether these findings will translate to human PJI.

  11. Evaluation of direct and indirect additive manufacture of maxillofacial prostheses.

    PubMed

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

    2012-09-01

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

  12. Clinical and Radiographic Outcomes of Unipolar and Bipolar Radial Head Prosthesis in Patients with Radial Head Fracture: A Systemic Review and Meta-Analysis.

    PubMed

    Chen, Hongwei; Wang, Ziyang; Shang, Yongjun

    2018-06-01

    To compare clinical outcomes of unipolar and bipolar radial head prosthesis in the treatment of patients with radial head fracture. Medline, Cochrane, EMBASE, Google Scholar databases were searched until April 18, 2016 using the following search terms: radial head fracture, elbow fracture, radial head arthroplasty, implants, prosthesis, unipolar, bipolar, cemented, and press-fit. Randomized controlled trials, retrospective, and cohort studies were included. The Mayo elbow performance score (MEPS), disabilities of the arm, shoulder, and hand (DASH) score, radiologic assessment, ROM, and grip strength following elbow replacement were similar between prosthetic devices. The pooled mean excellent/good ranking of MEPS was 0.78 for unipolar and 0.73 for bipolar radial head arthroplasty, and the pooled mean MEPS was 86.9 and 79.9, respectively. DASH scores for unipolar and bipolar prosthesis were 19.0 and 16.3, respectively. Range of motion outcomes were similar between groups, with both groups have comparable risk of flexion arc, flexion, extension deficit, rotation arc, pronation, and supination (p values <0.001 for both unipolar and bipolar prosthesis). However, bipolar radial head prosthesis was associated with an increased chance of heterotopic ossification and lucency (p values ≤0.049) while unipolar prosthesis was not (p values ≥0.088). Both groups had risk for development of capitellar osteopenia or erosion/wear (p values ≤0.039). Unipolar and bipolar radial head prostheses were similar with respect to clinical outcomes. Additional comparative studies are necessary to further compare different radial head prostheses used to treat radial head fracture.

  13. Bleaching and temporomandibular disorder using a half tray design: a clinical report.

    PubMed

    Robinson, F G; Haywood, V B

    2000-05-01

    A maxillary soft, custom-fitted tray was fabricated for a patient to perform nightguard vital bleaching. Treatment was interrupted after the patient experienced pain in the temporomandibular joint area shortly after wearing the bleaching prosthesis. The tray was trimmed so the labial, incisal and buccal cusps were covered and Sc) the patient had complete tooth-to-tooth contact in the maximum intercuspal position. The prosthesis proved to be retentive even without the presence of the bleaching material. The thick, sticky bleaching material was contained in the half tray design and the tray was held in place. The patient was able to continue the bleaching process for the 2-week duration necessary to achieve successful lightening of the teeth without further TMD symptoms.

  14. 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 additional degrees of freedom.

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

    PubMed

    Schöndorf, J; Pilorget, J; Gräber, S

    1980-05-01

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

  16. 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.

  17. THE BIOMECHANICAL RESPONSE OF PERSONS WITH TRANSFEMORAL AMPUTATION TO VARIATIONS IN PROSTHETIC KNEE ALIGNMENT DURING LEVEL WALKING

    PubMed Central

    Koehler-McNicholas, Sara R.; Lipschutz, Robert D.; Gard, Steven A.

    2017-01-01

    Prosthetic alignment is an important factor in the overall fit and performance of a lower-limb prosthesis. However, the association between prosthetic alignment and control strategies used by persons with transfemoral amputation to coordinate the movement of a passive prosthetic knee is poorly understood. This study investigated the biomechanical response of persons with transfemoral amputation to systematic perturbations in knee joint alignment during a level walking task. Quantitative gait data were collected for three alignment conditions: bench alignment, 2 cm anterior knee translation (ANT), and 2 cm posterior knee translation (POST). In response to a destabilizing alignment perturbation (ANT), subjects significantly increased their early-stance hip extension moment, confirming that persons with transfemoral amputation rely on a hip extensor strategy to maintain knee joint stability. However, subjects also decreased the rate at which they loaded their prosthesis, decreased their step length, increased their trunk flexion, and maintained their limb in a more vertical posture at the time of opposite toe off. Collectively, these results suggest that persons with transfemoral amputation rely on a combination of strategies to coordinate stance-phase knee flexion. Further, no significant changes were observed in response to the POST condition, suggesting that a bias toward posterior alignment may have fewer implications in terms of stance-phase, knee-joint control. PMID:28355034

  18. [Reconstruction and balance of soft tissue in hemi-shoulder replacement for patients with four-part fracture of the proximal humerus].

    PubMed

    Wu, Xing; Lou, Lie-ming; Chen, Zheng-rong; Zhang, Guang-jian

    2008-10-01

    To explore the effective skills of reconstruction and balance of soft tissue in hemi-shoulder replacement for patients with four-part fracture of the proximal humerus in order to avoid postoperative complications of joint instability and great tubercle displacement. From June 2002 to June 2006, 25 patients with Neer four-part fracture of the proximal humerus were adopted in the study which included 15 females and 10 males, with the mean age of 66 years (ranged from 56 years to 80 years). They were treated with humeral head replacement and should joint reparation simultaneously by modified operation approach and reconstruction and balance skills of soft tissue. The mean duration of follow-up was 2.3 years (ranged from 1 to 4.5 years). No infection, nerve damage and prosthesis loosing were found in all cases. Two cases of infra-forward dislocation or subluxation occurred due to affected limb placed on abduction splint postoperatively. One case occurred prosthesis upward displacement due to early active abduction exercise but no complains. Neither joint instability nor displacement and malunion of great tubercle were found in other patients. According to Neer scoring system, 6 cases were rated as excellent, 15 as good and 5 as fair. The good and excellent rate was 84%. In hemi-shoulder replacement for patients with Neer four-part fracture the modified operation approach and reconstruction and balance of soft tissue skills combined with rational rehabilitation exercise can prevent postoperative shoulder joint instability and displacement and malunion of great tubercle.

  19. Toward Balance Recovery With Leg Prostheses Using Neuromuscular Model Control

    PubMed Central

    Geyer, Hartmut

    2016-01-01

    Objective Lower limb amputees are at high risk of falling as current prosthetic legs provide only limited functionality for recovering balance after unexpected disturbances. For instance, the most established control method used on powered leg prostheses tracks local joint impedance functions without taking the global function of the leg in balance recovery into account. Here we explore an alternative control policy for powered transfemoral prostheses that considers the global leg function and is based on a neuromuscular model of human locomotion. Methods We adapt this model to describe and simulate an amputee walking with a powered prosthesis using the proposed control, and evaluate the gait robustness when confronted with rough ground and swing leg disturbances. We then implement and partially evaluate the resulting controller on a leg prosthesis prototype worn by a non-amputee user. Results In simulation, the proposed prosthesis control leads to gaits that are more robust than those obtained by the impedance control method. The initial hardware experiments with the prosthesis prototype show that the proposed control reproduces normal walking patterns qualitatively and effectively responds to disturbances in early and late swing. However, the response to mid-swing disturbances neither replicates human responses nor averts falls. Conclusions The neuromuscular model control is a promising alternative to existing prosthesis controls, although further research will need to improve on the initial implementation and determine how well these results transfer to amputee gait. Significance This work provides a potential avenue for future development of control policies that help improve amputee balance recovery. PMID:26315935

  20. Axial displacements in external and internal implant-abutment connection.

    PubMed

    Lee, Ji-Hye; Kim, Dae-Gon; Park, Chan-Jin; Cho, Lee-Ra

    2014-02-01

    The purpose of this study was to evaluate the axial displacement of the abutments during clinical procedures by the tightening torque and cyclic loading. Two different implant-abutment connection systems were used (external butt joint connection [EXT]; internal tapered conical connection [INT]). The master casts with two implant replicas, angulated 10° from each other, were fabricated for each implant connection system. Four types of impression copings were assembled and tightened with the corresponding implants (hex transfer impression coping, non-hex transfer impression coping, hex pick-up impression coping, non-hex pick-up impression coping). Resin splinted abutments and final prosthesis were assembled. The axial displacement was measured from the length of each assembly, which was evaluated repeatedly, after 30 Ncm torque tightening. After 250 N cyclic loading of final prosthesis for 1,000,000 cycles, additional axial displacement was recorded. The mean axial displacement was statistically analyzed (repeated measured ANOVA). There was more axial displacement in the INT group than that of the EXT group in impression copings, resin splinted abutments, and final prosthesis. Less axial displacement was found at 1-piece non-hex transfer type impression coping than other type of impression copings in the INT group. There was more axial displacement at the final prosthesis than resin splinted abutments in the INT and the EXT groups. After 250 N cyclic loading of final prosthesis, the INT group showed more axial displacement than that of the EXT group. Internal tapered conical connection demonstrated a varying amount of axial displacement with tightening torque and cyclic loading. © 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  1. 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.

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

    PubMed

    Rezaei, Farshid; Hassani, Kamran; Solhjoei, Nosratollah; Karimi, Alireza

    2015-12-01

    Total hip replacement (THR) has been ranked within the most typical surgical processes in the world. The durability of the prosthesis and loosening of prosthesis are the main concerns that mostly reported after THR surgeries. In THR, the femoral prosthesis can be fixed by either cement or cementless methods in the patient's bones. In both procedures, the stability of the prosthesis in the hosted bone has a key asset in its long-term durability and performance. This study aimed to execute a comparative finite element simulation to assess the load transfer between the prosthesis, which is made of carbon/PEEK composite and stainless steel/titanium, and the femur bone. The mechanical behavior of the cortical bone was assumed as a linear transverse isotropic while the spongy bone was modeled like a linear isotropic material. The implants were made of stainless steel (316L) and titanium alloy as they are common materials for implants. The results showed that the carbon/PEEK composites provide a flatter load transfer from the upper body to the leg compared to the stainless steel/titanium prosthesis. Furthermore, the results showed that the von Mises stress, principal stress, and the strain in the carbon/PEEK composites prosthesis were significantly lower than that made of the stainless steel/titanium. The results also imply that the carbon/PEEK composites can be applied to introduce a new optimum design for femoral prosthesis with adjustable stiffness, which can decrease the stress shielding and interface stress. These findings will help clinicians and biomedical experts to increase their knowledge about the hip replacement.

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

    PubMed

    Ramu, D; Ramesh, Rakesh S; Manjunath, Suraj; Shivakumar; Goel, Vipin; Hemnath, G N; Alexander, Annie

    2015-12-01

    In India, Breast cancer is now the most common cancer in urban and 2nd most common in rural areas [1]. The incidence is rising, more younger women are getting affected and due to increase in survival rates there is an increase in the total number of women suffering from breast Cancer. So far there are no studies evaluating the pattern of breast prosthesis use in Indian scenario. The aim of this study is to address the patterns of external breast prosthesis used in India and view of Indian women on such prosthesis after mastectomy for breast cancer. This was a descriptive longitudinal study. In this study we interviewed (telephonic) 63 people, after three years of completing treatment under The Department of Surgical Oncology, St. Johns medical college, Bangalore. Among the study group, 27 members (40 %) were using various prosthesis, rest 36 women were not using any type of prosthesis. Among the users of prosthesis, silicon prosthesis was used by 6 women, padded cups by 8 women, cloth or cotton by 12 women and 1 woman used other type of prosthesis. Most women use simple items like cloth and cotton (44 %). Next most commonly used prosthesis are padded cups(). Only 22 % of women were found using silicon prosthesis in this study. Most of the well educated patients used external prosthesis either in the form of silicon prosthesis or padded cups. Most of women below age of 50 used external breast prosthesis. Use of prosthesis was more in urban compared to rural population (48 % vs 25 %). Prosthesis users worried more about the body image than women not using prosthesis. 25 % of women using prosthesis had body image issues where as only 5 % of non prosthesis users had such problems. Prosthesis users need improvement in terms of comfort, size, shape and affordability. Most common reasons for not using prosthesis are age, lack of motivation and awareness. Less than half of the women included in this study used external prosthesis after mastectomy for breast cancer. Most of the women are used home made prosthesis like cloth and cotton (44.4 %). Education, age and urban status are the strong factors which influences use of prosthesis. Prosthesis users are those who are more concerned about their body image. There is a palpable need to develop better prosthesis at affordable price.

  4. Three-dimensional knee joint contact forces during walking in unilateral transtibial amputees.

    PubMed

    Silverman, Anne K; Neptune, Richard R

    2014-08-22

    Individuals with unilateral transtibial amputations have greater prevalence of osteoarthritis in the intact knee joint relative to the residual leg and non-amputees, but the cause of this greater prevalence is unclear. The purpose of this study was to compare knee joint contact forces and the muscles contributing to these forces between amputees and non-amputees during walking using forward dynamics simulations. We predicted that the intact knee contact forces would be higher than those of the residual leg and non-amputees. In the axial and mediolateral directions, the intact and non-amputee legs had greater peak tibio-femoral contact forces and impulses relative to the residual leg. The peak axial contact force was greater in the intact leg relative to the non-amputee leg, but the stance phase impulse was greater in the non-amputee leg. The vasti and hamstrings muscles in early stance and gastrocnemius in late stance were the largest contributors to the joint contact forces in the non-amputee and intact legs. Through dynamic coupling, the soleus and gluteus medius also had large contributions, even though they do not span the knee joint. In the residual leg, the prosthesis had large contributions to the joint forces, similar to the soleus in the intact and non-amputee legs. These results identify the muscles that contribute to knee joint contact forces during transtibial amputee walking and suggest that the peak knee contact forces may be more important than the knee contact impulses in explaining the high prevalence of intact leg osteoarthritis. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. 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.

  6. 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

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

    PubMed Central

    Lou, Jigang; Li, Yuanchao; Wang, Beiyu; Meng, Yang; Wu, Tingkui; Liu, Hao

    2017-01-01

    Abstract In vitro biomechanical analysis after cervical disc replacement (CDR) with a novel artificial disc prosthesis (mobile core) was conducted and compared with the intact model, simulated fusion, and CDR with a fixed-core prosthesis. The purpose of this experimental study was to analyze the biomechanical changes after CDR with a novel prosthesis and the differences between fixed- and mobile-core prostheses. Six human cadaveric C2–C7 specimens were biomechanically tested sequentially in 4 different spinal models: intact specimens, simulated fusion, CDR with a fixed-core prosthesis (Discover, DePuy), and CDR with a mobile-core prosthesis (Pretic-I, Trauson). Moments up to 2 Nm with a 75 N follower load were applied in flexion–extension, left and right lateral bending, and left and right axial rotation. The total range of motion (ROM), segmental ROM, and adjacent intradiscal pressure (IDP) were calculated and analyzed in 4 different spinal models, as well as the differences between 2 disc prostheses. Compared with the intact specimens, the total ROM, segmental ROM, and IDP at the adjacent segments showed no significant difference after arthroplasty. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment (C5/6) and total ROM than CDR with a fixed-core prosthesis (P > .05). Besides, the difference in IDP at C4/5 after CDR with 2 prostheses was without statistical significance in all the directions of motion. However, the IDP at C6/7 after CDR with a mobile-core prosthesis was lower than CDR with a fixed-core prosthesis in flexion, extension, and lateral bending, with significant difference (P < .05), but not under axial rotation. CDR with a novel prosthesis was effective to maintain the ROM at the target segment and did not affect the ROM and IDP at the adjacent segments. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment and total ROM, but lower IDP at the inferior adjacent segment than CDR with a fixed-core prosthesis. PMID:29019902

  8. A tumor endoprosthesis is useful in elderly rheumatoid arthritis patient with acute intercondylar fracture of the distal femur.

    PubMed

    Wakabayashi, Hiroki; Naito, Yohei; Hasegawa, Masahiro; Nakamura, Tomoki; Sudo, Akihiro

    2012-05-01

    The purpose of this paper is to report the use of total knee arthroplasty using a tumor prosthesis in the treatment of elderly patients with an intercondylar fracture of the distal femur. Supracondylar fractures of the femur in patients with rheumatoid arthritis are difficult to treat due to joint deformity. We present outcomes for treating intercondylar fractures of the distal femur in rheumatoid arthritis patient using a tumor endoprosthesis. This technique allows early mobilization of the patient, with restoration of a good range of knee motion. A tumor prosthesis appears to be a viable treatment option for intercondylar femoral fractures in elderly patients. It is well tolerated and permits early ambulation and return to activities of daily living.

  9. Medical Equipment Used to Support Operations in Southwest Asia

    DTIC Science & Technology

    2009-09-30

    services. USCENTCOM Medical Logistics Management In February 2006, the Chairman of the Joint Chiefs of Staff designated the U.S. Army Medical...Microbiology Psychiatry/Mental Health Pediatrics Radiology* Prosthesis Trauma Surgery (General, Orthopedic, Urologic, Obstetrics and Gynecology... automated capability to manage equipment assets from the time a customer starts the research for an equipment item to the point at which the equipment

  10. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...

  11. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...

  12. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...

  13. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...

  14. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone...

  15. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems... of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94...

  16. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems... of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94...

  17. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems... of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94...

  18. [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 the highest postoperative activity levels after inverted arthroplasty, followed by anatomic arthroplasty, and the lowest activity level after the implantation of a hemiprosthesis. Conclusion: There is a significant discrepancy between previous expert recommendations and the actual activity levels that may be achieved after the implantation of a joint prosthesis. Future studies have to define the sports level, the type of sports and the type of prosthesis that provide a positive benefit-risk ratio using state-of-the-art low-abrasion bearing surfaces and prosthesis designs. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Implant Failure After Motec Wrist Joint Prosthesis Due to Failure of Ball and Socket-Type Articulation-Two Patients With Adverse Reaction to Metal Debris and Polyether Ether Ketone.

    PubMed

    Karjalainen, Teemu; Pamilo, Konsta; Reito, Aleksi

    2018-04-21

    We describe 2 cases of articulation-related failures resulting in revision surgery after a Motec total wrist arthroplasty: one with an adverse reaction to metal debris and the other with an adverse reaction to polyether ether ketone. In the first patient, blood cobalt and chrome levels were elevated and magnetic resonance imaging showed clear signs of a pseudotumor. The other patient had an extensive release of polyether ether ketone particles into the surrounding synovia due to adverse wear conditions in the cup, leading to the formation of a fluid-filled cyst sac with a black lining and diffuse lymphocyte-dominated inflammation in the synovia. We recommend regular follow-up including x-rays, monitoring of cobalt and chrome ion levels, and a low threshold for cross-sectional imaging in patients who have undergone total wrist arthroplasty with a Motec joint prosthesis. Wear-related problems can also develop in implants in which polyether ether ketone is the bulk material. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  20. 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.

  1. Total Ossicular Replacement Prosthesis: A New Fat Interposition Technique.

    PubMed

    Saliba, Issam; Sabbah, Valérie; Poirier, Jackie Bibeau

    2018-01-01

    To compare audiometric results between the standard total ossicular replacement prosthesis (TORP-S) and a new fat interposition total ossicular replacement prosthesis (TORP-F) in pediatric and adult patients and to assess the complication and the undesirable outcome. This is a retrospective study. This study included 104 patients who had undergone titanium implants with TORP-F and 54 patients who had undergone the procedure with TORP-S between 2008 and 2013 in our tertiary care centers. The new technique consists of interposing a fat graft between the 4 legs of the universal titanium prosthesis (Medtronic Xomed Inc, Jacksonville, FL, USA) to provide a more stable TORP in the ovale window niche. Normally, this prosthesis is designed to fit on the stapes' head as a partial ossicular replacement prosthesis. The postoperative air-bone gap less than 25 dB for the combined cohort was 69.2% and 41.7% for the TORP-F and the TORP-S groups, respectively. The mean follow-up was 17 months postoperatively. By stratifying data, the pediatric cohort shows 56.5% in the TORP-F group (n = 52) compared with 40% in the TORP-S group (n = 29). However, the adult cohort shows 79.3% in the TORP-F group (n = 52) compared with 43.75% in the TORP-S group (n = 25). These improvements in hearing were statistically significant. There were no statistically significant differences in the speech discrimination scores. The only undesirable outcome that was statistically different between the 2 groups was the prosthesis displacement: 7% in the TORP-F group compared with 19% in the TORP-S group ( P  = .03). The interposition of a fat graft between the legs of the titanium implants (TORP-F) provides superior hearing results compared with a standard procedure (TORP-S) in pediatric and adult populations because of its better stability in the oval window niche.

  2. Total Ossicular Replacement Prosthesis: A New Fat Interposition Technique

    PubMed Central

    Saliba, Issam; Sabbah, Valérie; Poirier, Jackie Bibeau

    2018-01-01

    Objective: To compare audiometric results between the standard total ossicular replacement prosthesis (TORP-S) and a new fat interposition total ossicular replacement prosthesis (TORP-F) in pediatric and adult patients and to assess the complication and the undesirable outcome. Study design: This is a retrospective study. Methods: This study included 104 patients who had undergone titanium implants with TORP-F and 54 patients who had undergone the procedure with TORP-S between 2008 and 2013 in our tertiary care centers. The new technique consists of interposing a fat graft between the 4 legs of the universal titanium prosthesis (Medtronic Xomed Inc, Jacksonville, FL, USA) to provide a more stable TORP in the ovale window niche. Normally, this prosthesis is designed to fit on the stapes’ head as a partial ossicular replacement prosthesis. Results: The postoperative air-bone gap less than 25 dB for the combined cohort was 69.2% and 41.7% for the TORP-F and the TORP-S groups, respectively. The mean follow-up was 17 months postoperatively. By stratifying data, the pediatric cohort shows 56.5% in the TORP-F group (n = 52) compared with 40% in the TORP-S group (n = 29). However, the adult cohort shows 79.3% in the TORP-F group (n = 52) compared with 43.75% in the TORP-S group (n = 25). These improvements in hearing were statistically significant. There were no statistically significant differences in the speech discrimination scores. The only undesirable outcome that was statistically different between the 2 groups was the prosthesis displacement: 7% in the TORP-F group compared with 19% in the TORP-S group (P = .03). Conclusions: The interposition of a fat graft between the legs of the titanium implants (TORP-F) provides superior hearing results compared with a standard procedure (TORP-S) in pediatric and adult populations because of its better stability in the oval window niche. PMID:29326537

  3. 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.

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

    PubMed Central

    2011-01-01

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

  5. The effects of laterality on obstacle crossing performance in unilateral trans-tibial amputees.

    PubMed

    De Asha, Alan R; Buckley, John G

    2015-05-01

    Unilateral trans-tibial amputees have bilaterally reduced toe clearance, and an increased risk of foot contact, while crossing obstacles compared to the able-bodied. While the able-bodied tend to lead with a 'preferred' limb it is equivocal whether amputees prefer to lead with the intact or prosthetic limb. This study determined the effects of laterality, compared to side of amputation, on amputees' obstacle crossing performance. To help understand why laterality could affect performance we also assessed knee proprioception for both limbs. Foot placement and toe clearance parameters were recorded while nine amputees crossed obstacles of varying heights leading with both their intact and prosthetic limbs. Joint-position sense was also assessed. Participants self-reported which limb was their preferred (dominant) limb. There were no significant differences in foot placements or toe clearance variability across lead-limb conditions. There were no significant differences in toe clearance between intact and prosthetic lead-limbs (p=0.28) but toe clearance was significantly higher when amputees led with their preferred compared to non-preferred limb (p=0.025). There was no difference in joint-position sense between the intact and residual knees (p=0.34) but joint-position sense tended to be more accurate for the preferred, compared to non-preferred limb (p=0.08). Findings suggest that, despite the mechanical constraints imposed by use of a prosthesis, laterality may be as important in lower-limb amputees as it is in the able bodied. This suggests that amputees should be encouraged to cross obstacles leading with their preferred limb. Copyright © 2015. Published by Elsevier Ltd.

  6. [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.

  7. [Screening with angiographic images prior to (99m)Tc-HMPAO labelled leukocyte scintigraphy in the diagnosis of periprosthetic infection].

    PubMed

    Granados, U; Fuster, D; Soriano, A; García, S; Bori, G; Martínez, J C; Mayoral, M; Perlaza, P; Tomás, X; Pons, F

    2015-01-01

    To evaluate the impact of the angioscintigrapy of the three phase bone scan as screening method to rule out infection of the hip and knee prosthesis prior to performing the (99m)Tc-HMPAO leukocyte scintigraphy. A total of 120 (70 women, 50 men; mean age 71±11years) with clinical suspicion of hip (n=63) or knee (n=57) infection of the prosthesis and clinical suspicion of infection were evaluated prospectively. All patients underwent three-phase bone scan (angioscintigraphy, vascular and bone phase) and (99m)Tc-HMPAO-labelled white blood cell scintigraphy. Final diagnosis of infection was made by microbiological documentation or clinical follow-up for at least 12months. Eighteen out of 120 patients were diagnosed of infection of hip prosthesis (n=10) or knee prosthesis (n=8). The angioscintigraphy was positive in 15/18 infected cases and in 21/102 of the non-infected cases with a sensitivity of 83%, specificity of 79% and negative predictive value of 97%. Sensitivity and specificity of (99m)Tc-HMPAO leukocyte scintigraphy were 72% and 95%, respectively. If the leukocyte labeled scintigraphies had been used exclusively for patients with positive angioscintigraphy, this would have saved up to 70% of the (99m)Tc-HMPAO leukocyte scintigraphies performed. There were no cases of infection with positive labeled leukocyte scintigraphy and negative angioscintigraphy. Angioscintigraphy (blood flow phase of bone scan) is a useful technique for screening for hip and knee joint prosthesis infection, significantly reducing the need for (99m)Tc-HMPAO leukocyte scintigraphy without affecting the sensitivity of the technique. Copyright © 2014 Elsevier España, S.L.U. and SEMNIM. All rights reserved.

  8. 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 not be ignored when selecting RSP stiffness. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. A prospective 24 months follow-up of a three component press-fit prosthesis for hallux rigidus.

    PubMed

    Wassink, S; Burger, B J; Saragas, N P; Asunción Márquez, J; Trtik, L; Harlaar, J

    2017-09-01

    The aim of this study was to evaluate the results following total first metatarsophalangeal (FMTP) joint replacement arthroplasty using a modular three component press fit prosthesis at two year follow up. All patient data was collected in a prospective way in four study centres. Both preoperative and postoperative evaluation consisted of an assessment using the AOFAS-HMI score, visual analogue scale for pain, evaluation of the range of motion and patient satisfaction scores. Postoperative X-rays were reviewed for loosening and radiolucency up to two years. Fifty-five feet were available for analysis at 24 months. Two implants were removed during the study. Six more feet had additional surgery due to stiffness or malalignment. Postoperative AOFAS-HMI scores improved significantly by 32.4 points at two year follow-up (p<0.001). The visual analogue scale for pain improved significantly from 6.8 (std 1,6) preoperatively to 1.6 (std 1,9) postoperatively (p<0.0001). Mean dorsiflexion improved from 12.6 (std 10,1) degrees preoperatively to 31.2 (std 16,8) degrees postoperatively. Eighty-seven percent of patients were moderately to well satisfied with the end result. Eighteen prostheses showed radiolucency at 24 months. Implantation of a Metis ® modular three component press fit prosthesis for the metatarsophalangeal joint in hallux rigidus shows significant improvement in AOFAS-HMI scores and a decrease in pain. Concerns remain with regard to early reoperation rate (14.5%) and long term survival of the implant. Future studies will have to address these aspects. Copyright © 2016 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

  10. 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.

  11. [Knee disarticulation and through-knee amputation].

    PubMed

    Baumgartner, R

    2011-10-01

    A knee disarticulation or a through-knee stump is superior compared to a transfemoral stump. The thigh muscles are all preserved, and the muscle balance remains undisturbed. The range of motion of the hip joint is not limited. The bulbous shape of the stump allows full weight bearing at the stump end and can easily be fitted with a prosthesis. An amputee with a bilateral knee disarticulation is able to walk "barefoot". A more distal amputation level, e.g., an ultra-short transtibial amputation, is not possible. Important alternative to transfemoral amputations. Possible for any etiology except for Buerger-Winiwarter's disease. New indications are infected and loosened total knee replacements. Preservation of the knee joint is possible. Knee disarticulation is a very atraumatic procedure, compared to transfemoral amputations. Neither bones nor muscles have to be severed, just skin, ligaments, vessels, and nerves. Even the meniscal cartilages may be left in place to act as axial shock absorbers. The cartilage of the femur is not resected, but only bevelled in case of osteoarthritis. There are no tendon attachments or myoplastic procedures necessary. The patella remains in place and is held in position only by the retinacula. Skin closure must be performed without the slightest tension, and if possible not in the weight-bearing area. Transcondylar amputations across the femoral condyles only are indicated when there are not sufficient soft tissues for wound closure of a knee disarticulation. Alternatives as the techniques of Gritti, Klaes, and Eigler, the shortening of the femur and the Sauerbruch's rotation plasty [14] are presented and discussed. The risk of decubital ulcers is rather high. Correct bandaging of the stump is, therefore, particularly important. Prosthetic fitting is possible 3-6 weeks after surgery. The type of prosthesis depends on the amputee's activity level. The superior performance of amputees with knee disarticulations in sports prove the superiority of that amputation level compared to transfemoral amputees. However, because less than 5% of amputations are knee disarticulations, statements about statistical significance cannot be made. On the other hand, one should do everything to preserve an ultra-short transtibial stump.

  12. Wear properties of alumina/zirconia composite ceramics for joint prostheses measured with an end-face apparatus.

    PubMed

    Morita, Yusuke; Nakata, Kenichi; Kim, Yoon-Ho; Sekino, Tohru; Niihara, Koichi; Ikeuchi, Ken

    2004-01-01

    While only alumina is applied to all-ceramic joint prostheses at present, a stronger ceramic is required to prevent fracture and chipping due to impingement and stress concentration. Zirconia could be a potential substitute for alumina because it has high strength and fracture toughness. However, the wear of zirconia/zirconia combination is too high for clinical use. Although some investigations on composite ceramics revealed that mixing of different ceramics was able to improve the mechanical properties of ceramics, there are few reports about wear properties of composite ceramics for joint prosthesis. Since acetabular cup and femoral head of artificial hip joint are finished precisely, they indicate high geometric conformity. Therefore, wear test under flat contact was carried out with an end-face wear testing apparatus for four kinds of ceramics: alumina monolith, zirconia monolith, alumina-based composite ceramic, and zirconia based composite ceramic. Mean contact pressure was 10 MPa and sliding velocity was 40 mm/s. The wear test continued for 72 hours and total sliding distance was 10 km. After the test, the wear factor was calculated. Worn surfaces were observed with a scanning electron micrograph (SEM). The results of this wear test show that the wear factors of the both composite ceramics are similarly low and their mechanical properties are much better than those of the alumina monolith and the zirconia monolith. According to these results, it is predicted that joint prostheses of the composite ceramics are safer against break down and have longer lifetime compared with alumina/alumina joint prostheses.

  13. 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.

  14. 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.

  15. 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.

  16. Energy expenditure and activity of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees.

    PubMed

    Kaufman, Kenton R; Levine, James A; Brey, Robert H; McCrady, Shelly K; Padgett, Denny J; Joyner, Michael J

    2008-07-01

    To quantify the energy efficiency of locomotion and free-living physical activity energy expenditure of transfemoral amputees using a mechanical and microprocessor-controlled prosthetic knee. Repeated-measures design to evaluate comparative functional outcomes. Exercise physiology laboratory and community free-living environment. Subjects (N=15; 12 men, 3 women; age, 42+/-9 y; range, 26-57 y) with transfemoral amputation. Research participants were long-term users of a mechanical prosthesis (20+/-10 y as an amputee; range, 3-36 y). They were fitted with a microprocessor-controlled knee prosthesis and allowed to acclimate (mean time, 18+/-8 wk) before being retested. Objective measurements of energy efficiency and total daily energy expenditure were obtained. The Prosthetic Evaluation Questionnaire was used to gather subjective feedback from the participants. Subjects demonstrated significantly increased physical activity-related energy expenditure levels in the participant's free-living environment (P=.04) after wearing the microprocessor-controlled prosthetic knee joint. There was no significant difference in the energy efficiency of walking (P=.34). When using the microprocessor-controlled knee, the subjects expressed increased satisfaction in their daily lives (P=.02). People ambulating with a microprocessor-controlled knee significantly increased their physical activity during daily life, outside the laboratory setting, and expressed an increased quality of life.

  17. Comparison of techniques for correction of magnification of pelvic X-rays for hip surgery planning.

    PubMed

    The, Bertram; Kootstra, Johan W J; Hosman, Anton H; Verdonschot, Nico; Gerritsma, Carina L E; Diercks, Ron L

    2007-12-01

    The aim of this study was to develop an accurate method for correction of magnification of pelvic x-rays to enhance accuracy of hip surgery planning. All investigated methods aim at estimating the anteroposterior location of the hip joint in supine position to correctly position a reference object for correction of magnification. An existing method-which is currently being used in clinical practice in our clinics-is based on estimating the position of the hip joint by palpation of the greater trochanter. It is only moderately accurate and difficult to execute reliably in clinical practice. To develop a new method, 99 patients who already had a hip implant in situ were included; this enabled determining the true location of the hip joint deducted from the magnification of the prosthesis. Physical examination was used to obtain predictor variables possibly associated with the height of the hip joint. This included a simple dynamic hip joint examination to estimate the position of the center of rotation. Prediction equations were then constructed using regression analysis. The performance of these prediction equations was compared with the performance of the existing protocol. The mean absolute error in predicting the height of the hip joint center using the old method was 20 mm (range -79 mm to +46 mm). This was 11 mm for the new method (-32 mm to +39 mm). The prediction equation is: height (mm) = 34 + 1/2 abdominal circumference (cm). The newly developed prediction equation is a superior method for predicting the height of the hip joint center for correction of magnification of pelvic x-rays. We recommend its implementation in the departments of radiology and orthopedic surgery.

  18. One lesson from arthroplasty to osseointegration in search for better fixation of in-bone implanted prosthesis

    PubMed Central

    Pitkin, Mark

    2011-01-01

    Direct transcutaneous prosthetic attachment (osseointegration) consists of implanting directly into the residuum bone a metal pylon whose external fraction connects the residuum to the external prosthesis. Since the introduction of osseointegration about 20 years ago, the obvious challenge associated with this technology has been the skin-pylon interface as a source of infections. In comparison, the bone-device interface was considered less problematic because of the knowledge and experience inherited from dental implantology and total joint replacement (arthroplasty). Current methods of pylon fixation in osseointegration follow arthroplasty’s paradigm of positioning the pylon’s shaft inside the bone’s medullary canal. However, adopting the medullary canal as a holding compartment for the pylon’s shaft creates the problem of shaft loosening, which has not yet been solved in arthroplasty. PMID:18712634

  19. 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.

  20. Effects of positioning on radiographic measurements of ankle morphology: a computerized tomography-based simulation study

    PubMed Central

    2013-01-01

    Background Measurements of the morphology of the ankle joint, performed mostly for surgical planning of total ankle arthroplasty and for collecting data for total ankle prosthesis design, are often made on planar radiographs, and therefore can be very sensitive to the positioning of the joint during imaging. The current study aimed to compare ankle morphological measurements using CT-generated 2D images with gold standard values obtained from 3D CT data; to determine the sensitivity of the 2D measurements to mal-positioning of the ankle during imaging; and to quantify the repeatability of the 2D measurements under simulated positioning conditions involving random errors. Method Fifty-eight cadaveric ankles fixed in the neutral joint position (standard pose) were CT scanned, and the data were used to simulate lateral and frontal radiographs under various positioning conditions using digitally reconstructed radiographs (DRR). Results and discussion In the standard pose for imaging, most ankle morphometric parameters measured using 2D images were highly correlated (R > 0.8) to the gold standard values defined by the 3D CT data. For measurements made on the lateral views, the only parameters sensitive to rotational pose errors were longitudinal distances between the most anterior and the most posterior points of the tibial mortise and the tibial profile, which have important implications for determining the optimal cutting level of the bone during arthroplasty. Measurements of the trochlea tali width on the frontal views underestimated the standard values by up to 31.2%, with only a moderate reliability, suggesting that pre-surgical evaluations based on the trochlea tali width should be made with caution in order to avoid inappropriate selection of prosthesis sizes. Conclusions While highly correlated with 3D morphological measurements, some 2D measurements were affected by the bone poses in space during imaging, which may affect surgical decision-making in total ankle arthroplasty, including the amount of bone resection and the selection of the implant sizes. The linear regression equations for the relationship between 2D and 3D measurements will be helpful for correcting the errors in 2D morphometric measurements for clinical applications. PMID:24359413

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