Clinical trials: Knee Prosthesis
Osteoarthritis, Rheumatoid Arthritis
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis
- Trial name
- NCT00289107
- Testing
- Total Knee Arthroplasty, Total knee replacement
- Where
- 3 sites in United States
- Volunteers
- 149 people
- Sponsor
- DePuy Orthopaedics
Gonarthritis, Degenerative Disease
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
- Trial name
- UNI_XF_PRO (NCT06657248)
- Testing
- univation® XF Pro
- Where
- 4 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Implants
MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal
The purpose of the study is to improve image quality, increase speed of scanning and to see how well certain products test by scanning people who have an orthopedic hip or knee metallic implant.
- Trial name
- MRI (NCT01570543)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- GE Healthcare
Amputation, Prosthesis User
Metabolic Cost of Walking With Passive vs. Powered Microprocessor Controlled Knees
This study is conducted to evaluate the efficacy of the Power Knee Mainstream Dynamic compared to passive microprocessor-controlled knees (MPKs) regarding metabolic cost for high active transfemoral amputees.The test is of a…
- Trial name
- NCT05048355
- Testing
- Power Knee Mainstream Dynamic, Passive microprocessor controlled knee
- Where
- 2 sites in Germany, Iceland
- Volunteers
- 15 people
- Sponsor
- Össur Iceland ehf
Total Knee Replacement
A Post-market Observational ORIGIN® CR Clinical Study
The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e.
- Trial name
- NCT05607966
- Testing
- ORIGIN® CR devices
- Where
- 2 sites in Belgium
- Volunteers
- 199 people
- Sponsor
- Symbios Orthopedie SA
Total Knee Arthroplasty, Osteoarthritis
A Study to Compare the NexGen CR and CR-Flex Knee Implants
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant.
- Trial name
- NCT00761956
- Testing
- NexGen CR-Flex Fixed Bearing Knee, NexGen CR Knee
- Where
- 8 sites in United States
- Volunteers
- 189 people
- Sponsor
- Zimmer Biomet
Transfemoral Amputation, Artificial Limbs
Assist-Knee: Energy-Harvesting Knee Prosthesis
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy…
- Trial name
- NCT04023045
- Testing
- Assist-Knee, Habitual Prosthesis
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Orthocare Innovations, LLC
Total Knee Arthroplasty
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery…
- Trial name
- FHK-CK (NCT06124482)
- Testing
- Total Knee arthroplasty
- Where
- 7 sites in France
- Volunteers
- 92 people
- Sponsor
- FH ORTHO
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Prosthesis User, Amputation
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on…
- Trial name
- NCT04799145
- Testing
- Investigational device, Prescribed device
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation Above Knee (Injury)
New Microprocessor-Controlled Prosthetic Knee Evaluation
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK.
- Trial name
- NCT06017024
- Testing
- microprocessor-controlled knee (MPK) assessment
- Where
- 5 sites in France
- Volunteers
- 18 people
- Sponsor
- Proteor Group
Degenerative Arthritis, Osteoarthritis
Total Knee Replacement With Duracon® and Vanguard™ Prostheses
The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.
- Conditions
- Degenerative Arthritis, Osteoarthritis, Rheumatoid Arthritis, Knee Arthritis
- Trial name
- NCT00588887
- Testing
- Duracon®, Vanguard™
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Biomet Orthopedics, LLC
Arthroplasty, Replacement, Knee
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.
- Trial name
- X3vsN2Vac (NCT02525588)
- Testing
- Triathlon CS fixed bearing total knee prosthesis
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Stryker Orthopaedics
Infection of Total Knee Joint Prosthesis
Evaluating Bactisure Wound Lavage in Orthopedic Wounds
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
- Trial name
- NCT03192124
- Testing
- Bactisure
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Arthroplasty, Arthroplasty Replacement, Knee
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
- Conditions
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
- Trial name
- oneKNEE (NCT07682909)
- Testing
- oneKNEE®
- Volunteers
- 1,020 people
- Sponsor
- Aesculap AG
Knee Disease
Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer…
- Trial name
- NCT04578951
- Testing
- FHK® total knee prosthesis
- Where
- France
- Volunteers
- 50 people
- Sponsor
- FH ORTHO
Knee Osteoarthritis
A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants
The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA.
- Trial name
- NCT00733369
- Testing
- PFC Sigma RP-F, PFC Sigma RP
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 106 people
- Sponsor
- DePuy International
Knee Pain Chronic, Knee Osteoarthritis
BioPoly® Partial Resurfacing Knee Implant IDE
The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients…
- Conditions
- Knee Pain Chronic, Knee Osteoarthritis, Cartilage Damage, Cartilage Defects of the Knee
- Trial name
- NCT06915363
- Testing
- BioPoly, surgical standard of care (SSOC)
- Where
- 4 sites in United States
- Volunteers
- 152 people
- Sponsor
- BioPoly LLC
Cartilage Injury, Defect of Articular Cartilage
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic…
- Conditions
- Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage
- Trial name
- NCT01473199
- Testing
- BioPoly RS Partial Resurfacing Knee Implant
- Where
- 5 sites in United Kingdom
- Volunteers
- 38 people
- Sponsor
- BioPoly LLC