Actively Recruiting
Long-Term Safety and Performance Study of MADISON Total Knee Prosthesis for Knee Arthropathy
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-22
1000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the MADISON Total Knee Prosthesis, designed for total knee arthroplasty to reduce pain and restore knee joint mobility in adults diagnosed with knee arthropathy. This observational study aims to confirm the safety and performance of the MADISON prosthesis over a 15-year period, addressing current gaps in long-term clinical data and complying with European medical device regulations. Participants will receive the MADISON Total Knee Arthroplasty system, which includes implant features such as Posterior Stabilized or Ultra Congruent designs and different fixation methods. The study will collect data on these implant types and revisions of partial knee prostheses throughout the follow-up period to assess clinical outcomes. During the 15 years of follow-up, participants will undergo regular assessments including revision rates, survival rates, adverse events, and functional improvements measured by scores like the 2011 Knee Society Score KSS and Knee Injury and Osteoarthritis Outcome Score KOOS. Researchers will also evaluate pain reduction, patient satisfaction, quality of life, and mobility improvements to monitor long-term prosthesis performance and safety.
CONDITIONS
Brief Title
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Research Team
L
Lydie BONNEVAY
C
Clinical Department
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