Actively Recruiting
Post-Market Clinical Follow-Up for MADISON Total Knee Arthroplasty System to Assess Safety and Performance
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-22
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older covered by the French social security system
- Diagnosed with primary or secondary osteoarthritis or needing revision of a unicompartmental knee prosthesis
- Scheduled for surgery and implantation of the MADISON total knee arthroplasty
- Physically and mentally able to comply with study protocol, attend follow-up visits, and complete quality of life questionnaires
- Signed written informed consent
You will not qualify if you...
- Active or chronic infection near the surgical site or systemic infection affecting the joint
- Serious muscle, nerve, or blood vessel damage risking the affected limb
- Insufficient bone quality or bone loss that compromises prosthesis stability
- Skeletal immaturity
- Conditions that may impair implant function (e.g., osteomyelitis, neuropathic joint)
- Factors incompatible with good long-term results (e.g., certain age or weight limits)
- Neurological conditions preventing postoperative care requirements
- Known allergy to implant components
- Severe obesity with or without other health conditions
- Pregnant or nursing women
- Contraindication to radiography
- Patients deprived of liberty or hospitalized without consent
- Patients under legal protection such as guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Per operative period
Participants undergo surgery for implantation of the MADISON total knee arthroplasty and receive immediate post-operative care.
1 surgery visit and immediate post-operative care
Duration - Up to 15 years
Participants are monitored over time to assess safety, performance, and functional outcomes of the knee arthroplasty.
Periodic follow-up visits over 15 years
Trial Site Locations
Total: 1 location
1
Clinique de la Sauvegarde
Lyon, Rhône, France, 69009
Actively Recruiting
Research Team
L
Lydie BONNEVAY
C
Clinical Department
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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