Actively Recruiting
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-22
1000
Participants Needed
1
Research Sites
897 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee. Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. Thus, in order to maintain compliance with the EU regulation (2017/745) related to medical devices and following ISO 14/155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis. The primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.
CONDITIONS
Official Title
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults 18 years or older covered by French social security system
- Diagnosed with osteoarthritis (primary or secondary) or needing revision of a unicompartmental knee prosthesis
- Patient requiring surgery and implantation of a Madison total knee arthroplasty
- Patient physically and mentally able to comply with the study protocol, attend follow-up visits, and complete quality of life questionnaires
- Patient has signed written informed consent
You will not qualify if you...
- Presence of progressive, acute, or chronic infection locally or systemically affecting the operative site
- Severe loss of muscle or serious lesions of muscles, nerves, or blood vessels risking the affected limb
- Lack of bone substance or poor bone quality on femoral or tibial surfaces compromising prosthesis stability
- Skeletal immaturity
- Conditions that may impair implant function such as osteomyelitis or neuropathic joint
- Factors incompatible with satisfactory long-term results such as certain age or weight parameters
- Neurological conditions incompatible with post-operative constraints
- Known allergy to any implant components
- Severe obesity with or without comorbidities
- 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
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Trial Site Locations
Total: 1 location
1
Clinique de la Sauvegarde
Lyon, Rhône, France, 69009
Actively Recruiting
Research Team
L
Lydie BONNEVAY
CONTACT
C
Clinical Department
CONTACT
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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