Follow-up on the Madison Total Knee Prosthesis for knee pain relief
Official title: Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Run by Societe dEtude, de Recherche et de Fabrication · NCT06120023 · Data updated 2026-11-12
This study is testing how well the MADISON Total Knee Prosthesis works for people with knee pain over 15 years to see if it helps them feel better and stay safe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Societe dEtude, de Recherche et de Fabrication Industry-sponsored |
| Locations | 1 site (Lyon, Rhône) |
| Status | Recruiting |
| Started | October 17, 2023 |
| Main results expected | December 31, 2040 |
| Study ends | December 31, 2040 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06120023 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with osteoarthritis or requiring revision of a unicompartmental knee prosthesis who are eligible for Madison TKA implantation.
✕Probably not a fit
Patients with active infections, severe muscle or nerve damage, or inadequate bone quality may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the clinical safety and performance of the MADISON Total Knee Prosthesis used in total knee arthroplasty for patients with knee arthropathy. It will gather data over a 15-year period to evaluate the safety, survival rates, and clinical outcomes associated with the prosthesis. The study is designed to comply with EU regulations and ISO standards, ensuring that the device's long-term performance is adequately monitored. Participants will be required to complete follow-up visits and quality of life questionnaires.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the MADISON Total Knee Prosthesis, potentially improving patient outcomes.
How similar studies have gone: While similar post-market follow-up studies have been conducted, the specific approach for the MADISON prosthesis is tailored and may provide novel insights into its long-term performance.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female adults (≥ 18 years) covered by French social security system * Diagnosed with: * Osteoarthritis (primary and secondary), * Revision of a unicompartmental knee prosthesis. * Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty) * Patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire. * Patient having signed a written informed consent Exclusion Criteria: * Progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint, * Any loss of musculature or serious lesions of muscles, nerves and/or blood vessels deficiency, putting the affected limb at risk, * Lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components, * Skeletal immaturity, * Pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint), * Parameters incompatible with satisfactory long-term results (i.e. age, weight, * Neurological condition of the patient incompatible with the post-operative constraints associated with this type of intervention, * Known allergy to one of the implant components. * Severe obesity with or without comorbidities * Pregnant or nursing women, * Patients with a contraindication to radiography * Patients deprived of their liberty or hospitalised without their consent * Patients under legal protection (e.g. guardianship)
Where it's running
-
Clinique de la Sauvegarde
Lyon, Rhône, France Recruiting
Study contacts
- Study coordinator: Lydie BONNEVAY
- Email: l.bonnevay@serf.fr
- Phone: 04 72 05 60 10
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.