Follow-up on the Madison Total Knee Prosthesis for knee pain relief

Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison

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
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Societe dEtude, de Recherche et de Fabrication (industry)
• Locations: 1 site (Lyon, Rhône)
• Trial ID: NCT06120023 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with active infections, severe muscle or nerve damage, or inadequate bone quality may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Lyon, Rhône

• Clinique de la Sauvegarde — Lyon, Rhône, France (RECRUITING)

Study contacts

• Study coordinator: Lydie BONNEVAY

Conditions: Knee Arthropathy, total knee prosthesis