NCT06120023 Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
| NCT ID | NCT06120023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Societe dEtude, de Recherche et de Fabrication |
| Condition | Knee Arthropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-10-17 |
| Primary Completion | 2040-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-10-17 with a primary completion date of 2040-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06120023 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Arthropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06120023 currently recruiting?
Yes, NCT06120023 is actively recruiting participants. Contact the research team at l.bonnevay@serf.fr for enrollment information.
Where is the NCT06120023 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06120023 clinical trial?
NCT06120023 is sponsored by Societe dEtude, de Recherche et de Fabrication. The trial plans to enroll 1,000 participants.