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15-Year study to confirm knee implant safety

NCT ID NCT06120023

Knowledge-focused Sponsor: Societe dEtude, de Recherche et de Fabrication Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a long-term check on the safety and performance of the MADISON total knee replacement system. It will follow 1,000 adults in France who need knee replacement surgery for up to 15 years. The goal is to track how often the implant needs to be revised or causes problems, and to see how well it helps patients move and feel better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2040

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult subjects with a diagnosis of knee replacement surgery requiring to be implanted with a TKA (Total Knee Arthroplasty) system MADISON according to instructions for use. Patients will be followed according to current practice.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee arthropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinique de la Sauvegarde

    RECRUITING

    Lyon, Rhône, 69009, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.