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

NCT06120023 | Recruiting

• 1 other identifier: 2022-07_Madison3
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy

Keywords

total knee prosthesis

Outcome Measures

Primary Outcomes (1)

• Revision rate according to Kaplan-Meier

  Assess the revision rate, whatever the cause of revision, including infection at 15 years

  15 years

Secondary Outcomes (12)

• Survival rate according to Kaplan-Meier

  From per operative period to 15 years

• Adverse events

  From per operative period to 15 years

• Functional improvement using 2011KSS score

  From per operative period to 15 years

• Patient's expectation / satisfaction using 2011KSS score

  From per operative period to 15 years

• Pain reduction using 2011KSS score

  From per operative period to 15 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

Clinique de la Sauvegarde

Lyon, Rhône, 69009, France

RECRUITING

Central Study Contacts

Lydie BONNEVAY

CONTACT

04 72 05 60 10; l.bonnevay@serf.fr

Clinical Department

CONTACT

04 72 05 60 10; clinical@serf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 7, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)