Clinical Research Directory
Browse clinical research sites, groups, and studies.
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Sponsor: Societe dEtude, de Recherche et de Fabrication
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2023-10-17
Completion Date
2040-12-31
Last Updated
2025-03-18
Healthy Volunteers
No
Conditions
Locations (1)
Clinique de la Sauvegarde
Lyon, Rhône, France