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Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison — 2022-07  

Knee Arthropathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06120023
Study type Observational
Source Societe dEtude, de Recherche et de Fabrication
Contact Lydie BONNEVAY
Phone 04 72 05 60 10
Email l.bonnevay@serf.fr
Status Recruiting
Phase
Start date October 17, 2023
Completion date December 31, 2040
View Details
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