Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
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.
Inclusion Criteria:
Male or female adults (≥ 18 years) covered by French social security system
Diagnosed with:
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:
l.bonnevay@serf.fr04 72 05 60 10 ext. +33
clinical@serf.fr04 72 05 60 10 ext. +33