Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
ConditionKnee Arthropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociete dEtude, de Recherche et de Fabrication
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female adults (≥ 18 years) covered by French social security system
Osteoarthritis (primary and secondary),
Revision of a unicompartmental knee prosthesis.
Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty)
Disqualifiers
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,
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Revision rate according to Kaplan-Meier
Assess the revision rate, whatever the cause of revision, including infection at 15 years
Time frame
15 yearsSecondary outcomes
1
Survival rate according to Kaplan-Meier
Assess the survival rate, whatever the cause of revision, including infection at 1 year, 3 years, 5 years and 10 years follow-up
Time frame
From per operative period to 15 years2
Adverse events
List type and occurence of adverse events
Time frame
From per operative period to 15 years3
Functional improvement using 2011KSS score
2011 KSS stands for Knee Society Score Assessement of functional improvement picked up from global 2011KSS score. The functional score is composed of four subgroups and is rating from 0 to 100 (higher score means a better outcome).
Time frame
From per operative period to 15 years4
Patient's expectation / satisfaction using 2011KSS score
2011 KSS stands for Knee Society Score Evaluation of patient's expectation / satisfaction is picked up from global 2011KSS score. This evaluation is rating from 0 to 55 (higher score means a better outcome).
Time frame
From per operative period to 15 yearsSponsors and contacts
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Source ClinicalTrials.gov