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Recruiting NCT06120023

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

— Observational Knee Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Knee Arthropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Revision rate according to Kaplan-Meier [Time frame: 15 years]
Secondary outcome measures (12)
  • Survival rate according to Kaplan-Meier [Time frame: From per operative period to 15 years]
  • Adverse events [Time frame: From per operative period to 15 years]
  • Functional improvement using 2011KSS score [Time frame: From per operative period to 15 years]
  • Patient's expectation / satisfaction using 2011KSS score [Time frame: From per operative period to 15 years]
  • Pain reduction using 2011KSS score [Time frame: From per operative period to 15 years]
  • Pain Evaluation using KOOS [Time frame: From per operative period to 15 years]
  • Functional improvement in Daily Living using KOOS [Time frame: From per operative period to 15 years]
  • Functional improvement in Sport and Recreation using KOOS [Time frame: From per operative period to 15 years]
  • Functional improvement Other Symptoms using KOOS [Time frame: From per operative period to 15 years]
  • Assessement of Knee-Related Quality of Life using KOOS [Time frame: From per operative period to 15 years]
  • Oblivion of prosthesis [Time frame: From per operative period to 15 years]
  • Mobility improvement [Time frame: From per operative period to 15 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Clinique de la Sauvegarde — Lyon

Identifiers

NCT: NCT06120023 · 2022-07_Madison3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗