Clinical trial NCT06120023: Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Official title: Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Arthropathy
Keywords: total knee prosthesis
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.


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)

Primary outcomes:
measure: Revision rate according to Kaplan-Meier
timeFrame: 15 years
Secondary outcomes:
measure: Survival rate according to Kaplan-Meier
timeFrame: From per operative period to 15 years
measure: Adverse events
timeFrame: From per operative period to 15 years
measure: Functional improvement using 2011KSS score
timeFrame: From per operative period to 15 years
measure: Patient's expectation / satisfaction using 2011KSS score
timeFrame: From per operative period to 15 years
measure: Pain reduction using 2011KSS score
timeFrame: From per operative period to 15 years
measure: Pain Evaluation using KOOS
timeFrame: From per operative period to 15 years
measure: Functional improvement in Daily Living using KOOS
timeFrame: From per operative period to 15 years
measure: Functional improvement in Sport and Recreation using KOOS
timeFrame: From per operative period to 15 years
measure: Functional improvement Other Symptoms using KOOS
timeFrame: From per operative period to 15 years
measure: Assessement of Knee-Related Quality of Life using KOOS
timeFrame: From per operative period to 15 years
measure: Oblivion of prosthesis
timeFrame: From per operative period to 15 years
measure: Mobility improvement
timeFrame: From per operative period to 15 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
state: Rhône
Study officials:
References: