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

Launched by SOCIETE DETUDE, DE RECHERCHE ET DE FABRICATION · Nov 6, 2023

Keywords

ClinConnect Summary

The MADISON clinical trial is studying a new knee replacement system designed to help people with knee pain and difficulty moving due to conditions like osteoarthritis. The goal is to gather more information about how safe and effective this knee prosthesis is over a long period, specifically up to 15 years. This study is particularly important because there isn't enough information currently available to fully support the claims made about the prosthesis's performance throughout its lifetime.

To participate in the trial, candidates must be at least 18 years old, have a diagnosis of knee osteoarthritis, and be eligible for knee replacement surgery. Participants will need to be physically and mentally able to follow the study requirements and complete questionnaires about their quality of life. Those interested in joining the study should be aware that they will be closely monitored, and the information collected will help improve future knee replacement options for others.

Gender

ALL

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)