Status:
RECRUITING
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Lead Sponsor:
Societe dEtude, de Recherche et de Fabrication
Conditions:
Knee Arthropathy
Eligibility:
All Genders
18+ years
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 n...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2040
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06120023
Start Date
October 17 2023
End Date
December 31 2040
Last Update
March 18 2025
Active Locations (1)
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1
Clinique de la Sauvegarde
Lyon, Rhône, France, 69009