Clinical Trials in France / NCT06715917
Active, not recruiting
Observational
Multicentre GMK UNI Anatomical Cementless Study - FR
NCT06715917 · tracked via the Priya Life Science France tracker
Condition(s) studied
Osteoarthritis of the KneeAvascular Necrosis of the Femoral CondyleRevision Surgery
Study summary
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.
Eligibility
Inclusion Criteria:
* Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
* Patient's age between 18 and 75 years old;
* Patients must be willing to comply with the pre and postoperative evaluation schedule.
Exclusion Criteria:
* Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
* Any patient who cannot or will not provide informed consent for participation in the study;
* Patients who need a revision surgery
* Patients unable to understand and take action;
* Any case not described in the inclusion criteria;
* Patients aged under 18 years;
* Patients aged over 75 years;
Primary outcome measure(s)
- New Knee Society Score (KSS) — Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
The new Knee Society Knee Scoring System is both physician and patient derived. It includes versions to be administered preoperatively and postoperatively. It has an initial assessment of demographic details, including an expanded Charnley functional classification. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations. Given the diverse activity profiles of many contemporary patients, the functional component of the score was improved to include a patient-specific survey, which evaluates features such as standard activities of daily living, patient-specific sports and recreational activities, patient satisfaction, and patient expectations
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique Saint Vincent de Paul | Bourgoin | France | |
| Polyclinique du Parc | Caen | France | |
| Clinique du Mail | La Rochelle | France | |
| Centre Orthéo | Saint-Etienne | France | |
| Bürgerspital Solothurn | Solothurn | Switzerland |
More Medacta International SA trials in France
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06715917 on ClinicalTrials.gov ↗ ← All trials in France