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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.
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| Measure | Description | Time Frame |
|---|---|---|
| New Knee Society Score (KSS) | 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 | Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Kujala Score | The "Kujala Score" is the eponymous name for the Anterior Knee Pain Scale (AKPS). It is a patient-reported outcome survey and diagnostic tool that aims to assess the severity of symptoms and physical limitations in patients with patellofemoral pain syndrome (PFPS). The Kujala Score is a self-administered questionnaire for PFPS patients consisting of 13 questions that relate to specified activities, pain severity, and clinical symptoms. It is scored out of 100 points, which represents the summation of the scores for each individual question |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the inclusion/exclusion criteria to take part to the current clinical study will be invited to participate before the surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Vincent de Paul | Bourgoin | 38300 | France | |||
| Polyclinique du Parc |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 3 months, 1, 2, 3, 5, 7 and 10 years |
| Survival of the implant | Survival rate assessed with Kaplan Meier analysis | 3 months, 1, 2, 3, 5, 7 and 10 years |
| Safety of the implant | Recording of any adverse event and complication (including but not limited to: infection, loosening, deep venous thrombosis (DVT), fracture, reflex sympathetic dystrophy syndrome (RSD).) | Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years |
| Caen |
| 14000 |
| France |
| Clinique du Mail | La Rochelle | 17000 | France |
| Centre Orthéo | Saint-Etienne | 42100 | France |
| Bürgerspital Solothurn | Solothurn | CH-4500 | Switzerland |
| D012216 |
| Rheumatic Diseases |