NCT05062252 Mirror Medacta Shoulder System Pivotal Trial
| NCT ID | NCT05062252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Arthritis Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-01-05 |
| Primary Completion | 2026-12-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 yr * Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis * Willingness and ability to comply with study protocol Exclusion Criteria: * Medical condition or balance impairment that could lead to falls * Prior rotator cuff surgery * Cuff tear arthropathy/insufficient rotator cuff * Insufficient bone quality which may affect the stability of the implant * Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes * Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation * Active metastatic or neoplastic disease at the shoulder joint * Chemotherapy treatment/radiotherapy within 6 mo before surgery * \>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery * Pregnancy or plan to become pregnant during study period * Inability to understand study or a history of noncompliance with medical advice *