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The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirror group | Experimental | Mirror Medacta Shoulder System |
|
| Historical Control group | Active Comparator | Total shoulder arthroplasty system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirror Medacta Shoulder System | Device | Anatomic total shoulder arthroplasty system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score | 0 (worst) - 48 (best) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success Rate | Kaplan Meier survival curve, examining the following end-points:
| 24 months |
| Oxford Shoulder Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Viganò, PhD | Contact | +41 091 6966060 | m.vigano@medacta.ch |
| Name | Affiliation | Role |
|---|---|---|
| Matthias A Zumstein, Prof Dr. med | Lindenhofgruppe AG (Bern) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindenhofgruppe AG - Orthopädie Sonnenhof | Recruiting | Bern | 3006 | Switzerland |
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| Medacta Shoulder System |
| Device |
Anatomic total shoulder arthroplasty system - standard configuration |
|
0 (worst) - 48 (best)
| 24 months |
| Constant score | 0(worst) - 100 (best) | 24 months |
| Subjective Shoulder Value | 0(worst) - 100 (best) | 24 months |
| Device parameters | Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:
| 24 months |
| Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen | Recruiting | Sankt Gallen | 9007 | Switzerland |
|