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This is a post-marketing surveillance on Medacta Shoulder System
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medacta Shoulder System | Device | Total Shoulder Arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Kaplan Meier method | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | Constant & Murley Score | 1, 2, 5 and 10 years |
| Functional outcome | Oxford Shoulder Score | 1, 2, 5 and 10 years |
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Inclusion Criteria:
Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty
Exclusion Criteria:
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Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Zumstein, Prof Dr. Med | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du Sport et de Chirurgie Orthopédique | Marcq-en-Barœul | France | ||||
| Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation |
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| Radiographic performance of the implants | presence of radiolucencies | 3 months, 1, 2, 5 and 10 years |
| Quality of life | EQ-5D | 1, 2, 5 and 10 years |
| Adverse events | record of adverse event | up to 10 years |
| München |
| Germany |
| Orthopädie Sonnenhof | Bern | Canton of Bern | 3006 | Switzerland |
| Inselspital | Bern | Switzerland |
| Lindenhofspital | Bern | Switzerland |
| Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen, | Sankt Gallen | Switzerland |
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| D010020 | Osteonecrosis |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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