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| Name | Class |
|---|---|
| Ascension Orthopedics, Inc. | INDUSTRY |
| Swedish Shoulder and Elbow Arthroplasty Register | UNKNOWN |
| Karolinska Institutet | OTHER |
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The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyrocarbon | Active Comparator | Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty) |
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| CoCr | Active Comparator | Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PyroTITAN, Ascension Orthopedics, Inc. | Device | All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design. |
| Measure | Description | Time Frame |
|---|---|---|
| Fixation to bone as measured with radiostereometric analysis (RSA) | Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS) | Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator. | 24-48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic department, Danderyd Hospital | Stockholm | Stockholm County | 18288 | Sweden |
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| TITAN, Ascension Orthopedics, Inc. | Device |
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