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Sponsor terminated study early due to limited enrollment and follow-up.
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The purpose of this study is to perform a five-year, prospective evaluation of the Copelandâ„¢ Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copelandâ„¢ Humeral Resurfacing Head | Copelandâ„¢ Humeral Resurfacing Head |
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| Measure | Description | Time Frame |
|---|---|---|
| ASES Assessment | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | |
| X-rays | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of revision or removals | Any time |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring humeral resurfacing.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth J Beres, MD | Director, Clinical Research, Biomet Orthopedics, LLC | Study Director |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |