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Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegged through SP | Active Comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation. |
|
| Pegged through ST | Active Comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation. |
|
| Keeled through SP | Active Comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation. |
|
| Keeled through ST | Active Comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReUnion TSA, pegged design | Procedure | ReUnion total shoulder arthroplasty system, pegged design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Function of Subscapularis muscle as measured by belly-press test | 5 years | |
| Radiographic loosening | "glenoid at risk" proportion | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Morrey, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ReUnion TSA, keeled design | Procedure | ReUnion total shoulder arthroplasty system, keeled design |
|
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D010020 | Osteonecrosis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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