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This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA). Once eligibility criteria is met, the subject will be randomized to one of the two study arms. Subjects will be followed for ten years. Clinical and patient-reported outcome measures (PROMs) will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemiarthroplasty with pyrocarbon | Active Comparator |
| |
| Anatomic total shoulder arthroplasty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemiarthroplasty with pyrocarbon | Device | Hemiarthroplasty with pyrocarbon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single Assessment Numeric Evaluation score | Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain. | 2-years |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Visual Analog Pain Score | Assess pain relief. Range: 0-10. Zero is equivalent to no pain and 10 indicates the worst possible pain | 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years |
| Forgotten Joint score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Zmistowski, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| Anatomic total shoulder arthroplasty | Device | Anatomic total shoulder arthroplasty |
|
Assess shoulder function. The total score ranges from 0 to 100 with higher scores indicating a high degree of forgetting the artificial joint.
| 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years |
| Range of motion | Assess shoulder motion. Subjects will have their shoulder range of motion measured in degrees. | 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years |
| Assess rates of glenoid erosion | Assess rates of glenoid erosion associated with pyrocarbon hemiarthroplasty | 2-years, 5-years, 10-years |
| Assess rates of aseptic glenoid loosening | Assess rates of aseptic glenoid loosening associated with anatomic total shoulder arthroplasty | 2-years, 5-years, 10-years |
| Single Assessment Numeric Evaluation Score | Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain. | 5-years, 10-years |
| ID | Term |
|---|---|
| D062785 | Hemiarthroplasty |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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