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The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomic total shoulder arthroplasty (aTSA) | Other |
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| Reverse total shoulder arthroplasty (rTSA) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aTSA | Procedure | Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Questionnaire score | The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) Score | The Visual Analog Scale (VAS) is a 1 item self-report survey that asks the subject to rate the level of pain on a scale of 0 (no pain) - 10 (worst imaginable pain). | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Change in Single Assessment Numeric Evaluation (SANE) Score |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noelle M Drapeau, CCRP | Contact | 507-266-6397 | drapeau.noelle2@mayo.edu | |
| Xavier C Gendry | Contact | 507-266-0687 | gendry.xavier@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan D. Barlow, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| rTSA | Procedure | Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure. |
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The Single Assessment Numeric Evaluation (SANE) is a 2 item self-report survey that asks subjects to rate the percent of normal range on both the affected joint/region and the opposite joint/region. Scores range from 0% - 100%, with 100% indicating normal range. |
| Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score | The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain. | Baseline, 6 weeks, 3 months, 6 months, 24 months |
| Change in Shoulder Subjective Value (SSV) Score | The Subjective Shoulder Value (SSV) is 1 item self-report survey that asks subjects to rate their overall shoulder function as a percentage of a "normal" (100%) shoulder. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Change in Activities of Daily Living in External Rotation (ADLER) score | The Activities of Daily Living in External Rotation (ADLER) is a self-report tool used to assess shoulder disability by quantifying a patient's ability to perform 10 specific daily tasks requiring active external rotation. Higher maximum scores indicate better functional ability. | Baseline, 1 year |
| Change in Activities of Daily Living Includes Internal Rotation (ADLIR) score | The Activities of Daily Living Includes Internal Rotation (ADLIR) is a self-report tool used to assess shoulder disability by quantifying a patient's ability to perform 9 specific daily tasks requiring active internal rotation. Higher maximum scores indicate better functional ability. | Baseline, 1 year |