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There was difficulty getting the study up and running with the site, staffing issues, completing a DTA and concern over sufficient patient population. The study was stopped without any enrollment. No results were obtained.
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The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.
The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.
The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
In all cases, a deltopectoral incision will be used as the procedure type.
Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.
Reverse total shoulder arthroplasty (RTSA) was designed to treat cuff tear arthropathy. Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, investigators have reported equivalent functional results at >2-year follow-up. However, this study could not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients.The investigators therefore hypothesize that, in patients treated for glenohumeral osteoarthritis, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies have confirmed this hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomic total shoulder replacement | Experimental | Anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. |
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| Reverse total shoulder replacement | Experimental | Reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomic total shoulder replacement | Device | Humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. |
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| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | date of surgery |
| American Shoulder and Elbow Surgeons score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 6 months after date of surgery |
| American Shoulder and Elbow Surgeons score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 12 months after date of surgery |
| American Shoulder and Elbow Surgeons score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 24 months after date of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Joyce, M.D. | University of Utah Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopedics | Salt Lake City | Utah | 84108 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Reverse total shoulder replacement | Device | Polyethylene socket on the humeral side and the glenosphere going on the glenoid side. |
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