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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. The primary goal of our prospective randomized study is to determine whether 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.
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 with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral 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, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's 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. The primary goal of our prospective randomized study is to determine whether 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomic TSA | Active Comparator | The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis |
|
| RTSA | Experimental | The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total shoulder arthroplasty | Device | A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in American Shoulder and Elbow Surgeons score (ASES) | General clinical score (0-100, with 100 being the best score possible) | Between baseline and 2 postoperative years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Shoulder Value (SSV) | General clinical score (0-100, with 100 being the best score possible) | Between baseline and 2 postoperative years |
| Change in Range of motion in degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Lädermann, MD | Contact | +41 22 719 75 55 | alexandre.laedermann@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Lädermann, MD | La Tour Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Tour Hospital | Recruiting | Meyrin | 1217 | Switzerland |
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| ID | Term |
|---|---|
| D000072228 | Arthroplasty, Replacement, Shoulder |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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While the patients and care providers will be aware of the type of prosthesis, the physicians who assessed the outcomes and analyzed the data will be blinded to this information.
(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)
| Between baseline and 2 postoperative years |
| Complication rates | 2 postoperative years. |
| Change in pain on visual analogic scale (pVAS) | General clinical score (0-10, with 10 the worst score possible) | Between baseline and 2 postoperative years |
| Change in Constant score | General clinical score (0-100, with 100 being the best score possible) | Between baseline and 2 postoperative years |
| Change in Short Form -12 (SF-12) | General clinical score (0-100, with 100 being the best score possible) | Between baseline and 2 postoperative years |
| Radiographic outcomes | Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator | 2 postoperative years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |