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Slower than expected enrollment.
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There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonoperative Treatment | Other | Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts. |
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| Operative Course for rTSA | Other | Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reverse Total Shoulder Arthroplasty (rTSA) | Procedure | Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Function as described by ASES score at 1 year follow-up. | The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3. | 2 year follow-up |
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Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Barlow | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| D012784 | Shoulder Fractures |
| D000070599 | Shoulder Injuries |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D009140 | Musculoskeletal Diseases |
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| Nonoperative Treatment | Other | Subjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice. |
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