RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
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|ClinicalTrials.gov Identifier: NCT03599336|
Recruitment Status : Terminated (Slower than expected enrollment.)
First Posted : July 26, 2018
Last Update Posted : October 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Humerus Fracture Humerus Shoulder Fractures Shoulder Arthropathy Associated With Other Conditions Arthropathy Shoulder Shoulder Injury Arthropathy||Procedure: Reverse Total Shoulder Arthroplasty (rTSA) Other: Nonoperative Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||October 29, 2020|
|Actual Study Completion Date :||October 29, 2020|
Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.
Other: Nonoperative Treatment
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.
Operative Course for rTSA
Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.
Procedure: Reverse Total Shoulder Arthroplasty (rTSA)
Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation.
- Function as described by ASES score at 1 year follow-up. [ Time Frame: 2 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599336
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jonathan D Barlow||Mayo Clinic|