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. 2022 Jun 21;2022(6):CD000434. doi: 10.1002/14651858.CD000434.pub5

NCT03599336.

Study name RSA vs. nonop for 3 & 4‐part proximal humerus fractures
Official title: Reverse total shoulder arthroplasty versus nonoperative treatment of 3 & 4‐part proximal humerus fractures
Methods Open‐label randomised controlled trial
Participants 100 participants, aged 65 or older, with displaced 3‐ and 4‐part proximal humeral fractures
Interventions 1. Surgical management: ReUnion RSA (Reverse Shoulder Arthroplasty System)
2. Non‐operative treatment: sling immobilisation for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion, hygiene, and dressing only. At 3 weeks passive ROM in external rotation and forward elevation 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 participants for use at their discretion, as is current practice.
Outcomes Follow‐up: 1 and 2 years
Primary outcome: function as described by American Shoulder and Elbow Surgeons (ASES) score at 1 year follow‐up
Secondary outcomes: none reported
Starting date Start: 1 August 2018. Estimated study completion date: 1 August 2022
Contact information Contact: Jonathan Furuseth
507‐293‐6470
Email: furuseth.jonathan@mayo.edu
Notes Recruiting at Mayo Clinic in Rochester, USA