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 |