ReShAPE.

Study name	The ReShAPE trial: Reverse Shoulder Arthroplasty for treatment of Proximal humeral fractures in the Elderly
Methods	Multicentre (11 hospitals) randomised and observational study. Using: "Dynamic (adaptive) random allocation stratified by site using minimisation to allow for gender and age (70‐80, over 80)." "Central randomisation by phone"
Participants	72 (target) participants aged 70 years or older with 3‐ or 4‐part proximal humeral fracture according to the Neer classification
Interventions	1. Reverse total shoulder arthroplasty. Postoperatively, the arm will be placed in a shoulder immobiliser (either in internal rotation or some external rotation at the discretion of the treating surgeon). 2. Non‐surgical treatment starting with a shoulder immobiliser All participants will be instructed on elbow, wrist and hand exercises to commence immediately. After two weeks, pendular exercises and passive flexion to 90 degrees and passive external rotation to neutral will be commenced. Unrestricted passive and active‐assisted exercises will be allowed, graduating to active mobilisation (as tolerated) at 6 weeks. Resisted range‐of‐motion exercises will be allowed after 12 weeks. A minimum of 5 physiotherapy one‐on‐one, face‐to‐face contacts within 3 months of treatment will be required. Participants will perform self‐guided exercises every day as instructed in their face‐to‐face sessions.
Outcomes	Follow‐up: 2 years (main follow‐up), also 3 and 6 months, and 1, 5 and 10 years Primary outcome: ASES (American Shoulder and Elbow Surgeons) score at 24 months Secondary outcomes: DASH (Disability of the Arm, Shoulder and Hand) score; EQ‐5D and EuroQol‐VAS (quality of life and general health); pain (verbal analogue scale 0 to 10 points); radiological parameters (healing and positioning of tuberosities, scapula notching, prosthetic loosening, alignment); complications after reverse shoulder arthroplasty (repeat shoulder surgery, readmission, infection requiring treatment, neurological deficit, dislocation, death)
Starting date	Actual start date (recruitment): 9 March 2016 Anticipated end date (recruitment): 9 March 2018
Contact information	Dr Geoffrey Smith, Sydney Orthopaedic Trauma and Reconstructive Surgery 5/19 Kensington St, Kogarah. NSW 2217, Australia. Email: gcssmith@icloud.com
Notes	Non‐consenting patients were to be offered participation in the observational arm of the study. Their treatment was to consist of the same two treatment options as the RCT arm. Treatment being decided by patient preference as per usual practice at each institution.