ISRCTN76296703.

Study name	Effectiveness and cost‐effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non‐surgical care for acute 3 and 4 part fractures of the proximal humerus in participants aged over 65 years – the PROFHER‐2 randomised trial
Methods	Multi‐centre randomised controlled superiority pragmatic trial
Participants	380 participants who are aged 65 years or over with radiographically‐confirmed acute three‐part (including surgical neck) or four‐part displaced fracture of the proximal humerus (Neer Classification) including head‐splitting fractures of the humeral head and fracture dislocations; trial interventions can be provided within 5 weeks of injury
Interventions	1. Reverse shoulder arthroplasty (RSA) 2. Hemiarthroplasty (HA) 3. Non‐surgical care: supporting the injured arm in a sling for 3 weeks The study aims to randomise 152 to each of the surgical treatments and 76 to the non‐surgical treatment.
Outcomes	Follow‐up: 6, 12 and 24 months (5 years for subsequent surgery) Primary outcome: Oxford Shoulder Score Secondary outcomes: quality of life measured using EQ‐5D; pain measured using the Patient‐Reported Outcomes Measurement Information System (PROMIS) pain interference; pain measured using a visual analogue pain scale; range of shoulder motion measured at discharge from physiotherapy and independently assessed at 6 months; healing and implant position using X‐rays at 6 months; further procedures and complications; physiotherapy requirements and use (including time to start of physiotherapy; number of sessions; modalities used; and duration of rehabilitation) collected during the trial. Also, associated costs
Starting date	Recruitment start date: 01 June 2018 Recruitment end date: 31 May 2021
Contact information	1. Puvan Tharmanathan (scientific) York Trials Unit Lower Ground Floor ARRC Building Department of Health Science University of York Heslington York YO10 5DD United Kingdom Email: puvan.nathan@york.ac.uk 2. Catherine Arundel (public) Email: catherine.arundel@york.ac.uk
Notes	Funding for PROFHER‐2 by the NIHR Health Technology Assessment Programme: HTA 16/73/03. Funder website also includes 2 versions (01 November 2017 and 09 March 2018) of the trial protocol: https://www.fundingawards.nihr.ac.uk/award/16/73/03 Trial website: https://www.york.ac.uk/healthsciences/research/trials/research/trials/profher-2/ Recruitment into the trial was suspended because of COVID‐19. "Internal review. 16/04/2020: Due to current public health guidance, recruitment for this study has been paused.(notified on 5/5/20)".