NCT02913378.

Study name	Conservative vs surgical treatment for proximal humerus fractures in the elderly
Methods	Randomised controlled trial
Participants	58 participants (target) aged more than 60 years with displaced proximal humeral fractures (> 1 cm shaft translation; > 0.5 cm tuberosity displacement; head shaft angulation > 45 degrees; < 30 days from injury
Interventions	1. Surgery: open reduction and locking plate fixation 2. Not surgery: sling and physiotherapy rehabilitation only
Outcomes	Follow‐up: 2 years Primary outcome: Constant score relative to the unaffected shoulder Secondary outcomes: ASES (American Shoulder and Elbow Surgeons) shoulder score; Constant score; quality of life SF‐12; VAS pain; complication and reoperation rate; radiographic evaluation (union, head‐shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria); rotator cuff condition assessed using ultrasound and magnetic resonance
Starting date	January 2016 Estimated completion date: January 2020
Contact information	Dr Mauro EC Gracitelli University of São Paulo, São Paulo, Brazil Email: mgracitelli@gmail.com
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