NCT03786679.

Study name	Non‐operative treatment in Sweden of proximal humeral fractures, a randomised multicentre trial
Methods	Randomised trial, with assessors who are not involved in the treatment; radiological assessment of images will be assessed with anonymised images
Participants	400 people age 18 years or over with a proximal humeral fracture no older than 7 to 10 days
Interventions	1. Orthosis group (Ultrasling ER III orthosis). An orthosis with the broken arm in neutral position fixed for four weeks. After four weeks, the participant is instructed to start rehabilitation. 2. Early rehabilitation group. The participant is instructed to start early rehabilitation (early range‐of‐motion exercises) about one week after the trauma.
Outcomes	Follow‐up: 12 months Primary outcome: union of fracture Secondary outcomes: Oxford Shoulder Score, numerical pain reporting scale (pain at rest, at night and during activity); QuickDASH, global assessment of improvement, shoulder range of motion (elevation, abduction, internal and external rotation)
Starting date	Start: 25 February 2019. Estimated study completion date: 25 February 2024
Contact information	Dr Hanna C Björnsson Hallgren, Linkoeping University, Sweden Email: hanna.bjornsson.hallgren@regionostergotland.se
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