Feasiblity study: RCT of Bracing of shoulder fractures (N-Brace Trial)
Research type
Research Study
Full title
Does bracing of the arm in neutral rotation improve outcome in proximal humeral fractures. A feasibility study.
IRAS ID
169625
Contact name
Tobias Baring
Contact email
Sponsor organisation
Homerton University Foundation NHS Trust
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
Traditionally shoulder fractures have immobilised in a simple sling with the elbow flexed to 90 degrees and forearm laid across the abdomen. This is irrespective of their management (non-operative versus surgical intervention). This effectively places the shoulder in internal rotation. The anatomical position of the shoulder is in neutral rotation – with the elbow is flexed the forearm should be perpendicular to the coronal plan (parallel with the floor if lying on one’s back) of the body.
Given the lack of evidence on this topic the aim of this feasibility study is to provide provisional data to compare effectiveness of simple sling immobilization of the arm versus neutral rotation bracing for fractures of the proximal humerus (the ball part of the shoulder ball and socket joint). These data would be used to aid in design of a full multi-centre RCT.
On entry into the study they will undergo a CT of the shoulder. Once randomised in the 2 groups they will be managed according to their caring consultant’s own treatment principles. Operative treatment will be independent to randomisation as will the method of surgical fixation. For the conservatively managed patients they must wear their sling or brace for 4 weeks from the time of injury. For the operatively managed patients they must go into the same randomised group they were in prior to surgery and remain in the brace or sling for 4 weeks from the date of surgery. At 3 months all patients will undergo a repeat CT scan of the injured shoulder to assess the bony anatomy and evidence of union.
Primary endpoints will be limb function measured established shoulder outcome scores measured at 6 weeks, 3 and 12 months post-operatively. Secondary outcomes will be the rate of primary surgical fracture fixation, complication rate and secondary procedures.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1057
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion