HU-FIX Study: HUmeral shaft fracture FIXation
Research type
Research Study
Full title
HU-FIX Study: HUmeral shaft fracture FIXation. A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis
IRAS ID
244384
Contact name
Samuel G Molyneux
Contact email
Sponsor organisation
NHS Lothian Research & Development
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
HUmeral shaft fracture FIXation (HU-FIX) study
Fractures of the humeral shaft (upper arm bone) account for approximately 1% of all adult fractures in the UK. Historically, these injuries have been treated using a cast and/or brace, with immediate surgical fixation reserved for severely- or multiply-injured patients. However, treatment with a brace is associated with several important problems, including poor alignment of the healed bones and shoulder/elbow stiffness. The brace is usually worn for up to 3 months, which interferes with patients’ everyday activities and sleeping, and can predispose to skin problems. For 10-15% of patients treated with a brace, their fracture will not heal and will require surgery several months after the original injury, which is more difficult and carries a higher risk of nerve injury and infection. Recent studies suggest that undertaking immediate surgical fixation more often could improve healing and functional outcome for patients with humeral shaft fractures. The only relevant RCT is from Brazil, and showed no difference in clinical outcome between conservative and operative management; unfortunately, however, the operative technique used was unusual and would be considered highly suboptimal in most Western countries.
We will include adult patients (≥16 years), with capacity to consent and complete post-operative questionnaires in English, presenting to a single Orthopaedic trauma unit. Participants will be randomised to either non-operative treatment (with a brace) or operative treatment (i.e. surgical fixation). We will assess whether there is a difference between the groups in terms of patient-reported outcome scores, fracture healing, complications, pain and return to work/sport over a one-year follow-up period.
Participants will be enrolled into the trial following informed consent. Following randomisation (to either non-operative treatment or surgical fixation), participants will then be reviewed at several defined timepoints, with a combination of clinical examination, X-rays, 3D-ultrasound scans and patient-reported outcome scores. Our study results will hopefully enable surgeons to make better-informed decisions when managing patients with humeral shaft fractures.
REC name
South East Scotland REC 01
REC reference
18/SS/0073
Date of REC Opinion
19 Jul 2018
REC opinion
Further Information Favourable Opinion