Humeral shaft fracture Injury, Occupational Diseases, Poisoning Fracture of shaft of humerus
Conditions
Interventions
Participants will be randomised (online using RRAMP) in a 1:1 ratio stratified by centre
whether they are aged under 50 or 50 and over and whether they had a nerve injury at presentation or not, to either surgery or a brace. They will be randomised to be treated surgically or non-surgical
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years and older with a fracture of the humeral shaft (diaphysis) 2. Fracture of the humeral diaphysis which the surgeon believes may benefit from surgical fixation. ‘Diaphysis’ defined as the section of bone outside 1 Muller-square of the proximal and distal ends of the humerus (Müller 1990) 3. Participant is willing and able to give informed consent for participation in the study 4. Male or female, aged 18 years or above
Exclusion criteria
Exclusion criteria: 1. The fracture is open 2. The fracture is complicated by local tumour deposits 3. The index injury occurred more than 16 days prior to recruitment 4. The patient is unable to adhere to trial procedures 5. Other upper limb injuries which may reasonably be expected to affect responses to outcome PROMs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Function measured using the Disabilities of Arms Shoulders and Hand (DASH) patient-reported outcome questionnaire at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Function assessed using the Disabilities of Arms Shoulders and Hand (DASH) at baseline, 8 weeks, 3 and 6 months 2. Early pain recovery assessed using pain visual analogue scale (VAS) weekly in the first 8 weeks 3. Sport and performing arts functioning assessed using the DASH sports/performing arts at baseline, 8 weeks, 3, 6 and 12 months 4. Function assessed using the patient-reported outcome measurement information system (PROMIS) upper extremity at baseline, 4 weeks, 8 weeks, 3, 6 and 12 months 5. Function assessed using the PROMIS pain interference at baseline, 4 weeks, 8 weeks, 3, 6 and 12 months 6. Quality of life measured using the EQ-5D-5L at baseline, 8 weeks, 3, 6 and 12 months 7. Complications reported at 8 weeks, 3, 6 and 12 months 8. Cost-effectiveness measured using the Work Productivity and Activity Impairment Questionnaire at 3, 6 and 12 months 9. Time off work and driving recorded in the first 8 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed