The humeral shaft fracture trial: surgical versus non-surgical interventions for humeral shaft fractures in patients aged 18 years or older

INTERVENTION: 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‐surgically. The technique of surgery used for those patients allocated to the surgery group will be chosen by the surgeon. Surgery will typically be followed by 2 weeks in a sling. Patients treated non‐surgically will have a cast applied in the Emergency Department which they will use for 2 weeks. They will then change to a brace which is usually worn for a further 8‐10 weeks. Both groups will be given a structured rehabilitation programme. The trial will last for 12 months. Patients will be followed up at 6 months and 12 months after their injury. They will be asked about their quality of life, daily activities, pain, physiotherapy treatment and any complications. The researchers will also look at the resources and services they have used to determine the costs involved in both treatments. CONDITION: Humeral shaft fracture ; Injury, Occupational Diseases, Poisoning ; Fracture of shaft of humerus PRIMARY OUTCOME: Function measured using the Disabilities of Arms Shoulders and Hand (DASH) patient‐reported outcome questionnaire at 12 months SECONDARY OUTCOME: ; 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; 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