SHAFT – Shaft of Humerus Acute Fixation Trial. A study comparing clinical outcomes of the management of arm fractures in adults using non-operative treatment and operative treatment (plates or nails).

INTERVENTION: Patient will be randomised to intervention 1 or a control treatment to treat their humeral shaft fracture. Intervention 1 is operative treatment of the humeral shaft fracture. If randomised to this treatment the patient with undergo internal fixation of the humerus fracture by the treating Consultant Orthopaedic Surgeon. They may use whichever fixation method is usual for them. (In practice this will mean a plate and screws or an intramedullary nail fixation method.) The operation will take between 60 and 120 minutes. When well enough following the operation the patient will be allowed home and to begin moving their arm. They will be reviewed in the fracture clinic as is routine for these injuries at 2 weeks, 6 weeks and 12 weeks following their operation for a clinical check and check X‐ray by the treating Orthopaedic Surgeon CONDITION: Humerus fracture PRIMARY OUTCOME: DASH (Disability of Shoulder and Hand) scores between groups SECONDARY OUTCOME: Activity levels as monitored by activity bracelets. These will be worn by patients for the first week of each month for the first four months after injury. Complications such as infection, nerve injury metalwork failure. These will be assessed clinically and radiologically post‐operatively and at each clinical follow up (2, 6, 12, 26 and 52 weeks) and documented appropriately DASH (Disability of Shoulder and hand) scores Economic Analysis (Cost utility for each treatment arm). This will be calculated using costs of treatment as defined by the available schedules as well as including the patient out of pocket costs over their recovery period (including absence from work). The difference between the treatment groups will be calculated and a QALY figure assigned to each treatment groups Fracture non‐union rates ‐ this is assessed by radiological evaluation where there requires to be bridging callus on 3 out of 4 cortices for radiological union or the absence of a fracture line in the setting of plate fixation. Pain scores ‐ VAS 100mm analogue scale Re‐operation rates. Any further procedure following the initial procedure will be documented and expressed as a re‐operation rate compared to the total number of people operated on. Re‐operation could happen at any time but will be classified as early (<2 weeks), (intermediate 2‐12 weeks), or late (beyond 12 weeks) Readmission rates. The number of patients readmitted to hospital for further treatment related to their fracture will be compared between the two treatment groups. This will be assessed at early, middle and late timepoints (before 2 weeks, between 2 and 12 weeks and beyond 12 weeks post initial management. Return to Activities (Driving/Work). This will be assessed by direct questioning at clinic attendance to document the time after injury each patient returned to driving and work ; This will be a simple yes no question as to whether the patient has returned to driving and/or work. INCLUSION CRITERIA: Closed fracture presenting within 14 days. Humerus shaft fracture amenable to simple plate or nail fixation (ie not requiring peri‐articular plates) and without extension into either metaphysis. Medically fit enough to undergo surgery. No active malignancy. Ability to provide informed consent. English language sufficient to complete online outcome questionnaires.