None listed
Conditions
Brief summary
A multicentre randomised controlled trial comparing outcomes for humeral shaft fractures (arm fractures) treated with and without an operation to 'fix' the bone (with a metal plate and screws or a rod versus treating with an arm brace). 200 patients will be randomised over 14 hospitals (100 to each treatment type) and followed up over one year to determine if there is any difference in outcome. The hypothesis is that those treated with surgery will have better outcomes. The primary outcomes is the difference between the groups for scores on the Disabilities of hand and shoulder survey at one year post injury. Other outcome measure will be fracture healing, pain and quality of life scores, complication rates and return to activity levels as well as a cost analysis of both treatment types.
Interventions
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 bet
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
Sponsors
Central Adelaide Local Health Network Incorporated
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Exclusion criteria
Open fractures Other simultaneous injuries limited to: Other fractures or joint injuries in the same arm Any injury requiring restricted use of the contra-lateral upper limb Any injury requiring restricted weight bearing on either lower limb Head injuries Previous fractures with internal fixation in the same bone. Patients with no access to emails or internet usage. Patients with poor command of English language.
Outcome results
None listed