SUBMIT: Stability of Unicortical Vs Bicortical Metacarpal fracture Internal fixation Trial
Date opened: 01 June 2015
Type: Randomised Controlled Trial
Size: Single Centre
Recruitment to date: 8
Lead researchers: Lt Col. Mark Foster, Mr Rajive Jose
Hand fractures can be treated by fixing the bone with a plate and screws, which stabilise the bone while it heals. This screws can either fix to one side of the bone (unicortical), or to both sides of the bone (bicortical). Bicortical fixation is more commonly used but it is currently unknown which treatment is more effective for recovery. The SUBMIT (Stability of Unicortical Vs Bicortical Metacarpal fracture Internal fixation Trial) study is being completed to investigate which treatment may be more effective.
Who is eligible?
- Patients who are less than 10 days post injury
- Patients who are more than 18 years old
- Patients who have an isolated hand injury
- Poly trauma
- Non-osteoperotic pathological fracture
SUBMIT is a Randomised Controlled Trial (RCT), in which patients requiring surgery for their hand fractures are randomised to receive either one of the two types of surgery. The team will then look at a range of outcomes, including bone healing, patient reported outcomes, and range of movement, to determine which treatment may be better for these patients. Both the patients and the research hand therapists remain unaware which type of surgery has been undertaken until the end of the study.
The two conditions will be compared and success of each surgical method will be measured by:
- Bone healing
- Patient reported outcomes
- Range of movement