SOFFT: Simple Olecranon Fracture Fixation Trial
Research type
Research Study
Full title
Suture fixation versus tension band wiring for simple olecranon fracture fixation: a multi-centre randomised controlled trial (Simple Olecranon Fracture Fixation Trial – SOFFT)
IRAS ID
276873
Contact name
Adam C Watts
Contact email
Sponsor organisation
Wrightington, Wigan and Leigh NHS Foundation Trust
ISRCTN Number
ISRCTN 87904264
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Fractures (a break in the bone) of the olecranon (bony point of the elbow) are common and usually happen after a fall onto the elbow. The risk of having this fracture increases as we get older.
If a patient is well enough they usually have surgery to fix the fracture as a day case.
Commonly the bone is held using tension band wiring technique, a metal wire bent around the bone and two smooth pins. This is effective in holding the position for the fracture to heal. However, the wires can cause pain because they lie just under the skin. One in three patients will have a second operation to remove the wires, exposing them to further surgical risks and resulting in increased cost to the National Health Service.Another way to hold the bone is to use strong material cord (tension suture fixation). Some small studies looking at this technique have shown that this can reliably hold the bones in a good position while they heal and that the patient does not experience any discomfort from prominence of the suture material. One small study found the need for further surgery was reduced to less than one in twenty. This is better for the patients and could save the NHS about 4 million pounds a year but a larger study is needed to confirm this finding.
This randomised controlled trial will find out which treatment has a better outcome for patients. We will recruit 280 adults (aged 16 or older) who have an olecranon fracture from hospitals around the UK. Surgeons will review their injury to ensure that they meet the study entry criteria. If patients agree to take part they will be allocated at random to either receive fixation with metal wires or fixation with strong cord.
All other care would be routine care that patients could expect if they had not participated in the trial.
We will assess outcomes at the start of the study, then at 4, 12, and 18 months and some at 24 months when participants will complete questionnaires that measure elbow function and pain. Participants will attend a clinic visit that will include x-rays to check healing at 4 months.
The associated costs of both treatments to the NHS will also be evaluated.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0234
Date of REC Opinion
15 Jun 2020
REC opinion
Further Information Favourable Opinion