FLARE: FLexor repAir and REhabilitation Trial
A randomised trial to determine the clinical and cost effectiveness of repairing flexor digitorum profundus (FDP) alone versus repair of both FDP and flexor digitorum superficialis (FDS) for treatment of complete zone 2 flexor tendon injuries: the FLexor repAir and Rehabilitation (FLARE) trial.
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 8 months, 31 days
A deep cut through fingers is a common injury that damages the flexor tendons. Flexor tendons are two smooth cords that run from forearm to the fingers to allow fingers to bend. Usual treatment is surgery to stitch the severed flexor tendon ends together, followed by 12 weeks of rehabilitation. Repairing both tendons might give more strength, but this increases the risk of a bent finger with less movement. Repairing the one to the fingertip alone might give less strength but better movement and is less expensive. Good quality evidence is required to guide practice by assessing whether the repair of one flexor tendon is as effective as the repair of both, in a clinical trial.
This randomised controlled trial will recruit 310 adults (aged 16 years or older) who have a recent division of both flexor tendons, from up to 40 UK hospitals. Surgeons will review their injury before and at surgery, to ensure that they meet the trial inclusion criteria. If patients agree to participate, they will be randomly allocated to either receive the repair of one or both flexor tendons.
All other treatment will be routine care that patients could expect if they had not participated in the trial.
We will assess secondary outcomes at the start of the trial, then within 7 days, 6 weeks, 3 months and 6 months after surgery through routine and remote hand therapy clinic reviews. The participants will follow a hand therapy regimen according to routine practice at the site.
In addition, participants will be asked to complete a quality of life questionnaire at baseline, 6 weeks, 3 months and 6 months after surgery either by phone, email or post.
The associated costs of both treatments to the NHS will also be evaluated.
North West - Greater Manchester Central Research Ethics Committee
Date of REC Opinion
20 Feb 2023
Further Information Favourable Opinion