What is the FLARE Trial?
A deep cut in the fingers is a common injury that damages the flexor tendons. There are two flexor tendons in each finger, these join the muscles in the forearm to bones in the fingers. One tendon bends the middle knuckle, and the other bends the fingertip. If one or both tendons are cut, surgical treatment is required to stitch the damaged tendon ends together, followed by the use of a protective splint and up to 12 weeks of rehabilitation. Repairing both flexor tendons might give more strength, but there is an increased risk of thick scar tissue and a reduced range in motion. Repairing a single flexor tendon (the one attached to the fingertip alone) might give less strength but a better range of movement and is less expensive to the NHS. In order to generate good quality evidence that can guide future clinical practice, repair of one tendon alone needs to be formally tested in a clinical trial.
The FLARE Trial is a multi-centre, non-inferiority, paralell group, randomised controlled trial investigating the clinical and cost effectiveness of treatment for flexor tendon injury. This trial will involve patients over the age of 16 years old, with a recent open, zone 2 only, single finger, flexor tendon injury. The patients will be randomised into two treatment groups; one group will have the Flexor Digitorum Profundus (FDP) repaired only whilst the other group has both FDP and Flexor Digitorum Superificialis (FDS) repaired. Secondary data collection will take place at routine hand therapy clinic appointments (either in hospital or remotely) within 1 week, 6 weeks and 3 months post surgery. Participants will be asked to complete questionnaires 6 weeks, 3 months and 6 months after thier surgery remotely via post, email or over the phone.
In addition, a nested qualitative study will capture the experience of patients, surgeons and hand therapists involved in the trial, and a cost effective analysis of the two interventions will be conducted from the NHS perspective.
Flexor Digitorum Profundus and Flexor Digitorum Superficialis repaired
