Title: 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
Funder: Department of Health and Social Care

Abstract: RESEARCH QUESTION_x000D_ In adult patients with a recent injury to both flexor tendons in a finger, is repairing one tendon only no worse than repairing both and which of these treatments is cost-effective? _x000D_ _x000D_ BACKGROUND_x000D_ Flexor tendons are smooth cords that help fingers to bend. There are two flexor tendons in each finger, which join the muscles in the forearm to bones in the fingers. One tendon bends the middle knuckle, the other bends the fingertip. _x000D_ _x000D_ When people receive a deep cut in their finger, these tendons may get cut through. This happens relatively often in young adults. The usual treatment is an operation during which the surgeon stitches the tendon ends back together, followed by 12 weeks of rehabilitation._x000D_ _x000D_ Surgeons and researchers don’t know if it’s best to repair one or both tendons. Repairing both tendons might give more strength but there is an increased risk of a bent finger with less movement. Repairing only the tendon that bends the fingertip might give less strength but a better range of movement and is less expensive. _x000D_ _x000D_ In order to generate good quality evidence that can guide practice, repair of one tendon alone needs to be formally tested in a clinical trial. _x000D_ _x000D_ DESIGN AND METHODS_x000D_ Our trial will recruit 310 adult patients from up to 40 NHS hospitals across the UK. Patients will undergo surgery to have either the tendon bending the fingertip repaired or both tendons repaired. Patients will be asked to wear a splint to protect the repaired tendon or tendons. Within 7 days they will see a hand therapist and start a hand therapy regimen. Then at 6 weeks, 3 months and 6 months after surgery, we will ask patients about pain and about how well their finger is working. We will do this via questionnaires that patients can fill in when they are visiting the clinic as part of the care they receive as standard or by post or email. By 6 months, most patients will have completed their rehabilitation and been discharged. We believe that’s when we will gain most insight in how repairing one tendon compares to repairing both. So that’s our most important measuring point._x000D_ _x000D_ We will also interview some of the participants to understand patient experience and acceptability of different types of anaesthesia, surgery and use of splints. _x000D_ _x000D_ The trial will last 3 years and 4 months. During the first eight months, we will test if we can recruit enough patients to take part in the study, before we take it any further. _x000D_ _x000D_ PATIENT INVOLVEMENT_x000D_ Previous research shows that patients and healthcare workers think our research question is important. When we spoke to patients, they told us that their main concerns were getting back full finger motion, returning to work quickly and having a splint that allowed them to use their injured hand. We will continue to seek advice from patients about how we carry out the trial and how we tell people about the results._x000D_ _x000D_ DISSEMINATION_x000D_ Our study results will matter to patients, the NHS, and society as a whole. We will share them throughout the NHS, charities and those who write guidelines for doctors. We will write a summary of the results for patients, families, carers and all those who help deliver the trial in NHS hospitals. _x000D_ _x000D_ The study findings will help patients and clinicians to make informed choices about treatment.

Lay abstract: RESEARCH QUESTION_x000D_ In adults with recent injury to both flexor tendons in a finger, is repairing one tendon only no worse than repairing both and which of these treatments is cost-effective? _x000D_ _x000D_ BACKGROUND_x000D_ Flexor tendons are smooth cords that enable bending by connecting forearm muscles to finger bones. A typical injury, from a sharp cut, causes loss of bending. Treatment is surgical repair of the tendons followed by a 12 week period of rehabilitation. The latter promotes healing and full finger motion, without tendons getting stuck in scar tissue or coming apart. During the first 6 weeks, a splint is used to limit the range of finger motion and protect the tendon repair._x000D_ The most common and challenging injury is in zone 2, at the base of the finger where the two tendons run in the tight flexor sheath. There is low quality evidence as to whether repairing both flexor digitorum profundus (FDP) and flexor digitorum superficialis (FDS) is better than FDP alone. Our national service evaluations found equipoise amongst surgeons. Repairing both might increase strength but leave a bent finger. Repairing FDP alone might be weaker but give a better range of motion. After surgery, patients will complete a hand therapy rehabilitation regimen._x000D_ _x000D_ AIMS AND OBJECTIVES_x000D_ The aim is to conduct a two-arm randomised controlled trial comparing repair of FDP alone versus both FDP and FDS in complete zone 2 injuries. The primary objective is to ascertain the patient reported clinical effectiveness of these interventions at 6 months using the Patient Evaluation Measure. Secondary objectives include: Patient Reported Wrist/Hand Evaluation measure, surgical complications, need for further surgery, range of motion, grip strength, comparison of QALYs and cost effectiveness between the groups and a nested qualitative study exploring patient experience and aspects of service delivery (e.g. anaesthetic preferences)._x000D_ _x000D_ METHODS_x000D_ A multicentre two-arm non-inferiority RCT with patients and assessors masked to surgical procedure. It will be run over 40 months with patient questionnaires up to 6 months and longer term follow up using routine data. _x000D_ _x000D_ IMPACT AND DISSEMINATION_x000D_ This study will work very closely with the FIRST Study, which will investigate different hand therapy regimens. It will support patient and clinical decision making to ensure that the health service is providing effective treatment with the best patient outcomes and lowest complications and cost. _x000D_ Academic dissemination will include the funder report, scientific presentations and publications, publicity via professional societies. Patient and public dissemination will be through patient groups, the myinjuredhand.com website, other patient information resources and social media

Research activity codes: 6.3 MEDICAL DEVICES;6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS