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
Traumatic injury to the hand in zone 2 injuries causing the flexor digitorum profundus and flexor digitorum superficialis to be severed.
Main FLARE trial The intervention is repair of flexor digitorum profundus (FDP) alone, compared to the usual practice of the repair of FDP and flexor digitorum superficialis. Participants will undergo treatment as per the randomisation allocation schedule under the care of one of the participating surgeons Associate PI Study Within A Trial (API SWAT) A 2x2 factorial SWAT embedded in the main trial utilising the NIHR API Scheme. All sites recruiting to FLARE who have a confirmed Associate PI (API) will be included. Aim is to evaluate the effect on recruitment rates of using two interventions: Enhanced Associate Principal Investigator Package and Digital Nudging on participant recruitment rates.
Inclusion criteria for screening: 1. Patients aged 16 years old and over Inclusion Criteria for randomisation (confirmed in surgery): 2. Complete division of FDP and FDS in zone 2 of a single finger 3. Injury amenable to primary repair
Eligibility criteria for screening: 1. Injuries affecting more than one digit or the thumb 2. Injuries outside of Zone 2 3. Injuries affecting multiple zones 4. Clinically infected wounds 5. Closed flexor tendon injury 6. Previous tendon, bone or joint injury in the affected digit 7. Patient does not have capacity to give informed consent 8. Patient unable to complete follow-up requirements 9. Contraindications to surgery Exclusion criteria for randomisation (confirmed at surgery): 10. Injuries with loss of tendon substance or skin necessitating reconstruction 11. Division of both digital arteries resulting in revascularisation of injured digit 12. Division of both digital nerves