FLexor repAir and REhabilitation (FLARE) 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10918157

Enrollment

310

Registered

2023-01-12

Start date

2023-08-23

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic injury to the hand in zone 2 injuries causing the flexor digitorum profundus and flexor digitorum superficialis to be severed. Injury, Occupational Diseases, Poisoning

Interventions

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

Eligibility

Sex/Gender

All

Age

16 Years to 110 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main FLARE trial Patient assessment of treatment, hand health and overall hand assessment, measured using a Patient Evaluation Measure (PEM) at 6 months post-surgery	—

Secondary

Measure	Time frame
Main FLARE trial 1. Patient assessment of hand/wrist pain and disability in activities of daily living, measured using the Patient Related Wrist/Hand Evaluation (PRWHE) at baseline, 6 weeks, 3 months and 6 months post-surgery 2. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 6 weeks, 3 months and 6 months post-surgery 3. Complications and Adverse Events collected by patient-reported questionnaires and review of hospital records up to 6 months post-surgery 4. Total range of motion, measured using a goniometer at 6 weeks and 3 months post-surgery 5. Grip strength measured using a dynamometer at 3 months post-surgery 6. Adherence to the splint regimen measured using patient self-report at 6 weeks post-surgery 7. Work outcomes measured using patient self-report at 6 weeks, 3 months and 6 months post-surgery 8.Treatment and outcome satisfaction measured using a net promoter score and PEM at 6 weeks, 3 months and 6 months post-surgery 9. Healthcare resource use measured patient self-report and medical records at surgery, up to 1 week, 6 weeks, 3 months and 6 months post-surgery 10. Adherence to the therapy regimen measured using patient self-report at 6 weeks and 3 months post-surgery	—

Measure

Time frame

Main FLARE trial 1. Patient assessment of hand/wrist pain and disability in activities of daily living, measured using the Patient Related Wrist/Hand Evaluation (PRWHE) at baseline, 6 weeks, 3 months and 6 months post-surgery 2. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 6 weeks, 3 months and 6 months post-surgery 3. Complications and Adverse Events collected by patient-reported questionnaires and review of hospital records up to 6 months post-surgery 4. Total range of motion, measured using a goniometer at 6 weeks and 3 months post-surgery 5. Grip strength measured using a dynamometer at 3 months post-surgery 6. Adherence to the splint regimen measured using patient self-report at 6 weeks post-surgery 7. Work outcomes measured using patient self-report at 6 weeks, 3 months and 6 months post-surgery 8.Treatment and outcome satisfaction measured using a net promoter score and PEM at 6 weeks, 3 months and 6 months post-surgery 9. Healthcare resource use measured patient self-report and medical records at surgery, up to 1 week, 6 weeks, 3 months and 6 months post-surgery 10. Adherence to the therapy regimen measured using patient self-report at 6 weeks and 3 months post-surgery

—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026