FLexor repAir and REhabilitation (FLARE) Trial
- 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
- Registration Number
- ISRCTN10918157
- Lead Sponsor
- South Tees Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 310
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main FLARE trial<br>Patient assessment of treatment, hand health and overall hand assessment, measured using a Patient Evaluation Measure (PEM) at 6 months post-surgery
- Secondary Outcome Measures
Name Time Method