Single unilateral digital nerve injury appropriate for surgical repair Injury, Occupational Diseases, Poisoning Injury of digital nerve
Conditions
Interventions
Patients are randomised in theatre after consent and after confirmation of eligibility through surgical exploration. A web-based randomisation system will be used and the allocations will be computer-
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 years and above with a suspected complete digital nerve laceration in any single digit, including thumb and little finger, appropriate for surgical repair
Exclusion criteria
Exclusion criteria: 1. Bilateral injury (ie both radial and ulnar digital nerves) 2. Laceration outside the region between distal palmar crease and distal interphalangeal joint 3. Closed injury 4. Infected wounds 5. Injuries in which a significant nerve gap exists which would preclude direct tension free surgical end-end repair 6. Non-isolated or multi-level injury (ie common digital/wrist nerve injury, fracture) 7. Unable to give consent 8. Inability to comply with trial follow-up procedures 9. Date of surgery later than 10 days after injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of microsurgical nerve repair measured by the Impact of Hand Nerve Disorders (I-HaND) Patient Reported Outcome Measure at 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurosensory and functional recovery measured at 3 and 12 months post-randomisation by: 1.1. Hand Health Profile of the Patient Evaluation Measure 1.2. EQ-5D-5L index and –EQ-VAS 1.3. Static two-point discrimination test (2PD) 1.4. Tactile gnosis using Shape/Texture Identification (STI) test; and Touch thresholds using Weinstein Enhanced Sensory Test (WEST) monofilaments 2. Cost-effectiveness of microsurgical nerve repair, measured by Health resource use questionnaires and EQ-5D-5L index at 3 and 12 months post randomisation 3. Complications of surgery and clinically problematic neuroma rates measured at 3 and 12 months post-randomisation by: 3.1. Patient-reported complications 3.2. Clinical assessment (including Elliot score) 3.3. Complications and further procedures in medical records 3.4. Complications and further procedures based on medical records and routine data at 24 months post randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactSITU-NDORMS Team
Outcome results
None listed