ISRCTN97234566.
Study name | CoNNECT: a study of sutureless nerve repair |
Methods | Interventional 3‐arm RCT powered for equivalence. Computer randomisation. Participants and observers blinded. |
Participants | Patients aged 16–75 years with a traumatic complete digital nerve injury between the wrist and middle of the affected finger < 10 days old |
Interventions | Stitching injured nerve ends directly together Stitching nerve ends directly together and placing a nerve conduit around it Placing the injured nerve ends together without stitches and using the nerve conduit to maintain their position and heal |
Outcomes |
Primary outcome measure Sensory recovery using static and moving 2‐PD (tactile gnosis) for each repaired nerve. The comparable area on the opposite hand will be tested for static and moving 2‐PD to act as a baseline for assessment of recovery. These measurements will allow the modified Weber score to be calculated. This will be assessed at weeks 2, 6, 12, 26, and 52. Secondary outcome measures Monofilament pressure thresholds (innervation density), assessed using the WEST Monofilaments Upper extremity disability and symptoms, assessed using the DASH score Self‐rated health, assessed using the EQ‐5D Nerve irritation, assessed using differential Tinel's sign Pain, assessed using a VAS Cold intolerance, assessed using a VAS Hyperaesthesia, assessed using a VAS Site of repair, measured in mm from the hyponychium of the same digit (the duration of each repair will be recorded) For suture repairs, the quality of the repair will be recorded using the visual grading scale for suture‐only nerve repair For common digital nerve repair, the outcome for each digital nerve territory will be recorded Each assessed at weeks 2, 6, 12, 26, and 52 |
Starting date | 1 February 2017 |
Contact information | dominic.power@uhb.nhs.uk |
Notes | Retrospectively registered |