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Cast Or ePineural Suture for digital nerve injuries (COPS): study protocol for a randomized controlled trial
Carin Carlsson1,2, Johanna von Kieseritzky3,4, Marianne Arner3,4
1Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden. carin.carlsson@regionstockholm.se.
Background:
Injuries to digital nerves in the hand are very common and result in sensory disturbances, which can have a major negative impact on hand function. The gold standard of treatment is end-to-end nerve repair with sutures, at the latest within 2 weeks from injury. Despite operative treatment of digital nerve injuries, the clinical results are often poor. Recent literature questions the evidence supporting surgical repair of digital nerve injuries in adults.
Methods:
In this randomized controlled trial, we will allocate patients with injury to a single digital nerve to either surgical nerve repair and cast, or immobilization only. The primary outcome is the return of sensation, measured as static two-point discrimination, at 12 months after injury. Secondary outcomes include complications, the Semmes-Weinstein monofilament test, the Mini Sollerman hand function test, and patient-reported outcome measures.
Discussion:
The lack of high-quality studies comparing surgical repair of digital nerve injuries to simple immobilization of the finger motivates the conduct of this randomized study.
Trial Registration:
ClinicalTrials.gov. TRN: NCT05536609. Registered on 08/23/2022.
