Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study (COPS)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    166
  • sponsor
    Karolinska Institutet
Updated on 7 October 2022

Summary

Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.

Description

Patients over the age of 20 with an acute traumatic isolated digital nerve injury to any of the fingers and not in the thumb will be investigated for inclusion in the study. After informed written consent a sealed envelope randomisation will allocate patients to treatment with either surgical exposure and epineural suture or non-operative treatment in a cast. Due to the nature of treatment arms the allocation will not be blinded. Clinical follow-up and investigation of primary and secondary outcomes will be conducted at 3 weeks, 3 months, 6 months and 1 year after inclusion.

Details
Condition Digital Nerve Injury
Treatment Non-operative treatment, Epineural suture
Clinical Study IdentifierNCT05536609
SponsorKarolinska Institutet
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical signs of isolated traumatic digital nerve injury in digits 2, 3, 4 or 5
Patient age => 20 years on day of injury
Injury location on volar aspect of finger
Acute sensory dysfunction in suspected digital nerve injury area

Exclusion Criteria

Digital nerve injury ot the thumb
Digital nerve injury in the palm of the hand (i e proximal to the finger base)
Patient does not speak or read the Swedish language
Abusive drug or alcohol use
Dementia
Injury mor than 7 days at dianosis AND/OR operative treatment cannot be offered within 10 days from injury
Neurologic disease
Ongoing infektion in the injured finger
concomittant tendoninjury or fracture in injured or adjacent finger
Injury mechanism is of blunt or crush charachter
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