NCT05536609 Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
| NCT ID | NCT05536609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Digital Nerve Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2022-08-29 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 166 participants in total. It began in 2022-08-29 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Cecilia Mellstrand Navarro, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05536609 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Digital Nerve Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05536609 currently recruiting?
Yes, NCT05536609 is actively recruiting participants. Contact the research team at carin.carlsson@regionstockholm.se for enrollment information.
Where is the NCT05536609 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05536609 clinical trial?
NCT05536609 is sponsored by Karolinska Institutet. The principal investigator is Cecilia Mellstrand Navarro, MD, PhD at Karolinska Institutet. The trial plans to enroll 166 participants.