NCT05536609

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Digital Nerve Injury

Interventions

Type	Name	Description
PROCEDURE	Epineural suture	2 or three sutures
PROCEDURE	Non-operative treatment	The injured finger is protected in a plaster cast

Timeline

• Start date: 2022-08-29
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2022-09-13
• Last updated: 2025-12-12

Locations

1 site across 1 country: Sweden