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

Karolinska Institute

Status: Enrolling

Conditions: Digital Nerve Injury

Treatments: Procedure: Non-operative treatment; Procedure: Epineural suture

Study type: Interventional

Funder types: Other

Identifiers

NCT05536609

COPS - RCT dig nerve injuries

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Epineural suture

Experimental group

Description:

The injured digital nerve is exposed during a surgical intervention and sutured with 2 or three epineural sutures 8.0 or 9.0 synthetic monofilament non-resorbable suture. Postoperative treatment includes 3 weeks in a plaster cast followed by rehabilitation.

Treatment:

Procedure: Epineural suture

Non-operative treatment

Active Comparator group

Description:

The injured digital nerve is not surgically exposed. The skin is closed over the injury site and the finger is protected in a plaster cast for three weeks followed by rehabilitation.

Treatment:

Procedure: Non-operative treatment