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

NCT ID: NCT05536609

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2031-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epineural suture

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.

Group Type: EXPERIMENTAL

Epineural suture

Intervention Type: PROCEDURE

2 or three sutures

Non-operative treatment

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.

Group Type: ACTIVE_COMPARATOR

Non-operative treatment

Intervention Type: PROCEDURE

The injured finger is protected in a plaster cast

Interventions

Epineural suture

2 or three sutures

Intervention Type: PROCEDURE

Non-operative treatment

The injured finger is protected in a plaster cast

Intervention Type: PROCEDURE

Other Intervention Names

surgical repair; cast

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Cecilia Mellstrand Navarro

MD PhD Ass prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecilia Mellstrand Navarro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet Södersjukhuset, Department of clinical research and education

Stockholm, Stockholm County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Carin Carlsson, MD

Role: CONTACT

carin.carlsson@regionstockholm.se

+46 8 123 616 00

Cecilia Mellstrand Navarro, MD, PhD

Role: CONTACT

cecilia.mellstrand-navarro@sll.se

+46 709 280114

Facility Contacts

Carin Carlsson, MD

Role: primary

carin.carlsson@regionstockholm.se

+46 8 123 61600

Cecilia Mellstrand Navarro, MD, PhD

Role: backup

cecilia.mellstrand-navarro@sll.se

+46 709 280114

Other Identifiers

COPS - RCT dig nerve injuries

Identifier Type: -

Identifier Source: org_study_id