NCT05536609

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
69mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Aug 2022Dec 2031

First Submitted

Initial submission to the registry

August 23, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

8.3 years

First QC Date

August 23, 2022

Last Update Submit

December 5, 2025

Conditions

Digital Nerve Injury

Keywords

digital nerve injurydigital nerve lesionrandomised controlled studysurgical nerve repairnon-operative treatment

Outcome Measures

Primary Outcomes (1)

  • Static two points discrimination (S2PD)

    a static two points discrimination test performed by an occupational therapist of the injured finger

    one year after injury

Secondary Outcomes (13)

  • Active range of motion

    3 and 6 months and 1 year

  • Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger

    3 and 6 months and 1 year

  • Semmes-Weinstein monofilament test

    3 and 6 months and 1 year

  • Mini Sollerman test

    3 and 6 months and 1 year

  • Grip strength

    3 and 6 months and 1 year

  • +8 more secondary outcomes

Study Arms (2)

Epineural suture

EXPERIMENTAL

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.

Procedure: Epineural suture

Non-operative treatment

ACTIVE COMPARATOR

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.

Procedure: Non-operative treatment

Interventions

Epineural suturePROCEDURE

2 or three sutures

Also known as: surgical repair
Epineural suture
Non-operative treatmentPROCEDURE

The injured finger is protected in a plaster cast

Also known as: cast
Non-operative treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet Södersjukhuset, Department of clinical research and education

Stockholm, Stockholm County, 11883, Sweden

RECRUITING

MeSH Terms

Interventions

Wound HealingPOLR1G protein, human

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Cecilia Mellstrand Navarro, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carin Carlsson, MD

CONTACT

+46 8 123 616 00carin.carlsson@regionstockholm.se

Cecilia Mellstrand Navarro, MD, PhD

CONTACT

+46 709 280114cecilia.mellstrand-navarro@sll.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randmoised controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Ass prof

Study Record Dates

First Submitted

August 23, 2022

First Posted

September 13, 2022

Study Start

August 29, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations

SE(1)