Comparing surgical and non-surgical treatments for finger nerve injuries
Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
This study is testing whether surgery or a cast works better for helping adults with finger nerve injuries recover and regain feeling and movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Stockholm County) |
| Trial ID | NCT05536609 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two treatment approaches for isolated digital nerve injuries in fingers: surgical repair using epineural suture and non-operative treatment with a cast. Patients aged 20 and older with acute traumatic nerve injuries will be randomly assigned to one of the two treatment groups. The primary outcome will assess digital nerve function through two-point discrimination one year post-treatment, while secondary outcomes will evaluate finger mobility, dexterity, hand function, pain, anxiety, and sick leave duration. Follow-up assessments will occur at multiple intervals over the year following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with acute traumatic isolated digital nerve injuries to fingers 2, 3, 4, or 5.
Not a fit: Patients with thumb injuries, palm injuries, or those with certain medical conditions such as dementia or ongoing infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for digital nerve injuries, enhancing recovery and quality of life for patients.
How similar studies have performed: While there is limited research specifically comparing these two treatment methods, similar studies on nerve repair techniques have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Stockholm County
- Karolinska Institutet Södersjukhuset, Department of clinical research and education — Stockholm, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Cecilia Mellstrand Navarro, MD, PhD — Karolinska Institutet
- Study coordinator: Carin Carlsson, MD
- Email: carin.carlsson@regionstockholm.se
- Phone: +46 8 123 616 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.