Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epineural suture, Non-operative treatment.
- Who it may be relevant to
- Registry conditions: Digital Nerve Injury. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Epineural suture
2 or three sutures - Procedure Non-operative treatment
The injured finger is protected in a plaster cast
Primary outcome measures
- Static two points discrimination (S2PD) [Time frame: one year after injury]
Secondary outcome measures (12)
- Active range of motion [Time frame: 3 and 6 months and 1 year]
- Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger [Time frame: 3 and 6 months and 1 year]
- Semmes-Weinstein monofilament test [Time frame: 3 and 6 months and 1 year]
- Mini Sollerman test [Time frame: 3 and 6 months and 1 year]
- Grip strength [Time frame: 3 and 6 months and 1 year]
- Quick-DASH [Time frame: 3 and 6 months and 1 year]
- HQ-8 [Time frame: 3 and 6 months and 1 year]
- Neuropathic pain [Time frame: 3 and 6 months and 1 year]
- Anxiety and depression [Time frame: at inclusion]
- Pain catastrophising scale, (PCS) [Time frame: at inclusion]
- Sick leave time [Time frame: 1 year]
- Wait for surgery [Time frame: 3 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska Institutet Södersjukhuset, Department of clinical research and education — Stockholm
Identifiers
NCT: NCT05536609 · COPS - RCT dig nerve injuries