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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Digital Nerve Injury

Intervention / Treatment
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* Procedure: Epineural suture
* Procedure: Non-operative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randmoised controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epineural suture<br>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<br>* 2 or three sutures<br>* Other names: surgical repair;|
| Active Comparator: Non-operative treatment<br>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<br>* The injured finger is protected in a plaster cast<br>* Other names: cast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active range of motion | Range of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees) | 3 and 6 months and 1 year | 
| Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger | Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger | 3 and 6 months and 1 year | 
| Semmes-Weinstein monofilament test | Discriminatory sensory function as measured by Semmes-Weinstein monofilament test | 3 and 6 months and 1 year | 
| Mini Sollerman test | Hand function as measured by the Mini Sollerman test | 3 and 6 months and 1 year | 
| Grip strength | Grip strength of injured and non-injured hand as measured by Jamar dynamometer | 3 and 6 months and 1 year | 
| Quick-DASH | Patient Rated Outcome measure (PROM) for hand function as measured by the quick-DASH (Disability of the Arm, Shoulder and Hand). 11 items with 5-level Likert scales measures upper limb function. The scale ranges from 0 - 100 and 0 is the lowest possible disability. | 3 and 6 months and 1 year | 
| HQ-8 | Patient Rated Outcome measure (PROM) for hand function as measured by the HQ-8 (Eight item HAKIR questionnaire) | 3 and 6 months and 1 year | 
| Neuropathic pain | Occurrence of neuropathic pain as measured by Doleur Neuropathic 4 questions (DN4). 4 aspects of neuropathic pain are evaluated by 10 questions, with higher scores representing a worse state. | 3 and 6 months and 1 year | 
| Anxiety and depression | Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS) | at inclusion | 
| Pain catastrophising scale, (PCS) | Pain catastrophising scale, (PCS) measures 13 items on a 5 points Likert scale. Higher scores represent high degree of pain catastrophising scale, (PCS). | at inclusion | 
| Sick leave time | Days of absence from work | 1 year | 
| Wait for surgery | The number of days that have passed from the day of injury to the day of surgery are reported | 3 weeks | 
| Time in operating theatre | Time in operating theatre is measured in minutes | day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital nerve injury, digital nerve lesion, randomised controlled study, surgical nerve repair, non-operative treatment