Clinical trial NCT05536609: Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
Official title: Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digital Nerve Injury
Keywords: digital nerve injury
digital nerve lesion
randomised controlled study
surgical nerve repair
non-operative treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 166
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randmoised controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Static two points discrimination (S2PD)
timeFrame: one year after injury
Secondary outcomes:
measure: Active range of motion
timeFrame: 3 and 6 months and 1 year
measure: Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
timeFrame: 3 and 6 months and 1 year
measure: Semmes-Weinstein monofilament test
timeFrame: 3 and 6 months and 1 year
measure: Mini Sollerman test
timeFrame: 3 and 6 months and 1 year
measure: Grip strength
timeFrame: 3 and 6 months and 1 year
measure: Quick-DASH
timeFrame: 3 and 6 months and 1 year
measure: HQ-8
timeFrame: 3 and 6 months and 1 year
measure: Neuropathic pain
timeFrame: 3 and 6 months and 1 year
measure: Anxiety and depression
timeFrame: at inclusion
measure: Pain catastrophising scale, (PCS)
timeFrame: at inclusion
measure: Sick leave time
timeFrame: 1 year
measure: Wait for surgery
timeFrame: 3 weeks
measure: Time in operating theatre
timeFrame: day of surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet Södersjukhuset, Department of clinical research and education
Study officials:
affiliation: Karolinska Institutet
name: Cecilia Mellstrand Navarro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: