Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
ConditionDigital Nerve Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Epineural suture
Procedure/Surgery2 or three sutures
Non-operative treatment
Procedure/SurgeryThe injured finger is protected in a plaster cast
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Epineural sutureExperimental treatment 1 intervention
Group B: Non-operative treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Static two points discrimination (S2PD)
a static two points discrimination test performed by an occupational therapist of the injured finger
Time frame
one year after injurySecondary outcomes
1
Active range of motion
Range of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees)
Time frame
3 and 6 months and 1 year2
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Time frame
3 and 6 months and 1 year3
Semmes-Weinstein monofilament test
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Time frame
3 and 6 months and 1 year4
Mini Sollerman test
Hand function as measured by the Mini Sollerman test
Time frame
3 and 6 months and 1 yearSponsors and contacts
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Source ClinicalTrials.gov