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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05536609
Acronym
COPS
Enrollment
166
Registered
2022-09-13
Start date
2022-08-29
Completion date
2031-12-31
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital Nerve Injury

Keywords

digital nerve injury, digital nerve lesion, randomised controlled study, surgical nerve repair, non-operative 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.

Interventions

PROCEDUREEpineural suture

2 or three sutures

The injured finger is protected in a plaster cast

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

1:1 randmoised controlled study

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Static two points discrimination (S2PD)one year after injurya static two points discrimination test performed by an occupational therapist of the injured finger

Secondary

MeasureTime frameDescription
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger3 and 6 months and 1 yearRatio between S2PD in injured finger and S2PD in uninjured contralateral finger
Semmes-Weinstein monofilament test3 and 6 months and 1 yearDiscriminatory sensory function as measured by Semmes-Weinstein monofilament test
Mini Sollerman test3 and 6 months and 1 yearHand function as measured by the Mini Sollerman test
Grip strength3 and 6 months and 1 yearGrip strength of injured and non-injured hand as measured by Jamar dynamometer
Quick-DASH3 and 6 months and 1 yearPatient 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.
HQ-83 and 6 months and 1 yearPatient Rated Outcome measure (PROM) for hand function as measured by the HQ-8 (Eight item HAKIR questionnaire)
Active range of motion3 and 6 months and 1 yearRange of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees)
Anxiety and depressionat inclusionPsychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
Pain catastrophising scale, (PCS)at inclusionPain catastrophising scale, (PCS) measures 13 items on a 5 points Likert scale. Higher scores represent high degree of pain catastrophising scale, (PCS).
Sick leave time1 yearDays of absence from work
Wait for surgery3 weeksThe number of days that have passed from the day of injury to the day of surgery are reported
Time in operating theatreday of surgeryTime in operating theatre is measured in minutes
Neuropathic pain3 and 6 months and 1 yearOccurrence 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.

Countries

Sweden

Contacts

Primary ContactCarin Carlsson, MD
carin.carlsson@regionstockholm.se+46 8 123 616 00
Backup ContactCecilia Mellstrand Navarro, MD, PhD
cecilia.mellstrand-navarro@sll.se+46 709 280114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026