Digital Nerve InjuryCOPSNCT05536609
Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
A study testing Epineural suture and Non-operative treatment in people with Digital Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- Epineural suture and Non-operative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSweden
- Study dates
- 29 Aug 2022to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet Södersjukhuset, Department of clinical research and education
Stockholm, Stockholm County, 11883
Carin Carlsson, MD, +46 8 123 61600, carin.carlsson@regionstockholm.se
Cecilia Mellstrand Navarro, MD, PhD, +46 709 280114, cecilia.mellstrand-navarro@sll.se
About this study
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.
Read the 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.
- Conditions
- Digital Nerve Injury
- Being tested
- Epineural suture, Non-operative treatment
- Keywords
- digital nerve injury, digital nerve lesion, randomised controlled study, surgical nerve repair, non-operative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epineural sutureProcedure or surgery
Also called surgical repair
2 or three sutures
Non-operative treatmentProcedure or surgery
Also called cast
The injured finger is protected in a plaster cast
| Study group | Role | What they receive |
|---|---|---|
| Epineural suture | Experimental | 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. Receives: Procedure: Epineural suture |
| Non-operative treatment | Active comparator | 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. Receives: Procedure: Non-operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static two points discrimination (S2PD)
a static two points discrimination test performed by an occupational therapist of the injured finger
Measured: one year after injury
Secondary outcomes (13)
Active range of motion
Range of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees)
Measured: 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
Measured: 3 and 6 months and 1 year
Semmes-Weinstein monofilament test
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Measured: 3 and 6 months and 1 year
Mini Sollerman test
Hand function as measured by the Mini Sollerman test
Measured: 3 and 6 months and 1 year
Grip strength
Grip strength of injured and non-injured hand as measured by Jamar dynamometer
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 3 and 6 months and 1 year
Anxiety and depression
Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
Measured: 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).
Measured: at inclusion
Sick leave time
Days of absence from work
Measured: 1 year
Wait for surgery
The number of days that have passed from the day of injury to the day of surgery are reported
Measured: 3 weeks
Time in operating theatre
Time in operating theatre is measured in minutes
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start29 Aug 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digital Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randmoised controlled study
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
- Investigators
- Cecilia Mellstrand Navarro, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536609
- Sponsor's protocol ID
- COPS - RCT dig nerve injuries
- Acronym
- COPS
- Status last verified
- Dec 2025
- First submitted
- 23 Aug 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carlsson C, von Kieseritzky J, Arner M, Navarro CM. Cast Or ePineural Suture for digital nerve injuries (COPS): study protocol for a randomized controlled trial. Trials. 2026 Aug 26;27(1):548. doi: 10.1186/s13063-026-09956-1.
PubMed 42642770
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05536609
- Acronym / sponsor ID
- COPS / COPS - RCT dig nerve injuries
- Conditions
- Digital Nerve Injury
- Keywords
- digital nerve injury, digital nerve lesion, randomised controlled study, surgical nerve repair, non-operative treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randmoised controlled study
| Arm | Type | Receives |
|---|---|---|
| Epineural suture | Experimental | Procedure: Epineural sutureThe 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. |
| Non-operative treatment | Active comparator | Procedure: Non-operative treatmentThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epineural sutureAlso: surgical repair2 or three sutures | Procedure or surgery | Epineural suture |
| Non-operative treatmentAlso: castThe injured finger is protected in a plaster cast | Procedure or surgery | Non-operative treatment |
Primary outcome
Static two points discrimination (S2PD)
Time frame: one year after injury
a static two points discrimination test performed by an occupational therapist of the injured finger
13 secondary outcomes
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
Time in operating theatre
Time frame: day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 42642770Carlsson C, von Kieseritzky J, Arner M, Navarro CM. Cast Or ePineural Suture for digital nerve injuries (COPS): study protocol for a randomized controlled trial. Trials. 2026 Aug 26;27(1):548. doi: 10.1186/s13063-026-09956-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cecilia Mellstrand Navarro, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epineural suture and Non-operative treatment in people with Digital Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carin Carlsson, MD (+46 8 123 616 00, carin.carlsson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static two points discrimination (S2PD) (time frame: one year after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.