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

December 5, 2025 updated by: Cecilia Mellstrand Navarro, Karolinska Institutet
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 11883
        • Recruiting
        • Karolinska Institutet Södersjukhuset, Department of clinical research and education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cecilia Mellstrand Navarro, MD, PhD
        • Sub-Investigator:
          • Carin Carlsson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Epineural suture
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
2 or three sutures
Other Names:
  • surgical repair
Active Comparator: Non-operative treatment
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
The injured finger is protected in a plaster cast
Other Names:
  • cast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
one year after injury

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Active range of motion
Time Frame: 3 and 6 months and 1 year
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
Time Frame: 3 and 6 months and 1 year
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
3 and 6 months and 1 year
Semmes-Weinstein monofilament test
Time Frame: 3 and 6 months and 1 year
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
3 and 6 months and 1 year
Mini Sollerman test
Time Frame: 3 and 6 months and 1 year
Hand function as measured by the Mini Sollerman test
3 and 6 months and 1 year
Grip strength
Time Frame: 3 and 6 months and 1 year
Grip strength of injured and non-injured hand as measured by Jamar dynamometer
3 and 6 months and 1 year
Quick-DASH
Time Frame: 3 and 6 months and 1 year
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
Time Frame: 3 and 6 months and 1 year
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
Time Frame: 3 and 6 months and 1 year
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
Time Frame: at inclusion
Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
at inclusion
Pain catastrophising scale, (PCS)
Time Frame: at inclusion
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
Time Frame: 1 year
Days of absence from work
1 year
Wait for surgery
Time Frame: 3 weeks
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 Frame: day of surgery
Time in operating theatre is measured in minutes
day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cecilia Mellstrand Navarro, MD, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COPS - RCT dig nerve injuries

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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