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

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: Recruiting
• Conditions: Digital Nerve Injury
• Intervention / Treatment: Procedure: Epineural suture; Procedure: Non-operative treatment

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: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carin Carlsson, MD; Phone Number: +46 8 123 616 00; Email: carin.carlsson@regionstockholm.se
• Study Contact Backup: Name: Cecilia Mellstrand Navarro, MD, PhD; Phone Number: +46 709 280114; Email: cecilia.mellstrand-navarro@sll.se

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 11883
      • Recruiting
      • Karolinska Institutet Södersjukhuset, Department of clinical research and education
      • Contact: Cecilia Mellstrand Navarro, MD, PhD; Phone Number: +46 709 280114; Email: cecilia.mellstrand-navarro@sll.se
      • Contact: Carin Carlsson, MD; Phone Number: +46 8 123 61600; Email: carin.carlsson@regionstockholm.se
      • Principal Investigator: Cecilia Mellstrand Navarro, MD, PhD
      • Sub-Investigator: Carin Carlsson, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Static two points discrimination (S2PD)	a static two points discrimination test performed by an occupational therapist of the injured finger	one year after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active range of motion	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	Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger	3 and 6 months and 1 year
Semmes-Weinstein monofilament test	Discriminatory sensory function as measured by Semmes-Weinstein monofilament test	3 and 6 months and 1 year
Mini Sollerman test	Hand function as measured by the Mini Sollerman test	3 and 6 months and 1 year
Grip strength	Grip strength of injured and non-injured hand as measured by Jamar dynamometer	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.	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)	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.	3 and 6 months and 1 year
Anxiety and depression	Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)	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).	at inclusion
Sick leave time	Days of absence from work	1 year
Wait for surgery	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 in operating theatre is measured in minutes	day of surgery

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Cecilia Mellstrand Navarro, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: digital nerve injury; digital nerve lesion; randomised controlled study; surgical nerve repair; non-operative treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Biological Phenomena; Regeneration; POLR1G protein, human; Wound Healing
• Other Study ID 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