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

Primary Purpose

Digital Nerve Injury

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Epineural suture
Non-operative treatment
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digital Nerve Injury focused on measuring digital nerve injury, digital nerve lesion, randomised controlled study, surgical nerve repair, non-operative treatment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet Södersjukhuset, Department of clinical research and educationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epineural suture

Non-operative treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Static two points discrimination (S2PD)
a static two points discrimination test performed by an occupational therapist of the injured finger

Secondary Outcome Measures

Active range of motion
Range of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees)
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Semmes-Weinstein monofilament test
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Mini Sollerman test
Hand function as measured by the Mini Sollerman test
Grip strength
Grip strength of injured and non-injured hand as measured by Jamar dynamometer
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.
HQ-8
Patient Rated Outcome measure (PROM) for hand function as measured by the HQ-8 (Eight item HAKIR questionnaire)
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.
Anxiety and depression
Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
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).
Sick leave time
Days of absence from work
Wait for surgery
The number of days that have passed from the day of injury to the day of surgery are reported
Time in operating theatre
Time in operating theatre is measured in minutes

Full Information

First Posted
August 23, 2022
Last Updated
October 2, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05536609
Brief Title
Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
Acronym
COPS
Official Title
Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digital Nerve Injury
Keywords
digital nerve injury, digital nerve lesion, randomised controlled study, surgical nerve repair, non-operative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randmoised controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epineural suture
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-operative treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Epineural suture
Other Intervention Name(s)
surgical repair
Intervention Description
2 or three sutures
Intervention Type
Procedure
Intervention Name(s)
Non-operative treatment
Other Intervention Name(s)
cast
Intervention Description
The injured finger is protected in a plaster cast
Primary Outcome Measure Information:
Title
Static two points discrimination (S2PD)
Description
a static two points discrimination test performed by an occupational therapist of the injured finger
Time Frame
one year after injury
Secondary Outcome Measure Information:
Title
Active range of motion
Description
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 year
Title
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Description
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Time Frame
3 and 6 months and 1 year
Title
Semmes-Weinstein monofilament test
Description
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Time Frame
3 and 6 months and 1 year
Title
Mini Sollerman test
Description
Hand function as measured by the Mini Sollerman test
Time Frame
3 and 6 months and 1 year
Title
Grip strength
Description
Grip strength of injured and non-injured hand as measured by Jamar dynamometer
Time Frame
3 and 6 months and 1 year
Title
Quick-DASH
Description
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.
Time Frame
3 and 6 months and 1 year
Title
HQ-8
Description
Patient Rated Outcome measure (PROM) for hand function as measured by the HQ-8 (Eight item HAKIR questionnaire)
Time Frame
3 and 6 months and 1 year
Title
Neuropathic pain
Description
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.
Time Frame
3 and 6 months and 1 year
Title
Anxiety and depression
Description
Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
Time Frame
at inclusion
Title
Pain catastrophising scale, (PCS)
Description
Pain catastrophising scale, (PCS) measures 13 items on a 5 points Likert scale. Higher scores represent high degree of pain catastrophising scale, (PCS).
Time Frame
at inclusion
Title
Sick leave time
Description
Days of absence from work
Time Frame
1 year
Title
Wait for surgery
Description
The number of days that have passed from the day of injury to the day of surgery are reported
Time Frame
3 weeks
Title
Time in operating theatre
Description
Time in operating theatre is measured in minutes
Time Frame
day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carin Carlsson, MD
Phone
+46 8 123 616 00
Email
carin.carlsson@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Mellstrand Navarro, MD, PhD
Phone
+46 709 280114
Email
cecilia.mellstrand-navarro@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Mellstrand Navarro, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet Södersjukhuset, Department of clinical research and education
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carin Carlsson, MD
Phone
+46 8 123 61600
Email
carin.carlsson@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Cecilia Mellstrand Navarro, MD, PhD
Phone
+46 709 280114
Email
cecilia.mellstrand-navarro@sll.se
First Name & Middle Initial & Last Name & Degree
Cecilia Mellstrand Navarro, MD, PhD
First Name & Middle Initial & Last Name & Degree
Carin Carlsson, MD

12. IPD Sharing Statement

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

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