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

Digital Nerve Injury Clinical Trial

— COPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536609
• Other study ID #: COPS - RCT dig nerve injuries
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Carin Carlsson, MD
• Phone: +46 8 123 616 00
• Email: carin.carlsson[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digital Nerve Injury
• Wounds and Injuries

Intervention

Procedure:
• Epineural suture
2 or three sutures
• Non-operative treatment
The injured finger is protected in a plaster cast

Locations

Country	Name	City	State
Sweden	Karolinska Institutet Södersjukhuset, Department of clinical research and education	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Semmes-Weinstein monofilament test	Discriminatory sensory function as measured by Semmes-Weinstein monofilament test	3 and 6 months and 1 year
Secondary	Mini Sollerman test	Hand function as measured by the Mini Sollerman test	3 and 6 months and 1 year
Secondary	Grip strength	Grip strength of injured and non-injured hand as measured by Jamar dynamometer	3 and 6 months and 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Anxiety and depression	Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)	at inclusion
Secondary	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
Secondary	Sick leave time	Days of absence from work	1 year
Secondary	Wait for surgery	The number of days that have passed from the day of injury to the day of surgery are reported	3 weeks
Secondary	Time in operating theatre	Time in operating theatre is measured in minutes	day of surgery