Digital Nerve Injury - a Case Control Study

Digital Nerve Injury Clinical Trial

Official title:

Long-term Hand Function and Sensation Following Digital Nerve Injury and Repair- a Case Control Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337917
• Other study ID #: Digital nerve clinical results
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Case control study, investigating what hand function and sensory function do patients perform 3-10 years following digital nerve injury and repair. The aim is to investigate if hand function is more limited following digital nerve injury in the thumb, index- and little finger, compared to less unburdened sensory surfaces in the fingers. Secondary aim is to investigate the long term sensory function following digital nerve injury.

Description:

Eligible patients are individuals treated at the Department of Hand surgery in Stockholm, Sweden during 2012-2018. Inclusion criteria include diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29). Exclusion criteria are concomitant flexor tendon injury and/or skeletal injury, amputations, and severe soft tissue injuries. Patients residing outside the Stockholm region and children below 18 years of age are also excluded. Initially a total number of 1330 patients have been identified. All medical records have been thoroughly scrutinized. After excluding concomitant tendon injury, a total of 606 patients remained with isolated digital nerve injury. A randomly selected sample of participants have been assigned to two groups: Patients with an injury to the digital nerve of the thumb, digit II radial side, digit V ulnar side were assigned to the "case" group and matched "controls" were randomly selected among patients with an injury to the digital nerves of either the ulnar side of digit II, either nerve of digit III and digit IV or the radial nerve of digit V. Cases and controls have been matched according to sex, year of injury and patient age.

For the purpose of this study, a clinical evaluation to investigate hand function, sensory function, strength, and ability to discriminate warm and cold and sharp and dull will be conducted. Questionnaires are used for Patient Reported Outcome Measures (PROM): Disability of the Arm Shoulder, and Hand (QuickDASH), Patient questionnaire HQ8 arm and hand (HQ8), The Hospital Anxiety and Depression Scale (HADS), Saltin-Grimby Physical Activity Level Scale (SGPALS), and in addition Douleur Neuropathique en 4 Questions (DN4) for assessment of neuropathic pain will be performed. All outcomes will be compared between groups defined as case (digital injury to the thumb, radial nerve of the index finger or ulnar nerve of the little finger) or control (all other digital nerve injuries).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29).

• treatment completed in Södersjukhuset hospital 2012 - 2018

Exclusion Criteria:

• concomitant skeletal injury,

• amputations

• severe soft tissue injuries

• microvascular reconstruction

• residence outside the Stockholm region

• patient age below 18 years of age

Related Conditions & MeSH terms

• Digital Nerve Injury
• Wounds and Injuries

Intervention

Procedure:
• Surgical of the digital nerve
All patients (cases and controls) were subject to surgical repair of digital nerve injury.

Locations

Country	Name	City	State
Sweden	Linda Evertsson	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handfunction	Measured by Mini Sollerman test for handfunction.	3-10 years post operatively
Secondary	Sensation	Semmes Weinstein, Static two point discrimination	3-10 years post operatively
Secondary	Sensation	Static two point discrimination	3-10 years post operatively
Secondary	Patient Rated Outcome Measure (PROM) for hand function	QuickDASH (Disability of the Arm Shoulder and Hand)	3-10 yrs post op
Secondary	PROM for hand function	HQ8 (HAKIR Questionnaire 8 questions)	3-10 yrs post op
Secondary	PROM for hand function	SGPALS (Saltin-Grimby Physical Activity Level Scale)	3-10 yrs post op
Secondary	PROM for neuropathic pain	DN4 (Douleur neuropathique 4 levels)	3-10 yrs post op
Secondary	PROM for depression and anxiety	HADS (Hospital Anxiety and Depression Scale)	3-10 yrs post op
Secondary	PROM	Physical activity scale.	3-10 yrs post op
Secondary	Range of motion	Goniometer measurements of finger joints	3-10 yrs post op
Secondary	Pinch strength	Grip strength as measured by Pinch gauge	3-10 yrs post op
Secondary	Strength	Grip strength as measured by JAMAR	3-10 yrs post op