Digital Nerve Injury - a Case Control Study

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

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.

Study Overview

• Status: Completed
• Conditions: Digital Nerve Injury
• Intervention / Treatment: Procedure: Surgical of the digital nerve

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Linda Evertsson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with digital nerve injury were identified from a registry cohort consisting in 1330 patients. They were all treated due to a digital nerve injury at our hospital 2012 - 2018. A random sample of cases and controls were selected, matched for time from injury to evaluation, age and sex.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Injury to digital nerve: thumb, digit II radial side, digit V ulnar side	Procedure: Surgical of the digital nerve; All patients (cases and controls) were subject to surgical repair of digital nerve injury.
Control; Injury to digital nerve: digit II ulnarside, dig III, dig IV dig V radial side.	Procedure: Surgical of the digital nerve; All patients (cases and controls) were subject to surgical repair of digital nerve injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handfunction	Measured by Mini Sollerman test for handfunction.	3-10 years post operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Cecilia Mellstrand Navarro, MD Prof, Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Digital nerve clinical results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No