Digital Nerve Injury - a Case Control Study

NCT ID: NCT05337917

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-12-30

Brief 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.

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).

Conditions

Digital Nerve Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Case

Injury to digital nerve: thumb, digit II radial side, digit V ulnar side

Surgical of the digital nerve

Intervention Type: PROCEDURE

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.

Surgical of the digital nerve

Intervention Type: PROCEDURE

All patients (cases and controls) were subject to surgical repair of digital nerve injury.

Interventions

Surgical of the digital nerve

All patients (cases and controls) were subject to surgical repair of digital nerve injury.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Cecilia Mellstrand Navarro

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecilia Mellstrand Navarro, MD Prof

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm

Locations

Linda Evertsson

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Digital nerve clinical results

Identifier Type: -

Identifier Source: org_study_id