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Completed

NCT Number: NCT05337917

Digital Nerve Injury - 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Linda Evertsson

Stockholm, 11883, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical of the digital nerve

Procedure

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

Primary outcomes

  1. Handfunction

    Time frame: 3-10 years post operatively

    Measured by Mini Sollerman test for handfunction.

Secondary outcomes

  1. Sensation

    Time frame: 3-10 years post operatively

    Semmes Weinstein, Static two point discrimination

  2. Sensation

    Time frame: 3-10 years post operatively

    Static two point discrimination

  3. Patient Rated Outcome Measure (PROM) for hand function

    Time frame: 3-10 yrs post op

    QuickDASH (Disability of the Arm Shoulder and Hand)

  4. PROM for hand function

    Time frame: 3-10 yrs post op

    HQ8 (HAKIR Questionnaire 8 questions)

  5. PROM for hand function

    Time frame: 3-10 yrs post op

    SGPALS (Saltin-Grimby Physical Activity Level Scale)

  6. PROM for neuropathic pain

    Time frame: 3-10 yrs post op

    DN4 (Douleur neuropathique 4 levels)

  7. PROM for depression and anxiety

    Time frame: 3-10 yrs post op

    HADS (Hospital Anxiety and Depression Scale)

  8. PROM

    Time frame: 3-10 yrs post op

    Physical activity scale.

  9. Range of motion

    Time frame: 3-10 yrs post op

    Goniometer measurements of finger joints

  10. Pinch strength

    Time frame: 3-10 yrs post op

    Grip strength as measured by Pinch gauge

  11. Strength

    Time frame: 3-10 yrs post op

    Grip strength as measured by JAMAR

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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