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临床试验/NCT05337917
NCT05337917已完成不适用

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

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
1
主要终点
Handfunction

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • concomitant skeletal injury,
  • amputations
  • severe soft tissue injuries
  • microvascular reconstruction
  • residence outside the Stockholm region
  • patient age below 18 years of age

结局指标

主要结局

Handfunction

时间窗: 3-10 years post operatively

Measured by Mini Sollerman test for handfunction.

次要结局

  • Patient Rated Outcome Measure (PROM) for hand function(3-10 yrs post op)
  • Strength(3-10 yrs post op)
  • Sensation(3-10 years post operatively)
  • PROM for neuropathic pain(3-10 yrs post op)
  • PROM for depression and anxiety(3-10 yrs post op)
  • Range of motion(3-10 yrs post op)
  • PROM for hand function(3-10 yrs post op)
  • PROM(3-10 yrs post op)
  • Pinch strength(3-10 yrs post op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecilia Mellstrand Navarro

Principal investigator

Karolinska Institutet

研究点 (1)

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