Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study

Обзор

Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.

Подробное описание

Patients over the age of 20 with an acute traumatic isolated digital nerve injury to any of the fingers and not in the thumb will be investigated for inclusion in the study. After informed written consent a sealed envelope randomisation will allocate patients to treatment with either surgical exposure and epineural suture or non-operative treatment in a cast. Due to the nature of treatment arms the allocation will not be blinded. Clinical follow-up and investigation of primary and secondary outcomes will be conducted at 3 weeks, 3 months, 6 months and 1 year after inclusion.

Вмешательства

• Процедура Epineural suture
  2 or three sutures
• Процедура Non-operative treatment
  The injured finger is protected in a plaster cast

Первичные конечные точки

• Static two points discrimination (S2PD) [Срок оценки: one year after injury]

Вторичные конечные точки (12)

• Active range of motion [Срок оценки: 3 and 6 months and 1 year]
• Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger [Срок оценки: 3 and 6 months and 1 year]
• Semmes-Weinstein monofilament test [Срок оценки: 3 and 6 months and 1 year]
• Mini Sollerman test [Срок оценки: 3 and 6 months and 1 year]
• Grip strength [Срок оценки: 3 and 6 months and 1 year]
• Quick-DASH [Срок оценки: 3 and 6 months and 1 year]
• HQ-8 [Срок оценки: 3 and 6 months and 1 year]
• Neuropathic pain [Срок оценки: 3 and 6 months and 1 year]
• Anxiety and depression [Срок оценки: at inclusion]
• Pain catastrophising scale, (PCS) [Срок оценки: at inclusion]
• Sick leave time [Срок оценки: 1 year]
• Wait for surgery [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• Clinical signs of isolated traumatic digital nerve injury in digits 2, 3, 4 or 5.
• Patient age => 20 years on day of injury.
• Injury location on volar aspect of finger.
• Acute sensory dysfunction in suspected digital nerve injury area.

Критерии исключения

• Digital nerve injury ot the thumb
• Digital nerve injury in the palm of the hand (i e proximal to the finger base)
• Patient does not speak or read the Swedish language.
• Abusive drug or alcohol use
• Dementia.
• Injury mor than 7 days at dianosis AND/OR operative treatment cannot be offered within 10 days from injury.
• Neurologic disease.
• Ongoing infektion in the injured finger.
• concomittant tendoninjury or fracture in injured or adjacent finger.
• Injury mechanism is of blunt or crush charachter

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Karolinska Institutet Södersjukhuset, Department of clinical research and education — Stockholm

Идентификаторы

NCT: NCT05536609 · COPS - RCT dig nerve injuries

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗