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Идёт набор NCT06593977

Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome

Без фазы С лечением Carpal Tunnel Syndrome (CTS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dynavisc.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Syndrome (CTS). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия, Бразилия, Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome

Обзор

The trial will evaluate the efficacy of DYNAVISC in subjects with a diagnosis of persistent or recurrent carpal tunnel syndrome. This is a prospective, multicenter, randomized, evaluator-blinded clinical trial. Results will be stratified based on the method used for median nerve coverage: Group 1 (standard of care surgery followed by DYNAVISC surrounding the median nerve, n=25 participants), Group 2 (standard of care surgery followed by coverage of the median nerve with a hypothenar fat pad flap, n=25

Подробное описание

The trial will evaluate the efficacy of DYNAVISC in subjects with a diagnosis of persistent or recurrent carpal tunnel syndrome. This is a prospective, multicenter, randomized, evaluator-blinded clinical trial. Results will be stratified based on the method used for median nerve coverage: Group 1 (standard of care surgery followed by DYNAVISC surrounding the median nerve, n=25 participants), Group 2 (standard of care surgery followed by coverage of the median nerve with a hypothenar fat pad flap, n=25 participants).

All participants will gently mobilize their wrist and fingers immediately following surgery and multiple times daily thereafter. Strenuous movements will be allowed beginning 6 weeks following surgery. Participant's hand will be evaluated at 1 week, 4 weeks, and 12-weeks following surgery.

Pain measurement will be recorded by participant using visual analog scale (VAS Score); hand function measurement will be recorded by participant using Disabilities of the Arm, Shoulder and Hand (Quick DASH Score); neuropathic pain will be measured by DN4 Score; median nerve recovery will be measured by electroneuromyography (sensory conduction speed and distal motor latency); and grip strength will be measured by dynamometer. This information will be obtained and recorded at baseline and at evaluations by a person blinded to treatment assignment.

Вмешательства

  • Устройство Dynavisc
    DYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.

Первичные конечные точки

  • Pain using VAS [Срок оценки: 12 weeks]
Вторичные конечные точки (4)
  • Resumption of hand function using the Quick DASH Score. [Срок оценки: 12 weeks]
  • Grip strength of hand closing [Срок оценки: 12 weeks]
  • Improvement in nerve conduction and lateral deviation [Срок оценки: 12 weeks]
  • Evaluation of neuropathic pain using DN4 assessment [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Signed and dated informed consent form;
  • Stated willingness to comply with all study procedures and availability for the duration of the study;
  • Aged 18-65 years of age;
  • In good general health;
  • Patients experiencing recurrence or persistence of pain in the ipsilateral hand after previous carpal tunnel release for surgical treatment of primary carpal tunnel syndrome;
  • All of the following physical examination tests must be performed; at least one must be positive:
  • Physical examination demonstrates positive Phalen test;
  • Physical examination demonstrates positive Tinel's test;
  • Physical examination demonstrates positive monofilament test;
  • ENMG demonstrates median nerve velocity and deviation consistent with the diagnosis of carpal tunnel syndrome.

Критерии исключения

  • Inability to understand the clinical trial and/or sign the Informed Consent;
  • Unable or unwilling to attend all of the study prescribed visits and data collection forms;
  • Active infection requiring medication;
  • Drug requiring diabetes mellitus;
  • Collagenopathies;
  • Hypothyroidism requiring medication;
  • Rheumatoid arthritis requiring medication;
  • Autoimmune disease requiring medication;
  • Cervical nerve compression;
  • Hematopoietic disorders;
  • Lacertus fibrosis;
  • Psychiatric disorder requiring medical treatment;
  • Subject of workers compensation claim;
  • History of cancer, except for basal or squamous cell skin cancer;
  • Known allergic reactions to components of DYNAVISC;
  • Actively participating in another clinical trial.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Бельгия · 2 центра
  • UZ Leuven — Leuven
  • AZ Delta — Roeselare
Бразилия · 1 центр
  • Hospital Angelina Caron — Araçatuba
Италия · 1 центр
  • Azienda Ospedale Universita Padova — Padova

Идентификаторы

NCT: NCT06593977 · FZ-TN002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗