Short- to Medium-term Outcome of Minimally Invasive Carpal Tunnel Release
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: TCTR (thread carpal tunnel release), Standard-of-care.
- Кому может быть актуально
- Состояния в реестре: Carpal Tunnel. Базовые параметры: от 18 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
- Швейцария
- 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
Determining the Short- to Medium-term Outcome After Minimally Invasive Sonography Guided Release of the Carpal Tunnel Compared to Standard-of-care Open and Endoscopic Techniques: a Randomized Controlled Superiority Trial With an Internal Pilot-phase
Обзор
The aim of the study is to determine whether minimally invasive, ultrasound-guided thread carpal tunnel release leads to faster functional recovery compared to standard open and endoscopic techniques in patients with carpal tunnel syndrome.
Подробное описание
Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression disorder encountered in hand surgery. It affects a broad demographic, from young women (often linked to pregnancy and breastfeeding) and young men involved in manual labor, to elderly individuals. The condition causes pain, numbness, and functional impairment in the hand, which can progress to permanent disability if untreated. Typically, conservative treatment (e.g., night splints, corticosteroid injections) is the first step. However, when symptoms persist, surgical decompression of the median nerve becomes necessary.
The current gold standard for surgical treatment of CTS is open carpal tunnel release (OCTR). This involves making a 2-5 cm incision in the palm and cutting the transverse carpal ligament under direct vision. While effective in relieving nerve compression, this approach creates a scar in the load-bearing area of the palm, which can lead to prolonged post-operative pain, delayed wound healing, reduced grip strength, extended rehabilitation time and limitations in early hand use.
To address some of these drawbacks, endoscopic carpal tunnel release (ECTR) was developed. This technique uses a smaller incision at the wrist and a camera system to visualize and divide the ligament. While less invasive than OCTR, ECTR still involves an incision, and significant scar tissue may still develop, especially internally.
Both techniques require postoperative wound care, stitch removal, and carry risks of complications such as nerve or tendon injury, infection, or incomplete release. Additionally, these methods often result in delays in returning to work and daily activities, particularly burdensome for patients in physically demanding jobs.
In recent years, a novel percutaneous ultrasound-guided technique, known as thread carpal tunnel release (TCTR), has been introduced. This method uses two small puncture sites instead of incisions. Under real-time ultrasound guidance, a suture loop is passed around the transverse carpal ligament, which is then divided using a sawing motion. This technique bears several advantages including absence of external scar, reduced postoperative pain, no requirement for stitch removal, potential faster recovery allowing earlier return to normal function, daily activities and work.
The theoretical benefits of TCTR are supported by cadaveric and small clinical studies, but no large randomized controlled trials have yet compared TCTR directly with both open and endoscopic techniques. This study aims to fill that evidence gap by rigorously evaluating whether TCTR leads to quicker functional recovery, measured via validated functional assessments in a real-world clinical setting.
Вмешательства
- Процедура TCTR (thread carpal tunnel release)
Percutaneous sonography guided release of carpal tunnel release - Процедура Standard-of-care
Open or endoscopic carpal tunnel release based on patients' and physicians' preferences
Первичные конечные точки
- The objective functional assessment of the BCTQ score at 2 weeks [Срок оценки: 2 weeks post-operative]
Вторичные конечные точки (12)
- The objective functional assessment of the BCTQ score [Срок оценки: 4 and 6 weeks and 6 month post-operative]
- Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status. [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- The subjective symptom severity score of the BCTQ [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- Hand-specific health [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- Functional recovery time [Срок оценки: up to 6 months post-operative]
- Recovery from pain [Срок оценки: up to 6 months post-operative]
- Area of the median nerve [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- Range of motion [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- thenar atrophies [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- Strength in the abductor pollicis brevis [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- Two-point discrimination [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
- Grip strength [Срок оценки: 2, 4 and 6 weeks and 6 months post-operative]
Критерии участия
Критерии включения
- Patient aged 18 years or older
- Electroneurographically proven carpal tunnel syndrome
- Informed Consent for trial participation
Критерии исключения
- Revision surgery
- Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason
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
Швейцария · 1 центр
- University Hospital Basel — Basel
Идентификаторы
NCT: NCT06997172 · 2025-00406; mu25Kamphuis