Minimally Invasive Retrograde Carpal Tunnel Release Using the KeriKnife™ Under Direct Visualization

Обзор

Carpal tunnel syndrome surgery is one of the most common procedures in orthopedic and trauma surgery. Traditionally performed via an open incision or endoscopically, this procedure aims to decompress the median nerve by cutting the transverse carpal ligament. However, these techniques, while effective, have certain limitations, particularly in terms of postoperative pain, wound healing, functional recovery, and the risk of complications (hematoma or nerve injury). Recent advances have made it possible to perform median nerve release using minimally invasive surgery to improve patient comfort and speed up recovery. In this context, the use of devices designed for the controlled sectioning of the transverse carpal ligament represents a technical advancement of interest. This minimally invasive technique is also supported by anatomical studies demonstrating the safety and efficacy of the single-incision approach at the wrist. To date, clinical data regarding the use of the KeriKnife™ under visual guidance are limited. It therefore seems appropriate to conduct a prospective study aimed at documenting the feasibility, safety, and functional outcomes of this technique under standardized conditions of use. This project is part of a pragmatic clinical evaluation approach designed to generate objective data on an existing practice in order to assess its safety and short- and medium-term functional outcomes.

Вмешательства

• Устройство KeriKnife™ device under visual guidance
  Complete minimally invasive carpal tunnel release using the KeriKnife™ under visual guidance

Первичные конечные точки

• Composite endpoint that includes the technical success of the procedure and the absence of major complications related to the procedure at 30 days to evaluate the safety and feasibility of the intervention with the KeriKnife™ under visual guidance [Срок оценки: Day 30]

Критерии участия

Критерии включения

• Patients over the age of 18 with severe carpal tunnel syndrome as determined by electromyography
• No other concomitant condition affecting the hand
• Surgical indication for median nerve release
• Have signed an informed consent form
• Be enrolled in a social security program or be a beneficiary of such a program

Критерии исключения

• Contraindications to carpal tunnel surgery
• Presence of a concomitant condition affecting the hand to be operated on
• Secondary carpal tunnel syndrome (e.g., tumor, synovial cyst, anatomical malformation, post-traumatic sequelae)
• History of carpal tunnel surgery on the affected hand
• Associated neurological conditions (peripheral neuropathies, Amyotrophic Lateral Sclerosis, Charcot-Marie-Tooth, etc.)
• Coagulation disorders or anticoagulant therapy that cannot be discontinued
• Patients who are unable to give informed consent or cannot return for scheduled follow-up visits as required by the protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07692074 · 2025-36-SFN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗