Minimally Invasive Retrograde Carpal Tunnel Release Using the KeriKnife™ Under Direct Visualization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: Day 30
The safety and feasibility of minimally invasive carpal tunnel release performed with the KeriKnife™ under visual guidance, will be evaluated using a composite endpoint that includes the technical success of the procedure and the absence of major complications related to the procedure at 30 days. * Technical success of the procedure: complete performance of the minimally invasive carpal tunnel release using the KeriKnife™ under direct visualization, without intraoperative conversion to another technique * Absence of major complications related to the procedure or the device up to Day 30, including: Iatrogenic nerve injury Vascular injury Tendon injury Compressive hematoma requiring therapeutic intervention Surgical site infection requiring invasive treatment or reoperation Severe algodystrophy Reintervention related to the initial procedure within 30 days postoperatively
次要结局
未报告次要终点