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

Starting soon · Not applicable

Conditions studied: Carpal Tunnel Syndrome (CTS)

In brief

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.

Key facts

Study ID

NCT07692074

Run by

Clinique Saint François, Nice, France

People needed

74

Starts

2026-08-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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