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NOT YET RECRUITING
NCT07692074
NA

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

Sponsor: Clinique Saint François, Nice, France

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2026-08-01

Completion Date

2028-02-01

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DEVICE

KeriKnife™ device under visual guidance

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