Minimally Invasive Retrograde Carpal Tunnel Release Using the KeriKnife™ Under Direct Visualization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KeriKnife™ device under visual guidance.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome (CTS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device KeriKnife™ device under visual guidance
Complete minimally invasive carpal tunnel release using the KeriKnife™ under visual guidance
Primary outcome measures
- 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 [Time frame: Day 30]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07692074 · 2025-36-SFN