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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 KeriKnifeâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who underwent carpal tunnel surgery with the KeriKnifeâ„¢ under visual guidance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KeriKnifeâ„¢ device under visual guidance | Device | Complete minimally invasive carpal tunnel release using the KeriKnifeâ„¢ under visual guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 KeriKnifeâ„¢ under visual guidance | The safety and feasibility of minimally invasive carpal tunnel release performed with the KeriKnifeâ„¢ 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.
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 | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |