Ultrasound-Guided Percutaneous Release vs. Open Surgery for Carpal Tunnel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2025-02-01

Brief Summary

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The goal of this clinical trial is to compare the clinical and functional outcomes of two surgical approaches for the treatment of carpal tunnel syndrome (CTS): ultrasound-guided percutaneous release of the flexor retinaculum and conventional open surgery. The study population includes adults diagnosed with carpal tunnel syndrome who are candidates for surgical treatment.

The main questions this study aims to answer are:

Does ultrasound-guided percutaneous flexor retinaculum release provide superior short-term functional outcomes compared with conventional open surgery?

Does the minimally invasive approach lead to faster symptom relief and postoperative recovery?

Researchers will compare the percutaneous ultrasound-guided technique with the traditional open palmar incision to determine whether the minimally invasive method offers measurable clinical advantages.

Participants will:

Undergo either ultrasound-guided percutaneous release or standard open surgical release, depending on group allocation.

Complete validated clinical and functional assessments at predefined postoperative time points.

Report symptom severity, functional status, and any procedure-related adverse events.

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Detailed Description

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Conditions

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Carpal Tunnel Syndrome (CTS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous Ultrasound Guided Release

Group Type EXPERIMENTAL

Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament

Intervention Type PROCEDURE

A Kemis H3® knife (Newclip, France) with a 12MHz probe were utilized. An 8-10 mm incision was made on the ulnar side of the palmaris longus tendon proximal to the wrist crease. The Kemis H3® knife (Newclip, France) was introduced, with ultrasound visualization ensuring identification and protection of the median nerve and ulnar artery. The flexor retinaculum was sectioned under longitudinal and transverse ultrasound guidance.

Open surgery

Group Type ACTIVE_COMPARATOR

Open release surgery

Intervention Type PROCEDURE

A short palmar incision (\<4 cm) was made along the radial axis of the fourth finger, extending to Kaplan's line. Dissection proceeded to the palmar fascia and flexor retinaculum, which was divided under direct vision and with median nerve protection.

Interventions

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Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament

A Kemis H3® knife (Newclip, France) with a 12MHz probe were utilized. An 8-10 mm incision was made on the ulnar side of the palmaris longus tendon proximal to the wrist crease. The Kemis H3® knife (Newclip, France) was introduced, with ultrasound visualization ensuring identification and protection of the median nerve and ulnar artery. The flexor retinaculum was sectioned under longitudinal and transverse ultrasound guidance.

Intervention Type PROCEDURE

Open release surgery

A short palmar incision (\<4 cm) was made along the radial axis of the fourth finger, extending to Kaplan's line. Dissection proceeded to the palmar fascia and flexor retinaculum, which was divided under direct vision and with median nerve protection.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years or older
* Residence within the hospital's health area
* Clinical and neurophysiological diagnosis of carpal tunnel syndrome
* Underwent surgical treatment between January 2021 and January 2024
* Provided written informed consent for participation and for the publication of anonymized data

Exclusion Criteria

* Previous surgery for the same pathology in the same hand
* Presence of another associated hand pathology in the same hand
* Patients unable or incapacitated to follow the study protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No