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

NCT07230782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-17

No results posted yet for this study

Summary

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.

Conditions

  • Carpal Tunnel Syndrome (CTS)

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Fundacin Biomedica Galicia Sur

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2024-01-20
Completion
2025-02-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230782 on ClinicalTrials.gov