NCT07230782

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

Percutaneous Ultrasound-Guided Release of the Transverse Carpal Ligament Versus Open Surgery for Carpal Tunnel Syndrome: A Prospective Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Fundacin Biomedica Galicia Sur · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-01-10
• Primary completion: 2024-01-20
• Completion: 2025-02-01
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: Spain