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

Fundacin Biomedica Galicia Sur

Status: Completed

Conditions: Carpal Tunnel Syndrome (CTS)

Treatments: Procedure: Open release surgery; Procedure: Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament

Study type: Interventional

Funder types: Other

Identifiers

NCT07230782

2020/580

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Percutaneous Ultrasound Guided Release

Experimental group

Treatment:

Procedure: Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament

Open surgery

Active Comparator group

Treatment:

Procedure: Open release surgery