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

NCT07230782 | Completed

• 1 other identifier: 2020/580
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Carpal Tunnel Syndrome; Median Neuropathy; Ultrasonography; Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (1)

• Functional outcome measured by the Boston Carpal Tunnel Questionnaire

  The Boston Carpal Tunnel Questionnaire - Symptom Severity Scale and Functional Status Scale, each scored from 1 (no symptoms / no difficulty) to 5 (severe symptoms / inability to perform activities), where higher scores indicate worse clinical symptoms and greater functional impairment.

  3 and 12 months

Secondary Outcomes (5)

• Pain intensity measured using the Visual Analog Scale

  3 and 12 months

• Grip strength measured with a calibrated dynamometer

  3 and 12 months

• Rate of procedure-related adverse events

  Intraoperative and up to 12 months postoperative

• Time to return to normal daily activities

  Up to 12 months

• Scar-related symptoms and satisfaction

  3 and 12 months

Study Arms (2)

Percutaneous Ultrasound Guided Release

EXPERIMENTAL

Procedure: Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament

Open surgery

ACTIVE COMPARATOR

Procedure: Open release surgery

Interventions

Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament 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.

Percutaneous Ultrasound Guided Release

Open release surgery 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.

Open surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Alvaro Cunqueiro Hospital

Vigo, Pontevedra, 36208, Spain

Location

Related Publications (3)

• Petrover D, Silvera J, De Baere T, Vigan M, Hakime A. Percutaneous Ultrasound-Guided Carpal Tunnel Release: Study Upon Clinical Efficacy and Safety. Cardiovasc Intervent Radiol. 2017 Apr;40(4):568-575. doi: 10.1007/s00270-016-1545-5. Epub 2016 Dec 27.

  PMID: 28028577 BACKGROUND

• de la Fuente J, Miguel-Perez MI, Balius R, Guerrero V, Michaud J, Bong D. Minimally invasive ultrasound-guided carpal tunnel release: a cadaver study. J Clin Ultrasound. 2013 Feb;41(2):101-7. doi: 10.1002/jcu.21982. Epub 2012 Sep 11.

  PMID: 22965620 BACKGROUND

• Castro-Menendez M, Balvis-Balvis P, Denisiuk M, Vazquez-Cancela O. Assessing the learning curve for percutaneous ultrasound-guided release in carpal tunnel syndrome. J Hand Surg Eur Vol. 2025 Nov;50(10):1365-1370. doi: 10.1177/17531934251338970. Epub 2025 May 8.

  PMID: 40340491 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Attending phsysician. Orthopaedic Surgeon.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 10, 2021
• Primary Completion: January 20, 2024
• Study Completion: February 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)