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OpenTrials
Completed

NCT Number: NCT07230782

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

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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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alvaro Cunqueiro Hospital

Vigo, Pontevedra, 36208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Functional outcome measured by the Boston Carpal Tunnel Questionnaire

    Time frame: 3 and 12 months

    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.

Secondary outcomes

  1. Pain intensity measured using the Visual Analog Scale

    Time frame: 3 and 12 months

    The Visual Analog Scale for pain (0-10 points), where 0 represents no pain and 10 represents the worst imaginable pain, and higher scores indicate worse pain intensity.

  2. Grip strength measured with a calibrated dynamometer

    Time frame: 3 and 12 months

    Grip strength expressed in kilograms (kg) using a standardized dynamometry protocol. Higher values indicate better hand strength.

  3. Rate of procedure-related adverse events

    Time frame: Intraoperative and up to 12 months postoperative

    Incidence of complications directly attributable to the surgical procedure (e.g., neurovascular injury, pillar pain, infection, incomplete release). Reported as frequency and percentage.

    No scale applicable.

  4. Time to return to normal daily activities

    Time frame: Up to 12 months

    Self-reported number of days required to resume usual daily functions (work, household tasks, leisure). Lower values indicate faster recovery.

  5. Scar-related symptoms and satisfaction

    Time frame: 3 and 12 months

    Assessed using a numeric rating scale from 0 (no symptoms / completely satisfied) to 10 (severe symptoms / completely dissatisfied). Higher scores indicate worse scar-related discomfort or lower satisfaction.

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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