Percutaneous Ultrasound-Guided Release of the Transverse Carpal Ligament Versus Open Surgery for Carpal Tunnel Syndrome: A Prospective Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Functional outcome measured by the Boston Carpal Tunnel Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Percutaneous Ultrasound Guided Release
Intervention: Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament (Procedure)
Open surgery
Intervention: Open release surgery (Procedure)
Outcomes
Primary Outcomes
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
- Rate of procedure-related adverse events(Intraoperative and up to 12 months postoperative)
- Pain intensity measured using the Visual Analog Scale(3 and 12 months)
- Grip strength measured with a calibrated dynamometer(3 and 12 months)
- Time to return to normal daily activities(Up to 12 months)
- Scar-related symptoms and satisfaction(3 and 12 months)
Investigators
Diego Matías Domínguez Prado
Principal Investigator. Attending phsysician. Orthopaedic Surgeon.
Fundacin Biomedica Galicia Sur