Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery (CATS)

Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery: a Randomized Clinical Trial.

Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.

Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Open surgery; Procedure: Percutaneous surgery

Detailed Description

Background: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper limb, with a prevalence of around 1'14% and 14'4% of the population.

The clinical symptoms are usually pain, paresthesias and numbness on the sensitive distribution territory of the median nerve in the hand.

Conservative treatment is used for the mild cases, and surgery for the moderate and severe ones, or when the conservative treatment has failed.

Open carpal tunnel release is the gold standard surgery, with a short longitudinal volar approach that allows to visualize the complete division of the ligament.

Over the last few years, endoscopic techniques have been introduced, offering some advantages such as: lower postoperative pain, earlier return to work and less complications due to the wound. Despite this, it has not been popularised, probably, because it is a challenging and more expensive surgical procedure.

Based on the minimally invasive endoscopic approach, and with the aim of obtaining the same benefits, and avoid the complications of the open surgery, several devices have been developed to perform a percutaneous release.

Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.

Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.

Methods: Sixty patients reporting CTS symptoms, that are confirmed by clinical exam and nerve conduction studies, will be included. Participants will be randomized in two arms. Patients from one group will be operated with an open carpal tunnel release, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament. The other group will be operated with a percutaneous approach, ambulatory, with a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.

The main outcome measures will be the Boston Carpal Tunnel Questionnaire, Quick DASH questionnaire, Douleur Neuropathique 4 questions, Visual Numeric Scale and grip strength. The scales and questionnaires will be administrated to participants preoperative, 4 weeks and 24 weeks postoperative.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova/Lliria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years old.
• Positive electromyography, confirming carpal tunnel syndrome.
• Capable to understand risks and advantages of both procedures.
• Normal blood tests.

Exclusion Criteria:

• Previous carpal tunnel release in the same hand.
• Previous fracture or dislocation in the area around the forearm, wrist or hand.
• Signs or symptoms of infection.
• Psychiatric disorders.
• Antiplatelet or anticoagulant therapy, that cannot be suspended due to underlying pathology, and does not allow the surgery to be performed.
• Coagulation disorders, or any underlying pathology, with high risk of thrombosis or bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open surgery; 30 patients will be operated with an open carpal tunnel release.	Procedure: Open surgery; Open carpal tunnel release will be performed, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament.
Experimental: Percutaneous surgery; 30 patients will be operated with a percutaneous carpal tunnel release.	Procedure: Percutaneous surgery; Percutaneous carpal tunnel release will be performed, ambulatory, with a percutaneous scalpel, through a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Boston Carpal Tunnel Questionnaire	Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale. The range of the final results are from 19 (no symptoms) to 95 (severe symptoms).	Preoperative, 4 weeks and 24 weeks after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Numeric Scale	Pain relief will be measured with the VNS. The range of the scale is from 0 (no symptoms) to 10 (severe symptoms).	Preoperative, 4 weeks and 24 weeks after surgery.
Quick-DASH (Disabilities of Arm, Shoulder and Hand)	Disabilities of the hand will be measured with Quick-DASH. The range of the final results are from 0 (no symptoms) to 100 (severe symptoms).	Preoperative, 4 weeks and 24 weeks after surgery.
Douleur Neuropathique 4 questions (DN4)	Neuropathic pain relief with the DN4. The range of the final results are from 0 (no symptoms) to 10 (severe symptoms). A result of more than 4 indicates neuropathic pain.	Preoperative, 4 weeks and 24 weeks after surgery.
Consumer Reports Effectiveness Scale (CRES-4)	Patient´s satisfaction after the procedures The range of the final results are from 0 to 300. A higher score indicates a better outcome of the treatment for the patient.	24 weeks after surgery.
Time off work	Differences in time off work between both procedures measured in days.	24 weeks after surgery.
Grip strength	Measured in Kilograms with a "Deyard EH101" dynamometer	Preoperative, 4 weeks and 24 weeks after surgery.
Number of other complications	Any complication will be recorded.	4 weeks and 24 weeks after surgery.

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous carpal tunnel release
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: COTHAV1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No