Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery

Carpal Tunnel Syndrome Clinical Trial

— CATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117516
• Other study ID #: COTHAV1
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova/Lliria	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Time off work	Differences in time off work between both procedures measured in days.	24 weeks after surgery.
Secondary	Grip strength	Measured in Kilograms with a "Deyard EH101" dynamometer	Preoperative, 4 weeks and 24 weeks after surgery.
Secondary	Number of other complications	Any complication will be recorded.	4 weeks and 24 weeks after surgery.