Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Open surgery
* Procedure: Percutaneous surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open surgery<br>30 patients will be operated with an open carpal tunnel release. | Procedure: Open surgery<br>* 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.<br>|
| Experimental: Percutaneous surgery<br>30 patients will be operated with a percutaneous carpal tunnel release. | Procedure: Percutaneous surgery<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous carpal tunnel release