Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.

Official Title
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Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
* Procedure: Knifelight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary Carpal Tunnel Syndrome no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest) electrophysiological examination confirms the Carpal Tunnel Syndrome Exclusion Criteria: Secondary Carpal Tunnel Syndrome Pregnancy Rheumatoid diseases Previous trauma at hand or other condition that may effect the anatomy (eg infections)

Ages Eligible for Study
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Minimum Age: 35 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)<br>Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al. | Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)<br>* SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).<br>* Other names: SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.;|
| Active Comparator: Knifelight®<br>A mini-open technique will be performed, using the Knifelight® (Stryker). | Procedure: Knifelight<br>* A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)<br>* Other names: Knifelight®, Stryker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Satisfaction | Satisfaction will be assessed by two ways by answering to the question are you happy with the result of the surgery? with a VAS score (0-100) assessing the satisfaction | at 1 and 6 months postoperatively | 
| Complications | Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc | up to 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be assessed as a dichotomous outcome (yes/no) as a continuous outcome (VAS score) | at 1 and 6 months postoperatively | 
| Grip strength |  | at 1 and 6 months postoperatively | 
| key pinch |  | at 1 and 6 months postoperatively | 
| Time to return to Activities of Daily Living (ADL) and return to work | Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed. | up to the end of the study | 
| Recurrences and reoperations |  | up to the end of study | 
| Symptom Severity Scale (SSS) |  | at 1 and 6 months postoperatively | 
| Function Severity Status (FSS) |  | at 1 and 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal Tunnel Syndrome, transverse ligament, carpal tunnel release, endoscopic, minimal invasive, mini-open, median nerve