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

University of Ioannina

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Carpal Tunnel Syndrome

Interventions

Single-portal Endoscopic Carpal Tunnel Release (Microaire®)PROCEDURE

SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).

KnifelightPROCEDURE

A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital of Ioannina

Ioannina, Greece

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: up to 6 months postoperatively

Secondary Outcomes

Pain

Pain will be assessed * as a dichotomous outcome (yes/no) * as a continuous outcome (VAS score)

Time frame: at 1 and 6 months postoperatively

Grip strength

Time frame: at 1 and 6 months postoperatively

key pinch

Time frame: 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.

Time frame: up to the end of the study

Recurrences and reoperations

Time frame: up to the end of study

Symptom Severity Scale (SSS)

Time frame: at 1 and 6 months postoperatively

Function Severity Status (FSS)

Data from ClinicalTrials.gov

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