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

NCT ID: NCT01756820

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Single-portal Endoscopic Carpal Tunnel Release (Microaire®)

Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al.

Group Type ACTIVE_COMPARATOR

Single-portal Endoscopic Carpal Tunnel Release (Microaire®)

Intervention Type PROCEDURE

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

Knifelight®

A mini-open technique will be performed, using the Knifelight® (Stryker).

Group Type ACTIVE_COMPARATOR

Knifelight

Intervention Type PROCEDURE

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

Interventions

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Single-portal Endoscopic Carpal Tunnel Release (Microaire®)

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

Intervention Type PROCEDURE

Knifelight

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

Intervention Type PROCEDURE

Other Intervention Names

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SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire. Knifelight®, Stryker

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)
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Haris S Vasiliadis, MD, PhD

Lecturer in Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haris S Vasiliadis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

Theodoros Xenakis

Role: STUDY_CHAIR

Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

Grigorios Mitsionis

Role: STUDY_DIRECTOR

Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

Locations

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University Hospital of Ioannina

Ioannina, , Greece

Site Status

Countries

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Greece

Other Identifiers

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Ioannina-CTS-HV

Identifier Type: -

Identifier Source: org_study_id

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