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
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
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/).
Knifelight®
A mini-open technique will be performed, using the Knifelight® (Stryker).
Knifelight
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/).
Knifelight
A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)
* electrophysiological examination confirms the Carpal Tunnel Syndrome
Exclusion Criteria
* Pregnancy
* Rheumatoid diseases
* Previous trauma at hand or other condition that may effect the anatomy (eg infections)
35 Years
ALL
No
Sponsors
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University of Ioannina
OTHER
Responsible Party
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Haris S Vasiliadis, MD, PhD
Lecturer in Orthopaedics
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
Countries
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Other Identifiers
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Ioannina-CTS-HV
Identifier Type: -
Identifier Source: org_study_id
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