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

NCT01756820 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Carpal Tunnel Syndrome

Interventions

PROCEDURE

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/).

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)

Sponsors & Collaborators

  • University of Ioannina

    lead OTHER

Principal Investigators

  • Haris S Vasiliadis, MD, PhD · Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

  • Theodoros Xenakis · Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

  • Grigorios Mitsionis · Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756820 on ClinicalTrials.gov