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

May 10, 2016 updated by: Haris S Vasiliadis, MD, PhD, University of Ioannina

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioannina, Greece, 45500
        • University Hospital of Ioannina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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/).
Other Names:
  • SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.
Active Comparator: Knifelight®
A mini-open technique will be performed, using the Knifelight® (Stryker).
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)
Other Names:
  • Knifelight®, Stryker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Satisfaction
Time Frame: at 1 and 6 months postoperatively

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
Time Frame: up to 6 months postoperatively
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
Time Frame: at 1 and 6 months postoperatively

Pain will be assessed

  • as a dichotomous outcome (yes/no)
  • as a continuous outcome (VAS score)
at 1 and 6 months postoperatively
Grip strength
Time Frame: at 1 and 6 months postoperatively
at 1 and 6 months postoperatively
key pinch
Time Frame: at 1 and 6 months postoperatively
at 1 and 6 months postoperatively
Time to return to Activities of Daily Living (ADL) and return to work
Time Frame: up to the end of the study
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
Time Frame: up to the end of study
up to the end of study
Symptom Severity Scale (SSS)
Time Frame: at 1 and 6 months postoperatively
at 1 and 6 months postoperatively
Function Severity Status (FSS)
Time Frame: at 1 and 6 months postoperatively
at 1 and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Investigators

  • Principal Investigator: Haris S Vasiliadis, MD, PhD, Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
  • Study Chair: Theodoros Xenakis, Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
  • Study Director: Grigorios Mitsionis, Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 26, 2012

First Posted (Estimate)

December 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ioannina-CTS-HV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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