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

This study is not yet open for participant recruitment.
Verified December 2012 by University of Ioannina
Sponsor:
Information provided by (Responsible Party):
Haris S Vasiliadis, MD, PhD, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01756820
First received: December 20, 2012
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Carpal Tunnel Syndrome
 Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
Procedure: Knifelight
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • Overall Satisfaction [ Time Frame: at 1 and 6 months postoperatively ] [ Designated as safety issue: No ]

    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

  • Complications [ Time Frame: up to 6 months postoperatively ] [ Designated as safety issue: Yes ]
    Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc


Secondary Outcome Measures:
  • Pain [ Time Frame: at 1 and 6 months postoperatively ] [ Designated as safety issue: No ]

    Pain will be assessed

    • as a dichotomous outcome (yes/no)
    • as a continuous outcome (VAS score)

  • Grip strength [ Time Frame: at 1 and 6 months postoperatively ] [ Designated as safety issue: No ]
  • key pinch [ Time Frame: at 1 and 6 months postoperatively ] [ Designated as safety issue: No ]
  • Time to return to Activities of Daily Living (ADL) and return to work [ Time Frame: up to the end of the study ] [ Designated as safety issue: No ]
    Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed.

  • Recurrences and reoperations [ Time Frame: up to the end of study ] [ Designated as safety issue: Yes ]
  • Symptom Severity Scale (SSS) [ Time Frame: at 1 and 6 months postoperatively ] [ Designated as safety issue: No ]
  • Function Severity Status (FSS) [ Time Frame: at 1 and 6 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Knifelight®, Stryker

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756820

Contacts
Contact: Haris S Vasiliadis, MD, PhD +306974354545 vasiliadismd@gmail.com
Contact: Theodoros Xenakis, Prof MD +302651008097 xebiolab@cc.uoi.gr

Locations
Greece
University Hospital of Ioannina Not yet recruiting
Ioannina, Greece, 45500
Contact: Haris S Vasiliadis, MD     +306974354545     vasiliadismd@gmail.com    
Contact: Theodoros Xenakis, Prof         xebiolab@cc.uoi.gr    
Principal Investigator: Haris S Vasiliadis, MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Haris S Vasiliadis, MD, PhD, Lecturer in Orthopaedics, University of Ioannina
ClinicalTrials.gov Identifier: NCT01756820     History of Changes
Other Study ID Numbers: Ioannina-CTS-HV
Study First Received: December 20, 2012
Last Updated: December 26, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Ioannina:
Carpal Tunnel Syndrome
transverse ligament
carpal tunnel release
endoscopic
 minimal invasive
mini-open
median nerve

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013