Back to resultsSingle-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial (CTS-HV)
Primary Purpose
Carpal Tunnel Syndrome
Status
Withdrawn
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
Knifelight
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, transverse ligament, carpal tunnel release, endoscopic, minimal invasive, mini-open, median nerve
Eligibility 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)
Sites / Locations
- University Hospital of Ioannina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
Knifelight®
Arm Description
Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al.
A mini-open technique will be performed, using the Knifelight® (Stryker).
Outcomes
Primary Outcome Measures
Overall Satisfaction
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
Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc
Secondary Outcome Measures
Pain
Pain will be assessed
as a dichotomous outcome (yes/no)
as a continuous outcome (VAS score)
Grip strength
key pinch
Time to return to Activities of Daily Living (ADL) and return to work
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
Symptom Severity Scale (SSS)
Function Severity Status (FSS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01756820
Brief Title
Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial
Acronym
CTS-HV
Official Title
Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The principal investigator of the study relocated to another institution.
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, transverse ligament, carpal tunnel release, endoscopic, minimal invasive, mini-open, median nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
Arm Type
Active Comparator
Arm Description
Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al.
Arm Title
Knifelight®
Arm Type
Active Comparator
Arm Description
A mini-open technique will be performed, using the Knifelight® (Stryker).
Intervention Type
Procedure
Intervention Name(s)
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
Other Intervention Name(s)
SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.
Intervention Description
SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).
Intervention Type
Procedure
Intervention Name(s)
Knifelight
Other Intervention Name(s)
Knifelight®, Stryker
Intervention Description
A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)
Primary Outcome Measure Information:
Title
Overall Satisfaction
Description
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
Time Frame
at 1 and 6 months postoperatively
Title
Complications
Description
Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc
Time Frame
up to 6 months postoperatively
Secondary Outcome Measure Information:
Title
Pain
Description
Pain will be assessed
as a dichotomous outcome (yes/no)
as a continuous outcome (VAS score)
Time Frame
at 1 and 6 months postoperatively
Title
Grip strength
Time Frame
at 1 and 6 months postoperatively
Title
key pinch
Time Frame
at 1 and 6 months postoperatively
Title
Time to return to Activities of Daily Living (ADL) and return to work
Description
Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed.
Time Frame
up to the end of the study
Title
Recurrences and reoperations
Time Frame
up to the end of study
Title
Symptom Severity Scale (SSS)
Time Frame
at 1 and 6 months postoperatively
Title
Function Severity Status (FSS)
Time Frame
at 1 and 6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haris S Vasiliadis, MD, PhD
Organizational Affiliation
Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theodoros Xenakis
Organizational Affiliation
Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Grigorios Mitsionis
Organizational Affiliation
Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial
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