Back to resultsCarpal Tunnel Syndrome Release Using PSU Retractor
Primary Purpose
Carpal Tunnel Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Limited incision using PSU retractor
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, surgery, PSU retractor, carpal tunnel syndrome who failed to conservative treatment
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months
Exclusion Criteria:
- Underlying disease such as : DM, neuropathy
- Previous wrist or hand surgery in the same side
- Previous wrist and hand trauma
- Pregnancy
Sites / Locations
- Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
control
Arm Description
carpal tunnel release using standard incision
Outcomes
Primary Outcome Measures
CTS score
Secondary Outcome Measures
VAS score
return to work time
satisfaction score
complication rate
Full Information
NCT ID
NCT01017471
First Posted
November 17, 2009
Last Updated
May 12, 2012
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01017471
Brief Title
Carpal Tunnel Syndrome Release Using PSU Retractor
Official Title
Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision.
The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.
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, surgery, PSU retractor, carpal tunnel syndrome who failed to conservative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Experimental
Arm Description
carpal tunnel release using standard incision
Intervention Type
Procedure
Intervention Name(s)
Limited incision using PSU retractor
Intervention Description
carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons
Primary Outcome Measure Information:
Title
CTS score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
VAS score
Time Frame
1 year
Title
return to work time
Time Frame
1 year
Title
satisfaction score
Time Frame
1 year
Title
complication rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months
Exclusion Criteria:
Underlying disease such as : DM, neuropathy
Previous wrist or hand surgery in the same side
Previous wrist and hand trauma
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunthorn Wongsiri, MD
Organizational Affiliation
Prince of Songkla University, Hatyai, Songkhla, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
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Carpal Tunnel Syndrome Release Using PSU Retractor
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