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Carpal Tunnel Syndrome Release Using PSU Retractor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01017471
Recruitment Status : Unknown
Verified May 2012 by Boonsin Tangtrakulwanich, Prince of Songkla University.
Recruitment status was:  Enrolling by invitation
First Posted : November 20, 2009
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University

Tracking Information
First Submitted Date  ICMJE November 17, 2009
First Posted Date  ICMJE November 20, 2009
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
CTS score [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
  • VAS score [ Time Frame: 1 year ]
  • return to work time [ Time Frame: 1 year ]
  • satisfaction score [ Time Frame: 1 year ]
  • complication rate [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carpal Tunnel Syndrome Release Using PSU Retractor
Official Title  ICMJE Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE Procedure: Limited incision using PSU retractor
carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons
Study Arms  ICMJE Experimental: control
carpal tunnel release using standard incision
Intervention: Procedure: Limited incision using PSU retractor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01017471
Other Study ID Numbers  ICMJE 52-169-11-4-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boonsin Tangtrakulwanich, Prince of Songkla University
Study Sponsor  ICMJE Prince of Songkla University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunthorn Wongsiri, MD Prince of Songkla University, Hatyai, Songkhla, Thailand
PRS Account Prince of Songkla University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP