Carpal Tunnel Syndrome Release Using PSU Retractor

Verified by: Prince of Songkla University, November 2009
First Received: November 17, 2009 | Last Updated: November 20, 2009 | Phase: Phase 3 | Start Date: September 2009
Overall Status: Enrolling by invitation | Estimated Enrollment: 60
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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...

Brief Summary

Official Title: “Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2010

Intervention(s) in this Clinical Trial

  • Procedure: Limited incision using PSU retractor
    • carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: control
    • carpal tunnel release using standard incision

Outcome Measures for this Clinical Trial

Primary Measures

  • CTS score
    • Time Frame: 1 year
      Safety Issue?: No

Secondary Measures

  • VAS score
    • Time Frame: 1 year
      Safety Issue?: No
  • return to work time
    • Time Frame: 1 year
      Safety Issue?: No
  • satisfaction score
    • Time Frame: 1 year
      Safety Issue?: No
  • complication rate
    • Time Frame: 1 year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Prince of Songkla University Other

Overall Clinical Trial Officials and Contacts

Sunthorn Wongsiri, MD Principal Investigator Prince of Songkla University, Hatyai, Songkhla, Thailand  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01017471

Study ID Number: 52-169-11-4-2

ClinicalTrials.gov Identifier: NCT01017471

Health Authority: Thailand: Ethical Committee

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01017471