Carpal Tunnel Syndrome Release Using PSU Retractor

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017471
First received: November 17, 2009
Last updated: May 12, 2012
Last verified: May 2012

November 17, 2009
May 12, 2012
September 2009
September 2012   (final data collection date for primary outcome measure)
CTS score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017471 on ClinicalTrials.gov Archive Site
  • VAS score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • return to work time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • satisfaction score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • complication rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Carpal Tunnel Syndrome Release Using PSU Retractor
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
Procedure: Limited incision using PSU retractor
carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons
Experimental: control
carpal tunnel release using standard incision
Intervention: Procedure: Limited incision using PSU retractor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
15 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01017471
52-169-11-4-2
No
Boonsin Tangtrakulwanich, Prince of Songkla University
Prince of Songkla University
Not Provided
Principal Investigator: Sunthorn Wongsiri, MD Prince of Songkla University, Hatyai, Songkhla, Thailand
Prince of Songkla University
May 2012

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