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Clinical Trials/NCT01017471
NCT01017471
Unknown
Phase 3

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

Prince of Songkla University1 site in 1 country60 target enrollmentSeptember 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Prince of Songkla University
Enrollment
60
Locations
1
Primary Endpoint
CTS score
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Boonsin Tangtrakulwanich

Department of Orthopaedic surgery

Prince of Songkla University

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

Outcomes

Primary Outcomes

CTS score

Time Frame: 1 year

Secondary Outcomes

  • VAS score(1 year)
  • return to work time(1 year)
  • satisfaction score(1 year)
  • complication rate(1 year)

Study Sites (1)

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