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Carpal Tunnel Syndrome Release Using PSU Retractor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Boonsin Tangtrakulwanich, Prince of Songkla University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017471
First Posted: November 20, 2009
Last Update Posted: May 15, 2012
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.
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
  Purpose

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.


Condition Intervention Phase
Carpal Tunnel Syndrome Procedure: Limited incision using PSU retractor Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Boonsin Tangtrakulwanich, Prince of Songkla University:

Primary Outcome Measures:
  • CTS score [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: control
carpal tunnel release using standard incision
Procedure: Limited incision using PSU retractor
carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017471


Locations
Thailand
Prince of Songkla University
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Sunthorn Wongsiri, MD Prince of Songkla University, Hatyai, Songkhla, Thailand
  More Information

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017471     History of Changes
Other Study ID Numbers: 52-169-11-4-2
First Submitted: November 17, 2009
First Posted: November 20, 2009
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Boonsin Tangtrakulwanich, Prince of Songkla University:
carpal tunnel syndrome
surgery
PSU retractor
carpal tunnel syndrome who failed to conservative treatment

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries