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Carpal Tunnel Syndrome Release Using PSU Retractor

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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

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Limited incision using PSU retractor Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : September 2009
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012


Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. VAS score [ Time Frame: 1 year ]
  2. return to work time [ Time Frame: 1 year ]
  3. satisfaction score [ Time Frame: 1 year ]
  4. complication rate [ Time Frame: 1 year ]


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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

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

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 Posted: November 20, 2009    Key Record Dates
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:
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries