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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • CTS score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 17, 2009
Last Updated: May 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013