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NCT01017471 Clinical Trial

Carpal Tunnel Syndrome Release Using PSU Retractor

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01017471
Other study ID # 52-169-11-4-2
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received November 17, 2009
Last updated May 12, 2012
Start date September 2009
Est. completion date December 2012

Study information
Verified date May 2012
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Limited incision using PSU retractor
carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons

Locations
Country Name City State
Thailand Prince of Songkla University Hatyai Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary CTS score 1 year No
Secondary VAS score 1 year No
Secondary return to work time 1 year No
Secondary satisfaction score 1 year No
Secondary complication rate 1 year No
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