Carpal Tunnel Syndrome Release Using PSU Retractor

Phase 3

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Limited incision using PSU retractor

• Registration Number: NCT01017471
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-12
• Last Update Posted: 2012-05-15
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Limited incision using PSU retractor	carpal tunnel release using standard incision

Primary Outcome Measures

Name	Time	Method
CTS score	1 year

Secondary Outcome Measures

Name	Time	Method
VAS score	1 year
return to work time	1 year
satisfaction score	1 year
complication rate	1 year

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Hatyai, Songkhla, Thailand