Carpal Tunnel Syndrome Release Using PSU Retractor

NCT ID: NCT01017471

Last Updated: 2012-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

carpal tunnel release using standard incision

Group Type EXPERIMENTAL

Limited incision using PSU retractor

Intervention Type PROCEDURE

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

Interventions

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Limited incision using PSU retractor

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Boonsin Tangtrakulwanich

Department of Orthopaedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunthorn Wongsiri, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University, Hatyai, Songkhla, Thailand

Locations

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Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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52-169-11-4-2

Identifier Type: -

Identifier Source: org_study_id

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