Carpal Tunnel Syndrome Release Using PSU Retractor | NCT01017471

Studies
Carpal Tunnel Syndrome Release Using PSU Retractor

NCT01017471

Sponsor

Prince of Songkla University

Status

Unknown status

Last Update Posted

May 15, 2012Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Carpal Tunnel Syndrome

Interventions

Limited incision using PSU retractor

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2012

Last Update Posted Date

May 15, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Experimental	carpal tunnel release using standard incision	Procedure: Limited incision using PSU retractor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Limited incision using PSU retractor	Procedure	carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons	control

Measure	Description	Time Frame
CTS score		1 year

Measure	Description	Time Frame
VAS score		1 year
return to work time		1 year
satisfaction score

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sunthorn Wongsiri, MD	Prince of Songkla University, Hatyai, Songkhla, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided