NCT01017471

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

November 17, 2009

Last Update Submit

May 12, 2012

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndromesurgeryPSU retractorcarpal tunnel syndrome who failed to conservative treatment

Outcome Measures

Primary Outcomes (1)

  • CTS score

    1 year

Secondary Outcomes (4)

  • VAS score

    1 year

  • return to work time

    1 year

  • satisfaction score

    1 year

  • complication rate

    1 year

Study Arms (1)

control

EXPERIMENTAL

carpal tunnel release using standard incision

Procedure: Limited incision using PSU retractor

Interventions

Limited incision using PSU retractorPROCEDURE

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

control

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months

You may not qualify if:

  • Underlying disease such as : DM, neuropathy
  • Previous wrist or hand surgery in the same side
  • Previous wrist and hand trauma
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Sunthorn Wongsiri, MD

    Prince of Songkla University, Hatyai, Songkhla, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Orthopaedic surgery

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TH(1)