- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017900
Surgery Versus Manual Rupture for Dorsal Carpal Ganglion
May 12, 2012 updated by: Boonsin Tangtrakulwanich, Prince of Songkla University
Comparison Between Surgical Excision and Manual Rupture for Dorsal Carpal Ganglion
This study objectives are to compare the efficacy and safety between surgical excision and manual rupture for dorsal carpal ganglion.The participants with dorsal carpal ganglion will be randomized into 2 groups:surgical excision or manual rupture.The patients will be follow-up for at least 1 yr.Telephone interview will be used for outcome assessment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Songkhla
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Hat Yai, Songkhla, Thailand, 90110
- Songklanakarind hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with dorsal carpal ganglion
Exclusion Criteria:
- underlying rheumatic condition
- bleeding tendency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recurrence rate
Time Frame: 1,2 and 3 years
|
1,2 and 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to recurrence
Time Frame: 1,2 and 3 years
|
1,2 and 3 years
|
DASH score
Time Frame: 1,2 and 3 years
|
1,2 and 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D., Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 17, 2009
First Submitted That Met QC Criteria
November 20, 2009
First Posted (Estimate)
November 23, 2009
Study Record Updates
Last Update Posted (Estimate)
May 15, 2012
Last Update Submitted That Met QC Criteria
May 12, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 51-041-11-4-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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