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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01017900
Other study ID # 51-041-11-4-2
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2009
Last updated May 12, 2012
Start date August 2008
Est. completion date July 2011

Study information

Verified date May 2012
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria:

- patients with dorsal carpal ganglion

Exclusion Criteria:

- underlying rheumatic condition

- bleeding tendency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
local excision
surgical excision by orthopaedic surgeon under local anesthesia

Locations

Country Name City State
Thailand Songklanakarind hospital Hat Yai Songkhla

Sponsors (1)

Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence rate 1,2 and 3 years No
Secondary time to recurrence 1,2 and 3 years No
Secondary DASH score 1,2 and 3 years No