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Surgery Versus Manual Rupture for Dorsal Carpal Ganglion

Primary Purpose

Dorsal Carpal Ganglion

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
local excision
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dorsal Carpal Ganglion focused on measuring surgery, manual rupture, dorsal carpal ganglion

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with dorsal carpal ganglion

Exclusion Criteria:

  • underlying rheumatic condition
  • bleeding tendency

Sites / Locations

  • Songklanakarind hospital

Outcomes

Primary Outcome Measures

recurrence rate

Secondary Outcome Measures

time to recurrence
DASH score

Full Information

First Posted
November 17, 2009
Last Updated
May 12, 2012
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT01017900
Brief Title
Surgery Versus Manual Rupture for Dorsal Carpal Ganglion
Official Title
Comparison Between Surgical Excision and Manual Rupture for Dorsal Carpal Ganglion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dorsal Carpal Ganglion
Keywords
surgery, manual rupture, dorsal carpal ganglion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
local excision
Intervention Description
surgical excision by orthopaedic surgeon under local anesthesia
Primary Outcome Measure Information:
Title
recurrence rate
Time Frame
1,2 and 3 years
Secondary Outcome Measure Information:
Title
time to recurrence
Time Frame
1,2 and 3 years
Title
DASH score
Time Frame
1,2 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with dorsal carpal ganglion Exclusion Criteria: underlying rheumatic condition bleeding tendency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonsin Tangtrakulwanich, MD.,Ph.D.
Organizational Affiliation
Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songklanakarind hospital
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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Surgery Versus Manual Rupture for Dorsal Carpal Ganglion

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