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Surgery Versus Manual Rupture for Dorsal Carpal Ganglion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01017900
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dorsal Carpal Ganglion Procedure: local excision Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Surgical Excision and Manual Rupture for Dorsal Carpal Ganglion
Study Start Date : August 2008
Primary Completion Date : June 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. recurrence rate [ Time Frame: 1,2 and 3 years ]

Secondary Outcome Measures :
  1. time to recurrence [ Time Frame: 1,2 and 3 years ]
  2. DASH score [ Time Frame: 1,2 and 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with dorsal carpal ganglion

Exclusion Criteria:

  • underlying rheumatic condition
  • bleeding tendency
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017900


Locations
Thailand
Songklanakarind hospital
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D. Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110
More Information

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017900     History of Changes
Other Study ID Numbers: 51-041-11-4-2
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Boonsin Tangtrakulwanich, Prince of Songkla University:
surgery
manual rupture
dorsal carpal ganglion

Additional relevant MeSH terms:
Rupture
Ganglion Cysts
Synovial Cyst
Wounds and Injuries
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases