Surgery Versus Manual Rupture for Dorsal Carpal Ganglion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017900
First received: November 17, 2009
Last updated: May 12, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Dorsal Carpal Ganglion
Procedure: local excision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Surgical Excision and Manual Rupture for Dorsal Carpal Ganglion

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to recurrence [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]
  • DASH score [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: local excision
    surgical excision by orthopaedic surgeon under local anesthesia
  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with dorsal carpal ganglion

Exclusion Criteria:

  • underlying rheumatic condition
  • bleeding tendency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 17, 2009
Last Updated: May 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014