NCT01017900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

November 17, 2009

Last Update Submit

May 12, 2012

Conditions

Dorsal Carpal Ganglion

Keywords

surgerymanual rupturedorsal carpal ganglion

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

    1,2 and 3 years

Secondary Outcomes (2)

  • time to recurrence

    1,2 and 3 years

  • DASH score

    1,2 and 3 years

Interventions

local excisionPROCEDURE

surgical excision by orthopaedic surgeon under local anesthesia

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with dorsal carpal ganglion

You may not qualify if:

  • underlying rheumatic condition
  • bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanakarind hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D.

    Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Orthopaedic surgery

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 23, 2009

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TH(1)