Dorsal Carpal GanglionPhase 3NCT01017900
Surgery Versus Manual Rupture for Dorsal Carpal Ganglion
A Phase 3 study testing local excision in people with Dorsal Carpal Ganglion, run by Prince of Songkla University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Dorsal Carpal Ganglion
- What is being tested?
- local excision
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2008to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with dorsal carpal ganglion
Who cannot join
- underlying rheumatic condition
- bleeding tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Surgical Excision and Manual Rupture for Dorsal Carpal Ganglion
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.
- Conditions
- Dorsal Carpal Ganglion
- Being tested
- local excision
- Keywords
- surgery, manual rupture, dorsal carpal ganglion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local excisionProcedure or surgery
surgical excision by orthopaedic surgeon under local anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Measured: 1,2 and 3 years
Secondary outcomes (2)
time to recurrence
Measured: 1,2 and 3 years
DASH score
Measured: 1,2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dorsal Carpal GanglionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonsin Tangtrakulwanich, Prince of Songkla University
- Investigators
- Boonsin Tangtrakulwanich, MD.,Ph.D., Principal investigator, Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017900
- Sponsor's protocol ID
- 51-041-11-4-2
- Status last verified
- May 2012
- First submitted
- 17 Nov 2009
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Surgical Excision and Manual Rupture for Dorsal Carpal Ganglion
- ClinicalTrials.gov ID
- NCT01017900
- Acronym / sponsor ID
- 51-041-11-4-2
- Conditions
- Dorsal Carpal Ganglion
- Keywords
- surgery, manual rupture, dorsal carpal ganglion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with dorsal carpal ganglion
Key exclusion criteria (2 listed)
- underlying rheumatic condition
- bleeding tendency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local excisionsurgical excision by orthopaedic surgeon under local anesthesia | Procedure or surgery | – |
Primary outcome
recurrence rate
Time frame: 1,2 and 3 years
2 secondary outcomes
time to recurrence
Time frame: 1,2 and 3 years
DASH score
Time frame: 1,2 and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boonsin Tangtrakulwanich, MD.,Ph.D. principal investigator
Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing local excision in people with Dorsal Carpal Ganglion, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: 1,2 and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.