Dupuytren's DiseaseNCT00575458
Splinting for Dupuytren's Contracture Release
An observational study of Dupuytren's Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopaedic Hand Clinic
Who may be able to join
- 18 years or older
- males and females with Dupuytren's contracture
- patients with contracture of less than 30 degrees of MCP contractions and no contractions of the IP joints
Who cannot join
- previous surgical treatment for Dupuytren's
- contracture of MCP greater than 30 degrees
- contraindications for dynamic splinting (upper limb amputees, paresis, ect.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Prospective Randomized Comparison of Dynamic Versus Static Splinting After Dupuytren's Contracture Release
This study is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.
- Conditions
- Dupuytren's Disease
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Static Splint | |
| 2 | Dynamic Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJun 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- David C. Ring, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575458
- Sponsor's protocol ID
- 2005p002466
- Status last verified
- Nov 2010
- First submitted
- 14 Dec 2007
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Dynamic Versus Static Splinting After Dupuytren's Contracture Release
- ClinicalTrials.gov ID
- NCT00575458
- Acronym / sponsor ID
- 2005p002466
- Conditions
- Dupuytren's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Dec 2007 (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 is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Static Splint |
| 2 | – | –Dynamic Splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic Hand Clinic
Key inclusion criteria (3 listed)
- 18 years or older
- males and females with Dupuytren's contracture
- patients with contracture of less than 30 degrees of MCP contractions and no contractions of the IP joints
Key exclusion criteria (3 listed)
- previous surgical treatment for Dupuytren's
- contracture of MCP greater than 30 degrees
- contraindications for dynamic splinting (upper limb amputees, paresis, ect.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire
Time frame: 6 months
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 16 Nov 2010.
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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.
David C. Ring, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 3 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 16 Nov 2010. 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 United States. 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.
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?
DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire (time frame: 6 months). 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 16 Nov 2010.