- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575458
Splinting for Dupuytren's Contracture Release
November 15, 2010 updated by: Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Orthopaedic Hand Clinic
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- previous surgical treatment for Dupuytren's
- contracture of MCP greater than 30 degrees
- contraindications for dynamic splinting (upper limb amputees, paresis, ect.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Static Splint
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2
Dynamic Splint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David C. Ring, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 18, 2007
Study Record Updates
Last Update Posted (Estimate)
November 16, 2010
Last Update Submitted That Met QC Criteria
November 15, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005p002466
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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