Dupuytren's Contracture Clinical Trial
Official title:
The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study
Verified date | December 2013 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Background:
Dupuytren's contracture is a common hand problem that causes certain fingers to bend towards
the palm. Patients with this condition cannot perform daily activities and many are unable
to work. It is usually treated by an operation to straighten the fingers followed by therapy
if the angle that the fingers are bent at is large enough. However, no treatment has been
able to completely prevent the angle from persisting.
Objective:
This study is designed to examine whether or not the use of a drug in combination with
surgery will improve the angle at which the fingers are bent more than surgery alone.
Hypothesis:
Subjects who receive triamcinolone acetonide will have straighter fingers compared with
subjects who only have the operation and no triamcinolone acetonide at both 3 months and 6
months after the operation.
Methods:
Eligible patients interested in having the operation to treat Dupuytren's contracture will
be asked if they would like to join the study. Subjects will be randomly placed into one of
two groups: the steroid injection group or the control group. Subjects will have a
pre-operative visit, the surgery, and follow-ups at 6 weeks, 3 months and 6 months. All
subjects will have the operation, but only those in the steroid injection group will receive
an injection of the drug. During the 6 week and 3 month follow-ups, subjects in the steroid
injection group may receive another injection if their fingers are still bent. Angles are
measured at the pre-operative visit and at 3 and 6 months. The change in angle from before
to after and any differences in the groups, in time points and interactions between the two
will be analyzed.
Status | Completed |
Enrollment | 51 |
Est. completion date | June 2013 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Over the age of 18. - Literate in the English language. - Diagnosed by the PI with Dupuytren's contracture with an angle of contracture of 20° or greater. - Candidates for percutaneous needle aponeurotomy. - First surgery on the affected digit. Exclusion Criteria: - Allergy or sensitivity to triamcinolone acetonide or any of the non-medicinal components in the suspension. - Patient is not a candidate for steroid injection for other medical reasons, which will be determined by the PI. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre, Division of Plastic Surgery | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Canadian Society of Plastic Surgeons |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint of this study is the angle of contracture of the affected fingers (how bent the fingers are before and after the two treatments). | 6 months | No |
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