Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
Information source: Sunnybrook Health Sciences Centre
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dupuytren's Contracture
Intervention: Triamcinolone Acetonide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sunnybrook Health Sciences Centre Official(s) and/or principal investigator(s):
Paul A. Binhammer, MD,MSc, Principal Investigator, Affiliation: Division of Plastic Surgery, Sunnybrook Health Sciences Centre
Overall contact:
Catherine R. McMillan, MSc, Phone: 416.480.6100, Ext: 89846, Email: catherine.mcmillan@sunnybrook.ca
Summary
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.
Clinical Details
Official title: The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study
Study design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Catherine R. McMillan, MSc, Phone: 416.480.6100, Ext: 89846, Email: catherine.mcmillan@sunnybrook.ca
Sunnybrook Health Sciences Centre, Division of Plastic Surgery, Toronto, Ontario M4N 3M5, Canada; Recruiting
Catherine R. McMillan, MSc, Phone: 416.480.6100, Ext: 89846, Email: catherine.mcmillan@sunnybrook.ca
Paul A. Binhammer, MD, Phone: 416.480.6731, Email: p.binhammer@utoronto.ca
Paul A. Binhammer, MD, FRCS(C), MSc, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: November 2008
Last updated: October 9, 2008
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