Sunnybrook Health Sciences Centre, Division of Plastic Surgery
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT00565019
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Toronto, Ontario, M4N 3M5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Size of nodule/cord: 1-2 cm2, dosage 20-40 mg
Size of nodule/cord: 2-6 cm2, dosage 40-80 mg
Size of nodule/cord: 6-10 cm2, dosage 80-100 mg
Size of nodule/cord: >10 cm2, dosage 100-120 mg
Time frame: 6 months
Sunnybrook Health Sciences Centre
Other
The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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