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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre Canadian Society of Plastic Surgeons |
---|---|
Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
---|---|---|
Dupuytren's Contracture |
Drug: Triamcinolone Acetonide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study |
Estimated Enrollment: | 44 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
---|---|
Control: No Intervention | |
Steroid: Experimental |
Drug: Triamcinolone Acetonide
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine R. McMillan, MSc | 416.480.6100 ext 89846 | catherine.mcmillan@sunnybrook.ca |
Canada, Ontario | |
Sunnybrook Health Sciences Centre, Division of Plastic Surgery | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Catherine R. McMillan, MSc 416.480.6100 ext 89846 catherine.mcmillan@sunnybrook.ca | |
Contact: Paul A. Binhammer, MD 416.480.6731 p.binhammer@utoronto.ca | |
Principal Investigator: Paul A. Binhammer, MD, FRCS(C), MSc |
Principal Investigator: | Paul A. Binhammer, MD,MSc | Division of Plastic Surgery, Sunnybrook Health Sciences Centre |
Responsible Party: | Sunnybrook Health Sciences Centre ( Dr. Paul Binhammer ) |
Study ID Numbers: | DUPTRNS_STRD_RCT |
Study First Received: | November 28, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00565019 |
Health Authority: | Canada: Health Canada |
Triamcinolone Acetonide Muscular Diseases Musculoskeletal Diseases Contracture Joint Diseases Triamcinolone |
Connective Tissue Diseases Triamcinolone diacetate Dupuytren's Contracture Triamcinolone hexacetonide Dupuytren's contracture |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions |