Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
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|ClinicalTrials.gov Identifier: NCT00565019|
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : December 13, 2013
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.
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.
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.
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 or disease||Intervention/treatment||Phase|
|Dupuytren's Contracture||Drug: Triamcinolone Acetonide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||June 2013|
|No Intervention: Control|
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
- 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). [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565019
|Sunnybrook Health Sciences Centre, Division of Plastic Surgery|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Paul A. Binhammer, MD,MSc||Division of Plastic Surgery, Sunnybrook Health Sciences Centre|