Clinical Trial: Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study

Brief 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 gro

Detailed Summary:
Sponsor: Sunnybrook Health Sciences Centre

Current 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). [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: November 28, 2007
Date Started: November 2007
Date Completion:
Last Updated: December 12, 2013
Last Verified: December 2013