Clinical trial NCT00565019: Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
Official title: The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren's Contracture
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Society of Plastic Surgeons
First posted: 2007-11-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 groups, in time points and interactions between the two will be analyzed.


Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Division of Plastic Surgery
state: Ontario
Study officials:
affiliation: Division of Plastic Surgery, Sunnybrook Health Sciences Centre
name: Paul A. Binhammer, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: