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

Dupuytren's Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565019
• Other study ID #: DUPTRNS_STRD_RCT
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2007
• Last updated: December 12, 2013
• Start date: November 2007
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Intervention

Drug:
• Triamcinolone Acetonide
Triamcinolone acetonide will be administered into the cord following surgery with a tuberculin syringe and a 25-gauge needle. Doses will range from 60-120 mg depending on extent of the disease. Patients will receive injections at 6 weeks and 3 months for persisting nodules or cords. PI will determine the dosages. Estimates will be made based on the following: 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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre, Division of Plastic Surgery	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Society of Plastic Surgeons

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 months	No