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

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

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.

Study Overview

• Status: Completed
• Conditions: Dupuytren's Contracture
• Intervention / Treatment: Drug: Triamcinolone Acetonide

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, Division of Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Steroid	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Society of Plastic Surgeons
• Investigators: Principal Investigator: Paul A. Binhammer, MD,MSc, Division of Plastic Surgery, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 28, 2007
• First Submitted That Met QC Criteria: November 28, 2007
• First Posted (Estimate): November 29, 2007

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: DUPTRNS_STRD_RCT