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

Primary Purpose

Dupuytren's Contracture

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren's Contracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunnybrook Health Sciences Centre, Division of Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Steroid

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 28, 2007
Last Updated
December 12, 2013
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Society of Plastic Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT00565019
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Society of Plastic Surgeons

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Contracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Steroid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A. Binhammer, MD,MSc
Organizational Affiliation
Division of Plastic Surgery, Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre, Division of Plastic Surgery
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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