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Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
This study is currently recruiting participants.
Verified by Sunnybrook Health Sciences Centre, October 2008
Sponsors and Collaborators: Sunnybrook Health Sciences Centre
Canadian Society of Plastic Surgeons
Information provided by: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00565019
  Purpose

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.


Condition Intervention Phase
Dupuytren's Contracture
Drug: Triamcinolone Acetonide
Phase III

Drug Information available for: Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide Tuberculin Purified Protein Derivative
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study

Further study details as provided by Sunnybrook Health Sciences Centre:

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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: November 2007
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
Control: No Intervention
Steroid: Experimental 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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565019

Contacts
Contact: Catherine R. McMillan, MSc 416.480.6100 ext 89846 catherine.mcmillan@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre, Division of Plastic Surgery Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Catherine R. McMillan, MSc     416.480.6100 ext 89846     catherine.mcmillan@sunnybrook.ca    
Contact: Paul A. Binhammer, MD     416.480.6731     p.binhammer@utoronto.ca    
Principal Investigator: Paul A. Binhammer, MD, FRCS(C), MSc            
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Society of Plastic Surgeons
Investigators
Principal Investigator: Paul A. Binhammer, MD,MSc Division of Plastic Surgery, Sunnybrook Health Sciences Centre
  More Information

Responsible Party: Sunnybrook Health Sciences Centre ( Dr. Paul Binhammer )
Study ID Numbers: DUPTRNS_STRD_RCT
Study First Received: November 28, 2007
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00565019  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Triamcinolone Acetonide
Muscular Diseases
Musculoskeletal Diseases
Contracture
Joint Diseases
Triamcinolone
Connective Tissue Diseases
Triamcinolone diacetate
Dupuytren's Contracture
Triamcinolone hexacetonide
Dupuytren's contracture

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009