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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565019
First Posted: November 29, 2007
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Society of Plastic Surgeons
Information provided by (Responsible Party):
Dr. Paul Binhammer, Sunnybrook Health Sciences Centre
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Dr. Paul Binhammer, 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 ]

Enrollment: 51
Study Start Date: November 2007
Study Completion Date: June 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565019


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre, Division of Plastic Surgery
Toronto, Ontario, Canada, M4N 3M5
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: Dr. Paul Binhammer, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00565019     History of Changes
Other Study ID Numbers: DUPTRNS_STRD_RCT
First Submitted: November 28, 2007
First Posted: November 29, 2007
Last Update Posted: December 13, 2013
Last Verified: December 2013

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