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

This study has been completed.
Sponsor:
Collaborator:
Canadian Society of Plastic Surgeons
Information provided by (Responsible Party):
Dr. Paul Binhammer, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00565019
First received: November 28, 2007
Last updated: December 12, 2013
Last verified: December 2013
  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: 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 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Paul Binhammer, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00565019     History of Changes
Other Study ID Numbers: DUPTRNS_STRD_RCT
Study First Received: November 28, 2007
Last Updated: December 12, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Connective Tissue Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014