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

November 28, 2007
December 12, 2013
November 2007
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00565019 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dupuytren's Contracture
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

  • No Intervention: Control
  • Experimental: Steroid
    Intervention: Drug: Triamcinolone Acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
June 2013
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00565019
DUPTRNS_STRD_RCT
No
Dr. Paul Binhammer, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Canadian Society of Plastic Surgeons
Principal Investigator: Paul A. Binhammer, MD,MSc Division of Plastic Surgery, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP