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

NCT00565019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-12-13

No results posted yet for this study

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.

Conditions

  • Dupuytren's Contracture

Interventions

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

Sponsors & Collaborators

  • Canadian Society of Plastic Surgeons

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Paul A. Binhammer, MD,MSc · Division of Plastic Surgery, Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-08-31
Completion
2013-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00565019 on ClinicalTrials.gov