Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
NCT ID: NCT00565019
Last Updated: 2013-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
51 participants
INTERVENTIONAL
2007-11-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
No interventions assigned to this group
Steroid
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patient is not a candidate for steroid injection for other medical reasons, which will be determined by the PI.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Society of Plastic Surgeons
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Paul Binhammer
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul A. Binhammer, MD,MSc
Role: PRINCIPAL_INVESTIGATOR
Division of Plastic Surgery, Sunnybrook Health Sciences Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sunnybrook Health Sciences Centre, Division of Plastic Surgery
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DUPTRNS_STRD_RCT
Identifier Type: -
Identifier Source: org_study_id