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

NCT00565019 | Completed Phase 3

• 1 other identifier: DUPTRNS_STRD_RCT
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Study Arms (2)

Control

NO INTERVENTION

Steroid

EXPERIMENTAL

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

* 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

Steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Society of Plastic Surgeons: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre, Division of Plastic Surgery

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Paul A. Binhammer, MD,MSc

  Division of Plastic Surgery, Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 29, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: June 1, 2013
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

CA (1)