Effects of Steroid Injection With Percutaneous Needle Apo... | NCT00565019

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

NCT00565019

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Dec 13, 2013Estimated

Enrollment

51Actual

Phase

Phase 3

Conditions

Dupuytren's Contracture

Interventions

Triamcinolone Acetonide

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Aug 2011Actual

Completion Date

Jun 2013Actual

First Submitted Date

Nov 28, 2007

First Submission Date that Met QC Criteria

Nov 28, 2007

First Posted Date

Nov 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2013

Last Update Posted Date

Dec 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Paul Binhammer, MD, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Name	Class
Canadian Society of Plastic Surgeons	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention
Steroid	Experimental		Drug: Triamcinolone Acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul A. Binhammer, MD,MSc	Division of Plastic Surgery, Sunnybrook Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre, Division of Plastic Surgery		Toronto	Ontario	M4N 3M5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D004387	Dupuytren Contracture

Ancestor Terms

ID	Term
D005350	Fibroma
D018218	Neoplasms, Fibrous Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided