MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

Phase 4

Completed

• Conditions: Dupuytren's Disease
• Interventions: Biological: XIAFLEX

• Registration Number: NCT01450397
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

Detailed Description

Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Results First Submitted: 2013-10-29
• Results First Submitted QC: 2014-04-14
• Results First Posted: 2014-05-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
• Subject has only one finger affected by the disease.
• Patients will be 35 years of age of older.
• Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.

Exclusion Criteria

• Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
• Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
• Patient has known allergy to collagenase or any other excipient of Xiaflex.
• Patient has received any collagenase treatments before the first dose of Xiaflex.
• Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XIAFLEX	XIAFLEX	XIAFlEX

Primary Outcome Measures

Name	Time	Method
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.	Baseline and 30 days	Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.

Trial Locations

Locations (1)

Hosptial for Special Surgery; 🇺🇸 New York, New York, United States