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

Hospital for Special Surgery (HSS)

Status and phase

Completed

Phase 4

Conditions

Dupuytren's Disease

Treatments

Biological: XIAFLEX

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01450397

11052 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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.