CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

NCT ID: NCT01715467

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-10-31

Brief Summary

This observational study will prospectively collect data on treatment options, patient/investigator satisfaction, requirement for retreatment or additional treatment, and long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide additional health economics and utilization data.

Detailed Description

This is a prospective, multi-center, observational study. Patients will be recruited based on the usual care presentation at each investigative site, as regular practice would dictate. Consecutive patients deemed eligible for the study by their physician will be invited to participate during their usual care visit. Enrolled patients will receive evaluations and treatment for Dupuytren's contracture according to the standard of care and clinical practice at each study site. No study-specific visits will be required as part of the study. Treatment and Follow-up Visits will be determined by the treating physician. Treatments received for Dupuytren's contracture will be recorded (ie, XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy), including initial treatment and any subsequent therapy. The full prescribing information and medication guide for XIAFLEX is provided in this protocol as reference (Appendix B). Patient data (including treatment outcomes, joint contracture measured by the treating physician, and evidence of recurrence) and health care resource utilization data will be drawn from the patients' medical records, examination, and patient interviews. These data will be recorded via a web-based electronic data collection (EDC) system.

PROs will be collected by self-completed questionnaires given to each patient via web-based data collection or telephone interviews. The site will follow up with the patient according to usual practice. Information from the patient's visit may include goniometry and the physician's assessment of treatment outcome and healthcare utilization. Patients will be considered enrolled in the study for a maximum of 4 years post-enrollment or until death, withdrawal of consent, loss to follow-up, or study closure.

Conditions

Dupuytren's Contracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Women or men 18 years of age or older
• Patients with a Dupuytren's contracture of at least a single joint and a desire for correction
• Patients who are able to read and understand English
• Patients who are capable of understanding and cooperating with the requirements of the study
• Patients who are willing and able to respond to the posttreatment assessments via telephone or internet
• Patients must provide written informed consent, indicating that they understand the purpose of and requirements of the study and are willing to participate in the study.

Exclusion Criteria

• Patients who decide not to pursue correction of the Dupuytren's contracture.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urdaneta Veronica, MD

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Raven Orthopaedics, Inc.

Burbank, California, United States

Core Orthopaedic Medical Center

Encinitas, California, United States

Torrey Pines Orthopaedic Medical Group

La Jolla, California, United States

Brigid Freyne, MD, Inc.

Murrieta, California, United States

Hand Surgery Associates

Denver, Colorado, United States

Physicians for the Hand

Coral Gables, Florida, United States

Florida Medical Research Institute

Lady Lake, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

OrthoGeorgia

Macon, Georgia, United States

Rockford Orthopedic Associates, LTD

Rockford, Illinois, United States

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

The Hand Center

Wichita, Kansas, United States

Bluegrass Orthopaedics and Hand Care Research

Lexington, Kentucky, United States

Faith Regional Health Services

Norfolk, Nebraska, United States

The Minimally Invasive Hand Institute

Las Vegas, Nevada, United States

Central Jersey Hand Surgery

Eatontown, New Jersey, United States

Comprehensive Hand Surgery PC

Brooklyn, New York, United States

Beth Isreal Medical Center

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, United States

Core Orthopedics

Sioux Falls, South Dakota, United States

The Plastic Surgery Group

Chattanooga, Tennessee, United States

OrthoMemphis

Memphis, Tennessee, United States

Vanderbilt Orthopaedic Institute

Nashville, Tennessee, United States

Vanderbilt Orthopaedic Institute

Nashville, Tennessee, United States

Charlottesville Orthopaedic Center, PLC

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

AUX-CC-901

Identifier Type: -

Identifier Source: org_study_id