Spots Global Cancer Trial Database for CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
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Trial Identification
Brief Title: CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
Official Title: Community Registry Study Evaluating Dupuytren's Contracture Treatment. A Prospective, Observational, Longitudinal, Multicenter Study of the Treatment Patterns and Outcomes in Patients With Dupuytren's Contracture.
Study ID: NCT01715467
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Contact Details
Name: Urdaneta Veronica, MD
Affiliation: Endo Pharmaceuticals
Role: STUDY_DIRECTOR
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