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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

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