Clinical trial NCT01715467: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren's Contracture
Keywords: Dupuytren
Contracture
Auxilium
XIAFLEX
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community based sample

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 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.

Primary outcomes:
measure: The primary objective is to collect real-world data regarding patient reported outcomes of the 3 primary treatment modalities in patients with Dupuytren's contracture.
timeFrame: 4 years
Secondary outcomes:
measure: Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.
timeFrame: 4 years
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Raven Orthopaedics, Inc.
state: California
city: Encinitas
country: United States
facility: Core Orthopaedic Medical Center
state: California
city: La Jolla
country: United States
facility: Torrey Pines Orthopaedic Medical Group
state: California
city: Murrieta
country: United States
facility: Brigid Freyne, MD, Inc.
state: California
city: Denver
country: United States
facility: Hand Surgery Associates
state: Colorado
city: Coral Gables
country: United States
facility: Physicians for the Hand
state: Florida
city: Lady Lake
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Macon
country: United States
facility: OrthoGeorgia
state: Georgia
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, LTD
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: Wichita
country: United States
facility: The Hand Center
state: Kansas
city: Lexington
country: United States
facility: Bluegrass Orthopaedics and Hand Care Research
state: Kentucky
city: Norfolk
country: United States
facility: Faith Regional Health Services
state: Nebraska
city: Las Vegas
country: United States
facility: The Minimally Invasive Hand Institute
state: Nevada
city: Eatontown
country: United States
facility: Central Jersey Hand Surgery
state: New Jersey
city: Brooklyn
country: United States
facility: Comprehensive Hand Surgery PC
state: New York
city: New York
country: United States
facility: Beth Isreal Medical Center
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
city: Sioux Falls
country: United States
facility: Core Orthopedics
state: South Dakota
city: Chattanooga
country: United States
facility: The Plastic Surgery Group
state: Tennessee
city: Memphis
country: United States
facility: OrthoMemphis
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Orthopaedic Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Orthopaedic Institute
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Orthopaedic Center, PLC
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Urdaneta Veronica, MD
role: STUDY_DIRECTOR
References: