Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes. | The secondary objectives are as follows:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Community based sample
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Urdaneta Veronica, MD | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raven Orthopaedics, Inc. | Burbank | California | 91505 | United States | ||
| Core Orthopaedic Medical Center |
Not provided
Not provided
Not provided
Not provided
| 4 years |
| Encinitas |
| California |
| 92024 |
| United States |
| Torrey Pines Orthopaedic Medical Group | La Jolla | California | 92037 | United States |
| Brigid Freyne, MD, Inc. | Murrieta | California | 92563 | United States |
| Hand Surgery Associates | Denver | Colorado | 80210 | United States |
| Physicians for the Hand | Coral Gables | Florida | 33146 | United States |
| Florida Medical Research Institute | Lady Lake | Florida | 32159 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| OrthoGeorgia | Macon | Georgia | 31201 | United States |
| Rockford Orthopedic Associates, LTD | Rockford | Illinois | 61107 | United States |
| Indiana Hand to Shoulder Center | Indianapolis | Indiana | 46260 | United States |
| The Hand Center | Wichita | Kansas | 67208 | United States |
| Bluegrass Orthopaedics and Hand Care Research | Lexington | Kentucky | 40509 | United States |
| Faith Regional Health Services | Norfolk | Nebraska | 68701 | United States |
| The Minimally Invasive Hand Institute | Las Vegas | Nevada | 89147 | United States |
| Central Jersey Hand Surgery | Eatontown | New Jersey | 07724 | United States |
| Comprehensive Hand Surgery PC | Brooklyn | New York | 11219 | United States |
| Beth Isreal Medical Center | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27106 | United States |
| Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Core Orthopedics | Sioux Falls | South Dakota | 57103 | United States |
| The Plastic Surgery Group | Chattanooga | Tennessee | 37403 | United States |
| OrthoMemphis | Memphis | Tennessee | 38120 | United States |
| Vanderbilt Orthopaedic Institute | Nashville | Tennessee | 37232 | United States |
| Vanderbilt Orthopaedic Institute | Nashville | Tennessee | 37240 | United States |
| Charlottesville Orthopaedic Center, PLC | Charlottesville | Virginia | 22911 | United States |
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| D003286 | Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
Not provided
Not provided