CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
The secondary objectives are as follows:
- Examine the safety trends of various treatment options in patients with Dupuytren's contracture
- Examine the effectiveness trends of various treatment options, specifically evaluating long term contracture recurrence
- Examine the association between various treatment regimens and healthcare resource utilization
- Examine the association between various treatments and patient-reported outcomes (PROs) such as disease burden, ADLs, hand functionality, work performance, time to return to work, treatment satisfaction, and patient preference
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715467
Show 27 Study Locations
|Study Director:||James Tursi, MD||Auxilium Pharmaceuticals, Inc|