CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | September 2012 |
End Date: | January 2018 |
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.
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.
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.
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.
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.
We found this trial at
38
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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