Dupuytren's Contracture Clinical Trial
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01674634 -
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|
Phase 3 | |
| Completed |
NCT01407068 -
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|
Phase 3 | |
| Completed |
NCT00528931 -
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
|
Phase 1 | |
| Completed |
NCT00565019 -
Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
|
Phase 3 | |
| Completed |
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Collagenase Option for Reduction of Dupuytren's Contracture in Japan
|
Phase 3 | |
| Completed |
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Health-Related Quality of Life in Patients With Dupuytren's Disease
|
Phase 1 | |
| Completed |
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Post Approval Commitment Study
|
N/A | |
| Terminated |
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|
||
| Completed |
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|
Phase 3 | |
| Completed |
NCT01265420 -
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
|
Phase 4 | |
| Completed |
NCT00528606 -
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
|
Phase 3 | |
| Completed |
NCT00931567 -
Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing
|
Phase 2/Phase 3 | |
| Completed |
NCT00004409 -
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
|
Phase 2 | |
| Completed |
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|
Phase 3 |