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

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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.

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
Baltimore, Maryland 21204
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Brooklyn, New York 11219
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Burbank, California 91505
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Charlottesville, Virginia 22911
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Chattanooga, Tennessee 37403
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Coral Gables, Florida 33146
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Danville, Pennsylvania 17821
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Denver, Colorado 80210
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Eatontown, New Jersey 07724
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Encinitas, California 92024
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Englewood, New Jersey 07631
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Greenbrae, California 94904
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Greenville, South Carolina 29615
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Indianapolis, Indiana 46260
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La Jolla, California 92037
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Lady Lake, Florida 32159
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Las Vegas, Nevada 89147
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Louisville, Kentucky 40202
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Macon, Georgia 31201
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Memphis, Tennessee 38120
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Murrieta, California 92563
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Nashville, Tennessee 37232
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Nashville, Tennessee 37232
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, New York 10003
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Norfolk, Nebraska 68701
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Rockford, Illinois 61107
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Setauket, New York 11733
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Sioux Falls, South Dakota 57103
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Somerset, Kentucky 42503
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Staten Island, New York 10304
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Wichita, Kansas 67208
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Winston Salem, North Carolina 27157
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