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
1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
851
mi
from 43215
Oklahoma City, OK
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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...
129
mi
from 43215
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...
352
mi
from 43215
Durham, NC
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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...
971
mi
from 43215
Weston, FL
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Baltimore, Maryland 21204
341
mi
from 43215
Baltimore, MD
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Brooklyn, New York 11219
?
mi
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Brooklyn, NY
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Burbank, California 91505
?
mi
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Burbank, CA
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Charlottesville, Virginia 22911
278
mi
from 43215
Charlottesville, VA
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Chattanooga, Tennessee 37403
362
mi
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Chattanooga, TN
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Coral Gables, Florida 33146
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Coral Gables, FL
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Danville, Pennsylvania 17821
343
mi
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Danville, PA
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Denver, Colorado 80210
?
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Denver, CO
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Eatontown, New Jersey 07724
473
mi
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Eatontown, NJ
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Encinitas, California 92024
1949
mi
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Encinitas, CA
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Englewood, New Jersey 07631
?
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Englewood, NJ
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Greenbrae, California 94904
2111
mi
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Greenbrae, CA
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Greenville, South Carolina 29615
354
mi
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Greenville, SC
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Indianapolis, Indiana 46260
167
mi
from 43215
Indianapolis, IN
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La Jolla, California 92037
1953
mi
from 43215
La Jolla, CA
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Lady Lake, Florida 32159
765
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Lady Lake, FL
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Las Vegas, Nevada 89147
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Las Vegas, NV
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154
mi
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Lexington, KY
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Louisville, Kentucky 40202
187
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Louisville, KY
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Macon, Georgia 31201
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Macon, GA
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Memphis, Tennessee 38120
502
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Memphis, TN
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Murrieta, California 92563
1930
mi
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Murrieta, CA
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Nashville, Tennessee 37232
332
mi
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Nashville, TN
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Nashville, Tennessee 37232
332
mi
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Nashville, TN
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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
480
mi
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New York, NY
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New York, New York 10003
477
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New York, NY
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Norfolk, Nebraska 68701
762
mi
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Norfolk, NE
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Rockford, Illinois 61107
351
mi
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Rockford, IL
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Setauket, New York 11733
525
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Setauket, NY
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Sioux Falls, South Dakota 57103
747
mi
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Sioux Falls, SD
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Somerset, Kentucky 42503
217
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Somerset, KY
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Staten Island, New York 10304
472
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Staten Island, NY
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Wichita, Kansas 67208
785
mi
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Wichita, KS
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Winston Salem, North Carolina 27157
306
mi
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Winston Salem, NC
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