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
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2035
mi
from 91732
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...
2203
mi
from 91732
Durham, NC
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1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
1164
mi
from 91732
Oklahoma City, OK
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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...
2303
mi
from 91732
Weston, FL
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Baltimore, Maryland 21204
2300
mi
from 91732
Baltimore, MD
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Brooklyn, New York 11219
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Brooklyn, NY
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Burbank, California 91505
?
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Burbank, CA
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Charlottesville, Virginia 22911
2208
mi
from 91732
Charlottesville, VA
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Chattanooga, Tennessee 37403
1853
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
2295
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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
2431
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Eatontown, NJ
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Encinitas, California 92024
82
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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
369
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Greenbrae, CA
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Greenville, South Carolina 29615
2023
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Greenville, SC
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Indianapolis, Indiana 46260
1792
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Indianapolis, IN
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La Jolla, California 92037
95
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La Jolla, CA
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Lady Lake, Florida 32159
2144
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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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Lexington, KY
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Louisville, Kentucky 40202
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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
1597
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Memphis, TN
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Murrieta, California 92563
58
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Murrieta, CA
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Nashville, Tennessee 37232
1763
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Nashville, TN
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Nashville, Tennessee 37232
1763
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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
2434
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New York, NY
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New York, New York 10003
2432
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New York, NY
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Norfolk, Nebraska 68701
1244
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Norfolk, NE
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Rockford, Illinois 61107
1663
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Rockford, IL
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Setauket, New York 11733
2479
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Setauket, NY
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Sioux Falls, South Dakota 57103
1313
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Sioux Falls, SD
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Somerset, Kentucky 42503
1879
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Somerset, KY
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Staten Island, New York 10304
2429
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Staten Island, NY
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Wichita, Kansas 67208
1181
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Wichita, KS
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Winston Salem, North Carolina 27157
2125
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Winston Salem, NC
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