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CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment (CORRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01715467
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
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.

Condition or disease
Dupuytren's Contracture

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : September 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The primary objective is to collect real-world data regarding patient reported outcomes of the 3 primary treatment modalities in patients with Dupuytren's contracture. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes. [ Time Frame: 4 years ]

    The secondary objectives are as follows:

    • Examine the safety trends of various treatment options in patients with Dupuytren's contracture
    • Examine the effectiveness trends of various treatment options, specifically evaluating long term contracture recurrence
    • Examine the association between various treatment regimens and healthcare resource utilization
    • Examine the association between various treatments and patient-reported outcomes (PROs) such as disease burden, ADLs, hand functionality, work performance, time to return to work, treatment satisfaction, and patient preference

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community based sample

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01715467

  Hide Study Locations
United States, California
Raven Orthopaedics, Inc.
Burbank, California, United States, 91505
Core Orthopaedic Medical Center
Encinitas, California, United States, 92024
Torrey Pines Orthopaedic Medical Group
La Jolla, California, United States, 92037
Brigid Freyne, MD, Inc.
Murrieta, California, United States, 92563
United States, Colorado
Hand Surgery Associates
Denver, Colorado, United States, 80210
United States, Florida
Physicians for the Hand
Coral Gables, Florida, United States, 33146
Florida Medical Research Institute
Lady Lake, Florida, United States, 32159
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Rockford Orthopedic Associates, LTD
Rockford, Illinois, United States, 61107
United States, Indiana
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
United States, Kansas
The Hand Center
Wichita, Kansas, United States, 67208
United States, Kentucky
Bluegrass Orthopaedics and Hand Care Research
Lexington, Kentucky, United States, 40509
United States, Nebraska
Faith Regional Health Services
Norfolk, Nebraska, United States, 68701
United States, Nevada
The Minimally Invasive Hand Institute
Las Vegas, Nevada, United States, 89147
United States, New Jersey
Central Jersey Hand Surgery
Eatontown, New Jersey, United States, 07724
United States, New York
Comprehensive Hand Surgery PC
Brooklyn, New York, United States, 11219
Beth Isreal Medical Center
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27106
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29605
United States, South Dakota
Core Orthopedics
Sioux Falls, South Dakota, United States, 57103
United States, Tennessee
The Plastic Surgery Group
Chattanooga, Tennessee, United States, 37403
Memphis, Tennessee, United States, 38120
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, United States, 37232
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, United States, 37240
United States, Virginia
Charlottesville Orthopaedic Center, PLC
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Endo Pharmaceuticals
Study Director: Urdaneta Veronica, MD Endo Pharmaceuticals

Responsible Party: Endo Pharmaceuticals Identifier: NCT01715467     History of Changes
Other Study ID Numbers: AUX-CC-901
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Endo Pharmaceuticals:

Additional relevant MeSH terms:
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Connective Tissue Diseases