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

June 12, 2015 updated by: Endo Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community based sample

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Investigators

  • Study Director: Urdaneta Veronica, MD, Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (ESTIMATE)

October 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUX-CC-901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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