Trial record 1 of 2 for:    correct dupuytren
Previous Study | Return to List | Next Study

CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

This study is currently recruiting participants.
Verified July 2013 by Auxilium Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01715467
First received: October 25, 2012
Last updated: October 30, 2013
Last verified: July 2013
  Purpose

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
Dupuytren's Contracture

Study Type: Observational
Study Design: 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.

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

    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


Estimated Enrollment: 420
Study Start Date: September 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community based sample

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715467

  Hide Study Locations
Locations
United States, California
Raven Orthopaedics, Inc. Recruiting
Burbank, California, United States, 91505
Contact: Raymond Raven, MD    818-841-3936    rbraven@mac.com   
Principal Investigator: Raymond Raven, MD         
Core Orthopaedic Medical Center Recruiting
Encinitas, California, United States, 92024
Contact: Farouk Awad    760-943-6710 ext 162    fawad@coreorthopaedic.com   
Principal Investigator: Robert Gelb, MD         
David Nelson, MD Recruiting
Greenbrae, California, United States, 94904
Contact: David Nelson, MD    415-925-0501    nelsondl@pacbell.net   
Principal Investigator: David Nelson, MD         
Torrey Pines Orthopaedic Medical Group Recruiting
La Jolla, California, United States, 92037
Contact: Germaine Luyckx    858-334-3359    germaine@luyckx.com   
Principal Investigator: Richard Brown, MD         
Brigid Freyne, MD, Inc. Recruiting
Murrieta, California, United States, 92563
Contact: Brigid Freyne, MD    951-696-4601    brigidfreyne@gmail.com   
Principal Investigator: Brigid Freyne, MD         
United States, Colorado
Hand Surgery Associates Recruiting
Denver, Colorado, United States, 80210
Contact: Eric Britton, MD    303-777-4563    enbritton@mac.com   
Principal Investigator: Eric Britton, MD         
United States, Florida
Physicians for the Hand Recruiting
Coral Gables, Florida, United States, 33146
Contact: Anna-Lena Makowski    518-834-9365    amakowski@thehandplace.com   
Principal Investigator: Anne E Ouellette, MD         
Florida Medical Research Institute Recruiting
Lady Lake, Florida, United States, 32159
Contact: Dena Sancherico    352-251-0981    hands@simedpl.com   
Principal Investigator: Cynthia Harding, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Gregory Davis    954-659-6204    Davisg3@ccf.org   
Principal Investigator: David Friedman, MD         
United States, Georgia
OrthoGeorgia Recruiting
Macon, Georgia, United States, 31201
Contact: Guy Foulkes, MD    478-745-4206      
Principal Investigator: Guy Foulkes, MD         
United States, Illinois
Rockford Orthopedic Associates, LTD Recruiting
Rockford, Illinois, United States, 61107
Contact: Sharon Ruggles    815-381-7456    sharonr@rockfordortho.com   
Principal Investigator: Brian Bear, MD         
United States, Indiana
Indiana Hand to Shoulder Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Suzanne Cornelius    317-471-4317    scornelius@ihtsc.com   
Principal Investigator: F. Thomas Kaplan, MD         
United States, Kansas
The Hand Center Recruiting
Wichita, Kansas, United States, 67208
Contact: Mark Melhorn, MD    316-688-5656    melhorn@onemain.com   
Principal Investigator: Mark Melhorn, MD         
United States, Kentucky
Bluegrass Orthopaedics and Hand Care Research Recruiting
Lexington, Kentucky, United States, 40509
Contact: Elaine Wilhite    859-263-5140    wloneil@insightbb.com   
Principal Investigator: William O'Neill, MD         
Christine M Kleinert Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina Kaufman    502-562-0390    ckaufman@cmki.org   
Principal Investigator: Joseph Kutz, MD         
Lake Cumberland Rheumatology Recruiting
Somerset, Kentucky, United States, 42503
Contact: Amber Burton    606-802-2300    amberburton87@yahoo.com   
Principal Investigator: Scott Lewis, MD         
United States, Maryland
Towson Orthopaedic Associates Recruiting
Baltimore, Maryland, United States, 21204
Contact: Bruce Wolock, MD    410-746-4908    bswolock@gmail.com   
Principal Investigator: Bruce Wolock, MD         
United States, Nebraska
Faith Regional Health Services Recruiting
Norfolk, Nebraska, United States, 68701
Contact: Tristan Hartzell, MD    402-844-8241    thartzell@frhs.org   
Principal Investigator: Tristan Hartzell, MD         
United States, Nevada
The Minimally Invasive Hand Institute Recruiting
Las Vegas, Nevada, United States, 89147
Contact: Jonathan Sorrelle, MD    702-739-4263    drsorelle@tmihi.com   
Principal Investigator: Jonathan Sorrelle, MD         
United States, New Jersey
Central Jersey Hand Surgery Recruiting
Eatontown, New Jersey, United States, 07724
Contact: Gary Pess, MD    732-542-4477    handman613@gmail.com   
Principal Investigator: Gary Pess, MD         
Englewood Orthopedic Associates Recruiting
Englewood, New Jersey, United States, 07631
Contact: Damien Davis, MD    201-569-2770    davisd1@hotmail.com   
Principal Investigator: Damien Davis, MD         
United States, New York
Comprehensive Hand Surgery PC Recruiting
Brooklyn, New York, United States, 11219
Contact: Mukund Patel, MD    718-435-4944    mukund.patel@me.com   
Principal Investigator: Mukund Patel, MD         
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Quyhn Tran    212-774-2981    TranQ@HSS.edu   
Principal Investigator: Robert Hotchkiss, MD         
Beth Isreal Medical Center Recruiting
New York, New York, United States, 10003
Contact: Eitan Melamed    347-933-3407    emelamed@chpnet.org   
Principal Investigator: Steven Beldner, MD         
Stony Brook Orthopaedic Center, PLC Recruiting
Setauket, New York, United States, 11733
Contact: Marie Badalamente    631-444-1489    marie.badalamente@stonybrookmedicine.edu   
Principal Investigator: Lawrence Hurst, MD         
Healthcare Associates in Medicine, PC Recruiting
Staten Island, New York, United States, 10304
Contact: Sheri Neufold    718-667-7500 ext 368    s.neufeld@hca-si.com   
Principal Investigator: Vincent Ruggiero, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27708
Contact: Jennifer Friend    919-668-4373    jennifer.friend@duke.edu   
Principal Investigator: Fraser Leversedge, MD         
Wake Forest University Health Sciences Recruiting
Winston Salem, North Carolina, United States, 27106
Contact: Deanne Sizemore    336-716-7104    dsizemore@wakehealth.edu   
Principal Investigator: Zhongyu John Li, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Debora Bork    216-445-8533    borkd@ccf.org   
Principal Investigator: Peter Evans, MD         
United States, Oklahoma
Health Research Institute Recruiting
Oklahoma City, Oklahoma, United States, 73109
Contact: Julie White    405-616-4888    jwhite@ortho-ok.com   
Principal Investigator: Joel Frazier, MD         
United States, Pennsylvania
Geisinger Woodbine Outpatient Clinic Recruiting
Danville, Pennsylvania, United States, 17821
Contact: Teresa Swenson    570-214-6178    tkswenson@geisinger.edu   
Principal Investigator: Joel Klena, MD         
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Carlisle Shealy    864-454-7458    Carlisle.shealy@hawkinsfoundation.com   
Principal Investigator: Nick Pappas, MD         
United States, South Dakota
Core Orthopedics Recruiting
Sioux Falls, South Dakota, United States, 57103
Contact: Beth Kruse    605-553-0754    bethkruse@coreorthopedicsavera.org   
Principal Investigator: Scott McPherson, MD         
United States, Tennessee
The Plastic Surgery Group Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Annie Harpe    423-598-8802    harpea@thepsg.org   
Principal Investigator: David Jemison, MD         
OrthoMemphis Recruiting
Memphis, Tennessee, United States, 38120
Contact: Melinda Cohea    901-259-1636    mcohea@orthomemphic.com   
Principal Investigator: William Bourland, MD         
Vanderbilt Orthopaedic Institute Recruiting
Nashville, Tennessee, United States, 37232
Contact: Marcia Spear    615-343-8426    marcia.spear@vanderbilt.edu   
Principal Investigator: Wesley Thayer, MD         
Vanderbilt Orthopaedic Institute Recruiting
Nashville, Tennessee, United States, 37240
Contact: Julie Daniels    615-322-4506    Julie.M.Daniels@Vanderbilt.edu   
Principal Investigator: Douglas Weikert, MD         
United States, Virginia
Charlottesville Orthopaedic Center, PLC Recruiting
Charlottesville, Virginia, United States, 22911
Contact: David Nielsen, DO    434-244-8414    dave@cvilleortho.com   
Principal Investigator: David Nielsen, DO         
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: James Tursi, MD Auxilium Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01715467     History of Changes
Other Study ID Numbers: AUX-CC-901
Study First Received: October 25, 2012
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Auxilium Pharmaceuticals:
Dupuytren
Contracture
Auxilium
XIAFLEX

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 17, 2014