<clinical_study>
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01715467</url>
  </required_header>
  <id_info>
    <org_study_id>AUX-CC-901</org_study_id>
    <nct_id>NCT01715467</nct_id>
  </id_info>
  <brief_title>CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment</brief_title>
  <acronym>CORRECT</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endo Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endo Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study will prospectively collect data on treatment options,&#xD;
      patient/investigator satisfaction, requirement for retreatment or additional treatment, and&#xD;
      long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle&#xD;
      aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide&#xD;
      additional health economics and utilization data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, observational study. Patients will be recruited based on&#xD;
      the usual care presentation at each investigative site, as regular practice would dictate.&#xD;
      Consecutive patients deemed eligible for the study by their physician will be invited to&#xD;
      participate during their usual care visit. Enrolled patients will receive evaluations and&#xD;
      treatment for Dupuytren's contracture according to the standard of care and clinical practice&#xD;
      at each study site. No study-specific visits will be required as part of the study. Treatment&#xD;
      and Follow-up Visits will be determined by the treating physician. Treatments received for&#xD;
      Dupuytren's contracture will be recorded (ie, XIAFLEX, fasciectomy, or fasciotomy/needle&#xD;
      aponeurotomy), including initial treatment and any subsequent therapy. The full prescribing&#xD;
      information and medication guide for XIAFLEX is provided in this protocol as reference&#xD;
      (Appendix B). Patient data (including treatment outcomes, joint contracture measured by the&#xD;
      treating physician, and evidence of recurrence) and health care resource utilization data&#xD;
      will be drawn from the patients' medical records, examination, and patient interviews. These&#xD;
      data will be recorded via a web-based electronic data collection (EDC) system.&#xD;
&#xD;
      PROs will be collected by self-completed questionnaires given to each patient via web-based&#xD;
      data collection or telephone interviews. The site will follow up with the patient according&#xD;
      to usual practice. Information from the patient's visit may include goniometry and the&#xD;
      physician's assessment of treatment outcome and healthcare utilization. Patients will be&#xD;
      considered enrolled in the study for a maximum of 4 years post-enrollment or until death,&#xD;
      withdrawal of consent, loss to follow-up, or study closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.</measure>
    <time_frame>4 years</time_frame>
    <description>The secondary objectives are as follows:&#xD;
Examine the safety trends of various treatment options in patients with Dupuytren's contracture&#xD;
Examine the effectiveness trends of various treatment options, specifically evaluating long term contracture recurrence&#xD;
Examine the association between various treatment regimens and healthcare resource utilization&#xD;
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</description>
  </secondary_outcome>
  <enrollment type="Actual">162</enrollment>
  <condition>Dupuytren's Contracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Community based sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women or men 18 years of age or older&#xD;
&#xD;
          -  Patients with a Dupuytren's contracture of at least a single joint and a desire for&#xD;
             correction&#xD;
&#xD;
          -  Patients who are able to read and understand English&#xD;
&#xD;
          -  Patients who are capable of understanding and cooperating with the requirements of the&#xD;
             study&#xD;
&#xD;
          -  Patients who are willing and able to respond to the posttreatment assessments via&#xD;
             telephone or internet&#xD;
&#xD;
          -  Patients must provide written informed consent, indicating that they understand the&#xD;
             purpose of and requirements of the study and are willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who decide not to pursue correction of the Dupuytren's contracture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urdaneta Veronica, MD</last_name>
    <role>Study Director</role>
    <affiliation>Endo Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Raven Orthopaedics, Inc.</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Orthopaedic Medical Center</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrey Pines Orthopaedic Medical Group</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigid Freyne, MD, Inc.</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hand Surgery Associates</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians for the Hand</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Medical Research Institute</name>
      <address>
        <city>Lady Lake</city>
        <state>Florida</state>
        <zip>32159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoGeorgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockford Orthopedic Associates, LTD</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Hand to Shoulder Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hand Center</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluegrass Orthopaedics and Hand Care Research</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faith Regional Health Services</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Minimally Invasive Hand Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Jersey Hand Surgery</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Hand Surgery PC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Isreal Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston Salem</city>
        <state>North Carolina</state>
        <zip>27106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steadman Hawkins Clinic of the Carolinas</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Orthopedics</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Plastic Surgery Group</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoMemphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Orthopaedic Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Orthopaedic Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Orthopaedic Center, PLC</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>June 12, 2015</last_update_submitted>
  <last_update_submitted_qc>June 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dupuytren</keyword>
  <keyword>Contracture</keyword>
  <keyword>Auxilium</keyword>
  <keyword>XIAFLEX</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dupuytren Contracture</mesh_term>
    <mesh_term>Contracture</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01715467
org study id: AUX-CC-901
nct id: NCT01715467
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: 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
measure: Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.
time frame: 4 years
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urdaneta Veronica, MD
role: Study Director
affiliation: Endo Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Dupuytren Contracture
mesh term: Contracture