<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <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/NCT01673347</url>
  </required_header>
  <id_info>
    <org_study_id>2010-182</org_study_id>
    <secondary_id>ISO 13485</secondary_id>
    <nct_id>NCT01673347</nct_id>
  </id_info>
  <brief_title>Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe</brief_title>
  <acronym>MTP</acronym>
  <official_title>Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paul Fortin, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Musculoskeletal Transplant Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using the concept of an implant acting as a spacer and stabilizer, the proposed study will&#xD;
      evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of&#xD;
      the great toe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A variety of surgical procedures have been developed for the treatment of MTP joint&#xD;
      osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and&#xD;
      stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the&#xD;
      treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain&#xD;
      and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years&#xD;
      postoperatively or until allograft failure. Stability of the allograft will be evaluated by&#xD;
      the surgeon at these time points per radiographic imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2010</start_date>
  <completion_date type="Actual">March 10, 2017</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Allograft Stability</measure>
    <time_frame>5-years postoperative</time_frame>
    <description>Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>3-months postoperative</time_frame>
    <description>Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion Plantarflexion</measure>
    <time_frame>3-months postoperative</time_frame>
    <description>Range of Motion Plantarflexion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion Dorsiflexion</measure>
    <time_frame>3-months postoperative</time_frame>
    <description>Range of Motion Dorsiflexion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>MENISCAL ALLOGRAFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meniscal Allograft</intervention_name>
    <description>Meniscal allograft</description>
    <arm_group_label>MENISCAL ALLOGRAFT</arm_group_label>
    <other_name>Musculoskeletal Transplant Foundation</other_name>
    <other_name>Meniscal transplant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptomatic of stage 3 osteoarthritis of the great toe&#xD;
&#xD;
          -  symptoms recalcitrant to nonoperative management as determined clinically by the&#xD;
             principal investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  kidney insufficiency&#xD;
&#xD;
          -  oa in the adjacent joints&#xD;
&#xD;
          -  malignancy with in the past 10 yrs&#xD;
&#xD;
          -  minors (&lt; 18 yrs of age)&#xD;
&#xD;
          -  pregnant women and fetus&#xD;
&#xD;
          -  mentally disabled or cognitively impaired individuals&#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>PAUL FORTIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>WILLIAM BEAUMONT HOSPITAL ROYAL OAK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://beaumonthospitals.com</url>
    <description>Beaumont Hospital</description>
  </link>
  <reference>
    <citation>COLE BJ, CARTER TR, RODEO SA,</citation>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>April 19, 2017</results_first_submitted>
  <results_first_submitted_qc>April 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 23, 2017</results_first_posted>
  <last_update_submitted>April 19, 2017</last_update_submitted>
  <last_update_submitted_qc>April 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Paul Fortin, MD</investigator_full_name>
    <investigator_title>Orthopedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>allograft</keyword>
  <keyword>great toe</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MENISCAL ALLOGRAFT</title>
          <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.&#xD;
Meniscal Allograft: Meniscal allograft</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>failure of allograft</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MENISCAL ALLOGRAFT</title>
          <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.&#xD;
Meniscal Allograft: Meniscal allograft</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" spread="7.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.27" spread="4.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Allograft Stability</title>
        <description>Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.</description>
        <time_frame>5-years postoperative</time_frame>
        <population>Study terminated prior to 5-year endpoint, no participants evaluated</population>
        <group_list>
          <group group_id="O1">
            <title>MENISCAL ALLOGRAFT</title>
            <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.</description>
          </group>
        </group_list>
        <measure>
          <title>Allograft Stability</title>
          <description>Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.</description>
          <population>Study terminated prior to 5-year endpoint, no participants evaluated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain</title>
        <description>Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain</description>
        <time_frame>3-months postoperative</time_frame>
        <population>17 participants available to analyze at 3 months due to early allograft failure in 7 participants</population>
        <group_list>
          <group group_id="O1">
            <title>MENISCAL ALLOGRAFT</title>
            <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain</title>
          <description>Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain</description>
          <population>17 participants available to analyze at 3 months due to early allograft failure in 7 participants</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.65" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Range of Motion Plantarflexion</title>
        <description>Range of Motion Plantarflexion</description>
        <time_frame>3-months postoperative</time_frame>
        <population>17 participants available to analyze at 3 months due to early allograft failure in 7 participants</population>
        <group_list>
          <group group_id="O1">
            <title>MENISCAL ALLOGRAFT</title>
            <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.</description>
          </group>
        </group_list>
        <measure>
          <title>Range of Motion Plantarflexion</title>
          <description>Range of Motion Plantarflexion</description>
          <population>17 participants available to analyze at 3 months due to early allograft failure in 7 participants</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="8.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Range of Motion Dorsiflexion</title>
        <description>Range of Motion Dorsiflexion</description>
        <time_frame>3-months postoperative</time_frame>
        <population>17 participants available to analyze at 3 months due to early allograft failure in 7 participants</population>
        <group_list>
          <group group_id="O1">
            <title>MENISCAL ALLOGRAFT</title>
            <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.</description>
          </group>
        </group_list>
        <measure>
          <title>Range of Motion Dorsiflexion</title>
          <description>Range of Motion Dorsiflexion</description>
          <population>17 participants available to analyze at 3 months due to early allograft failure in 7 participants</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="15.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years postoperative</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MENISCAL ALLOGRAFT</title>
          <description>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.&#xD;
Meniscal Allograft: Meniscal allograft</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Allograft failure</sub_title>
                <description>dissolution of allograft and obliteration of the MTP joint space</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Allograft failure (dissolution) and obliteration of the MTP joint space found in 29% of subjects within 2 years of follow-up; therefore study was discontinued. No data collected for later time points.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Erin Baker, PhD</name_or_title>
      <organization>William Beaumont Hospital</organization>
      <phone>248-551-1816</phone>
      <email>erin.baker@beaumont.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01673347
org study id: 2010-182
secondary id: ISO 13485
nct id: NCT01673347
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Using the concept of an implant acting as a spacer and stabilizer, the proposed study will
      evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of
      the great toe.
A variety of surgical procedures have been developed for the treatment of MTP joint
      osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and
      stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the
      treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain
      and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years
      postoperatively or until allograft failure. Stability of the allograft will be evaluated by
      the surgeon at these time points per radiographic imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Allograft Stability
time frame: 5-years postoperative
description: Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.
measure: Pain
time frame: 3-months postoperative
description: Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
measure: Range of Motion Plantarflexion
time frame: 3-months postoperative
description: Range of Motion Plantarflexion
measure: Range of Motion Dorsiflexion
time frame: 3-months postoperative
description: Range of Motion Dorsiflexion
arm group label: MENISCAL ALLOGRAFT
arm group type: Experimental
description: The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
intervention type: Biological
intervention name: Meniscal Allograft
description: Meniscal allograft
arm group label: MENISCAL ALLOGRAFT
other name: Musculoskeletal Transplant Foundation
other name: Meniscal transplant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: PAUL FORTIN, MD
role: Principal Investigator
affiliation: WILLIAM BEAUMONT HOSPITAL ROYAL OAK
facility: 
country: United States
url: http://beaumonthospitals.com
description: Beaumont Hospital
citation: COLE BJ, CARTER TR, RODEO SA,
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Paul Fortin, MD
investigator title: Orthopedic Surgeon
mesh term: Osteoarthritis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Allograft failure (dissolution) and obliteration of the MTP joint space found in 29% of subjects within 2 years of follow-up; therefore study was discontinued. No data collected for later time points.
point of contact: 