<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/NCT03304119</url>
  </required_header>
  <id_info>
    <org_study_id>RGDS TTA study</org_study_id>
    <nct_id>NCT03304119</nct_id>
  </id_info>
  <brief_title>Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?</brief_title>
  <official_title>Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ramsay Générale de Santé</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dr Vincent Chassaing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Clinical Trial Experts Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ramsay Générale de Santé</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often&#xD;
      seen in young subjects, especially among adolescents. It is commonly accompanied by&#xD;
      anatomical factors. A new factor not described in bibliographic sources and characterized by&#xD;
      an external torsion of the tibial tuberosity is frequently found in patients with patellar&#xD;
      instability thanks to MRIs. This does not seem to be the case when there is no patellar&#xD;
      pathology. A statistical study is needed to assess this rotary anomaly. Validate the&#xD;
      predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent&#xD;
      patellar dislocation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often&#xD;
      seen in young subjects, especially among adolescents. It is commonly accompanied by&#xD;
      anatomical factors known to be driving: Dysplasia of the trochlea, patella alta,&#xD;
      lateralisation of the tibial tuberosity, patellar torsion and misalignment, tearing of the&#xD;
      Medial Patello Femoral Ligament... The assessment of these factors is essential to evaluate&#xD;
      the instability and guide the procedures of the surgical treatment. MRIs have become an&#xD;
      important test for the analysis and measurement of these factors. A new factor not described&#xD;
      in bibliographic sources and characterized by an external torsion of the tibial tuberosity is&#xD;
      frequently found in patients with patellar instability thanks to MRIs. This does not seem to&#xD;
      be the case when there is no patellar pathology. A statistical study is needed to assess this&#xD;
      rotary anomaly. It will be necessary to take it into account in the future regarding&#xD;
      indications and techniques for tibial tuberosity osteotomies, often used to correct patellar&#xD;
      instability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</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>Existence of Tibial Tuberosity Torsion.</measure>
    <time_frame>4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.</time_frame>
    <description>This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of Patellar Tilt</measure>
    <time_frame>4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre</time_frame>
    <description>Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance TT-TG Tibial Tuberosity and Trochlear Groove</measure>
    <time_frame>4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.</time_frame>
    <description>distance between Tibial Tuberosity and Trochlear Groove</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Patellar Instability</condition>
  <condition>Patellar Dislocation</condition>
  <arm_group>
    <arm_group_label>Patellar instability group</arm_group_label>
    <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group control</arm_group_label>
    <description>Group that has not been checked for patellar instability.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        group of patients with patellar instability stemming from a recurrent patellar&#xD;
        dislocationand a control group that has not been checked for patellar instability.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women&#xD;
&#xD;
          -  Subjects who have not expressed opposition to the use of the data for research&#xD;
             purposes&#xD;
&#xD;
        Clinical criteria:&#xD;
&#xD;
          -  Unstable group:&#xD;
&#xD;
               -  Medical history with 2 patellar dislocations or more,&#xD;
&#xD;
               -  with or without requiring surgical treatment after an MRI Control group: Men or&#xD;
                  women over 18 years old&#xD;
&#xD;
               -  Subjects who have not expressed opposition to the use of the data for research&#xD;
                  purposes&#xD;
&#xD;
          -  Control group:&#xD;
&#xD;
               -  Patients showing meniscal injury on MRI who may or may not have been treated&#xD;
                  (meniscectomy or stitches)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable group:&#xD;
&#xD;
               -  MRI performed on one knee operated for patellar instability&#xD;
&#xD;
               -  Associated tearing of the ligament (ACL, PCL)&#xD;
&#xD;
          -  Control group:&#xD;
&#xD;
               -  Patients with a medical history of patellar pathology&#xD;
&#xD;
               -  Patients with associated ligament injury (ACL, PCL)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ECTEN</name>
      <address>
        <city>Paris</city>
        <state>IDF</state>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Skelley N, Friedman M, McGinnis M, Smith C, Hillen T, Matava M. Inter- and intraobserver reliability in the MRI measurement of the tibial tubercle-trochlear groove distance and trochlea dysplasia. Am J Sports Med. 2015 Apr;43(4):873-8. doi: 10.1177/0363546514565768. Epub 2015 Jan 28.</citation>
    <PMID>25632054</PMID>
  </reference>
  <reference>
    <citation>The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors</citation>
  </reference>
  <reference>
    <citation>Diederichs G, Issever AS, Scheffler S. MR imaging of patellar instability: injury patterns and assessment of risk factors. Radiographics. 2010 Jul-Aug;30(4):961-81. doi: 10.1148/rg.304095755. Erratum In: Radiographics. 2011 Mar-Apr;31(2):624.</citation>
    <PMID>20631363</PMID>
  </reference>
  <reference>
    <citation>Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German.</citation>
    <PMID>18682913</PMID>
  </reference>
  <reference>
    <citation>Pache T, Meystre JL, Delgado-Martins H, Schnyder P. [Transplantation of the anterior tibial tubercle by the Elmslie-Trillat technic. Indications as a function of morphotype]. Rev Chir Orthop Reparatrice Appar Mot. 1985;71(6):359-64. French.</citation>
    <PMID>4081137</PMID>
  </reference>
  <reference>
    <citation>Rhee SJ, Pavlou G, Oakley J, Barlow D, Haddad F. Modern management of patellar instability. Int Orthop. 2012 Dec;36(12):2447-56. doi: 10.1007/s00264-012-1669-4. Epub 2012 Oct 7.</citation>
    <PMID>23052278</PMID>
  </reference>
  <reference>
    <citation>Guilbert S, Chassaing V, Radier C, Hulet C, Remy F, Chouteau J, Chotel F, Boisrenoult P, Sebilo A, Ferrua P, Ehkirch FP, Bertin D, Dejour D; French Arthroscopy Society (SFA). Axial MRI index of patellar engagement: a new method to assess patellar instability. Orthop Traumatol Surg Res. 2013 Dec;99(8 Suppl):S399-405. doi: 10.1016/j.otsr.2013.10.006. Epub 2013 Nov 20.</citation>
    <PMID>24268843</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>February 26, 2018</results_first_submitted>
  <results_first_submitted_qc>November 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2019</results_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Torsion of tibial tuberosity</keyword>
  <keyword>Recurrent patellar dislocation</keyword>
  <keyword>MRI Measurements</keyword>
  <keyword>Patellar instability</keyword>
  <keyword>Patellar dislocation</keyword>
  <keyword>Tibial tubercle position</keyword>
  <keyword>Tibial tubercle torsion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Patellar Dislocation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patellar Instability Group</title>
          <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
        </group>
        <group group_id="P2">
          <title>Control Group Control</title>
          <description>Group that has not been checked for patellar instability.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patellar Instability Group</title>
          <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
        </group>
        <group group_id="B2">
          <title>Control Group Control</title>
          <description>Group that has not been checked for patellar instability.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="55"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>mean</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="55"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.6" spread="10.7"/>
                    <measurement group_id="B2" value="46" spread="14"/>
                    <measurement group_id="B3" value="39" spread="15.4"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="55"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="55"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Existence of Tibial Tuberosity Torsion.</title>
        <description>This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM</description>
        <time_frame>4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.</time_frame>
        <population>Analysis based on the IRM available</population>
        <group_list>
          <group group_id="O1">
            <title>Patellar Instability Group</title>
            <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
          </group>
          <group group_id="O2">
            <title>Control Group Control</title>
            <description>Group that has not been checked for patellar instability.</description>
          </group>
        </group_list>
        <measure>
          <title>Existence of Tibial Tuberosity Torsion.</title>
          <description>This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM</description>
          <population>Analysis based on the IRM available</population>
          <units>degre</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="13.0" upper_limit="23.9"/>
                    <measurement group_id="O2" value="5.3" lower_limit="3.4" upper_limit="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Patellar Tilt</title>
        <description>Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.</description>
        <time_frame>4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre</time_frame>
        <population>Patients with IRM available.</population>
        <group_list>
          <group group_id="O1">
            <title>Patellar Instability Group</title>
            <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
          </group>
          <group group_id="O2">
            <title>Control Group Control</title>
            <description>Group that has not been checked for patellar instability.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Patellar Tilt</title>
          <description>Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.</description>
          <population>Patients with IRM available.</population>
          <units>degre</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" lower_limit="13.8" upper_limit="27.6"/>
                    <measurement group_id="O2" value="5.3" lower_limit="2.5" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distance TT-TG Tibial Tuberosity and Trochlear Groove</title>
        <description>distance between Tibial Tuberosity and Trochlear Groove</description>
        <time_frame>4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patellar Instability Group</title>
            <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
          </group>
          <group group_id="O2">
            <title>Control Group Control</title>
            <description>Group that has not been checked for patellar instability.</description>
          </group>
        </group_list>
        <measure>
          <title>Distance TT-TG Tibial Tuberosity and Trochlear Groove</title>
          <description>distance between Tibial Tuberosity and Trochlear Groove</description>
          <units>milimeters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="12.2" upper_limit="20.1"/>
                    <measurement group_id="O2" value="8.4" lower_limit="6.7" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not Applicable. Study consist in IRM reading. NO adverse events has been collected. Not applicable, retrospective study based on available IRM</time_frame>
      <desc>Not Applicable. Study consist in IRM reading. NO adverse events has been collected. Not applicable, retrospective study based on available IRM</desc>
      <group_list>
        <group group_id="E1">
          <title>Patellar Instability Group</title>
          <description>Group of patients with patellar instability stemming from a recurrent patellar dislocation</description>
        </group>
        <group group_id="E2">
          <title>Control Group Control</title>
          <description>Group that has not been checked for patellar instability.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>V Chassaing</name_or_title>
      <organization>Hôpital Privé Antony</organization>
      <phone>+33 1 46 74 37 00</phone>
      <email>vchassaing92@gmail.com</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/NCT03304119
org study id: RGDS TTA study
nct id: NCT03304119
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often
      seen in young subjects, especially among adolescents. It is commonly accompanied by
      anatomical factors. A new factor not described in bibliographic sources and characterized by
      an external torsion of the tibial tuberosity is frequently found in patients with patellar
      instability thanks to MRIs. This does not seem to be the case when there is no patellar
      pathology. A statistical study is needed to assess this rotary anomaly. Validate the
      predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent
      patellar dislocation.
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often
      seen in young subjects, especially among adolescents. It is commonly accompanied by
      anatomical factors known to be driving: Dysplasia of the trochlea, patella alta,
      lateralisation of the tibial tuberosity, patellar torsion and misalignment, tearing of the
      Medial Patello Femoral Ligament... The assessment of these factors is essential to evaluate
      the instability and guide the procedures of the surgical treatment. MRIs have become an
      important test for the analysis and measurement of these factors. A new factor not described
      in bibliographic sources and characterized by an external torsion of the tibial tuberosity is
      frequently found in patients with patellar instability thanks to MRIs. This does not seem to
      be the case when there is no patellar pathology. A statistical study is needed to assess this
      rotary anomaly. It will be necessary to take it into account in the future regarding
      indications and techniques for tibial tuberosity osteotomies, often used to correct patellar
      instability.
observational model: Cohort
time perspective: Prospective
measure: Existence of Tibial Tuberosity Torsion.
time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
description: This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM
measure: Measure of Patellar Tilt
time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre
description: Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.
measure: Distance TT-TG Tibial Tuberosity and Trochlear Groove
time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
description: distance between Tibial Tuberosity and Trochlear Groove
arm group label: Patellar instability group
description: Group of patients with patellar instability stemming from a recurrent patellar dislocation
arm group label: Control group control
description: Group that has not been checked for patellar instability.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
citation: Skelley N, Friedman M, McGinnis M, Smith C, Hillen T, Matava M. Inter- and intraobserver reliability in the MRI measurement of the tibial tubercle-trochlear groove distance and trochlea dysplasia. Am J Sports Med. 2015 Apr;43(4):873-8. doi: 10.1177/0363546514565768. Epub 2015 Jan 28.
PMID: 25632054
citation: The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors
citation: Diederichs G, Issever AS, Scheffler S. MR imaging of patellar instability: injury patterns and assessment of risk factors. Radiographics. 2010 Jul-Aug;30(4):961-81. doi: 10.1148/rg.304095755. Erratum In: Radiographics. 2011 Mar-Apr;31(2):624.
PMID: 20631363
citation: Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German.
PMID: 18682913
citation: Pache T, Meystre JL, Delgado-Martins H, Schnyder P. [Transplantation of the anterior tibial tubercle by the Elmslie-Trillat technic. Indications as a function of morphotype]. Rev Chir Orthop Reparatrice Appar Mot. 1985;71(6):359-64. French.
PMID: 4081137
citation: Rhee SJ, Pavlou G, Oakley J, Barlow D, Haddad F. Modern management of patellar instability. Int Orthop. 2012 Dec;36(12):2447-56. doi: 10.1007/s00264-012-1669-4. Epub 2012 Oct 7.
PMID: 23052278
citation: Guilbert S, Chassaing V, Radier C, Hulet C, Remy F, Chouteau J, Chotel F, Boisrenoult P, Sebilo A, Ferrua P, Ehkirch FP, Bertin D, Dejour D; French Arthroscopy Society (SFA). Axial MRI index of patellar engagement: a new method to assess patellar instability. Orthop Traumatol Surg Res. 2013 Dec;99(8 Suppl):S399-405. doi: 10.1016/j.otsr.2013.10.006. Epub 2013 Nov 20.
PMID: 24268843
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Patellar Dislocation
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 