<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/NCT01693367</url>
  </required_header>
  <id_info>
    <org_study_id>DLS 5.0</org_study_id>
    <nct_id>NCT01693367</nct_id>
  </id_info>
  <brief_title>Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation</brief_title>
  <official_title>A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AO Innovation Translation Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AO Innovation Translation Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used&#xD;
      to stabilize the shaft component of distal femur fractures in comparison to standard locking&#xD;
      screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC&#xD;
      score) due to increased and more symmetrical callus formation and fewer non-unions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The medical device has been withdrawn from the market due to technical issues.&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario and McMaster Universities Index (WOMAC)</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>To assess pain, stiffness, and physical function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed Up-and-go Test (TUG)</measure>
    <time_frame>12 weeks ± 7 days, 6 months ± 30 days</time_frame>
    <description>The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command &quot;ready - go&quot; and stopped when the seated position is reached again.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (EuroQol-5D)</measure>
    <time_frame>Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery</time_frame>
    <description>Assessment of passive ROM of the knee (flexion - extension)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Full Weight-bearing Status</measure>
    <time_frame>weekly measurement at home</time_frame>
    <description>Assessment of the timepoint when the patient :&#xD;
can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds&#xD;
can walk without walking aid&#xD;
has no intake of analgesics&#xD;
has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC</measure>
    <time_frame>Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery</time_frame>
    <description>To assess pain, stiffness, and physical function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Distal Femur Fractures</condition>
  <arm_group>
    <arm_group_label>DLS 5.0 (Dynamic Locking Screws)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ORIF with DLS 5.0 (Dynamic Locking Screws)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLS (Standard locking screw)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ORIF with SLS (Standard locking screw)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DLS 5.0 (Dynamic locking screws)</intervention_name>
    <description>Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
    <arm_group_label>DLS 5.0 (Dynamic Locking Screws)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SLS (Standard locking screw)</intervention_name>
    <description>Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
    <arm_group_label>SLS (Standard locking screw)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  21 years and older&#xD;
&#xD;
          -  Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur&#xD;
             fractures above a total knee arthroplasty&#xD;
&#xD;
          -  Ability to walk independently prior to injury&#xD;
&#xD;
          -  Eligible for treatment with ORIF of the distal femur with a large fragment locking&#xD;
             plate (LISS, LCP)&#xD;
&#xD;
          -  Willing and able to comply with post-operative protocol and return for follow-up.&#xD;
&#xD;
          -  Ability to understand the content of the patient information / informed consent form&#xD;
             and participate in the clinical investigation&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional ipsi- or contralateral lower extremity fracture&#xD;
&#xD;
          -  Any kind of implant at the ipsilateral proximal femur&#xD;
&#xD;
          -  Pre-existing malunion or nonunion of the ipsilateral lower extremity&#xD;
&#xD;
          -  Segmental bone defect requiring bone grafting&#xD;
&#xD;
          -  More than 4 weeks between injury and surgery&#xD;
&#xD;
          -  Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)&#xD;
&#xD;
          -  Polytrauma&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Any not medically managed severe systemic disease&#xD;
&#xD;
          -  Recent history of substance abuse (ie, recreational drugs, alcohol) that would&#xD;
             preclude reliable assessment&#xD;
&#xD;
          -  Pregnancy or women planning to conceive within the study period&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  Participation in any other medical device or medicinal product study within the&#xD;
             previous month that could influence the results of the present study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J. Gardner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sean E. Nork, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Orthopaedics</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University Orthopedics</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Berlin, Campus Virchow Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BGU Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cantonal Hospital Chur</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luzerner Kantonsspital</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>April 8, 2016</results_first_submitted>
  <results_first_submitted_qc>May 24, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 1, 2016</results_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Femoral fracture</keyword>
  <keyword>Periprosthetic fracture</keyword>
  <keyword>Fracture fixation, internal</keyword>
  <keyword>Distal femur fractures</keyword>
  <keyword>Dynamic Locking Screw</keyword>
  <keyword>WOMAC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
    <mesh_term>Femoral Fractures, Distal</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The multicenter international study enrolled patients with distal femur fractures which were either stabilize with a Dynamic Locking Screw or a standard locking screw. The study was stopped due to implant breakages observed after planned implant removals in non-study patients treated with the DLS 5.0mm.</recruitment_details>
      <pre_assignment_details>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DLS 5.0 (Dynamic Locking Screws)</title>
          <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
        </group>
        <group group_id="P2">
          <title>SLS (Standard Locking Screw)</title>
          <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study was stopped</population>
      <group_list>
        <group group_id="B1">
          <title>DLS 5.0 (Dynamic Locking Screws)</title>
          <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
        </group>
        <group group_id="B2">
          <title>SLS (Standard Locking Screw)</title>
          <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</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="2"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.5" lower_limit="52" upper_limit="85"/>
                    <measurement group_id="B2" value="55" lower_limit="23" upper_limit="71"/>
                    <measurement group_id="B3" value="60.4" lower_limit="23" upper_limit="85"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <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>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Western Ontario and McMaster Universities Index (WOMAC)</title>
        <description>To assess pain, stiffness, and physical function</description>
        <time_frame>12 months after surgery</time_frame>
        <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
        <group_list>
          <group group_id="O1">
            <title>DLS 5.0 (Dynamic Locking Screws)</title>
            <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
          </group>
          <group group_id="O2">
            <title>SLS (Standard Locking Screw)</title>
            <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Universities Index (WOMAC)</title>
          <description>To assess pain, stiffness, and physical function</description>
          <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timed Up-and-go Test (TUG)</title>
        <description>The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command &quot;ready - go&quot; and stopped when the seated position is reached again.</description>
        <time_frame>12 weeks ± 7 days, 6 months ± 30 days</time_frame>
        <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
        <group_list>
          <group group_id="O1">
            <title>DLS 5.0 (Dynamic Locking Screws)</title>
            <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
          </group>
          <group group_id="O2">
            <title>SLS (Standard Locking Screw)</title>
            <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
          </group>
        </group_list>
        <measure>
          <title>Timed Up-and-go Test (TUG)</title>
          <description>The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command &quot;ready - go&quot; and stopped when the seated position is reached again.</description>
          <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (EuroQol-5D)</title>
        <time_frame>Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery</time_frame>
        <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
        <group_list>
          <group group_id="O1">
            <title>DLS 5.0 (Dynamic Locking Screws)</title>
            <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
          </group>
          <group group_id="O2">
            <title>SLS (Standard Locking Screw)</title>
            <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (EuroQol-5D)</title>
          <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Range of Motion (ROM)</title>
        <description>Assessment of passive ROM of the knee (flexion - extension)</description>
        <time_frame>6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery</time_frame>
        <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
        <group_list>
          <group group_id="O1">
            <title>DLS 5.0 (Dynamic Locking Screws)</title>
            <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
          </group>
          <group group_id="O2">
            <title>SLS (Standard Locking Screw)</title>
            <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
          </group>
        </group_list>
        <measure>
          <title>Range of Motion (ROM)</title>
          <description>Assessment of passive ROM of the knee (flexion - extension)</description>
          <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Full Weight-bearing Status</title>
        <description>Assessment of the timepoint when the patient :&#xD;
can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds&#xD;
can walk without walking aid&#xD;
has no intake of analgesics&#xD;
has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable</description>
        <time_frame>weekly measurement at home</time_frame>
        <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
        <group_list>
          <group group_id="O1">
            <title>DLS 5.0 (Dynamic Locking Screws)</title>
            <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
          </group>
          <group group_id="O2">
            <title>SLS (Standard Locking Screw)</title>
            <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
          </group>
        </group_list>
        <measure>
          <title>Full Weight-bearing Status</title>
          <description>Assessment of the timepoint when the patient :&#xD;
can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds&#xD;
can walk without walking aid&#xD;
has no intake of analgesics&#xD;
has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable</description>
          <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC</title>
        <description>To assess pain, stiffness, and physical function</description>
        <time_frame>Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery</time_frame>
        <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
        <group_list>
          <group group_id="O1">
            <title>DLS 5.0 (Dynamic Locking Screws)</title>
            <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
          </group>
          <group group_id="O2">
            <title>SLS (Standard Locking Screw)</title>
            <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC</title>
          <description>To assess pain, stiffness, and physical function</description>
          <population>Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>DLS 5.0 (Dynamic Locking Screws)</title>
          <description>ORIF with DLS 5.0 (Dynamic Locking Screws)&#xD;
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0</description>
        </group>
        <group group_id="E2">
          <title>SLS (Standard Locking Screw)</title>
          <description>ORIF with SLS (Standard locking screw)&#xD;
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)</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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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>
    <point_of_contact>
      <name_or_title>Clinical Operations Manager of Clinical Investigation and Documentation</name_or_title>
      <organization>AO Foundation</organization>
      <phone>0041 44 200 24 67</phone>
      <email>andreas.faeh@aofoundation.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/NCT01693367
org study id: DLS 5.0
nct id: NCT01693367
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used
      to stabilize the shaft component of distal femur fractures in comparison to standard locking
      screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC
      score) due to increased and more symmetrical callus formation and fewer non-unions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Western Ontario and McMaster Universities Index (WOMAC)
time frame: 12 months after surgery
description: To assess pain, stiffness, and physical function
measure: Timed Up-and-go Test (TUG)
time frame: 12 weeks ± 7 days, 6 months ± 30 days
description: The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again.
measure: Quality of Life (EuroQol-5D)
time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Range of Motion (ROM)
time frame: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
description: Assessment of passive ROM of the knee (flexion - extension)
measure: Full Weight-bearing Status
time frame: weekly measurement at home
description: Assessment of the timepoint when the patient :
can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds
can walk without walking aid
has no intake of analgesics
has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable
measure: WOMAC
time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
description: To assess pain, stiffness, and physical function
arm group label: DLS 5.0 (Dynamic Locking Screws)
arm group type: Active Comparator
description: ORIF with DLS 5.0 (Dynamic Locking Screws)
arm group label: SLS (Standard locking screw)
arm group type: Active Comparator
description: ORIF with SLS (Standard locking screw)
intervention type: Device
intervention name: DLS 5.0 (Dynamic locking screws)
description: Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
arm group label: DLS 5.0 (Dynamic Locking Screws)
intervention type: Device
intervention name: SLS (Standard locking screw)
description: Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
arm group label: SLS (Standard locking screw)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 120 Years
healthy volunteers: No
last name: Michael J. Gardner, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Sean E. Nork, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
mesh term: Femoral Fractures, Distal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 