<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/NCT01667887</url>
  </required_header>
  <id_info>
    <org_study_id>MotionLoc Screw</org_study_id>
    <nct_id>NCT01667887</nct_id>
  </id_info>
  <brief_title>Plating of Distal Femur Fractures by Far Cortical Locking Using MotionLoc Screws</brief_title>
  <official_title>MotionLoc Study: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Legacy Biomechanics Laboratory</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Slocum Center for Orthopaedics, Eugene, OR</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Legacy Biomechanics Laboratory</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to document callus formation and healing of fractures&#xD;
      stabilized with locking plates utilizing modern MotionLoc screws that provide controlled&#xD;
      axial micro-motion to actively promote fracture healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rigid locked plating constructs can suppress fracture healing, particularly at the near&#xD;
      cortex adjacent to the plate where interfragmentary motion is minimal. Dynamic fixation with&#xD;
      Far Cortical Locking (FCL) screws reduces construct stiffness and induces axial&#xD;
      interfragmentary motion to stimulate symmetric callus formation and healing. Two versions of&#xD;
      FCL screws are commercially available, but the clinical durability of this novel concept has&#xD;
      not been documented to date. This prospective observational study documented our early&#xD;
      clinical experience with MotionLoc® FCL screws for stabilization of distal femur fractures to&#xD;
      assess their durability and potential complications.&#xD;
&#xD;
      Thirty-two consecutive patients with 33 distal femur fractures (AO/OTA types 33-A and 33-C)&#xD;
      were prospectively enrolled at three trauma centers. Fractures were stabilized by plate&#xD;
      osteosynthesis with MotionLoc® FCL screws without supplemental bone graft or bone morphogenic&#xD;
      proteins. Thirty patients with 31 fractures were available for follow-up until union or&#xD;
      revision. Follow-up visits at 6, 12, and 24 weeks comprised functional and radiographic&#xD;
      assessment of implant fixation and fracture healing, including computed tomography scans at&#xD;
      week 12. The primary endpoint was fracture healing in absence of complications and revision.&#xD;
&#xD;
      There was no incidence of implant breakage or diaphyseal fixation failure. Thirty of 31&#xD;
      fractures healed within 15.6 ± 6.2 weeks, as evident by bridging callus and pain-free load&#xD;
      bearing. There were two revisions, one at 5 days post surgery to correct a mal-rotation, and&#xD;
      one at 6 months post surgery to revise a non-union. Periosteal callus distribution at week 6&#xD;
      was symmetrical, with similar amounts of callus at the medial cortex (35%) anterior cortex&#xD;
      (30%) and posterior cortex (35%). In 23 fractures (74%), callus formation extended to the&#xD;
      lateral cortex under the plate.&#xD;
&#xD;
      Absence of hardware and fixation failure suggests that dynamic plating of distal femur&#xD;
      fractures with FCL screws provides safe and effective fixation. Moreover, the amount and&#xD;
      symmetric distribution of periosteal callus suggests that dynamic fixation with FCL screws&#xD;
      may promote increased fracture healing over standard locked plating. However, this hypothesis&#xD;
      on the stimulatory effect of dynamic fixation on fracture healing requires investigation in a&#xD;
      future randomized control trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Fracture Healing</measure>
    <time_frame>6, 12, and 24 weeks post surgery</time_frame>
    <description>Fracture healing is defined clinically by the ability of pain-free weight bearing, and radiographically by callus formation and bridging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periosteal Callus Size</measure>
    <time_frame>6, 12, 24 weeks post surgery</time_frame>
    <description>Periosteal callus size is assessed at the anterior, posterior, and medial aspects on radiographs using a validated computational algorithm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bridging Callus from CT</measure>
    <time_frame>12 weeks post surgery</time_frame>
    <description>Cross-sectional image analysis, supported by 3-D rendering, to detect bony bridging at the anterior, posterior, and lateral aspects of the femur.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fixation Failure</measure>
    <time_frame>24 weeks post surgery</time_frame>
    <description>Assessed in terms of loss of alignment at 12 and 24 weeks post surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hardware failure</measure>
    <time_frame>6, 12, 24 weeks post surgery</time_frame>
    <description>Breakage of screw or plate</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Fracture of Distal Femur</condition>
  <arm_group>
    <arm_group_label>Femur Fractures</arm_group_label>
    <description>Patients with Distal Femur Fractures</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Distal femur fractures (AO/OTA Type 33A and 33C)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with distal femur fracture (AO/OTA Type 33A and 33C)&#xD;
&#xD;
          2. Patients 17 years of age and over.&#xD;
&#xD;
          3. Patients able to be operated on by selected surgeons at the participating centers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Patients who are enrolled in an investigational treatment trial.&#xD;
&#xD;
          3. Patients who are not expected to survive the follow-up period.&#xD;
&#xD;
          4. Considered an inappropriate participant by the study physician.&#xD;
&#xD;
          5. Revision surgery&#xD;
&#xD;
          6. Patients currently incarcerated or awaiting incarceration.&#xD;
&#xD;
          7. Severe spinal injury with neurological deficit resulting in paralysis.&#xD;
&#xD;
          8. Fracture fixed more then 28 days after injury.&#xD;
&#xD;
          9. Acute or chronic local or systemic infections&#xD;
&#xD;
         10. Periprosthetic fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Bottlang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Legacy Biomechanics Laboratory</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Madey, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Legacy Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Legacy Health System</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://orthoportal.aaos.org/oko/article.aspx?article=OKO_TRA041</url>
    <description>Orthopaedic Knowledge Online Article: Biomechanics and Use of Far Cortical Locking in Orthopaedic Trauma</description>
  </link>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>January 28, 2013</last_update_submitted>
  <last_update_submitted_qc>January 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Legacy Biomechanics Laboratory</investigator_affiliation>
    <investigator_full_name>Michael Bottlang, PhD</investigator_full_name>
    <investigator_title>Director, Legacy Biomechanics Laboratory</investigator_title>
  </responsible_party>
  <keyword>Far Cortical Locking</keyword>
  <keyword>Distal Femur Fracture</keyword>
  <keyword>Locking Plate</keyword>
  <keyword>MotionLoc</keyword>
  <keyword>Fracture Fixation</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667887
org study id: MotionLoc Screw
nct id: NCT01667887
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The objective of this study is to document callus formation and healing of fractures
      stabilized with locking plates utilizing modern MotionLoc screws that provide controlled
      axial micro-motion to actively promote fracture healing.
Rigid locked plating constructs can suppress fracture healing, particularly at the near
      cortex adjacent to the plate where interfragmentary motion is minimal. Dynamic fixation with
      Far Cortical Locking (FCL) screws reduces construct stiffness and induces axial
      interfragmentary motion to stimulate symmetric callus formation and healing. Two versions of
      FCL screws are commercially available, but the clinical durability of this novel concept has
      not been documented to date. This prospective observational study documented our early
      clinical experience with MotionLoc® FCL screws for stabilization of distal femur fractures to
      assess their durability and potential complications.

      Thirty-two consecutive patients with 33 distal femur fractures (AO/OTA types 33-A and 33-C)
      were prospectively enrolled at three trauma centers. Fractures were stabilized by plate
      osteosynthesis with MotionLoc® FCL screws without supplemental bone graft or bone morphogenic
      proteins. Thirty patients with 31 fractures were available for follow-up until union or
      revision. Follow-up visits at 6, 12, and 24 weeks comprised functional and radiographic
      assessment of implant fixation and fracture healing, including computed tomography scans at
      week 12. The primary endpoint was fracture healing in absence of complications and revision.

      There was no incidence of implant breakage or diaphyseal fixation failure. Thirty of 31
      fractures healed within 15.6 ± 6.2 weeks, as evident by bridging callus and pain-free load
      bearing. There were two revisions, one at 5 days post surgery to correct a mal-rotation, and
      one at 6 months post surgery to revise a non-union. Periosteal callus distribution at week 6
      was symmetrical, with similar amounts of callus at the medial cortex (35%) anterior cortex
      (30%) and posterior cortex (35%). In 23 fractures (74%), callus formation extended to the
      lateral cortex under the plate.

      Absence of hardware and fixation failure suggests that dynamic plating of distal femur
      fractures with FCL screws provides safe and effective fixation. Moreover, the amount and
      symmetric distribution of periosteal callus suggests that dynamic fixation with FCL screws
      may promote increased fracture healing over standard locked plating. However, this hypothesis
      on the stimulatory effect of dynamic fixation on fracture healing requires investigation in a
      future randomized control trial.
observational model: Cohort
time perspective: Prospective
measure: Fracture Healing
time frame: 6, 12, and 24 weeks post surgery
description: Fracture healing is defined clinically by the ability of pain-free weight bearing, and radiographically by callus formation and bridging.
measure: Periosteal Callus Size
time frame: 6, 12, 24 weeks post surgery
description: Periosteal callus size is assessed at the anterior, posterior, and medial aspects on radiographs using a validated computational algorithm.
measure: Bridging Callus from CT
time frame: 12 weeks post surgery
description: Cross-sectional image analysis, supported by 3-D rendering, to detect bony bridging at the anterior, posterior, and lateral aspects of the femur.
measure: Fixation Failure
time frame: 24 weeks post surgery
description: Assessed in terms of loss of alignment at 12 and 24 weeks post surgery
measure: Hardware failure
time frame: 6, 12, 24 weeks post surgery
description: Breakage of screw or plate
arm group label: Femur Fractures
description: Patients with Distal Femur Fractures
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Bottlang, PhD
role: Principal Investigator
affiliation: Legacy Biomechanics Laboratory
last name: Steven Madey, MD
role: Study Chair
affiliation: Legacy Health System
facility: 
country: United States
url: http://orthoportal.aaos.org/oko/article.aspx?article=OKO_TRA041
description: Orthopaedic Knowledge Online Article: Biomechanics and Use of Far Cortical Locking in Orthopaedic Trauma
responsible party type: Principal Investigator
investigator affiliation: Legacy Biomechanics Laboratory
investigator full name: Michael Bottlang, PhD
investigator title: Director, Legacy Biomechanics Laboratory
mesh term: Fractures, Bone
mesh term: Femoral Fractures
mesh term: Femoral Fractures, Distal