<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/NCT03040232</url>
  </required_header>
  <id_info>
    <org_study_id>2011-1984</org_study_id>
    <nct_id>NCT03040232</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes Following Patellar Dislocation in Young Athletes</brief_title>
  <official_title>Clinical Outcomes Following Patellar Dislocation in Young Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify predictors of future injury and disability following&#xD;
      LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with&#xD;
      LPD following surgical and non-surgical management. Currently, there is limited information&#xD;
      available to clinicians regarding appropriate criteria for returning athletes to sports&#xD;
      participation following LPD. The evidence produced by this study will provide necessary&#xD;
      information to develop appropriate rehabilitation strategies that may reduce the risk for&#xD;
      future patellar instability and associated patellofemoral joint dysfunction and pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The basis of the proposed study is to determine the clinical outcomes following lateral&#xD;
      patellar dislocation (LPD). Despite surgical and non-surgical interventions, young athletes&#xD;
      are at high risk for sustaining subsequent dislocations that magnify the effects of&#xD;
      disability. It is suspected that if athletes return to high-level activities and expose their&#xD;
      knees to substantial forces without normalized movement strategies, then this may increase&#xD;
      the risk for future joint injury. Currently, there are no evidence-based criteria to&#xD;
      determine an athlete's readiness for sports activity following LPD. The purpose of this study&#xD;
      is to characterize clinical outcomes, function, and neuromuscular control strategies employed&#xD;
      by athletes following LPD at the time when they are returning to sports participation.&#xD;
&#xD;
      A prospective, longitudinal study design will be utilized. A cohort of up to 100 athletes&#xD;
      (ages 12 - 25 years) who have sustained LPD during sports activities that require jumping,&#xD;
      cutting, or pivoting maneuvers will be consecutively recruited from the offices of local&#xD;
      orthopaedic surgeons, primary care physicians, and sports physical therapists for this study.&#xD;
      Investigators will target a subset of surgically managed athletes and a subset of&#xD;
      non-surgically managed athletes with LPD. A cohort of up to 100 individuals without history&#xD;
      of knee injury will be recruited from local schools and universities to serve as control&#xD;
      participants. Data will be collected to evaluate clinical outcomes, thigh and hip strength,&#xD;
      lower body function, balance and neuromuscular control strategies. Clinical outcomes will be&#xD;
      assessed using self-report questionnaires and performance-based measures, including hop and&#xD;
      agility tests. Thigh and hip strength will be assessed utilizing an isokinetic dynamometer.&#xD;
      Lower body function will be assessed using a series of single-leg and double-leg hopping&#xD;
      tests. Balance will be assessed utilizing a clinical lower extremity reach test.&#xD;
      Neuromuscular control will be evaluated by 3-D motion analysis during running, jumping, and&#xD;
      cutting activities. Overall, this study will provide a comprehensive evaluation of athletes&#xD;
      following LPD. It will provide important information for the future development of&#xD;
      rehabilitation approaches that may maximize clinical outcomes for the at risk population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in biomechanical assessment using motion analysis</measure>
    <time_frame>6 months</time_frame>
    <description>measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Patella Dislocation Recurrent</condition>
  <condition>Patellar Dislocation</condition>
  <arm_group>
    <arm_group_label>MPFl Reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects that have had MPFL reconstruction surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects that have not had MPFL reconstruction surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biomechanical assessment</intervention_name>
    <description>biomechanical and strength assessment of both groups</description>
    <arm_group_label>Active Controls</arm_group_label>
    <arm_group_label>MPFl Reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with LPD who have been managed with non-surgical rehabilitation,&#xD;
             pre-surgical rehabilitation, and medial patellofemoral ligament reconstruction&#xD;
             (MPFL-R) may be included.&#xD;
&#xD;
          -  Participants may be included in this study is they have completed supervised&#xD;
             rehabilitation and have been cleared to return to sports participation by their&#xD;
             physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. lower extremity orthopedic surgeries other than procedures for patellar instability&#xD;
&#xD;
          2. lower extremity injuries within the last 3 months other than patellar dislocation&#xD;
&#xD;
          3. neurological disorders&#xD;
&#xD;
          4. medical conditions that might affect neuromuscular performance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory D Myer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cincinanti Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT03040232
org study id: 2011-1984
nct id: NCT03040232
lead sponsor: 
has dmc: Yes
The purpose of this study is to identify predictors of future injury and disability following
      LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with
      LPD following surgical and non-surgical management. Currently, there is limited information
      available to clinicians regarding appropriate criteria for returning athletes to sports
      participation following LPD. The evidence produced by this study will provide necessary
      information to develop appropriate rehabilitation strategies that may reduce the risk for
      future patellar instability and associated patellofemoral joint dysfunction and pain.
The basis of the proposed study is to determine the clinical outcomes following lateral
      patellar dislocation (LPD). Despite surgical and non-surgical interventions, young athletes
      are at high risk for sustaining subsequent dislocations that magnify the effects of
      disability. It is suspected that if athletes return to high-level activities and expose their
      knees to substantial forces without normalized movement strategies, then this may increase
      the risk for future joint injury. Currently, there are no evidence-based criteria to
      determine an athlete's readiness for sports activity following LPD. The purpose of this study
      is to characterize clinical outcomes, function, and neuromuscular control strategies employed
      by athletes following LPD at the time when they are returning to sports participation.

      A prospective, longitudinal study design will be utilized. A cohort of up to 100 athletes
      (ages 12 - 25 years) who have sustained LPD during sports activities that require jumping,
      cutting, or pivoting maneuvers will be consecutively recruited from the offices of local
      orthopaedic surgeons, primary care physicians, and sports physical therapists for this study.
      Investigators will target a subset of surgically managed athletes and a subset of
      non-surgically managed athletes with LPD. A cohort of up to 100 individuals without history
      of knee injury will be recruited from local schools and universities to serve as control
      participants. Data will be collected to evaluate clinical outcomes, thigh and hip strength,
      lower body function, balance and neuromuscular control strategies. Clinical outcomes will be
      assessed using self-report questionnaires and performance-based measures, including hop and
      agility tests. Thigh and hip strength will be assessed utilizing an isokinetic dynamometer.
      Lower body function will be assessed using a series of single-leg and double-leg hopping
      tests. Balance will be assessed utilizing a clinical lower extremity reach test.
      Neuromuscular control will be evaluated by 3-D motion analysis during running, jumping, and
      cutting activities. Overall, this study will provide a comprehensive evaluation of athletes
      following LPD. It will provide important information for the future development of
      rehabilitation approaches that may maximize clinical outcomes for the at risk population.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: change in biomechanical assessment using motion analysis
time frame: 6 months
description: measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures
arm group label: MPFl Reconstruction
arm group type: Experimental
description: subjects that have had MPFL reconstruction surgery
arm group label: Active Controls
arm group type: Active Comparator
description: subjects that have not had MPFL reconstruction surgery
intervention type: Other
intervention name: biomechanical assessment
description: biomechanical and strength assessment of both groups
arm group label: Active Controls
arm group label: MPFl Reconstruction
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Cincinanti Childrens Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Patellar Dislocation
sharing ipd: No