<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/NCT04464343</url>
  </required_header>
  <id_info>
    <org_study_id>OR006</org_study_id>
    <nct_id>NCT04464343</nct_id>
  </id_info>
  <brief_title>The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction</brief_title>
  <official_title>The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      Investigating the biomechanics for the PCL ruptured or reconstructed patients during walking,&#xD;
      jogging, cutting, jumping. To establish a knee joint biomechanical evaluation model to&#xD;
      quantify and evaluate the plantar pressure information under dynamic load-bearing state after&#xD;
      PCL fracture. Provide a precise basis for the biomechanical state of the knee, and establish&#xD;
      a clinically practical automatic analysis of plantar pressure information and an expert&#xD;
      diagnostic system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The posterior cruciate ligament (PCL) is an essential structure in knee&#xD;
      stabilization. Knee cartilage degeneration after a PCL injury has been reported in several&#xD;
      studies. Understanding the changes in movement patterns of patients with PCL ruptures could&#xD;
      help clinicians make specific treatment protocols to restore patients' sporting ability and&#xD;
      prevent joint degeneration. However, the kinematics and kinetics of the lower limb in&#xD;
      patients with PCL injuries are still not clear.&#xD;
&#xD;
      Methods: Three-dimensional gait analysis system, force plate, electromyography will be used&#xD;
      for 55 healthy male participants (control group) and 55 male patients with isolated&#xD;
      PCL-deficiency (PCL-d group) during walking, jogging, cutting, jumping. Repeated measurement&#xD;
      two-factor analysis of variance will be performed to determine differences between involved&#xD;
      and uninvolved legs in the PCL-d group and control group at different rehabilitation times&#xD;
      (prior reconstruction surgery, 6 months, and 1-year post PCL reconstruction surgery).&#xD;
      Three-dimensional gait analysis and computer-aided analysis technology of plantar pressure&#xD;
      information were used to study the changes of PCL after fracture and reconstruction. Based on&#xD;
      the plantar pressure information, the movement parameters, and individual attribute&#xD;
      parameters, establish a knee joint biomechanical evaluation model to quantify and evaluate&#xD;
      the plantar pressure information under dynamic load-bearing state after PCL fracture. Provide&#xD;
      a precise basis for the biomechanical state of the knee, and establish a clinically practical&#xD;
      automatic analysis of plantar pressure information and an expert diagnostic system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2014</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 27, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee extension in the gait cycle</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee flexion in the gait cycle</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100. The higher is better.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Posterior Cruciate Ligament Tear</condition>
  <arm_group>
    <arm_group_label>Posterior cruciate ligament injury group</arm_group_label>
    <description>According to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal control group</arm_group_label>
    <description>According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>This is an observation study, with no intervention</description>
    <arm_group_label>Posterior cruciate ligament injury group</arm_group_label>
    <arm_group_label>normal control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion：age of 18-45 years old. Healthy volunteers: no history of neuro or&#xD;
        musculoskeletal system injury that may affect the movements. Isolated PCL rupture patients:&#xD;
        The inclusion criteria included an isolated PCL rupture of at least 3 months' duration. The&#xD;
        exclusion criteria were (1) additional knee ligament or meniscal damage; (2) severe damage&#xD;
        to the ipsilateral hip, ankle joint, or contralateral lower limb (ligament ruptures or bone&#xD;
        fractures); (3) age &gt;50 years (to avoid age-induced osteoarthritis interference); (4) any&#xD;
        cartilage injury grade &gt;2 according to the Outerbridge classification; and (5) Tegner&#xD;
        score18 &lt;3.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 18-45 years old&#xD;
&#xD;
          -  Isolated PCL rupture patients: The inclusion criteria included an isolated PCL rupture&#xD;
             of at least 3 months' duration.&#xD;
&#xD;
          -  Healthy volunteers: no history of neuro or musculoskeletal system injury that may&#xD;
             affect the movements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  additional knee ligament or meniscal damage&#xD;
&#xD;
          -  severe damage to the ipsilateral hip, ankle joint, or contralateral lower limb&#xD;
             (ligament ruptures or bone fractures)&#xD;
&#xD;
          -  age &gt;50 years (to avoid age-induced osteoarthritis interference)&#xD;
&#xD;
          -  any cartilage injury grade &gt;2 according to the Outerbridge classification&#xD;
&#xD;
          -  Tegner score18 &lt;3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hongshi Huang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>posterior cruciate ligament</keyword>
  <keyword>knee</keyword>
  <keyword>hip</keyword>
  <keyword>ankle</keyword>
  <keyword>biomechanics</keyword>
  <keyword>walking</keyword>
  <keyword>jogging</keyword>
  <keyword>cutting</keyword>
  <keyword>jumping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</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/NCT04464343
org study id: OR006
nct id: NCT04464343
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigating the biomechanics for the PCL ruptured or reconstructed patients during walking,
      jogging, cutting, jumping. To establish a knee joint biomechanical evaluation model to
      quantify and evaluate the plantar pressure information under dynamic load-bearing state after
      PCL fracture. Provide a precise basis for the biomechanical state of the knee, and establish
      a clinically practical automatic analysis of plantar pressure information and an expert
      diagnostic system.
Background: The posterior cruciate ligament (PCL) is an essential structure in knee
      stabilization. Knee cartilage degeneration after a PCL injury has been reported in several
      studies. Understanding the changes in movement patterns of patients with PCL ruptures could
      help clinicians make specific treatment protocols to restore patients' sporting ability and
      prevent joint degeneration. However, the kinematics and kinetics of the lower limb in
      patients with PCL injuries are still not clear.

      Methods: Three-dimensional gait analysis system, force plate, electromyography will be used
      for 55 healthy male participants (control group) and 55 male patients with isolated
      PCL-deficiency (PCL-d group) during walking, jogging, cutting, jumping. Repeated measurement
      two-factor analysis of variance will be performed to determine differences between involved
      and uninvolved legs in the PCL-d group and control group at different rehabilitation times
      (prior reconstruction surgery, 6 months, and 1-year post PCL reconstruction surgery).
      Three-dimensional gait analysis and computer-aided analysis technology of plantar pressure
      information were used to study the changes of PCL after fracture and reconstruction. Based on
      the plantar pressure information, the movement parameters, and individual attribute
      parameters, establish a knee joint biomechanical evaluation model to quantify and evaluate
      the plantar pressure information under dynamic load-bearing state after PCL fracture. Provide
      a precise basis for the biomechanical state of the knee, and establish a clinically practical
      automatic analysis of plantar pressure information and an expert diagnostic system.
observational model: Case-Control
time perspective: Cross-Sectional
measure: walking speed
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee flexion in the gait cycle
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: The International Knee Documentation Committee (IKDC) score
time frame: On the day of enrollment.
description: The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100. The higher is better.
arm group label: Posterior cruciate ligament injury group
description: According to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury.
arm group label: normal control group
description: According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
intervention type: Other
intervention name: no intervention
description: This is an observation study, with no intervention
arm group label: Posterior cruciate ligament injury group
arm group label: normal control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
last name: Hongshi Huang, Doctor
role: Study Chair
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Rupture
sharing ipd: No