<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/NCT04418596</url>
  </required_header>
  <id_info>
    <org_study_id>S62916</org_study_id>
    <nct_id>NCT04418596</nct_id>
  </id_info>
  <brief_title>Longitudinal Follow-up of Male Soccer Players Prone to Developing CAM Hip Deformity</brief_title>
  <acronym>FAI</acronym>
  <official_title>Integrated Longitudinal Research on the Etiology of CAM Deformity in Adolescent Male Elite Soccer Players and Matched Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johnson &amp; Johnson</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Femoroacetabular impingement (FAI) is a clinical problem in which abnormal contact occurs&#xD;
      between the thighbone and the hip socket. In intensive, mostly still young, male athletes,&#xD;
      this problem seems to be related to a bony deformity on the head of this thighbone, a&#xD;
      so-called CAM. FAI itself gives rise to pain symptoms, but in time can even lead to premature&#xD;
      osteoarthritis. However, the cause of a CAM deformity itself, nor how FAI then arises, is&#xD;
      insufficiently known. In view of FAI prevention and its better treatment, this project thus&#xD;
      tries to better understand the underlying mechanisms. For this purpose, we will combine&#xD;
      detailed biomechanical evaluations of specific movement patterns with advanced medical&#xD;
      imaging and state of the art clinical evaluations to longitudinally follow up a group with a&#xD;
      known high risk of developing a CAM deformity, being young male elite soccer players.&#xD;
      Findings within this study will be additionally compared with similar analyses performed in&#xD;
      patients with FAI. This research aims to thus form a basis to define novel (sports-specific)&#xD;
      training schemes for the prevention of FAI, but also to define the actual treatment and&#xD;
      rehabilitation plans in more patient-specific and a better-informed way.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a longitudinal follow-up study in which subjects are invited for data collection&#xD;
      twice, the baseline time-point and the two years time-point.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      12-16 years old male soccer players (40 elite level players , and 40 recreational level&#xD;
      players)&#xD;
&#xD;
      In both data collection time-points the following measurements are preformed:&#xD;
&#xD;
        1. Clinical screening of hip joint&#xD;
&#xD;
        2. Radial MRI of bilateral hips&#xD;
&#xD;
        3. Biplanar and conventional x-ray Imaging of hip and pelvic region&#xD;
&#xD;
        4. Athlete-specific 3D motion analysis&#xD;
&#xD;
        5. Questionnaires on injury history and physical activity levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>The formation of CAM deformity on the anterior head-neck junction of the femur</measure>
    <time_frame>two years post baseline measurements</time_frame>
    <description>Detected using alpha angle on MRI/ Dunn's View x-ray</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Femoro Acetabular Impingement</condition>
  <condition>CAM</condition>
  <arm_group>
    <arm_group_label>Elite Soccer Players</arm_group_label>
    <description>Adolescent male aged 12-16 years old elite athletes that are recruited from special sport school in Leuven-Belgium and play football at a high level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recreational Soccer players (control)</arm_group_label>
    <description>Adolescent male aged 12-16 years old recruited from ordinary school in Flanders Belgium that play soccer or any other sport recreationally with no high intensity training</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>bi-planer radiography (EOS), Conventional rediography (Hip+pelvis)</intervention_name>
    <description>low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.</description>
    <arm_group_label>Elite Soccer Players</arm_group_label>
    <arm_group_label>Recreational Soccer players (control)</arm_group_label>
    <other_name>Clinical Screening</other_name>
    <other_name>Motion Analysis</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescent healthy males that are starting the final age of skeletal maturity(12-18 years&#xD;
        of age). The 2 groups of the study are separated principally on the frequency and intensity&#xD;
        of their athletic training.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For the the Elite Group: Playing soccer at high level and training for more that 10&#xD;
             hours a week&#xD;
&#xD;
          -  For the Control group: Playing soccer or any other sport recreationally for a less&#xD;
             than 5 hours a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior history of major trauma or injury to the lower limbs and spine&#xD;
&#xD;
          -  No prior history of neurological conditions that can effect movement and mobility&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Genetic component of being a male is required .</gender_description>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Stijn Ghijselings, M.D</last_name>
    <phone>016 33 88 18</phone>
    <email>stijn.ghijselings@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Orthopaedic Research</last_name>
    <phone>016 33 88 18</phone>
    <email>Orthopedie.Research@uz.kuleuven.ac.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Leuven Hospitals</name>
      <address>
        <city>Leuven</city>
        <state>Flanders</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dalia Al Otti, Masters</last_name>
      <phone>0032483198061</phone>
      <email>dalia.alotti@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Dalia Al otti, Masters</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stijn Ghijselings, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</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>Femoracetabular Impingement</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/NCT04418596
org study id: S62916
nct id: NCT04418596
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Femoroacetabular impingement (FAI) is a clinical problem in which abnormal contact occurs
      between the thighbone and the hip socket. In intensive, mostly still young, male athletes,
      this problem seems to be related to a bony deformity on the head of this thighbone, a
      so-called CAM. FAI itself gives rise to pain symptoms, but in time can even lead to premature
      osteoarthritis. However, the cause of a CAM deformity itself, nor how FAI then arises, is
      insufficiently known. In view of FAI prevention and its better treatment, this project thus
      tries to better understand the underlying mechanisms. For this purpose, we will combine
      detailed biomechanical evaluations of specific movement patterns with advanced medical
      imaging and state of the art clinical evaluations to longitudinally follow up a group with a
      known high risk of developing a CAM deformity, being young male elite soccer players.
      Findings within this study will be additionally compared with similar analyses performed in
      patients with FAI. This research aims to thus form a basis to define novel (sports-specific)
      training schemes for the prevention of FAI, but also to define the actual treatment and
      rehabilitation plans in more patient-specific and a better-informed way.
This is a longitudinal follow-up study in which subjects are invited for data collection
      twice, the baseline time-point and the two years time-point.

      Population:

      12-16 years old male soccer players (40 elite level players , and 40 recreational level
      players)

      In both data collection time-points the following measurements are preformed:

        1. Clinical screening of hip joint

        2. Radial MRI of bilateral hips

        3. Biplanar and conventional x-ray Imaging of hip and pelvic region

        4. Athlete-specific 3D motion analysis

        5. Questionnaires on injury history and physical activity levels.
observational model: Cohort
time perspective: Prospective
measure: The formation of CAM deformity on the anterior head-neck junction of the femur
time frame: two years post baseline measurements
description: Detected using alpha angle on MRI/ Dunn's View x-ray
arm group label: Elite Soccer Players
description: Adolescent male aged 12-16 years old elite athletes that are recruited from special sport school in Leuven-Belgium and play football at a high level.
arm group label: Recreational Soccer players (control)
description: Adolescent male aged 12-16 years old recruited from ordinary school in Flanders Belgium that play soccer or any other sport recreationally with no high intensity training
intervention type: Radiation
intervention name: bi-planer radiography (EOS), Conventional rediography (Hip+pelvis)
description: low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
arm group label: Elite Soccer Players
arm group label: Recreational Soccer players (control)
other name: Clinical Screening
other name: Motion Analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Genetic component of being a male is required .
minimum age: 12 Years
maximum age: 17 Years
last name: Stijn Ghijselings, M.D
phone: 016 33 88 18
email: stijn.ghijselings@uzleuven.be
last name: Orthopaedic Research
phone: 016 33 88 18
email: Orthopedie.Research@uz.kuleuven.ac.be
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Belgium
responsible party type: Sponsor
mesh term: Femoracetabular Impingement