<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/NCT03784235</url>
  </required_header>
  <id_info>
    <org_study_id>BFH_NaF-PET</org_study_id>
    <nct_id>NCT03784235</nct_id>
  </id_info>
  <brief_title>Bone Metabolic Activity in the Patellofemoral Joint in Patients With Unilateral PFP</brief_title>
  <official_title>Study of Subchondral Bone Remodeling With 18F NaF-PET / CT in Patients With Patellofemoral Pain. A Substudy for: Comparative Effectiveness of Therapeutic Hip and Knee Exercise for Patellofemoral Pain: a Pragmatic Randomised Trial (the COMPETE Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Bispebjerg and Frederiksberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Bispebjerg and Frederiksberg</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>
      This study aims to examine whether individuals with unilateral patellofemoral pain (PFP) have&#xD;
      increased subchondral bone remodelling and thus increased 18F Sodium Fluoride (18F-NaF)&#xD;
      uptake in the painful knee compared to the opposite knee measured by simultaneous positron&#xD;
      emission tomography and computed tomography (PET/CT) and to examine whether the increased&#xD;
      uptake is associated with pain intensity, with patient-reported function and with pain&#xD;
      localization. Furthermore we aim to investigate the effect of an acute patellofemoral loading&#xD;
      bout on the bone remodelling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition mainly affecting&#xD;
      younger people, causing pain, physical disability, and reduced quality of life. The cause of&#xD;
      PFP is still unknown. It is, i.e., unclear whether there is a link between PFP and changes in&#xD;
      the cartilaginous (subchondral) bone in the joint between the patella and the femur.&#xD;
&#xD;
      Our goals are to use 18F NaF PET/CT to evaluate whether subjects with unilateral&#xD;
      patellofemoral pain exhibit elevated bone metabolic activity in the painful knee compared to&#xD;
      the pain free knee and to determine whether bone metabolic activity correlates with pain&#xD;
      intensity and location of pain. Furthermore, we aim to investigate the effects of acute&#xD;
      loading on the bone metabolic activity.&#xD;
&#xD;
      The primary objective of this cross-sectional study is to assess whether patients with&#xD;
      unilateral PFP have increased bone metabolic activity in the painful knee compared to the&#xD;
      pain free knee. We will assess quantitative parameters indicative of bone metabolic activity&#xD;
      (Standardized Uptake Value (SUV) and kinetic data) and compare values between the painful&#xD;
      knee and the pain free knee. The secondary objectives are to 1) determine whether a bout of&#xD;
      single leg weight bearing knee bends standing on a wedge result in increased bone metabolic&#xD;
      activity acutely in the painful knee compared to the pain free knee, and 2) identify &quot;hot&quot;&#xD;
      regions of abnormal tracer uptake and compare area and SUV values between the painful knee&#xD;
      and the pain free knee.&#xD;
&#xD;
      An explorative objective is to determine the correlation between bone metabolic activity and&#xD;
      pain intensity and location of pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>18F NaF-PET/CT uptake</measure>
    <time_frame>Cross sectional assessment at baseline, i.e., before the loading programme.</time_frame>
    <description>Difference between painful knee and contralateral knee in mean, peak and maximum Standardized Uptake Value (SUV) and in kinetic parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>18F NaF-PET/CT uptake</measure>
    <time_frame>Assessed before and after an acute loading programme (on the same day).</time_frame>
    <description>Response to acute patellofemoral joint loading in mean, peak and maximum SUV and in kinetic parameters. The outcome represents changes in the parameters from before to after the loading programme</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regions of abnormal tracer uptake</measure>
    <time_frame>Cross sectional assessment at baseline, i.e., before the loading programme</time_frame>
    <description>Identify &quot;hot&quot; regions of abnormal tracer uptake and compare area and SUV values between the painful knee and the pain free knee</description>
  </secondary_outcome>
  <other_outcome>
    <measure>18F NaF-PET/CT uptake and pain intensity, pain localization and physical function.</measure>
    <time_frame>Cross sectional assessment at baseline, i.e., before the loading programme</time_frame>
    <description>Correlation between tracer uptake parameters and pain intensity measured by pain algometry, pain localization measured by pain drawings and physical function measured by the Anterior Knee Pain Scale</description>
  </other_outcome>
  <enrollment type="Actual">27</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <condition>Anterior Knee Pain Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>18F NaF-PET/CT and cone beam CT scans</intervention_name>
    <description>Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults (n = 30) with unilateral anterior knee pain / PFP (3&gt; 10 NRS) will be included from&#xD;
        the main study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinical diagnosis of PFP in at least one knee confirmed by an experienced sports&#xD;
             medicine doctor.&#xD;
&#xD;
          -  Visual analogue score rating of pain during activities of daily living during the&#xD;
             previous week at a minimum of 3 on a 10 cm scale.&#xD;
&#xD;
          -  Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.&#xD;
&#xD;
          -  Pain in the anterior knee associated with at least 3 of the following:&#xD;
&#xD;
               -  During or after activity&#xD;
&#xD;
               -  Prolonged sitting&#xD;
&#xD;
               -  Stair ascent or descent&#xD;
&#xD;
               -  Squatting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meniscal or other intra-articular injury&#xD;
&#xD;
          -  Cruciate or collateral ligament laxity or tenderness&#xD;
&#xD;
          -  Patellar tendon, iliotibial band, or pes anserine tenderness&#xD;
&#xD;
          -  Osgood-Schlatter or Sinding-Larsen-Johansson syndrome&#xD;
&#xD;
          -  History of recurrent patellar subluxation or dislocation&#xD;
&#xD;
          -  History of surgery to the knee joint&#xD;
&#xD;
          -  History of head injury or vestibular disorder within the last 6 months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>København NV</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Bispebjerg and Frederiksberg</investigator_affiliation>
    <investigator_full_name>Rudi Neergaard Hansen</investigator_full_name>
    <investigator_title>PT, MSc.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT03784235
org study id: BFH_NaF-PET
nct id: NCT03784235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to examine whether individuals with unilateral patellofemoral pain (PFP) have
      increased subchondral bone remodelling and thus increased 18F Sodium Fluoride (18F-NaF)
      uptake in the painful knee compared to the opposite knee measured by simultaneous positron
      emission tomography and computed tomography (PET/CT) and to examine whether the increased
      uptake is associated with pain intensity, with patient-reported function and with pain
      localization. Furthermore we aim to investigate the effect of an acute patellofemoral loading
      bout on the bone remodelling.
Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition mainly affecting
      younger people, causing pain, physical disability, and reduced quality of life. The cause of
      PFP is still unknown. It is, i.e., unclear whether there is a link between PFP and changes in
      the cartilaginous (subchondral) bone in the joint between the patella and the femur.

      Our goals are to use 18F NaF PET/CT to evaluate whether subjects with unilateral
      patellofemoral pain exhibit elevated bone metabolic activity in the painful knee compared to
      the pain free knee and to determine whether bone metabolic activity correlates with pain
      intensity and location of pain. Furthermore, we aim to investigate the effects of acute
      loading on the bone metabolic activity.

      The primary objective of this cross-sectional study is to assess whether patients with
      unilateral PFP have increased bone metabolic activity in the painful knee compared to the
      pain free knee. We will assess quantitative parameters indicative of bone metabolic activity
      (Standardized Uptake Value (SUV) and kinetic data) and compare values between the painful
      knee and the pain free knee. The secondary objectives are to 1) determine whether a bout of
      single leg weight bearing knee bends standing on a wedge result in increased bone metabolic
      activity acutely in the painful knee compared to the pain free knee, and 2) identify "hot"
      regions of abnormal tracer uptake and compare area and SUV values between the painful knee
      and the pain free knee.

      An explorative objective is to determine the correlation between bone metabolic activity and
      pain intensity and location of pain.
observational model: Case-Control
time perspective: Cross-Sectional
measure: 18F NaF-PET/CT uptake
time frame: Cross sectional assessment at baseline, i.e., before the loading programme.
description: Difference between painful knee and contralateral knee in mean, peak and maximum Standardized Uptake Value (SUV) and in kinetic parameters
measure: 18F NaF-PET/CT uptake
time frame: Assessed before and after an acute loading programme (on the same day).
description: Response to acute patellofemoral joint loading in mean, peak and maximum SUV and in kinetic parameters. The outcome represents changes in the parameters from before to after the loading programme
measure: Regions of abnormal tracer uptake
time frame: Cross sectional assessment at baseline, i.e., before the loading programme
description: Identify "hot" regions of abnormal tracer uptake and compare area and SUV values between the painful knee and the pain free knee
measure: 18F NaF-PET/CT uptake and pain intensity, pain localization and physical function.
time frame: Cross sectional assessment at baseline, i.e., before the loading programme
description: Correlation between tracer uptake parameters and pain intensity measured by pain algometry, pain localization measured by pain drawings and physical function measured by the Anterior Knee Pain Scale
intervention type: Other
intervention name: 18F NaF-PET/CT and cone beam CT scans
description: Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital Bispebjerg and Frederiksberg
investigator full name: Rudi Neergaard Hansen
investigator title: PT, MSc.
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: No