<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/NCT04403178</url>
  </required_header>
  <id_info>
    <org_study_id>P-2019-143 2</org_study_id>
    <nct_id>NCT04403178</nct_id>
  </id_info>
  <brief_title>Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark</brief_title>
  <official_title>Prediction of Hip Displacement in Children With Cerebral Palsy Among Patients Participating in the Danish Cerebral Palsy Follow-up Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mette Røn Kristensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</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>
      Children with cerebral palsy have an increased risk of hip dislocation, which is a painful&#xD;
      and severe complication of cerebral palsy. The 20-years evaluation of the Swedish&#xD;
      surveillance programme shows that hip dislocation in children with cerebral palsy can be&#xD;
      prevented with regular clinical and radiographic examination and early intervention.&#xD;
&#xD;
      We would like to determine the individual risk for hip displacement for Danish children with&#xD;
      CP in The Danish Cerebral Palsy Follow-up Program. This could be a valuable clinical tool in&#xD;
      deciding on further follow-up and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Migration percentage (MP) which is measured from the pelvis radiograph is commonly used to&#xD;
      assess lateral displacement of the femoral head and is being used in the Swedish and in the&#xD;
      Danish surveillance programme. Most children with an MP &gt; 40 % need surgery to prevent&#xD;
      further displacement and prevent dislocation of the hip. In the Swedish surveillance&#xD;
      programme they have developed the Cerebral Palsy Follow-Up Programme (CPUP) hip score as a&#xD;
      risk score to determine which children are at high or low risk for hip displacement (MP &gt; 40&#xD;
      %) within five years after first radiographic examination.&#xD;
&#xD;
      The aim of this study is to predict the likelihood that a child with cerebral palsy will&#xD;
      develop hip displacement (MI&gt; 40) within three years. The design is a prediction study.&#xD;
&#xD;
      Data will be obtained from the national clinical quality database the Danish Cerebral Palsy&#xD;
      Follow-up Program and the Danish National Patient Register.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2008</start_date>
  <completion_date type="Anticipated">December 27, 2020</completion_date>
  <primary_completion_date type="Actual">May 27, 2020</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>Development of hip displacement or not measured by the Migration Percentage</measure>
    <time_frame>Follow-up period of three years.</time_frame>
    <description>Migration Percentage (MP) is measured from a pelvis radiograph and is used to assess lateral displacement of the femoral head. A MP &lt; 40 % on either hip is a good outcome, whereas a MP &gt; 40 % on either hip is a worse outcome.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Child</condition>
  <condition>Cerebral Palsy</condition>
  <condition>Radiography</condition>
  <condition>Hip Dislocation</condition>
  <condition>Hip Displacement</condition>
  <condition>Prospective Studies</condition>
  <arm_group>
    <arm_group_label>Children who develops hip displacement</arm_group_label>
    <description>Patient group 1 includes children who developed a Migration Percentage of &gt; 40 % in either hip over a follow-up period of three years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children who do not develops hip displacement</arm_group_label>
    <description>Patient group 2 includes children who did not develop a Migration Percentage of &gt; 40 % on either hip over a follow-up period of three years</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Radiographic examination with a Migration of &gt; 40 %</intervention_name>
    <description>Radiographic examination</description>
    <arm_group_label>Children who do not develops hip displacement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with cerebral palsy in Denmark. Data will be obtained from the national clinical&#xD;
        quality database the Danish Cerebral Palsy Follow-up Program and the Danish National&#xD;
        Patient Register.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with cerebral palsy&#xD;
&#xD;
          -  Gross Motor Function Classification System III to V&#xD;
&#xD;
          -  Migration Percentage &lt; 40 % for both hips at the first pelvic radiographic examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous femoral osteotomy&#xD;
&#xD;
          -  Previous pelvic osteotomy&#xD;
&#xD;
          -  Previous selective dorsal rhizotomy&#xD;
&#xD;
          -  Intrathecal baclofen pump treatment&#xD;
&#xD;
          -  Children whose diagnosis was not confirmed&#xD;
&#xD;
          -  Children who were no longer followed in the children's ward at the hospital&#xD;
&#xD;
          -  Children who moved out of the area&#xD;
&#xD;
          -  Children who died during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Røn Kristensen, PT, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Afsnit 234- 236, Fysio- og ergoterapien, Hvidovre Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>Region Hovedstaden</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Hermanson M, Hagglund G, Riad J, Rodby-Bousquet E, Wagner P. Prediction of hip displacement in children with cerebral palsy: development of the CPUP hip score. Bone Joint J. 2015 Oct;97-B(10):1441-4. doi: 10.1302/0301-620X.97B10.35978.</citation>
    <PMID>26430023</PMID>
  </reference>
  <reference>
    <citation>Rasmussen HM, Nordbye-Nielsen K, Moller-Madsen B, Johansen M, Ellitsgaard N, Pedersen CR, Rackauskaite G, Engberg H, Pedersen NW. The Danish Cerebral Palsy Follow-up Program. Clin Epidemiol. 2016 Oct 25;8:457-460. doi: 10.2147/CLEP.S99474. eCollection 2016.</citation>
    <PMID>27822084</PMID>
  </reference>
  <reference>
    <citation>Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.</citation>
    <PMID>25371472</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Mette Røn Kristensen</investigator_full_name>
    <investigator_title>Regional coordinator for CPOP in the capital region of Denmark</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Dislocation</mesh_term>
    <mesh_term>Cerebral Palsy</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/NCT04403178
org study id: P-2019-143 2
nct id: NCT04403178
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Children with cerebral palsy have an increased risk of hip dislocation, which is a painful
      and severe complication of cerebral palsy. The 20-years evaluation of the Swedish
      surveillance programme shows that hip dislocation in children with cerebral palsy can be
      prevented with regular clinical and radiographic examination and early intervention.

      We would like to determine the individual risk for hip displacement for Danish children with
      CP in The Danish Cerebral Palsy Follow-up Program. This could be a valuable clinical tool in
      deciding on further follow-up and treatment.
Migration percentage (MP) which is measured from the pelvis radiograph is commonly used to
      assess lateral displacement of the femoral head and is being used in the Swedish and in the
      Danish surveillance programme. Most children with an MP > 40 % need surgery to prevent
      further displacement and prevent dislocation of the hip. In the Swedish surveillance
      programme they have developed the Cerebral Palsy Follow-Up Programme (CPUP) hip score as a
      risk score to determine which children are at high or low risk for hip displacement (MP > 40
      %) within five years after first radiographic examination.

      The aim of this study is to predict the likelihood that a child with cerebral palsy will
      develop hip displacement (MI> 40) within three years. The design is a prediction study.

      Data will be obtained from the national clinical quality database the Danish Cerebral Palsy
      Follow-up Program and the Danish National Patient Register.
observational model: Cohort
time perspective: Prospective
measure: Development of hip displacement or not measured by the Migration Percentage
time frame: Follow-up period of three years.
description: Migration Percentage (MP) is measured from a pelvis radiograph and is used to assess lateral displacement of the femoral head. A MP < 40 % on either hip is a good outcome, whereas a MP > 40 % on either hip is a worse outcome.
arm group label: Children who develops hip displacement
description: Patient group 1 includes children who developed a Migration Percentage of > 40 % in either hip over a follow-up period of three years.
arm group label: Children who do not develops hip displacement
description: Patient group 2 includes children who did not develop a Migration Percentage of > 40 % on either hip over a follow-up period of three years
intervention type: Diagnostic Test
intervention name: Radiographic examination with a Migration of > 40 %
description: Radiographic examination
arm group label: Children who do not develops hip displacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mette Røn Kristensen, PT, MSc
role: Principal Investigator
affiliation: Afsnit 234- 236, Fysio- og ergoterapien, Hvidovre Hospital
facility: 
country: Denmark
citation: Hermanson M, Hagglund G, Riad J, Rodby-Bousquet E, Wagner P. Prediction of hip displacement in children with cerebral palsy: development of the CPUP hip score. Bone Joint J. 2015 Oct;97-B(10):1441-4. doi: 10.1302/0301-620X.97B10.35978.
PMID: 26430023
citation: Rasmussen HM, Nordbye-Nielsen K, Moller-Madsen B, Johansen M, Ellitsgaard N, Pedersen CR, Rackauskaite G, Engberg H, Pedersen NW. The Danish Cerebral Palsy Follow-up Program. Clin Epidemiol. 2016 Oct 25;8:457-460. doi: 10.2147/CLEP.S99474. eCollection 2016.
PMID: 27822084
citation: Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
PMID: 25371472
responsible party type: Sponsor-Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Mette Røn Kristensen
investigator title: Regional coordinator for CPOP in the capital region of Denmark
mesh term: Hip Dislocation
mesh term: Cerebral Palsy
sharing ipd: No