<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/NCT03827980</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02393</org_study_id>
    <nct_id>NCT03827980</nct_id>
  </id_info>
  <brief_title>Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients</brief_title>
  <acronym>LOOP</acronym>
  <official_title>LOOP- Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Ulrich Heininger</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Luzerner Kantonsspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Children's Hospital Basel</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>
      Multi-centre clinical follow-up study on patients with a history of acute haematogenous&#xD;
      osteomyelitis and/or septic arthritis. The aim is to describe the frequency of sequelae in&#xD;
      these former patients with osteoarticular infections. Patients will be invited to participate&#xD;
      in a single follow-up visit including a standardised interview and a clinical examination.&#xD;
      The collected data will be analyzed together with data from the patient's hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical follow-up study on patients with a history of acute haematogenous osteomyelitis&#xD;
      and/or septic arthritis and were admitted to one of the participating centres between 2005&#xD;
      and 2014.&#xD;
&#xD;
      Former patients will be invited to participate in a single-follow-up visit which comprises a&#xD;
      standardised interview (pain, disabilities in daily life and regarding sports) and a&#xD;
      standardized clinical examination of the previously affected body part. This includes&#xD;
      assessment of range of motion in affected and adjacent joints and in case of previously&#xD;
      affected lower extremity leg axis, gait and body height (percentile).&#xD;
&#xD;
      The data collected during the follow-up visit will be analyzed in a descriptive manner&#xD;
      together with data of the patient's hospital stay including baseline data, laboratory works,&#xD;
      microbiological results and both antibiotic and surgical treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>subjective sequelae score of previously affected body region: lower extremity</measure>
    <time_frame>Day 1 (at single study visit)</time_frame>
    <description>Assessment of current pain and ability to perform physical activities summarized in a Subjective Sequelae Score modified after the PODCI (Pediatric Outcomes Data Collection Instrument) questionnaire and score:&#xD;
Lower Extremity: 11 Questions, Points 0-35, 0 = no disabilities, 1-11 = minor disability, 12-23 = moderate disability, 24-35 = severe disability Question 1: Current pain: (0-5 Points: never/less than once a month/once a month/once a week/more than once a week/daily) Questions 2-11 (0-3 Points never/less than once a month/once a month/once a week/more than once a week/daily) 2) Short distance running 3) Long distance running 4) Walking &gt; 100m 5) Walking &gt; 1000m 6) Climbing stairs 7) Walking uphill 8) Walking downhill 9) Participation in ball games/sports 10) Kneeling down 11) Sitting low (e.g. car, couch)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>subjective sequelae score of previously affected body region: upper extremity</measure>
    <time_frame>Day 1 (at single study visit)</time_frame>
    <description>Assessment of current pain and ability to perform physical activities summarized in a Subjective Sequelae Score modified after the PODCI (Pediatric Outcomes Data Collection Instrument) questionnaire and score:&#xD;
Upper Extremity: 6 Questions, Points 0-35, 0 = no disabilities, 1-6 = minor disability, 7-13 = moderate disability, 14-20 = severe disability Question 1: Current pain: (0-5 Points: never/less than once a month/once a month/once a week/more than once a week/daily) Questions 2-6 (0-3 Points never/less than once a month/once a month/once a week/more than once a week/daily) 2) Light work with upper body 3) Heavy work (e.g. Lifting heavy things) 4) Using Tools 5) Putting weight on upper body 6) Overhead work</description>
  </primary_outcome>
  <primary_outcome>
    <measure>relevant restricted range of motion</measure>
    <time_frame>Day 1 (at single study visit)</time_frame>
    <description>restricted range of motion of &gt; 20° of previously affected body part / joint compared to the other side</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>asymmetric axis of leg or arm</measure>
    <time_frame>Day 1 (at single study visit)</time_frame>
    <description>asymmetric leg or arm axis of previously affected lower or upper limb, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>limb length discrepancy of &gt; 1cm</measure>
    <time_frame>Day 1 (at single study visit)</time_frame>
    <description>asymmetric length of legs/arms of previously affected lower or upper limb, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abnormal gait (only in case of previously affected lower limb)</measure>
    <time_frame>Day 1 (at single study visit)</time_frame>
    <description>abnormal gait (e.g. limping) at examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>z-score decline of body height since hospital discharge (only in case of previously affected lower limb)</measure>
    <time_frame>variable, between 4 and 14 years, depending on time frame between date of discharge and today's study visit.</time_frame>
    <description>decline in body height between hospital discharge and study visit</description>
  </secondary_outcome>
  <enrollment type="Actual">78</enrollment>
  <condition>Acute Haematogenous Osteomyelitis</condition>
  <condition>Septic Arthritis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention, only clinical examination</intervention_name>
    <description>standardised interview and clinical examination</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Former patients admitted to one of the participating centres for an acute osteoarticular&#xD;
        infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were previously admitted to the participating centres between January&#xD;
             2005 and November 2014&#xD;
&#xD;
          -  Patients with an International Classification of Disease code (ICD-10) discharge code&#xD;
             of acute osteomyelitis (M86.00-M86.99) and/or septic arthritis (M00.00-M00.99)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  onset of symptoms &gt; 2 weeks before admission&#xD;
&#xD;
          -  history of penetrating wound or Prior surgery at affected limb&#xD;
&#xD;
          -  incorrect ICD-10 coding&#xD;
&#xD;
          -  chronic or severe underlying disease or Treatment at time of infection that possibly&#xD;
             compromises the patient's immunologic Response (e.g. cancer, immunodeficiency,&#xD;
             immunosuppressive therapy)&#xD;
&#xD;
          -  insufficient command of German language to understand patient Information and informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>32 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nora Manz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Children's Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Children's Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel-Stadt</state>
        <zip>4056</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Lucerne</name>
      <address>
        <city>Lucerne</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Manz N, Krieg AH, Heininger U, Ritz N. Evaluation of the current use of imaging modalities and pathogen detection in children with acute osteomyelitis and septic arthritis. Eur J Pediatr. 2018 Jul;177(7):1071-1080. doi: 10.1007/s00431-018-3157-3. Epub 2018 May 4.</citation>
    <PMID>29728840</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Children's Hospital Basel</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Ulrich Heininger</investigator_full_name>
    <investigator_title>Chair, Infectious Diseases/Vaccinology</investigator_title>
  </responsible_party>
  <keyword>Acute Haematogenous Osteomyelitis</keyword>
  <keyword>Septic Arthritis</keyword>
  <keyword>Outcome</keyword>
  <keyword>Osteoarticular Infections</keyword>
  <keyword>Follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03827980
org study id: 2018-02393
nct id: NCT03827980
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multi-centre clinical follow-up study on patients with a history of acute haematogenous
      osteomyelitis and/or septic arthritis. The aim is to describe the frequency of sequelae in
      these former patients with osteoarticular infections. Patients will be invited to participate
      in a single follow-up visit including a standardised interview and a clinical examination.
      The collected data will be analyzed together with data from the patient's hospital stay.
Clinical follow-up study on patients with a history of acute haematogenous osteomyelitis
      and/or septic arthritis and were admitted to one of the participating centres between 2005
      and 2014.

      Former patients will be invited to participate in a single-follow-up visit which comprises a
      standardised interview (pain, disabilities in daily life and regarding sports) and a
      standardized clinical examination of the previously affected body part. This includes
      assessment of range of motion in affected and adjacent joints and in case of previously
      affected lower extremity leg axis, gait and body height (percentile).

      The data collected during the follow-up visit will be analyzed in a descriptive manner
      together with data of the patient's hospital stay including baseline data, laboratory works,
      microbiological results and both antibiotic and surgical treatment.
observational model: Other
time perspective: Cross-Sectional
measure: subjective sequelae score of previously affected body region: lower extremity
time frame: Day 1 (at single study visit)
description: Assessment of current pain and ability to perform physical activities summarized in a Subjective Sequelae Score modified after the PODCI (Pediatric Outcomes Data Collection Instrument) questionnaire and score:
Lower Extremity: 11 Questions, Points 0-35, 0 = no disabilities, 1-11 = minor disability, 12-23 = moderate disability, 24-35 = severe disability Question 1: Current pain: (0-5 Points: never/less than once a month/once a month/once a week/more than once a week/daily) Questions 2-11 (0-3 Points never/less than once a month/once a month/once a week/more than once a week/daily) 2) Short distance running 3) Long distance running 4) Walking > 100m 5) Walking > 1000m 6) Climbing stairs 7) Walking uphill 8) Walking downhill 9) Participation in ball games/sports 10) Kneeling down 11) Sitting low (e.g. car, couch)
measure: subjective sequelae score of previously affected body region: upper extremity
time frame: Day 1 (at single study visit)
description: Assessment of current pain and ability to perform physical activities summarized in a Subjective Sequelae Score modified after the PODCI (Pediatric Outcomes Data Collection Instrument) questionnaire and score:
Upper Extremity: 6 Questions, Points 0-35, 0 = no disabilities, 1-6 = minor disability, 7-13 = moderate disability, 14-20 = severe disability Question 1: Current pain: (0-5 Points: never/less than once a month/once a month/once a week/more than once a week/daily) Questions 2-6 (0-3 Points never/less than once a month/once a month/once a week/more than once a week/daily) 2) Light work with upper body 3) Heavy work (e.g. Lifting heavy things) 4) Using Tools 5) Putting weight on upper body 6) Overhead work
measure: relevant restricted range of motion
time frame: Day 1 (at single study visit)
description: restricted range of motion of > 20° of previously affected body part / joint compared to the other side
measure: asymmetric axis of leg or arm
time frame: Day 1 (at single study visit)
description: asymmetric leg or arm axis of previously affected lower or upper limb, respectively.
measure: limb length discrepancy of > 1cm
time frame: Day 1 (at single study visit)
description: asymmetric length of legs/arms of previously affected lower or upper limb, respectively.
measure: abnormal gait (only in case of previously affected lower limb)
time frame: Day 1 (at single study visit)
description: abnormal gait (e.g. limping) at examination
measure: z-score decline of body height since hospital discharge (only in case of previously affected lower limb)
time frame: variable, between 4 and 14 years, depending on time frame between date of discharge and today's study visit.
description: decline in body height between hospital discharge and study visit
intervention type: Other
intervention name: no intervention, only clinical examination
description: standardised interview and clinical examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 32 Years
healthy volunteers: No
last name: Nora Manz, MD
role: Principal Investigator
affiliation: University Children's Hospital Basel
facility: 
facility: 
country: Switzerland
citation: Manz N, Krieg AH, Heininger U, Ritz N. Evaluation of the current use of imaging modalities and pathogen detection in children with acute osteomyelitis and septic arthritis. Eur J Pediatr. 2018 Jul;177(7):1071-1080. doi: 10.1007/s00431-018-3157-3. Epub 2018 May 4.
PMID: 29728840
responsible party type: Sponsor-Investigator
investigator affiliation: University Children's Hospital Basel
investigator full name: Prof. Dr. Ulrich Heininger
investigator title: Chair, Infectious Diseases/Vaccinology
mesh term: Infections
mesh term: Osteomyelitis
mesh term: Arthritis, Infectious
mesh term: Arthritis
sharing ipd: Undecided