<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/NCT04408885</url>
  </required_header>
  <id_info>
    <org_study_id>Danish EC: 1-10-72-25-20</org_study_id>
    <nct_id>NCT04408885</nct_id>
  </id_info>
  <brief_title>Rehabilitation Treatment of Anterior Cruciate Ligament Rupture</brief_title>
  <official_title>Rehabilitation Treatment of Anterior Cruciate Ligament Rupture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Horsens Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Jutland Regional Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regionshospitalet Silkeborg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Herning Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose with this present study is to investigate the effect og a non-surgical regime in&#xD;
      patients with an Anterior Cruciate ligament injury.&#xD;
&#xD;
      The effect will be measured by patient reported outcome scores, level of function and how&#xD;
      many of the patients are converting to operative treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Changes in patient reported outcome score (IKDC)</measure>
    <time_frame>Baseline - 2 Years</time_frame>
    <description>The International Knee Documentation Committee (0-100)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in patient reported outcome score (KOOS)</measure>
    <time_frame>Baseline - 2 Years</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patient reported outcome score (KNEES-ACL)</measure>
    <time_frame>Baseline - 2 Years</time_frame>
    <description>Knee Numeric-Entity Evaluation Score (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patient reported outcome score (TEGNER)</measure>
    <time_frame>Baseline - 2 Years</time_frame>
    <description>Activity scale (0-10)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>ACL Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will include 400 patients with Anterior cruciate ligament injury. Patients will be&#xD;
        included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anterior cruciate ligament injury where rehabilitation regime is selected as&#xD;
             treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other knee ligament instability&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Morbus Bechterews Disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Torsten G Nielsen, PT</last_name>
    <phone>+4540491184</phone>
    <email>torsne@rm.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Lind, Professor</last_name>
    <phone>+4530248244</phone>
    <email>martli@rm.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Sports Trauma, Palle Juul-Jensens Boulevard 99</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Lind, Professor</last_name>
      <phone>+45 30248244</phone>
      <email>martli@rm.dk</email>
    </contact>
    <contact_backup>
      <last_name>Torsten Nielsen, coordinator</last_name>
      <phone>+45 40491184</phone>
      <email>torsne@rm.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Martin Lind</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be available for other researchers</ipd_description>
  </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/NCT04408885
org study id: Danish EC: 1-10-72-25-20
nct id: NCT04408885
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose with this present study is to investigate the effect og a non-surgical regime in
      patients with an Anterior Cruciate ligament injury.

      The effect will be measured by patient reported outcome scores, level of function and how
      many of the patients are converting to operative treatment.
observational model: Cohort
time perspective: Prospective
measure: Changes in patient reported outcome score (IKDC)
time frame: Baseline - 2 Years
description: The International Knee Documentation Committee (0-100)
measure: Changes in patient reported outcome score (KOOS)
time frame: Baseline - 2 Years
description: Knee injury and Osteoarthritis Outcome Score (0-100)
measure: Changes in patient reported outcome score (KNEES-ACL)
time frame: Baseline - 2 Years
description: Knee Numeric-Entity Evaluation Score (0-100)
measure: Changes in patient reported outcome score (TEGNER)
time frame: Baseline - 2 Years
description: Activity scale (0-10)
intervention type: Other
intervention name: Rehabilitation
description: Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Torsten G Nielsen, PT
phone: +4540491184
email: torsne@rm.dk
last name: Martin Lind, Professor
phone: +4530248244
email: martli@rm.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Martin Lind
investigator title: Professor
mesh term: Rupture
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: No
ipd description: Data will not be available for other researchers