<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/NCT02974205</url>
  </required_header>
  <id_info>
    <org_study_id>579239</org_study_id>
    <nct_id>NCT02974205</nct_id>
  </id_info>
  <brief_title>Rehabilitation of Patient With Acute Isolated PCL Rupture</brief_title>
  <official_title>Kneelaxity and Self-reported Knee Function After Rehabilitation With the Use of Dynamic Kneeorthosis for Patients With Acute Isolated Posterior Cruciate Ligament Injury: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are&#xD;
      varying. The purpose of the study is to explore if one rehabilitation option is preferable to&#xD;
      one other for patients with acute PCL injury, by examining whether there will be differences&#xD;
      in laxity in the knee joints and patient-reported knee function by three different&#xD;
      rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be&#xD;
      followed up 3 and 12 months after injury. The groups will be compared using kneelaxity&#xD;
      (stress - X) and subjective knee function (KOOS, IKDC-2000)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are&#xD;
      varying. The purpose of the study is to explore if one rehabilitation option is preferable to&#xD;
      one other for patients with acute PCL injury, by examining whether there will be differences&#xD;
      in laxity in the knee joints and patient-reported knee function by three different&#xD;
      rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be&#xD;
      followed up 3 and 12 months after injury. The groups will be compared using kneelaxity&#xD;
      (stress - X) and subjective knee function (KOOS, IKDC-2000) to indicate whether one&#xD;
      rehabilitation alternative is preferable in terms of less knee joint laxity and improve knee&#xD;
      function. Participants considered included in the study if he or she agrees to participate in&#xD;
      the study by signing the informed consent. Inclusion criteria will be whether the patient has&#xD;
      an acute isolated PCL injury. Exclusion is additional injuries of ligaments, cartilage and&#xD;
      meniscus of the knee. Randomization to groups is done continuously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCL stress-radiograph</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>KOOS (Knee Injury and Osteoarthritis Outcome score)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IKDC-2000 (Subjective Knee Evaluation Form)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One leg hop (in meters)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>PCL</condition>
  <arm_group>
    <arm_group_label>Rehabilitation with orthosis (Jack brace)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation without orthosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation with orthosis (össur brace)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Jack brace</intervention_name>
    <description>Rehabilitation after acute isolated PCL rupture with orthosis</description>
    <arm_group_label>Rehabilitation with orthosis (Jack brace)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>Rehabilitation after acute isolated PCL rupture without orthosis</description>
    <arm_group_label>Rehabilitation without orthosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>össur brace</intervention_name>
    <description>Rehabilitation after acute isolated PCL rupture</description>
    <arm_group_label>Rehabilitation with orthosis (össur brace)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute isolated PCL injury : 0- 3 weeks ( maximum 21 days) from the initial injury&#xD;
&#xD;
          -  Isolated PCL rupture (grade I, II and III)&#xD;
&#xD;
          -  Patient age should be between 16-60 years ( with closed epiphyseal plate )&#xD;
&#xD;
          -  Understood and accepted written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injury to the ACL or other ligaments in the knee&#xD;
&#xD;
          -  Extensive injury to the cartilage or meniscus , requiring repairs&#xD;
&#xD;
          -  Unfit to understand or to sign consent&#xD;
&#xD;
          -  History of alcohol or drug abuse in the past three years&#xD;
&#xD;
          -  Current serious illness or injury that makes rehabilitation difficult.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Engebretsen, Dr. Med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ingrid Trøan, PT</last_name>
    <phone>+479888593</phone>
    <email>ingrid.troan@ous-hf.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karin Bredland, PT, MSc</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hilde Stømner, PT</last_name>
      <email>Hilde.Christina.Stomner@ahus.no</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0182</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingrid Trøan, PT</last_name>
      <phone>22117213</phone>
      <email>uxtrai@ous-hf.no</email>
    </contact>
    <contact_backup>
      <last_name>Karin Bredland, PT, MSc</last_name>
      <phone>22117213</phone>
      <email>uxkbar@ous-hf.no</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Ingrid Trøan</investigator_full_name>
    <investigator_title>PT, MSc</investigator_title>
  </responsible_party>
  <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/NCT02974205
org study id: 579239
nct id: NCT02974205
lead sponsor: 
collaborator: 
has dmc: Yes
The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are
      varying. The purpose of the study is to explore if one rehabilitation option is preferable to
      one other for patients with acute PCL injury, by examining whether there will be differences
      in laxity in the knee joints and patient-reported knee function by three different
      rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be
      followed up 3 and 12 months after injury. The groups will be compared using kneelaxity
      (stress - X) and subjective knee function (KOOS, IKDC-2000)
The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are
      varying. The purpose of the study is to explore if one rehabilitation option is preferable to
      one other for patients with acute PCL injury, by examining whether there will be differences
      in laxity in the knee joints and patient-reported knee function by three different
      rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be
      followed up 3 and 12 months after injury. The groups will be compared using kneelaxity
      (stress - X) and subjective knee function (KOOS, IKDC-2000) to indicate whether one
      rehabilitation alternative is preferable in terms of less knee joint laxity and improve knee
      function. Participants considered included in the study if he or she agrees to participate in
      the study by signing the informed consent. Inclusion criteria will be whether the patient has
      an acute isolated PCL injury. Exclusion is additional injuries of ligaments, cartilage and
      meniscus of the knee. Randomization to groups is done continuously.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PCL stress-radiograph
time frame: 12 month
measure: KOOS (Knee Injury and Osteoarthritis Outcome score)
time frame: 12 month
measure: IKDC-2000 (Subjective Knee Evaluation Form)
time frame: 12 month
measure: One leg hop (in meters)
time frame: 12 month
arm group label: Rehabilitation with orthosis (Jack brace)
arm group type: Active Comparator
arm group label: Rehabilitation without orthosis
arm group type: Active Comparator
arm group label: Rehabilitation with orthosis (össur brace)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Jack brace
description: Rehabilitation after acute isolated PCL rupture with orthosis
arm group label: Rehabilitation with orthosis (Jack brace)
intervention type: Device
intervention name: Rehabilitation
description: Rehabilitation after acute isolated PCL rupture without orthosis
arm group label: Rehabilitation without orthosis
intervention type: Device
intervention name: össur brace
description: Rehabilitation after acute isolated PCL rupture
arm group label: Rehabilitation with orthosis (össur brace)
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lars Engebretsen, Dr. Med
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Ingrid Trøan, PT
phone: +479888593
email: ingrid.troan@ous-hf.no
last name: Karin Bredland, PT, MSc
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Ingrid Trøan
investigator title: PT, MSc
sharing ipd: No