<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/NCT03800225</url>
  </required_header>
  <id_info>
    <org_study_id>Danish EC - 1-10-72-223-18.</org_study_id>
    <nct_id>NCT03800225</nct_id>
  </id_info>
  <brief_title>Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.</brief_title>
  <official_title>Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus 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>
      The purpose of this study is to determine whether anterior cruciate ligament injury in&#xD;
      patients wishing to return to sports activities may be treated with repair supplemented with&#xD;
      internal brace compared with a standard operation using a patella tendon autograft.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    A new scientific study shows that surgery with internal brace is worse than convensional&#xD;
    surgery tecnic. This new knowledge stops this trial.&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">September 4, 2019</completion_date>
  <primary_completion_date type="Actual">September 4, 2019</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Laxity</measure>
    <time_frame>12 Months</time_frame>
    <description>KT-1000 arthrometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>12 Months</time_frame>
    <description>Koos (Knee injury and Osteoarthritis Outcome Score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>12 Months</time_frame>
    <description>IKDC (International Knee Documentation Committee)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measurement</measure>
    <time_frame>12 Months</time_frame>
    <description>NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Ligament; Laxity, Knee</condition>
  <condition>Anterior Cruciate Ligament Injury</condition>
  <arm_group>
    <arm_group_label>Repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anterior cruciate ligament repair with internal brace after anterior ligament rupture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patella tendon graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Repair</intervention_name>
    <description>Anterior ligament repair with internal brace.</description>
    <arm_group_label>Patella tendon graft</arm_group_label>
    <arm_group_label>Repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anterior cruciate ligament rupture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current malignant disease&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Other knee ligament instability&#xD;
&#xD;
          -  Obesity BMI &gt;30&#xD;
&#xD;
          -  Morbus Bechterew&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</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>
  <!-- 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/NCT03800225
org study id: Danish EC - 1-10-72-223-18.
nct id: NCT03800225
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether anterior cruciate ligament injury in
      patients wishing to return to sports activities may be treated with repair supplemented with
      internal brace compared with a standard operation using a patella tendon autograft.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Knee Laxity
time frame: 12 Months
description: KT-1000 arthrometer
measure: Patient reported outcome scores
time frame: 12 Months
description: Koos (Knee injury and Osteoarthritis Outcome Score)
measure: Patient reported outcome scores
time frame: 12 Months
description: IKDC (International Knee Documentation Committee)
measure: Pain measurement
time frame: 12 Months
description: NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)
arm group label: Repair
arm group type: Experimental
description: Anterior cruciate ligament repair with internal brace after anterior ligament rupture.
arm group label: Patella tendon graft
arm group type: Active Comparator
description: The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.
intervention type: Procedure
intervention name: Repair
description: Anterior ligament repair with internal brace.
arm group label: Patella tendon graft
arm group label: Repair
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
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