<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/NCT02993679</url>
  </required_header>
  <id_info>
    <org_study_id>Hospital Znojmo</org_study_id>
    <nct_id>NCT02993679</nct_id>
  </id_info>
  <brief_title>Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction</brief_title>
  <official_title>Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Znojmo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Znojmo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this randomised cohort study was to evaluate the knee rotational stability&#xD;
      after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and&#xD;
      to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when&#xD;
      the ALL is necessary to reconstruct.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Rotational instability after the anterior cruciate ligament (ACL) injury and&#xD;
      subsequent reconstruction may be caused by the rupture of the anterolateral structures of the&#xD;
      knee, specifically the anterolateral ligament (ALL).&#xD;
&#xD;
      There are more techniques to improve the rotational stability of the knee. The objective of&#xD;
      this randomised cohort study was: (1) To evaluate the knee rotational stability after the&#xD;
      single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare&#xD;
      it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is&#xD;
      necessary to reconstruct.&#xD;
&#xD;
      Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In&#xD;
      thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB&#xD;
      technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With&#xD;
      another thirty patients the ACL was reconstructed performing DB technique with the use of&#xD;
      hamstring tendons (DB group). The rotational stability was studied before and after the&#xD;
      reconstruction of the ACL in time &quot;zero&quot; using the computer navigation system. In the ALL&#xD;
      group, the rotational stability was also analysed after the ALL reconstruction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.</measure>
    <time_frame>24 months after the operation</time_frame>
    <description>Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cruciate Ligament Rupture</condition>
  <arm_group>
    <arm_group_label>double-bundle ACL reconstruction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>surgical reconstruction of the anterior cruciate ligament</description>
  </arm_group>
  <arm_group>
    <arm_group_label>anterolateral ligament reconstruction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>surgical reconstruction of the anterolateral ligament</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>reconstruction of the ACL and anterolateral ligament</intervention_name>
    <description>reconstruction of the ACL and anterolateral ligament</description>
    <arm_group_label>anterolateral ligament reconstruction</arm_group_label>
    <arm_group_label>double-bundle ACL reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The isolated ACL lesion&#xD;
&#xD;
          -  The absence of the previous surgery on the knee joint&#xD;
&#xD;
          -  The body mass index (BMI) less than 30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated injuries of the tissue around the knee joint&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Znojmo</investigator_affiliation>
    <investigator_full_name>Komzak Martin, M.D.</investigator_full_name>
    <investigator_title>General Hospital Znojmo</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</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/NCT02993679
org study id: Hospital Znojmo
nct id: NCT02993679
lead sponsor: 
has dmc: No
The objective of this randomised cohort study was to evaluate the knee rotational stability
      after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and
      to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when
      the ALL is necessary to reconstruct.
Background Rotational instability after the anterior cruciate ligament (ACL) injury and
      subsequent reconstruction may be caused by the rupture of the anterolateral structures of the
      knee, specifically the anterolateral ligament (ALL).

      There are more techniques to improve the rotational stability of the knee. The objective of
      this randomised cohort study was: (1) To evaluate the knee rotational stability after the
      single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare
      it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is
      necessary to reconstruct.

      Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In
      thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB
      technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With
      another thirty patients the ACL was reconstructed performing DB technique with the use of
      hamstring tendons (DB group). The rotational stability was studied before and after the
      reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL
      group, the rotational stability was also analysed after the ALL reconstruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.
time frame: 24 months after the operation
description: Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.
arm group label: double-bundle ACL reconstruction
arm group type: Other
description: surgical reconstruction of the anterior cruciate ligament
arm group label: anterolateral ligament reconstruction
arm group type: Other
description: surgical reconstruction of the anterolateral ligament
intervention type: Procedure
intervention name: reconstruction of the ACL and anterolateral ligament
description: reconstruction of the ACL and anterolateral ligament
arm group label: anterolateral ligament reconstruction
arm group label: double-bundle ACL reconstruction
criteria: 
gender: All
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital Znojmo
investigator full name: Komzak Martin, M.D.
investigator title: General Hospital Znojmo
mesh term: Rupture
sharing ipd: Undecided