xml: <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/NCT06001164</url>
    </required_header>
    <id_info>
      <org_study_id>R20001</org_study_id>
      <nct_id>NCT06001164</nct_id>
    </id_info>
    <brief_title>Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction</brief_title>
    <official_title>Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tampere University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tampere 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 of this study is to compare double-bundle and single-bundle techniques for ACL&#xD;
        reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is&#xD;
        better than the SB technique.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 6, 2021</start_date>
    <completion_date type="Actual">September 30, 2022</completion_date>
    <primary_completion_date type="Actual">September 30, 2022</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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>osteoarthritis (OA)</measure>
      <time_frame>15 years</time_frame>
      <description>which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pivot shift</measure>
      <time_frame>15 years</time_frame>
      <description>which group has more positive pivot shift tests? Always compared to a &quot;healthy&quot; knee.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>KT-1000 arthrometer difference</measure>
      <time_frame>15 years</time_frame>
      <description>Anteroposterior translation. Always compared to a &quot;healthy&quot; knee. mm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lysholm score</measure>
      <time_frame>15 years</time_frame>
      <description>subjective evaluation form. Scale 0-100 (100=best)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IKDC subjective evaluation. Scale 0-100 (100=best)</measure>
      <time_frame>15 years</time_frame>
      <description>subjective evaluation form</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IKDC objective score. Scale 1-4 (1=best)</measure>
      <time_frame>15 years</time_frame>
      <description>Overall evaluation of the knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>graft failures</measure>
      <time_frame>15 years</time_frame>
      <description>which group has more graft failures? The number of graft failures was assessed by revision surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range on motion (ROM) of the knee</measure>
      <time_frame>15 years</time_frame>
      <description>Which group has more lack of knee extension or lack of knee flexion? Injured knee is always compared to a contralateral &quot;healthy&quot; knee. Measurements were performed with a goniometer. ROM included lack of passive extension (normal &lt; 3°, nearly normal 3-5°, abnormal 6-10°, and severely abnormal &gt; 10°) and lack of passive flexion (normal 0-5°, nearly normal 6-15°, abnormal 16-25°, and severely abnormal &gt; 25°).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>One leg hop test</measure>
      <time_frame>15 years</time_frame>
      <description>One leg hop test was performed to assess the functional capacity of the knee. The patient hopped a maximum length three times on each leg separately and the best result was recorded for both legs. The result of the operated leg was then compared with that of the non-operated leg.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">153</enrollment>
    <condition>ACL Injury</condition>
    <arm_group>
      <arm_group_label>Double-bundle</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Single-bundle</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ACL reconstruction: Double bundle</intervention_name>
      <description>DB: Two tunnels were created on the femoral side through an anteromedial portal. These tunnels were created manually. On the tibial side, the tunnels were created using a guide to ensure they matched the anatomic insertion site of the ACL at the tibia. The hamstring grafts for the procedure were then harvested from the same leg and doubled. The femoral side was fixed from the inside out, whereas the tibial side was fixed from the outside in. bioresorbable screws were used.</description>
      <arm_group_label>Double-bundle</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ACL reconstruction: Single bundle</intervention_name>
      <description>SB: The femoral tunnel was created using an anteromedial portal. A freehand technique was used. For the tibial tunnel, a tibial guide was used to ensure it was positioned at the midpoint of the tibial ACL attachment site. The tendons of the semitendinosus and gracilis muscles were then harvested, doubled over, and inserted through the tibial tunnel, extending into the femur, and fixed with metallic or bioabsorbable interference screws.</description>
      <arm_group_label>Single-bundle</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be eligible for the study, patients had to meet certain criteria, including primary&#xD;
               ACL reconstruction, closed growth plates, and no ligamentous injuries to the&#xD;
               contralateral knee.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Orthopaedics, Tampere University Hospital</name>
        <address>
          <city>Tampere</city>
          <country>Finland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Finland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tampere University Hospital</investigator_affiliation>
      <investigator_full_name>Arttu Seppanen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001164
  org study id: R20001
  nct id: NCT06001164
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare double-bundle and single-bundle techniques for ACL
        reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is
        better than the SB technique.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: osteoarthritis (OA)
  time frame: 15 years
  description: which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
  measure: Pivot shift
  time frame: 15 years
  description: which group has more positive pivot shift tests? Always compared to a "healthy" knee.
  measure: KT-1000 arthrometer difference
  time frame: 15 years
  description: Anteroposterior translation. Always compared to a "healthy" knee. mm.
  measure: Lysholm score
  time frame: 15 years
  description: subjective evaluation form. Scale 0-100 (100=best)
  measure: IKDC subjective evaluation. Scale 0-100 (100=best)
  time frame: 15 years
  description: subjective evaluation form
  measure: IKDC objective score. Scale 1-4 (1=best)
  time frame: 15 years
  description: Overall evaluation of the knee
  measure: graft failures
  time frame: 15 years
  description: which group has more graft failures? The number of graft failures was assessed by revision surgery.
  measure: Range on motion (ROM) of the knee
  time frame: 15 years
  description: Which group has more lack of knee extension or lack of knee flexion? Injured knee is always compared to a contralateral "healthy" knee. Measurements were performed with a goniometer. ROM included lack of passive extension (normal < 3°, nearly normal 3-5°, abnormal 6-10°, and severely abnormal > 10°) and lack of passive flexion (normal 0-5°, nearly normal 6-15°, abnormal 16-25°, and severely abnormal > 25°).
  measure: One leg hop test
  time frame: 15 years
  description: One leg hop test was performed to assess the functional capacity of the knee. The patient hopped a maximum length three times on each leg separately and the best result was recorded for both legs. The result of the operated leg was then compared with that of the non-operated leg.
  arm group label: Double-bundle
  arm group type: Active Comparator
  arm group label: Single-bundle
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: ACL reconstruction: Double bundle
  description: DB: Two tunnels were created on the femoral side through an anteromedial portal. These tunnels were created manually. On the tibial side, the tunnels were created using a guide to ensure they matched the anatomic insertion site of the ACL at the tibia. The hamstring grafts for the procedure were then harvested from the same leg and doubled. The femoral side was fixed from the inside out, whereas the tibial side was fixed from the outside in. bioresorbable screws were used.
  arm group label: Double-bundle
  intervention type: Procedure
  intervention name: ACL reconstruction: Single bundle
  description: SB: The femoral tunnel was created using an anteromedial portal. A freehand technique was used. For the tibial tunnel, a tibial guide was used to ensure it was positioned at the midpoint of the tibial ACL attachment site. The tendons of the semitendinosus and gracilis muscles were then harvested, doubled over, and inserted through the tibial tunnel, extending into the femur, and fixed with metallic or bioabsorbable interference screws.
  arm group label: Single-bundle
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Finland
  responsible party type: Principal Investigator
  investigator affiliation: Tampere University Hospital
  investigator full name: Arttu Seppanen
  investigator title: Principal Investigator
  mesh term: Anterior Cruciate Ligament Injuries
  sharing ipd: No