<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/NCT01727739</url>
  </required_header>
  <id_info>
    <org_study_id>B2012:059</org_study_id>
    <nct_id>NCT01727739</nct_id>
  </id_info>
  <brief_title>Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews</brief_title>
  <official_title>Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panam Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panam Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings&#xD;
      autograft may contribute to failure of the graft and/or present technical challenges&#xD;
      secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be&#xD;
      made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing&#xD;
      the biomechanical properties of the graft construct. The purpose of this investigation is to&#xD;
      examine the tibial tunnel widening relationship between bioabsorbable interference screws&#xD;
      composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws&#xD;
      composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as&#xD;
      tibial fixation devices.&#xD;
&#xD;
      Specifically the study has the following objectives: 1) To quantify the extent of tibial&#xD;
      tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled&#xD;
      hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the&#xD;
      bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To&#xD;
      hypothesize mechanisms for any observed differences between tibial fixation devices; and 4)&#xD;
      To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the&#xD;
      PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial&#xD;
      tunnel widening around the implant but rather between the implant and articular surface,&#xD;
      compared to the PLLA alone screw. It is also hypothesized that there will be no effect of&#xD;
      observed tunnel widening on clinical outcomes or graft failure rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>Radiographs</measure>
    <time_frame>12 months post op</time_frame>
    <description>At 3-, 6- and 12-months post-operatively, subjects will undergo radiographic examination of their affected knee (standardized AP and lateral views) for analysis of tibial tunnel parameters. Radiographic analysis will be conducted by a single orthopaedic surgeon/fellow/resident blinded to subject group and clinical examination results. Parameters to be recorded and analyzed according to a standardized method: tibial tunnel diameter (max/min).&#xD;
We will also look for: Evidence of lysis in the tunnel and changes in morphological features of tunnel over time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ACL Quality of Life Scores</measure>
    <time_frame>12 months post op</time_frame>
    <description>Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>IKDC Assessment</measure>
    <time_frame>12 months post op</time_frame>
    <description>Range of motion assessment at 3-,6-and 12-months post operatively.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>ACL</condition>
  <arm_group>
    <arm_group_label>PLLA bioscrew</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>poly-L-lactic acid bioscrew</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLLA+TCP bioscrew</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>poly-l-lactic acid with beta tricalcium phosphate bioscrew</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Linvatec PLLA+TCP</intervention_name>
    <description>Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.</description>
    <arm_group_label>PLLA+TCP bioscrew</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Linvatec PLLA</intervention_name>
    <description>Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.</description>
    <arm_group_label>PLLA bioscrew</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have a unilateral ACL rupture&#xD;
&#xD;
          -  Patients must be between 18 and 45 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant medial collateral, lateral collateral, or posterior collateral ligament&#xD;
             tears&#xD;
&#xD;
          -  Severe chondromalacia or severe meniscal tear&#xD;
&#xD;
          -  Previous history of ipsilateral knee joint pathology, surgery, or trauma to that knee&#xD;
&#xD;
          -  Unwillingness to be followed for 12 months post-operatively&#xD;
&#xD;
          -  History of arthritis (osteoarthritis or rheumatoid)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Psychiatric illness that precludes informed consent&#xD;
&#xD;
          -  Unable to speak or read English/French&#xD;
&#xD;
          -  Major medical illness (life expectancy less than 1 year or unacceptably high operative&#xD;
             risk)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter B MacDonald, MD FRCS(C)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pan Am Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pan Am Clinic</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3M 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>March 15, 2019</last_update_submitted>
  <last_update_submitted_qc>March 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Panam Clinic</investigator_affiliation>
    <investigator_full_name>Peter MacDonald</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <keyword>Tibial tunnel widening</keyword>
  <keyword>Interference screws</keyword>
  <!-- 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/NCT01727739
org study id: B2012:059
nct id: NCT01727739
lead sponsor: 
has dmc: No
Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings
      autograft may contribute to failure of the graft and/or present technical challenges
      secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be
      made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing
      the biomechanical properties of the graft construct. The purpose of this investigation is to
      examine the tibial tunnel widening relationship between bioabsorbable interference screws
      composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws
      composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as
      tibial fixation devices.

      Specifically the study has the following objectives: 1) To quantify the extent of tibial
      tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled
      hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the
      bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To
      hypothesize mechanisms for any observed differences between tibial fixation devices; and 4)
      To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the
      PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial
      tunnel widening around the implant but rather between the implant and articular surface,
      compared to the PLLA alone screw. It is also hypothesized that there will be no effect of
      observed tunnel widening on clinical outcomes or graft failure rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Radiographs
time frame: 12 months post op
description: At 3-, 6- and 12-months post-operatively, subjects will undergo radiographic examination of their affected knee (standardized AP and lateral views) for analysis of tibial tunnel parameters. Radiographic analysis will be conducted by a single orthopaedic surgeon/fellow/resident blinded to subject group and clinical examination results. Parameters to be recorded and analyzed according to a standardized method: tibial tunnel diameter (max/min).
We will also look for: Evidence of lysis in the tunnel and changes in morphological features of tunnel over time
measure: ACL Quality of Life Scores
time frame: 12 months post op
description: Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.
measure: IKDC Assessment
time frame: 12 months post op
description: Range of motion assessment at 3-,6-and 12-months post operatively.
arm group label: PLLA bioscrew
arm group type: Active Comparator
description: poly-L-lactic acid bioscrew
arm group label: PLLA+TCP bioscrew
arm group type: Active Comparator
description: poly-l-lactic acid with beta tricalcium phosphate bioscrew
intervention type: Device
intervention name: Linvatec PLLA+TCP
description: Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.
arm group label: PLLA+TCP bioscrew
intervention type: Device
intervention name: Linvatec PLLA
description: Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
arm group label: PLLA bioscrew
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Peter B MacDonald, MD FRCS(C)
role: Principal Investigator
affiliation: Pan Am Clinic
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Panam Clinic
investigator full name: Peter MacDonald
investigator title: Research Associate