<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/NCT03302013</url>
  </required_header>
  <id_info>
    <org_study_id>11916</org_study_id>
    <secondary_id>ISRCTN12584521</secondary_id>
    <nct_id>NCT03302013</nct_id>
  </id_info>
  <brief_title>All Ligaments Left In Knee Arthroplasty Trial</brief_title>
  <acronym>ALLIKAT</acronym>
  <official_title>Multi-center Clinical Study of Vanguard XP Bicruciate Knee System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the&#xD;
      Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an&#xD;
      intact anterior cruciate ligament.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is&#xD;
      to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate&#xD;
      (Vanguard XP) by comparing it with a control group of patients implanted with an established&#xD;
      single cruciate retaining device (Vanguard CR). The study also aims to examine short and long&#xD;
      term descriptive cohort outcome data. A small preference cohort group of 60 patients&#xD;
      receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data&#xD;
      will be used to confirm the external validity of the RCT group and to contribute to the&#xD;
      safety data for the British Orthopaedic Association's Beyond Compliance Programme.&#xD;
&#xD;
      Evaluation will include intra-operative and post-operative complications, longer term&#xD;
      survivorship and patient reported outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 5, 2016</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">September 4, 2021</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>Oxford Knee Score-Activity &amp; Participation Questionnaire (OKS-APQ)</measure>
    <time_frame>3 years post randomisation</time_frame>
    <description>Patient Reported Outcome Score - disease specific</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-3L</measure>
    <time_frame>Post-operation (within 6 weeks); 1 &amp; 3 years post randomisation</time_frame>
    <description>Quality of Life Patient Reported Outcome Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgotten Joint Score</measure>
    <time_frame>Post operation (within 6 weeks), 1, 2 &amp; 3 years post randomisation</time_frame>
    <description>Patient Reported Outcome Score - disease specific</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Knee Society Score</measure>
    <time_frame>Post operation (within 6 weeks), 1, 2 &amp; 3 years post randomisation</time_frame>
    <description>Functional Assessment of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Post operation (within 6 weeks), 1 &amp; 3 years post randomisation</time_frame>
    <description>Adverse events and complications related to the knee surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Radiographic Assessment</measure>
    <time_frame>1 &amp; 3 Years Post Randomisation</time_frame>
    <description>Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Primary Osteoarthritis of Knee Nos</condition>
  <arm_group>
    <arm_group_label>Vanguard XP Knee Replacement Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vanguard CR Knee Replacement Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vanguard XP Bi-cruciate Retaining Knee Replacement System</intervention_name>
    <description>Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.</description>
    <arm_group_label>Vanguard XP Knee Replacement Surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vanguard CR Single Cruciate Retaining Knee System</intervention_name>
    <description>Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.</description>
    <arm_group_label>Vanguard CR Knee Replacement Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary Osteoarthritis of the knee involving one or more compartments of the joint.&#xD;
&#xD;
          -  Intact Anterior and Posterior Cruciate Ligaments.&#xD;
&#xD;
          -  Intact collateral ligaments.&#xD;
&#xD;
          -  Correctable coronal deformity.&#xD;
&#xD;
          -  No more than 15 degrees of fixed flexion deformity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years.&#xD;
&#xD;
          -  Revision knee replacement surgery.&#xD;
&#xD;
          -  Rheumatoid Arthritis.&#xD;
&#xD;
          -  Traumatic aetiology.&#xD;
&#xD;
          -  History or clinical signs of ACL rupture.&#xD;
&#xD;
          -  Previous arthroscopy related to ACL injury or reconstruction.&#xD;
&#xD;
          -  Correction of a flexion contracture that may require extensive resection of distal&#xD;
             femur.&#xD;
&#xD;
          -  Altered pain perception and / or neurologic affection (for example as a complication&#xD;
             arising from diabetes).&#xD;
&#xD;
          -  Unable to consent for themselves.&#xD;
&#xD;
          -  Patients with language or cognitive issues that may prevent them completing the follow&#xD;
             up requirements.&#xD;
&#xD;
          -  Contraindications for the device:&#xD;
&#xD;
               -  Cementless application of components.&#xD;
&#xD;
               -  BMI ≥40 kg/m2.&#xD;
&#xD;
               -  Use of Anterior Stabilized Bearings.&#xD;
&#xD;
               -  Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees.&#xD;
&#xD;
               -  Correction or revision of previous joint replacement procedure on index knee.&#xD;
&#xD;
               -  Infection.&#xD;
&#xD;
               -  Sepsis.Osteomyelitis.&#xD;
&#xD;
               -  Osteoporosis (requiring treatment).&#xD;
&#xD;
          -  Relative contraindications include:&#xD;
&#xD;
               -  Unco-operative patient or patient with neurologic disorders who is incapable of&#xD;
                  following directions.&#xD;
&#xD;
               -  Osteoporosis.&#xD;
&#xD;
               -  Metabolic disorders which may impair bone formation.&#xD;
&#xD;
               -  Osteomalacia.&#xD;
&#xD;
               -  Distant foci of infections which may spread to the implant site.&#xD;
&#xD;
               -  Rapid joint destruction, marked bone loss or bone resorption apparent on&#xD;
                  roentgenogram.&#xD;
&#xD;
               -  Vascular insufficiency, muscular atrophy, neuromuscular disease.&#xD;
&#xD;
               -  Incomplete or deficient soft tissue surrounding the knee, including the anterior&#xD;
                  cruciate ligament.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Price</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel Dorman</last_name>
    <phone>00441865227715</phone>
    <email>ALLIKAT@ndorms.ox.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cushla Cooper</last_name>
    <phone>00441865737643</phone>
    <email>ALLIKAT@ndorms.ox.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Headington</city>
        <state>Oxford</state>
        <zip>OX3 7HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pam Lovegrove, RN</last_name>
    </contact>
    <investigator>
      <last_name>William Jackson</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew J Price</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicholas J Bottomley</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Royal Orthopaedic Hospital NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B31 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dionne Wortley, RN</last_name>
    </contact>
    <investigator>
      <last_name>Faisal Hussain</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Bristol NHS Trust</name>
      <address>
        <city>Bristol</city>
        <zip>BS9 3QN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Bray, RN</last_name>
    </contact>
    <investigator>
      <last_name>Andrew J Porteous</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Murray</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Frimley Health NHS Foundation Trust</name>
      <address>
        <city>Frimley</city>
        <zip>GU16 7UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justine Amero, RN</last_name>
    </contact>
    <investigator>
      <last_name>Hugh Chissell</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Graham Smith</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>May 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arthroplasty</keyword>
  <keyword>Knee</keyword>
  <keyword>Bicruciate retaining</keyword>
  <keyword>Vanguard XP</keyword>
  <keyword>Vanguard CR</keyword>
  <keyword>Surgery</keyword>
  <keyword>Zimmer Biomet</keyword>
  <keyword>Joint Replacement</keyword>
  <keyword>Osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <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/NCT03302013
org study id: 11916
secondary id: ISRCTN12584521
nct id: NCT03302013
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the
      Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an
      intact anterior cruciate ligament.
The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is
      to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate
      (Vanguard XP) by comparing it with a control group of patients implanted with an established
      single cruciate retaining device (Vanguard CR). The study also aims to examine short and long
      term descriptive cohort outcome data. A small preference cohort group of 60 patients
      receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data
      will be used to confirm the external validity of the RCT group and to contribute to the
      safety data for the British Orthopaedic Association's Beyond Compliance Programme.

      Evaluation will include intra-operative and post-operative complications, longer term
      survivorship and patient reported outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
time frame: 3 years post randomisation
description: Patient Reported Outcome Score - disease specific
measure: EQ-5D-3L
time frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation
description: Quality of Life Patient Reported Outcome Score
measure: Forgotten Joint Score
time frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
description: Patient Reported Outcome Score - disease specific
measure: American Knee Society Score
time frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
description: Functional Assessment of the knee
measure: Complications
time frame: Post operation (within 6 weeks), 1 & 3 years post randomisation
description: Adverse events and complications related to the knee surgery
measure: Radiographic Assessment
time frame: 1 & 3 Years Post Randomisation
description: Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration
arm group label: Vanguard XP Knee Replacement Surgery
arm group type: Experimental
description: Participants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee.
arm group label: Vanguard CR Knee Replacement Surgery
arm group type: Active Comparator
description: Participants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS.
intervention type: Procedure
intervention name: Vanguard XP Bi-cruciate Retaining Knee Replacement System
description: Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.
arm group label: Vanguard XP Knee Replacement Surgery
intervention type: Procedure
intervention name: Vanguard CR Single Cruciate Retaining Knee System
description: Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.
arm group label: Vanguard CR Knee Replacement Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Price
role: Principal Investigator
affiliation: University of Oxford
last name: Rachel Dorman
phone: 00441865227715
email: ALLIKAT@ndorms.ox.ac.uk
last name: Cushla Cooper
phone: 00441865737643
email: ALLIKAT@ndorms.ox.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No