<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/NCT02256098</url>
  </required_header>
  <id_info>
    <org_study_id>P14.142</org_study_id>
    <nct_id>NCT02256098</nct_id>
  </id_info>
  <brief_title>RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA</brief_title>
  <acronym>APKnee</acronym>
  <official_title>A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE™ Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Center Haaglanden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DePuy International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent&#xD;
      clinical track record, good survival rates (98% 10 years survival in patients aged &lt; 55&#xD;
      years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at&#xD;
      two years follow-up)(von et al., 2009).&#xD;
&#xD;
      The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is&#xD;
      designed to provide better range of motion and address the unstable feeling some patients&#xD;
      experience during everyday activities, such as stair descent and bending. To date (March&#xD;
      2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and&#xD;
      positive feedback was received regarding patient recovery, stability and motion.&#xD;
&#xD;
      The objective of this study is to accurately assess and compare migration, clinical and&#xD;
      radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented&#xD;
      ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing&#xD;
      Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary&#xD;
      objective of this study is to compare the magnitude and pattern of migration of the&#xD;
      prostheses (Femoral and Tibial component). The secondary objective of this study is to&#xD;
      compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective&#xD;
      of this study is to compare clinical and radiological outcome and PROMS of the prostheses&#xD;
      with migration data.&#xD;
&#xD;
      This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System&#xD;
      and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC&#xD;
      Sigma Knee System will be included in this study.&#xD;
&#xD;
      The study population will consist of patients with symptomatic osteoarthritis of the knee&#xD;
      scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The&#xD;
      Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of&#xD;
      which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other&#xD;
      indications. We anticipate that inclusion can be accomplished within a 1 year period and that&#xD;
      the total study duration is 3 years.&#xD;
&#xD;
      Main study parameters/endpoints are:&#xD;
&#xD;
        -  Migration of the prosthesis with respect to the host bone measured by means of roentgen&#xD;
           stereophotogrammetric analysis (RSA).&#xD;
&#xD;
        -  Patient Reported Outcome Measures by means of questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</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>Migration, measured by means of RSA.</measure>
    <time_frame>2 Years</time_frame>
    <description>Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>2 Years</time_frame>
    <description>General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KOOS</measure>
    <time_frame>2 Years</time_frame>
    <description>Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain</measure>
    <time_frame>2 Years</time_frame>
    <description>- Pain score after activity and during rest; (Likert scale 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2 Anchor questions</measure>
    <time_frame>2 Years</time_frame>
    <description>Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Osteoarthritis Arthritis</condition>
  <condition>Joint Diseases</condition>
  <condition>Musculoskeletal Diseases</condition>
  <condition>Rheumatic Diseases</condition>
  <arm_group>
    <arm_group_label>ATTUNE™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total Knee Replacement Surgery with ATTUNE™ Knee Prosthesis by DePuy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PFC Sigma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ATTUNE™ Knee Prosthesis by DePuy</intervention_name>
    <description>Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy</description>
    <arm_group_label>ATTUNE™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PFC Sigma Knee Prosthesis by DePuy</intervention_name>
    <description>Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy</description>
    <arm_group_label>PFC Sigma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary&#xD;
             knee arthroplasty&#xD;
&#xD;
          -  All consecutive patients (&quot;usual care&quot;) are included to prevent selection bias in the&#xD;
             migration analysis.&#xD;
&#xD;
          -  Patient is capable of giving informed consent and expressing a willingness to comply&#xD;
             with this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.&#xD;
&#xD;
               -  Insufficiency of the posterior cruciate ligament (PCL)&#xD;
&#xD;
               -  Status after patellectomy&#xD;
&#xD;
               -  In case flexion is less than 90 degrees&#xD;
&#xD;
               -  When it is expected that the tibia cut during surgery will compromise the&#xD;
                  attachment of the PCL (because of bony defects)&#xD;
&#xD;
          -  The patient is unable or unwilling to sign the Informed Consent specific to this study&#xD;
&#xD;
          -  The patient does not understand the Dutch or English language good enough to&#xD;
             participate&#xD;
&#xD;
          -  Patients indicated for revision arthroplasty&#xD;
&#xD;
          -  When there are not enough markers visible in the baseline RSA photograph and it will&#xD;
             not improve by placing the patient in another position, the patient will be excluded&#xD;
             from the study (secondary exclusion criteria).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rob G Nelissen, Prof. PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. Orthopaedics, Leiden University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edward R Valstar, Prof. PhD. MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. Orthopaedics, Leiden University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter H den Hollander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. Orthopaedics, Medisch Centrum Haaglanden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medisch Centrum Haaglanden</name>
      <address>
        <city>Den Haag</city>
        <zip>2501CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2300RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>R.G.H.H. Nelissen</investigator_full_name>
    <investigator_title>Prof. PhD MD Head of the Department of Orthopaedics</investigator_title>
  </responsible_party>
  <keyword>Comparative Study</keyword>
  <keyword>Knee Prosthesis</keyword>
  <keyword>Prosthesis Design</keyword>
  <keyword>Treatment Outcome</keyword>
  <keyword>Follow-Up Studies</keyword>
  <keyword>Arthroplasty, Replacement, Knee/methods</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Collagen Diseases</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/NCT02256098
org study id: P14.142
nct id: NCT02256098
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent
      clinical track record, good survival rates (98% 10 years survival in patients aged < 55
      years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at
      two years follow-up)(von et al., 2009).

      The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is
      designed to provide better range of motion and address the unstable feeling some patients
      experience during everyday activities, such as stair descent and bending. To date (March
      2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and
      positive feedback was received regarding patient recovery, stability and motion.

      The objective of this study is to accurately assess and compare migration, clinical and
      radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented
      ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing
      Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary
      objective of this study is to compare the magnitude and pattern of migration of the
      prostheses (Femoral and Tibial component). The secondary objective of this study is to
      compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective
      of this study is to compare clinical and radiological outcome and PROMS of the prostheses
      with migration data.

      This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System
      and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC
      Sigma Knee System will be included in this study.

      The study population will consist of patients with symptomatic osteoarthritis of the knee
      scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The
      Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of
      which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other
      indications. We anticipate that inclusion can be accomplished within a 1 year period and that
      the total study duration is 3 years.

      Main study parameters/endpoints are:

        -  Migration of the prosthesis with respect to the host bone measured by means of roentgen
           stereophotogrammetric analysis (RSA).

        -  Patient Reported Outcome Measures by means of questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Migration, measured by means of RSA.
time frame: 2 Years
description: Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
measure: EQ-5D
time frame: 2 Years
description: General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire
measure: KOOS
time frame: 2 Years
description: Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire
measure: VAS pain
time frame: 2 Years
description: - Pain score after activity and during rest; (Likert scale 0-10)
measure: 2 Anchor questions
time frame: 2 Years
description: Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.
arm group label: ATTUNE™
arm group type: Experimental
description: Total Knee Replacement Surgery with ATTUNE™ Knee Prosthesis by DePuy
arm group label: PFC Sigma
arm group type: Active Comparator
description: Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy
intervention type: Device
intervention name: ATTUNE™ Knee Prosthesis by DePuy
description: Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy
arm group label: ATTUNE™
intervention type: Device
intervention name: PFC Sigma Knee Prosthesis by DePuy
description: Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy
arm group label: PFC Sigma
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Rob G Nelissen, Prof. PhD, MD
role: Principal Investigator
affiliation: Dep. Orthopaedics, Leiden University Medical Center
last name: Edward R Valstar, Prof. PhD. MSc
role: Principal Investigator
affiliation: Dep. Orthopaedics, Leiden University Medical Center
last name: Peter H den Hollander, MD
role: Principal Investigator
affiliation: Dep. Orthopaedics, Medisch Centrum Haaglanden
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: R.G.H.H. Nelissen
investigator title: Prof. PhD MD Head of the Department of Orthopaedics
mesh term: Osteoarthritis
mesh term: Rheumatic Diseases
mesh term: Joint Diseases
mesh term: Musculoskeletal Diseases
mesh term: Collagen Diseases