<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/NCT01693627</url>
  </required_header>
  <id_info>
    <org_study_id>2011/133</org_study_id>
    <nct_id>NCT01693627</nct_id>
  </id_info>
  <brief_title>Cemented Marathon/Corail Versus Pinnacle/Corail</brief_title>
  <official_title>Cemented Marathon/Corail Versus Pinnacle/Corail. Comparison of Polyethylene Wear, Component Migration and Periprosthetic Bone Mineral Density. A Randomised Study of 48 Hips Using Radiostereometry and Dual-energy X-ray Absorptiometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:&#xD;
&#xD;
        1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented&#xD;
           femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy,&#xD;
           Warsaw, Indiana) and&#xD;
&#xD;
        2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral&#xD;
           stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw,&#xD;
           Indiana)&#xD;
&#xD;
      There will be a further in-group randomisation to a Corail femoral stem with or without a&#xD;
      collar, creating a number of 4 study-groups in total.&#xD;
&#xD;
      The aims of the study are:&#xD;
&#xD;
        -  To compare polyethylene wear and migration of the moderately cross-linked Marathon&#xD;
           polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)&#xD;
&#xD;
        -  To evaluate micromigration and periacetabular bone mineral density of the 2 cups using&#xD;
           radiostereometry(RSA)&#xD;
&#xD;
        -  To evaluate the migration patterns and proximal femoral bone density changes around the&#xD;
           Corail stems with and without a collar&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 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>Polyethylene wear</measure>
    <time_frame>After 5 years of follow-up</time_frame>
    <description>Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Component migration-cup</measure>
    <time_frame>After 5 years of follow-up</time_frame>
    <description>Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periprosthetic bone mineral density</measure>
    <time_frame>After 2 years of follow-up</time_frame>
    <description>Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Component migration-stem</measure>
    <time_frame>After 5 years of follow-up</time_frame>
    <description>Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome</measure>
    <time_frame>After 5 years of follow-up</time_frame>
    <description>Comparison of clinical results between study groups using HHS and PROMs</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Arthritis of the Hip</condition>
  <arm_group>
    <arm_group_label>Pinnacle/Corail with collar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Marathon/Corail with collar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pinnacle/Corail without collar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Marathon/Corail without collar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pinnacle/Corail with collar</intervention_name>
    <description>Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.</description>
    <arm_group_label>Pinnacle/Corail with collar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Marathon/Corail with collar</intervention_name>
    <description>Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.</description>
    <arm_group_label>Marathon/Corail with collar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pinnacle/Corail without collar</intervention_name>
    <description>Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.</description>
    <arm_group_label>Pinnacle/Corail without collar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Marathon/Corail without collar</intervention_name>
    <description>Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.</description>
    <arm_group_label>Marathon/Corail without collar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of&#xD;
             the femoral head, acute hip fracture or sequelae after hip fracture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active malignant disease, rheumatoid arthritis or other generalised auto-immune&#xD;
             arthritic disease,&#xD;
&#xD;
          -  BMI &gt; 35,&#xD;
&#xD;
          -  insulin dependent diabetes mellitus, 0 chronic or recurrent infection,&#xD;
&#xD;
          -  liver disease,&#xD;
&#xD;
          -  Paget's disease,&#xD;
&#xD;
          -  dementia or lack of compliance for other reasons,&#xD;
&#xD;
          -  uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the&#xD;
             contralateral hip does not exclude the patient, but only one hip in each patient can&#xD;
             be included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leif I Havelin, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benedikt A Jonsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geir Hallan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ove Furnes, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clara G Gjesdal, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Rheumatology, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristin Haugan, MA</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arne K Skredderstuen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Terje Stokke</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Radiology, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedic Surgery, Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5096</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>March 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT01693627
org study id: 2011/133
nct id: NCT01693627
lead sponsor: 
has dmc: Yes
A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:

        1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented
           femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy,
           Warsaw, Indiana) and

        2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral
           stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw,
           Indiana)

      There will be a further in-group randomisation to a Corail femoral stem with or without a
      collar, creating a number of 4 study-groups in total.

      The aims of the study are:

        -  To compare polyethylene wear and migration of the moderately cross-linked Marathon
           polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)

        -  To evaluate micromigration and periacetabular bone mineral density of the 2 cups using
           radiostereometry(RSA)

        -  To evaluate the migration patterns and proximal femoral bone density changes around the
           Corail stems with and without a collar
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Polyethylene wear
time frame: After 5 years of follow-up
description: Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
measure: Component migration-cup
time frame: After 5 years of follow-up
description: Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
measure: Periprosthetic bone mineral density
time frame: After 2 years of follow-up
description: Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.
measure: Component migration-stem
time frame: After 5 years of follow-up
description: Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.
measure: Clinical outcome
time frame: After 5 years of follow-up
description: Comparison of clinical results between study groups using HHS and PROMs
arm group label: Pinnacle/Corail with collar
arm group type: Active Comparator
description: Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
arm group label: Marathon/Corail with collar
arm group type: Active Comparator
description: Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
arm group label: Pinnacle/Corail without collar
arm group type: Active Comparator
description: Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
arm group label: Marathon/Corail without collar
arm group type: Active Comparator
description: Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
intervention type: Device
intervention name: Pinnacle/Corail with collar
description: Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
arm group label: Pinnacle/Corail with collar
intervention type: Device
intervention name: Marathon/Corail with collar
description: Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
arm group label: Marathon/Corail with collar
intervention type: Device
intervention name: Pinnacle/Corail without collar
description: Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
arm group label: Pinnacle/Corail without collar
intervention type: Device
intervention name: Marathon/Corail without collar
description: Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
arm group label: Marathon/Corail without collar
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Leif I Havelin, MD, PhD
role: Study Director
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
last name: Benedikt A Jonsson, MD
role: Principal Investigator
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
last name: Geir Hallan, MD, PhD
role: Principal Investigator
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
last name: Ove Furnes, MD, PhD
role: Study Chair
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
last name: Clara G Gjesdal, MD, PhD
role: Study Chair
affiliation: Department of Rheumatology, Haukeland University Hospital, Bergen, Norway
last name: Kristin Haugan, MA
role: Study Chair
affiliation: Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway
last name: Arne K Skredderstuen, MD
role: Study Chair
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
last name: Terje Stokke
role: Study Chair
affiliation: Department of Radiology, Haukeland University Hospital, Bergen, Norway
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Arthritis