<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/NCT01695213</url>
  </required_header>
  <id_info>
    <org_study_id>Symax DEXA study</org_study_id>
    <secondary_id>MEC 02-072</secondary_id>
    <nct_id>NCT01695213</nct_id>
  </id_info>
  <brief_title>RCT Comparing the DEXA Results of the HA-Omnifit Versus the Symax Uncemented Hip Stem</brief_title>
  <official_title>A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker European Operations BV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thr purpose of this study is to compare the clinical and radiological results, as well as the&#xD;
      femur bone density measurements of two uncemented total hip prostheses during 5 years of&#xD;
      follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is of great importance for the function of uncemented total hip arthroplasty that the&#xD;
      anchorage of the prosthesis in the bone of the femur is sufficient. This is of great&#xD;
      importance in the prevention of stress shielding of the bone and to insure tranfer of forces&#xD;
      from the prosthesis to the femur.&#xD;
&#xD;
      The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical&#xD;
      stability.&#xD;
&#xD;
      In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used&#xD;
      and long term evaluated uncemented hip prosthesis) During the fist two years of follow up&#xD;
      DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient&#xD;
      fuction score and radiological evaluation measurements are done during 5 years of follow up.&#xD;
&#xD;
      Our primary objective is: comparison of the short term bone remodelling surrounding the Symax&#xD;
      hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by&#xD;
      bone densitometry, clinical and radiographic evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2003</start_date>
  <completion_date type="Actual">July 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</primary_completion_date>
  <phase>Phase 4</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>short term bone remodeling</measure>
    <time_frame>6 times within 2 years</time_frame>
    <description>Bone remodeling is determined by measuring the Bone mineral density during time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications and reoperations</measure>
    <time_frame>during 5 years</time_frame>
    <description>Reporting all complications and reoperations of the two different hip prostheses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical performance</measure>
    <time_frame>9 times within 5 years</time_frame>
    <description>Comparison of the clinical performance of the two different hip prostheses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological evaluation</measure>
    <time_frame>9 times within 5 years</time_frame>
    <description>Evaluation of Xrays according to the engh classifications</description>
  </secondary_outcome>
  <other_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>9 times within 5 years</time_frame>
    <description>comparison of patient satisfaction between the two different prostheses</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis</condition>
  <arm_group>
    <arm_group_label>HA-Omnifit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who receive a HA-Omnifit uncemented hip stem</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symax hip stem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with the Symax uncemented hip stem</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>uncemented total hip arthroplasty</intervention_name>
    <arm_group_label>HA-Omnifit</arm_group_label>
    <arm_group_label>Symax hip stem</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Male or non pregnant female patients &gt;18 years&#xD;
&#xD;
          -  Patient with degenerative or traumatic changes to hip requiring hip replacement&#xD;
&#xD;
          -  Patient with BMI&lt;35&#xD;
&#xD;
          -  Patient signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic anti-inflammatory medication use&gt; 3 months&#xD;
&#xD;
          -  revision surgery to the affected femur&#xD;
&#xD;
          -  Cancer therapy including immunosuppression, chemotherapy and radiation&#xD;
&#xD;
          -  Pathological fractures, delayed ossification or non-union is likely to occur&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lodewijk van Rhijn</last_name>
    <role>Study Director</role>
    <affiliation>azM</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 25, 2012</last_update_submitted>
  <last_update_submitted_qc>September 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>uncemented hip</keyword>
  <keyword>bone remodeling</keyword>
  <keyword>DEXA</keyword>
  <keyword>clinical evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT01695213
org study id: Symax DEXA study
secondary id: MEC 02-072
nct id: NCT01695213
lead sponsor: 
collaborator: 
has dmc: No
Thr purpose of this study is to compare the clinical and radiological results, as well as the
      femur bone density measurements of two uncemented total hip prostheses during 5 years of
      follow up.
It is of great importance for the function of uncemented total hip arthroplasty that the
      anchorage of the prosthesis in the bone of the femur is sufficient. This is of great
      importance in the prevention of stress shielding of the bone and to insure tranfer of forces
      from the prosthesis to the femur.

      The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical
      stability.

      In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used
      and long term evaluated uncemented hip prosthesis) During the fist two years of follow up
      DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient
      fuction score and radiological evaluation measurements are done during 5 years of follow up.

      Our primary objective is: comparison of the short term bone remodelling surrounding the Symax
      hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by
      bone densitometry, clinical and radiographic evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: short term bone remodeling
time frame: 6 times within 2 years
description: Bone remodeling is determined by measuring the Bone mineral density during time
measure: complications and reoperations
time frame: during 5 years
description: Reporting all complications and reoperations of the two different hip prostheses
measure: clinical performance
time frame: 9 times within 5 years
description: Comparison of the clinical performance of the two different hip prostheses
measure: Radiological evaluation
time frame: 9 times within 5 years
description: Evaluation of Xrays according to the engh classifications
measure: patient satisfaction
time frame: 9 times within 5 years
description: comparison of patient satisfaction between the two different prostheses
arm group label: HA-Omnifit
arm group type: Active Comparator
description: Patients who receive a HA-Omnifit uncemented hip stem
arm group label: Symax hip stem
arm group type: Active Comparator
description: Patients with the Symax uncemented hip stem
intervention type: Procedure
intervention name: uncemented total hip arthroplasty
arm group label: HA-Omnifit
arm group label: Symax hip stem
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lodewijk van Rhijn
role: Study Director
affiliation: azM
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip