<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/NCT03279276</url>
  </required_header>
  <id_info>
    <org_study_id>N-20170030</org_study_id>
    <nct_id>NCT03279276</nct_id>
  </id_info>
  <brief_title>Selecting the Right Hip Prosthesis for Young Patients</brief_title>
  <official_title>Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern Orthopaedic Division, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northern Orthopaedic Division, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There have been no previously published clinical randomized studies comparing Primoris®,&#xD;
      short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone&#xD;
      density and function development. This is the subject for this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall purpose of this study is to show whether the Primoris® hip prosthesis results in&#xD;
      a smaller loss of bone density than standard hip prosthesis, which in the longer term may&#xD;
      result in an improved survival of prosthesis No. 2 after revision / replacement of a&#xD;
      Primoris® hip prosthesis.&#xD;
&#xD;
      The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to&#xD;
      standard hip prosthesis measured by DXA scanning.&#xD;
&#xD;
      The secondary outcomes are to assess:&#xD;
&#xD;
        1. The hip function measured by gait analysis.&#xD;
&#xD;
        2. Hip strength at pressure gauge.&#xD;
&#xD;
        3. Prosthetic migration / migration measured by radio-stereometric analysis (RSA).&#xD;
&#xD;
        4. Patient satisfaction measured by PROMs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 2029</completion_date>
  <primary_completion_date type="Actual">December 10, 2019</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>2 -10 years</time_frame>
    <description>Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait analysis</measure>
    <time_frame>1 year</time_frame>
    <description>Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radio Stereometric Analysis (RSA)</measure>
    <time_frame>2-10 years</time_frame>
    <description>Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of life in 5 Dimensions (EQ5D)</measure>
    <time_frame>2-10 years</time_frame>
    <description>This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score (HHS)</measure>
    <time_frame>2-10 years</time_frame>
    <description>This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Hip Score (OHS),</measure>
    <time_frame>2-10 years</time_frame>
    <description>This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>University of California Los Angeles Activity Score (UCLA)</measure>
    <time_frame>2-10 years</time_frame>
    <description>This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
    <time_frame>2-10 years</time_frame>
    <description>This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgotten Joint Score (FJS)</measure>
    <time_frame>2-10 years</time_frame>
    <description>This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>Primoris</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Echo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Hip Arthroplasty</intervention_name>
    <description>The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load.&#xD;
By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector.</description>
    <arm_group_label>Echo</arm_group_label>
    <arm_group_label>Primoris</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.&#xD;
&#xD;
        Patients who wish to participate in the project and give written consent after oral and&#xD;
        written information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with previous bone disease, metabolic disease, including diabetes, or the use&#xD;
             of drugs that affect bone density.&#xD;
&#xD;
          2. Smoking more than 20 cigarettes daily&#xD;
&#xD;
          3. Patients with fracture in the femur or acetabulum.&#xD;
&#xD;
          4. Patients who do not understand the given patient information&#xD;
&#xD;
          5. Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid,&#xD;
             cytostatics).&#xD;
&#xD;
          6. Estimated residual life &lt;10 years&#xD;
&#xD;
          7. Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).&#xD;
&#xD;
          8. Previous surgery on the relevant hip joint.&#xD;
&#xD;
          9. Co-Morbidity (ASA Group 3-5).&#xD;
&#xD;
         10. Neurological disorder that compromises motor skills and rehabilitation.&#xD;
&#xD;
         11. Pregnancy.&#xD;
&#xD;
         12. Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis,&#xD;
             Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.&#xD;
&#xD;
         13. Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).&#xD;
&#xD;
         14. Previously detected osteoporosis or osteoporosis detected by current DXA scanning.&#xD;
&#xD;
         15. Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor&#xD;
             modulators and parathyroid hormone, etc.).&#xD;
&#xD;
         16. Aseptic caput necrosis (posttraumatic, idiopathic).&#xD;
&#xD;
         17. Varus or valgus deformity in proximal femur (collum angle &lt;125 ° or&gt; 145 °.)&#xD;
&#xD;
         18. Collum femoris assessed too retro- or anteverted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mogens Laursen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northern ODD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital</name>
      <address>
        <city>Farsø</city>
        <state>Northern Jutland</state>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT03279276
org study id: N-20170030
nct id: NCT03279276
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There have been no previously published clinical randomized studies comparing Primoris®,
      short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone
      density and function development. This is the subject for this study.
The overall purpose of this study is to show whether the Primoris® hip prosthesis results in
      a smaller loss of bone density than standard hip prosthesis, which in the longer term may
      result in an improved survival of prosthesis No. 2 after revision / replacement of a
      Primoris® hip prosthesis.

      The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to
      standard hip prosthesis measured by DXA scanning.

      The secondary outcomes are to assess:

        1. The hip function measured by gait analysis.

        2. Hip strength at pressure gauge.

        3. Prosthetic migration / migration measured by radio-stereometric analysis (RSA).

        4. Patient satisfaction measured by PROMs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Bone Mineral Density
time frame: 2 -10 years
description: Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
measure: Gait analysis
time frame: 1 year
description: Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.
measure: Radio Stereometric Analysis (RSA)
time frame: 2-10 years
description: Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes
measure: European Quality of life in 5 Dimensions (EQ5D)
time frame: 2-10 years
description: This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
measure: Harris Hip Score (HHS)
time frame: 2-10 years
description: This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
measure: Oxford Hip Score (OHS),
time frame: 2-10 years
description: This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
measure: University of California Los Angeles Activity Score (UCLA)
time frame: 2-10 years
description: This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
time frame: 2-10 years
description: This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
measure: Forgotten Joint Score (FJS)
time frame: 2-10 years
description: This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
arm group label: Primoris
arm group type: Experimental
description: Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.
arm group label: Echo
arm group type: Active Comparator
description: Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®.
intervention type: Procedure
intervention name: Total Hip Arthroplasty
description: The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load.
By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector.
arm group label: Echo
arm group label: Primoris
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Mogens Laursen, MD, PhD
role: Principal Investigator
affiliation: Northern ODD
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip
sharing ipd: No