xml: <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/NCT06019026</url>
    </required_header>
    <id_info>
      <org_study_id>Tri-Lock vs. Summit</org_study_id>
      <nct_id>NCT06019026</nct_id>
    </id_info>
    <brief_title>Five-year Migration Pattern and Bone Mineral Density for the Tri-Lock and Summit Femoral Stems.</brief_title>
    <official_title>Five-year Migration Pattern and Changes in Bone Mineral Density for the Tri-Lock and Summit Femoral Stems - Radiostereometric Analysis and Dual-energy X-ray Absorptiometry of 50 Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Regional Hospital Holstebro</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Regional Hospital Holstebro</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The incidence of primary hip joint prosthesis is 180 per. 100,000 inhabitants. In male&#xD;
        patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over&#xD;
        15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and&#xD;
        78 % over 15 years.&#xD;
  &#xD;
        As revision surgery is associated with higher complication risk for the patient and poorer&#xD;
        out-come and implant survival it is necessary to examine possible methods that may increase&#xD;
        long-term survival of the primary hip prosthesis or facilitate better outcomes after revision&#xD;
        of hip joint prostheses for younger patients.&#xD;
  &#xD;
        In younger patients the prosthesis often is inserted without the use of cement. When not&#xD;
        using cement, it is crucial for the final result, that there is a direct bone ingrowth of the&#xD;
        prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate&#xD;
        mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic&#xD;
        surface.&#xD;
  &#xD;
        This study investigates a new bone sparing implant with a new surface compared to a&#xD;
        conventional implant.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2015</start_date>
    <completion_date type="Actual">June 10, 2023</completion_date>
    <primary_completion_date type="Actual">August 31, 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>
      <intervention_model_description>Randomized clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Migration (3D rotation and translation) Measured with radiostereometric analysis</measure>
      <time_frame>5 years</time_frame>
      <description>Subsidence (distal translation mm) and retroversion (negative vertical rotation deg.)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BMD measured with dual x-ray absorpmetry</measure>
      <time_frame>5 years</time_frame>
      <description>By Gruen zones, calculated as changes from baseline recording.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>EQ5D</measure>
      <time_frame>5 years</time_frame>
      <description>Patient reported outcome. Generic - calculated as normalized time trade offf score up to 1 (best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxford hip score</measure>
      <time_frame>5 years</time_frame>
      <description>Patient reported outcome. hip-score - from 0 to 48 (best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain measured with VAS</measure>
      <time_frame>5 years</time_frame>
      <description>active and passive measures from 0 (worst) to 10 (best)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">52</enrollment>
    <condition>Osteoarthritis, Hip</condition>
    <arm_group>
      <arm_group_label>Tri-Lock</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Total hiparthroplasty performed through posterolateral access using the uncemented Tri-Lock short stem.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Summit</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Total hiparthroplasty performed through posterolateral access using the uncemented Summit standard stem.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tri-Lock</intervention_name>
      <description>Implant Stem</description>
      <arm_group_label>Tri-Lock</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Summit</intervention_name>
      <description>Implant Stem</description>
      <arm_group_label>Summit</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with primary hip osteoarthritis&#xD;
  &#xD;
            2. Patients with adequate bone stock for insertion of uncemented components(no&#xD;
               osteoporo-sis as assessed by pre-operative DXA scans)&#xD;
  &#xD;
            3. Informed, written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with neuromuscular or vascular diseases in the affected leg&#xD;
  &#xD;
            2. Patients intraoperatively found unfit to uncemented components&#xD;
  &#xD;
            3. Patients who can not refrain from the use of non-steroidal anti-inflammatory drugs&#xD;
               (NSAIDs) in post-operative recovery&#xD;
  &#xD;
            4. Patients with pre-operative fracture sequelae&#xD;
  &#xD;
            5. Women who are, or have a wish for pregnancy during the study period.&#xD;
  &#xD;
            6. Hip dysplasia or sequelae to Calves Perthes.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Torben Bæk Hansen, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gødstrup Hospital</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Regional Hospital Holstebro</investigator_affiliation>
      <investigator_full_name>Torben B. Hansen</investigator_full_name>
      <investigator_title>Professor, MD PhD</investigator_title>
    </responsible_party>
    <keyword>THA</keyword>
    <keyword>hip</keyword>
    <keyword>RSA</keyword>
    <keyword>Cementless</keyword>
    <keyword>Radiostereometric analysis</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>
      <ipd_description>The main outcome is x-ray images and not fit for sharing due to GDPR</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019026
  org study id: Tri-Lock vs. Summit
  nct id: NCT06019026
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The incidence of primary hip joint prosthesis is 180 per. 100,000 inhabitants. In male
        patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over
        15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and
        78 % over 15 years.
  
        As revision surgery is associated with higher complication risk for the patient and poorer
        out-come and implant survival it is necessary to examine possible methods that may increase
        long-term survival of the primary hip prosthesis or facilitate better outcomes after revision
        of hip joint prostheses for younger patients.
  
        In younger patients the prosthesis often is inserted without the use of cement. When not
        using cement, it is crucial for the final result, that there is a direct bone ingrowth of the
        prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate
        mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic
        surface.
  
        This study investigates a new bone sparing implant with a new surface compared to a
        conventional implant.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized clinical trial
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Migration (3D rotation and translation) Measured with radiostereometric analysis
  time frame: 5 years
  description: Subsidence (distal translation mm) and retroversion (negative vertical rotation deg.)
  measure: BMD measured with dual x-ray absorpmetry
  time frame: 5 years
  description: By Gruen zones, calculated as changes from baseline recording.
  measure: EQ5D
  time frame: 5 years
  description: Patient reported outcome. Generic - calculated as normalized time trade offf score up to 1 (best)
  measure: Oxford hip score
  time frame: 5 years
  description: Patient reported outcome. hip-score - from 0 to 48 (best)
  measure: Pain measured with VAS
  time frame: 5 years
  description: active and passive measures from 0 (worst) to 10 (best)
  arm group label: Tri-Lock
  arm group type: Experimental
  description: Total hiparthroplasty performed through posterolateral access using the uncemented Tri-Lock short stem.
  arm group label: Summit
  arm group type: Active Comparator
  description: Total hiparthroplasty performed through posterolateral access using the uncemented Summit standard stem.
  intervention type: Device
  intervention name: Tri-Lock
  description: Implant Stem
  arm group label: Tri-Lock
  intervention type: Device
  intervention name: Summit
  description: Implant Stem
  arm group label: Summit
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Torben Bæk Hansen, MD, PhD
  role: Principal Investigator
  affiliation: Gødstrup Hospital
  responsible party type: Principal Investigator
  investigator affiliation: Regional Hospital Holstebro
  investigator full name: Torben B. Hansen
  investigator title: Professor, MD PhD
  mesh term: Osteoarthritis, Hip
  sharing ipd: No
  ipd description: The main outcome is x-ray images and not fit for sharing due to GDPR