<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/NCT03753100</url>
  </required_header>
  <id_info>
    <org_study_id>Stein Ugland</org_study_id>
    <nct_id>NCT03753100</nct_id>
  </id_info>
  <brief_title>Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study</brief_title>
  <official_title>Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients: a 5-year Follow up Study Addressing the Influence of Surgical Approach on Periprosthetic Bone Mineral Density.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sorlandet Hospital HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sorlandet Hospital HF</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study&#xD;
      addressing the influence of surgical approach on periprosthetic bone mineral density.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand,&#xD;
      Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and&#xD;
      registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between&#xD;
      70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and&#xD;
      the ability to walk with or without a walking aid prior to falling were asked for their&#xD;
      agreement to be enrolled and partition occurred after informed consent.A subgroup analysis&#xD;
      looking at periprosthetic bone mineral density around the femoral component was part of this&#xD;
      level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and&#xD;
      future examination of bone remodeling in these patients is now planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">March 25, 2020</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry</measure>
    <time_frame>5-year follow- up study</time_frame>
    <description>Change in bone mineral density</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Bone Mineral Density</condition>
  <condition>Femoral Neck Fractures</condition>
  <arm_group>
    <arm_group_label>Periprosthetic BMD; anterolateral approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Periprosthetic bone mineral density will be measured using a DXA scanner from GE Lunar Prodigy. The initial scan was performed post-operatively during hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periprosthetic BMD; lateral approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Periprosthetic bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint</intervention_name>
    <description>The measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered.</description>
    <arm_group_label>Periprosthetic BMD; anterolateral approach</arm_group_label>
    <arm_group_label>Periprosthetic BMD; lateral approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 70 and 90 years of age with displaced femoral neck fractures&#xD;
&#xD;
          -  Intact cognitive function&#xD;
&#xD;
          -  Ability to walk with or without a walking aid prior to falling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Fractures in pathologic bone&#xD;
&#xD;
          -  Patients not belonging to the hospital community&#xD;
&#xD;
          -  Patients with sepsis or local infection&#xD;
&#xD;
          -  Fracture not eligible to be treated with a hemiarthroplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glen Haugeberg, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement of Orthopaedics, Sorlandet Hospital</name>
      <address>
        <city>Kristiansand</city>
        <zip>4600</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</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>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Neck Fractures</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/NCT03753100
org study id: Stein Ugland
nct id: NCT03753100
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study
      addressing the influence of surgical approach on periprosthetic bone mineral density.
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand,
      Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and
      registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between
      70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and
      the ability to walk with or without a walking aid prior to falling were asked for their
      agreement to be enrolled and partition occurred after informed consent.A subgroup analysis
      looking at periprosthetic bone mineral density around the femoral component was part of this
      level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and
      future examination of bone remodeling in these patients is now planned.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry
time frame: 5-year follow- up study
description: Change in bone mineral density
arm group label: Periprosthetic BMD; anterolateral approach
arm group type: Active Comparator
description: Periprosthetic bone mineral density will be measured using a DXA scanner from GE Lunar Prodigy. The initial scan was performed post-operatively during hospitalization
arm group label: Periprosthetic BMD; lateral approach
arm group type: Active Comparator
description: Periprosthetic bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization.
intervention type: Other
intervention name: Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint
description: The measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered.
arm group label: Periprosthetic BMD; anterolateral approach
arm group label: Periprosthetic BMD; lateral approach
criteria: 
gender: All
minimum age: 70 Years
maximum age: 90 Years
healthy volunteers: No
last name: Glen Haugeberg, MD,PhD
role: Principal Investigator
affiliation: Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures