<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/NCT02247661</url>
  </required_header>
  <id_info>
    <org_study_id>SM_II</org_study_id>
    <nct_id>NCT02247661</nct_id>
  </id_info>
  <brief_title>Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture</brief_title>
  <acronym>HASAP</acronym>
  <official_title>Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture: A Comparison Between the Lateral and Posterolateral Approaches</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sundsvall Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sundsvall Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective cohort study to compare the direct lateral and poster-lateral approach&#xD;
      concerning abductor function. Patients admitted with a femoral neck fracture operated with a&#xD;
      hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for&#xD;
      inclusion. Patients with altered mental status SPMSQ &gt;7, pathological fractures, non-walkers&#xD;
      were excluded.&#xD;
&#xD;
      Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1&#xD;
      year postoperatively by clinical examination. Sample size were estimated to 30 patient in&#xD;
      each group. Primary outcome variables were trendelenburg test, abductor strength measured&#xD;
      with dynamometry, trochanteric tenderness measured with algometry and palptation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Trendelenburg Test</measure>
    <time_frame>1 year</time_frame>
    <description>30 seconds standing on the operated leg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abductor strenght</measure>
    <time_frame>1 year</time_frame>
    <description>Dynamometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trochanteric tenderness</measure>
    <time_frame>1 year</time_frame>
    <description>Algometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trochanteric tenderness</measure>
    <time_frame>1 year</time_frame>
    <description>Palptation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Femoral Neck Fracture</condition>
  <condition>Trochanteric Pain</condition>
  <arm_group>
    <arm_group_label>Direct lateral approach</arm_group_label>
    <description>Total or hemiarthroplasty operated with direct-lateral approach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postero-lateral approach</arm_group_label>
    <description>Total or hemiarthroplasty operated with postero-lateral approach.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to Sundsvall hospital with a displaced femoral neck fracture operated&#xD;
        with either a total or hemiarthroplasty.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Displaced femoral neck fracture&#xD;
&#xD;
          -  Walker&#xD;
&#xD;
          -  Hemarthroplasty&#xD;
&#xD;
          -  Preiffer test &gt;7/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathological fracture&#xD;
&#xD;
          -  Non-walker&#xD;
&#xD;
          -  Pfeiffer test &lt;7/10 indicating mental alteration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopaedic department, Sundsvall hospital</name>
      <address>
        <city>Sundsvall</city>
        <state>Västernorrlands län</state>
        <zip>851 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.</citation>
    <PMID>20860452</PMID>
  </reference>
  <reference>
    <citation>Pai VS. Significance of the Trendelenburg test in total hip arthroplasty. Influence of lateral approaches. J Arthroplasty. 1996 Feb;11(2):174-9. doi: 10.1016/s0883-5403(05)80013-0.</citation>
    <PMID>8648312</PMID>
  </reference>
  <reference>
    <citation>Kiyama T, Naito M, Shinoda T, Maeyama A. Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty. 2010 Jan;25(1):76-80. doi: 10.1016/j.arth.2008.11.001. Epub 2009 Apr 8.</citation>
    <PMID>19359133</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sundsvall Hospital</investigator_affiliation>
    <investigator_full_name>Lennart Bråbäck</investigator_full_name>
    <investigator_title>Head FoU</investigator_title>
  </responsible_party>
  <keyword>Femoral neck fracture,surgical approach, limp, abductor strenght, trochanteric pain</keyword>
  <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/NCT02247661
org study id: SM_II
nct id: NCT02247661
lead sponsor: 
has dmc: No
A prospective cohort study to compare the direct lateral and poster-lateral approach
      concerning abductor function. Patients admitted with a femoral neck fracture operated with a
      hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for
      inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers
      were excluded.

      Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1
      year postoperatively by clinical examination. Sample size were estimated to 30 patient in
      each group. Primary outcome variables were trendelenburg test, abductor strength measured
      with dynamometry, trochanteric tenderness measured with algometry and palptation.
observational model: Cohort
time perspective: Prospective
measure: Trendelenburg Test
time frame: 1 year
description: 30 seconds standing on the operated leg
measure: Abductor strenght
time frame: 1 year
description: Dynamometry
measure: Trochanteric tenderness
time frame: 1 year
description: Algometry
measure: Trochanteric tenderness
time frame: 1 year
description: Palptation
arm group label: Direct lateral approach
description: Total or hemiarthroplasty operated with direct-lateral approach.
arm group label: Postero-lateral approach
description: Total or hemiarthroplasty operated with postero-lateral approach.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
citation: Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.
PMID: 20860452
citation: Pai VS. Significance of the Trendelenburg test in total hip arthroplasty. Influence of lateral approaches. J Arthroplasty. 1996 Feb;11(2):174-9. doi: 10.1016/s0883-5403(05)80013-0.
PMID: 8648312
citation: Kiyama T, Naito M, Shinoda T, Maeyama A. Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty. 2010 Jan;25(1):76-80. doi: 10.1016/j.arth.2008.11.001. Epub 2009 Apr 8.
PMID: 19359133
responsible party type: Principal Investigator
investigator affiliation: Sundsvall Hospital
investigator full name: Lennart Bråbäck
investigator title: Head FoU
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures