<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/NCT04438226</url>
  </required_header>
  <id_info>
    <org_study_id>NL63378.100.17</org_study_id>
    <nct_id>NCT04438226</nct_id>
  </id_info>
  <brief_title>Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral</brief_title>
  <acronym>APOLLO</acronym>
  <official_title>Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JointResearch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JointResearch</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>
      Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the&#xD;
      posterolateral and the direct lateral approach. Currently there is no conclusive evidence&#xD;
      which of these two approaches results in better patient outcomes.&#xD;
&#xD;
      Objective: Assessing the patient outcome comparing the posterolateral with the direct lateral&#xD;
      approach in patients being treated with cemented hemiarthroplasty after femoral neck&#xD;
      fractures.&#xD;
&#xD;
      Study design: A randomised controlled multi-center superiority trial and natural experiment&#xD;
      with an economic evaluation alongside.&#xD;
&#xD;
      Study population: All patients older than 18 years with a femoral neck fracture whereby&#xD;
      treatment with cemented hemiarthroplasty is recommended according the national guidelines.&#xD;
&#xD;
      Intervention: Treatment with cemented hemiarthroplasty using the posterolateral approach.&#xD;
&#xD;
      Standard intervention to be compared to: Treatment with cemented hemiarthroplasty using the&#xD;
      direct lateral approach.&#xD;
&#xD;
      Main study parameters/endpoints: The primary outcome is the patient-rated quality of life&#xD;
      (EQ-5D-5L) at 6 months after surgery.&#xD;
&#xD;
      Secondary outcomes are: ADL functionality (KATZ), Balance test (SPPB), Tendency to Fall&#xD;
      (FES-I), Pain (NRS), Re-interventions, Mobility, Discharge destination, Complications, and&#xD;
      cost-effectiveness.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: The different approaches in the two treatment arms of the randomised controlled&#xD;
      trial are widely used techniques in the Netherlands and many of the outcome measures are part&#xD;
      of the standard clinical follow-up after hip fracture. Therefore, there is no extra risk or&#xD;
      burden for participating patients, except for the time to complete some additional follow-up&#xD;
      measurements. The primary outcome measurement and secondary outcomes, will be assessed&#xD;
      through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months&#xD;
      postoperatively. The assessment of the Short Physical Performance Battery (SPPB) balance&#xD;
      test, will be performed by one of the study researchers or nurse practitioner to protect&#xD;
      continuity and feasibility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">July 7, 2022</completion_date>
  <primary_completion_date type="Actual">January 7, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>at 6 months after surgery</time_frame>
    <description>The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-interventions</measure>
    <time_frame>at 6 months after surgery</time_frame>
    <description>Number of patients which are undergoing a re-intervention in the first 6 months after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPPB</measure>
    <time_frame>at 4 months after surgery</time_frame>
    <description>Balance test (SPPB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FES-I</measure>
    <time_frame>at 6 months after surgery</time_frame>
    <description>The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about fallingduring 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The minimum score is 16 (no concern about falling) to the maximum score of 64 (severe concern about falling).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS</measure>
    <time_frame>at 6 months after surgery</time_frame>
    <description>Numeric Rating Scale (NRS) is a numeric scale to assess pain. The minimum score is 0 (no pain) and the maximum score is 10 (the worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KATZ</measure>
    <time_frame>at 6 months after surgery</time_frame>
    <description>Katz Index of Independence in Activities of Daily Living (ADL) is an instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>at 6 months after surgery</time_frame>
    <description>Mobility according to the mobility score. We'll assess the mobility according to the following options: no walking aids, 1 walking stick, walker or two crutches, in-house mobility but outside no mobility without aids, no functional mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>During admission, 3 and 6 months post-operative</time_frame>
    <description>The number of post-operative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge destination</measure>
    <time_frame>After admission, at 3 and 6 months post-operative</time_frame>
    <description>Discharge destination: We'll ask where the patient is going to live after discharge, which we compare with the place where the patient was living before the trauma. The options are: independently at home, at home with care, nursing home, rehabilitation center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>at 4 weeks, 3 and 6 months post-operative</time_frame>
    <description>An economic evaluation will be performed for physical functioning and Quality Adjusted Life Years (QALYs). For estimating QALYs, the patients' EQ-5D-5L health states will be converted into utility scores using the Dutch tariff. QALYs will subsequently be calculated using linear interpolation between measurement points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">555</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Surgical Approach</condition>
  <condition>Hemiarthroplasty</condition>
  <condition>Posterolateral</condition>
  <condition>Direct Lateral</condition>
  <arm_group>
    <arm_group_label>Posterolateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with a hemiarthroplasty using the posterolateral approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct lateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with a hemiarthroplasty using the direct lateral approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical approach</intervention_name>
    <description>The surgical approach of hemiarthroplasty after femoral neck fracture</description>
    <arm_group_label>Direct lateral</arm_group_label>
    <arm_group_label>Posterolateral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years at time of trauma&#xD;
&#xD;
          -  Acute hip fracture&#xD;
&#xD;
          -  Hemiarthroplasty as recommended treatment according the national guidelines&#xD;
&#xD;
          -  Dutch or English fluency and literacy&#xD;
&#xD;
          -  Informed consent or by proxy in patients with mental impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multi-trauma-patient (ISS &gt; 15)&#xD;
&#xD;
          -  Secondary surgery after failed internal fixation&#xD;
&#xD;
          -  Patients with a known metastatic disease and a confirmed pathological fracture of the&#xD;
             hip&#xD;
&#xD;
          -  Fracture &gt; 7 days at time of surgery&#xD;
&#xD;
          -  High risk of non-compliance/adherence to study procedures (e.g. no Dutch residency&#xD;
             during follow-up period, or other factors that impair follow-up data collection)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1090 HM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 11, 2019</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</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>Hip Fractures</mesh_term>
    <mesh_term>Femoral Neck Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04438226
org study id: NL63378.100.17
nct id: NCT04438226
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the
      posterolateral and the direct lateral approach. Currently there is no conclusive evidence
      which of these two approaches results in better patient outcomes.

      Objective: Assessing the patient outcome comparing the posterolateral with the direct lateral
      approach in patients being treated with cemented hemiarthroplasty after femoral neck
      fractures.

      Study design: A randomised controlled multi-center superiority trial and natural experiment
      with an economic evaluation alongside.

      Study population: All patients older than 18 years with a femoral neck fracture whereby
      treatment with cemented hemiarthroplasty is recommended according the national guidelines.

      Intervention: Treatment with cemented hemiarthroplasty using the posterolateral approach.

      Standard intervention to be compared to: Treatment with cemented hemiarthroplasty using the
      direct lateral approach.

      Main study parameters/endpoints: The primary outcome is the patient-rated quality of life
      (EQ-5D-5L) at 6 months after surgery.

      Secondary outcomes are: ADL functionality (KATZ), Balance test (SPPB), Tendency to Fall
      (FES-I), Pain (NRS), Re-interventions, Mobility, Discharge destination, Complications, and
      cost-effectiveness.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The different approaches in the two treatment arms of the randomised controlled
      trial are widely used techniques in the Netherlands and many of the outcome measures are part
      of the standard clinical follow-up after hip fracture. Therefore, there is no extra risk or
      burden for participating patients, except for the time to complete some additional follow-up
      measurements. The primary outcome measurement and secondary outcomes, will be assessed
      through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months
      postoperatively. The assessment of the Short Physical Performance Battery (SPPB) balance
      test, will be performed by one of the study researchers or nurse practitioner to protect
      continuity and feasibility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: EQ-5D-5L
time frame: at 6 months after surgery
description: The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
measure: Re-interventions
time frame: at 6 months after surgery
description: Number of patients which are undergoing a re-intervention in the first 6 months after surgery
measure: SPPB
time frame: at 4 months after surgery
description: Balance test (SPPB)
measure: FES-I
time frame: at 6 months after surgery
description: The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about fallingduring 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The minimum score is 16 (no concern about falling) to the maximum score of 64 (severe concern about falling).
measure: NRS
time frame: at 6 months after surgery
description: Numeric Rating Scale (NRS) is a numeric scale to assess pain. The minimum score is 0 (no pain) and the maximum score is 10 (the worst imaginable pain)
measure: KATZ
time frame: at 6 months after surgery
description: Katz Index of Independence in Activities of Daily Living (ADL) is an instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
measure: Mobility
time frame: at 6 months after surgery
description: Mobility according to the mobility score. We'll assess the mobility according to the following options: no walking aids, 1 walking stick, walker or two crutches, in-house mobility but outside no mobility without aids, no functional mobility
measure: Complications
time frame: During admission, 3 and 6 months post-operative
description: The number of post-operative complications
measure: Discharge destination
time frame: After admission, at 3 and 6 months post-operative
description: Discharge destination: We'll ask where the patient is going to live after discharge, which we compare with the place where the patient was living before the trauma. The options are: independently at home, at home with care, nursing home, rehabilitation center.
measure: Cost-effectiveness
time frame: at 4 weeks, 3 and 6 months post-operative
description: An economic evaluation will be performed for physical functioning and Quality Adjusted Life Years (QALYs). For estimating QALYs, the patients' EQ-5D-5L health states will be converted into utility scores using the Dutch tariff. QALYs will subsequently be calculated using linear interpolation between measurement points.
arm group label: Posterolateral
arm group type: Experimental
description: Patients treated with a hemiarthroplasty using the posterolateral approach
arm group label: Direct lateral
arm group type: Experimental
description: Patients treated with a hemiarthroplasty using the direct lateral approach
intervention type: Procedure
intervention name: Surgical approach
description: The surgical approach of hemiarthroplasty after femoral neck fracture
arm group label: Direct lateral
arm group label: Posterolateral
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Femoral Neck Fractures
sharing ipd: Undecided