<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/NCT04408053</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180585</org_study_id>
    <nct_id>NCT04408053</nct_id>
  </id_info>
  <brief_title>Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture</brief_title>
  <acronym>PREFIX</acronym>
  <official_title>Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      In France, the annual incidence of hip fracture is about 80 000 with more than 75% of these&#xD;
      fractures occurring in patients aged 80 years old or more. About 10% percent of patients&#xD;
      presenting with a hip fracture will sustain a contralateral hip fracture, most within 3&#xD;
      years. The consequences of a hip fracture are dramatic: 20% of patients die in the first year&#xD;
      and less than half those who survive regain their previous level of function. Hip fractures&#xD;
      are invariably associated with chronic pain, reduced mobility, disability, and an increasing&#xD;
      degree of dependence. The efficacy of pharmacological treatments to prevent a contralateral&#xD;
      hip fracture is marginal and postponed and compliance is known to be poor.&#xD;
&#xD;
      Osteoporosis is associated with cortical thinning and trabecular bone loss. Therefore, the&#xD;
      mini-invasive preventive fixation (MIPF) of the contralateral femoral neck is appealing. The&#xD;
      effect is immediate and compliance is certain. Morbidity is minimal because it is performed&#xD;
      during the same operation as the fixation of the femoral neck fracture.&#xD;
&#xD;
      The main objective of this study is to determine whether the mini-invasive preventive&#xD;
      fixation (MIPF) of the contralateral femoral neck in patients having a femoral neck fracture&#xD;
      is superior to no fixation regarding the occurrence of a contralateral hip fracture within 3&#xD;
      years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence of a contralateral fracture of the proximal femur</measure>
    <time_frame>at 3 years after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>within 3 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason</measure>
    <time_frame>within 3 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's autonomy</measure>
    <time_frame>at 3 months after randomization</time_frame>
    <description>Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's autonomy</measure>
    <time_frame>at 1 year after randomization</time_frame>
    <description>Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's autonomy</measure>
    <time_frame>at 2 years after randomization</time_frame>
    <description>Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's autonomy</measure>
    <time_frame>at 3 years after randomization</time_frame>
    <description>Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's function</measure>
    <time_frame>at 3 months after randomization</time_frame>
    <description>Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as &quot;no difficulty&quot;, with an aid&quot;; &quot;with the help from another person&quot;; &quot;not at all&quot;. Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's function</measure>
    <time_frame>at 1 year after randomization</time_frame>
    <description>Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as &quot;no difficulty&quot;, with an aid&quot;; &quot;with the help from another person&quot;; &quot;not at all&quot;. Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's function</measure>
    <time_frame>at 2 years after randomization</time_frame>
    <description>Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as &quot;no difficulty&quot;, with an aid&quot;; &quot;with the help from another person&quot;; &quot;not at all&quot;. Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's function</measure>
    <time_frame>at 3 years after randomization</time_frame>
    <description>Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as &quot;no difficulty&quot;, with an aid&quot;; &quot;with the help from another person&quot;; &quot;not at all&quot;. Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients receiving an antiosteoporotic treatment</measure>
    <time_frame>at 3 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls since the last follow-up visit</measure>
    <time_frame>at 3 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls since the last follow-up visit</measure>
    <time_frame>at 1 year after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls since the last follow-up visit</measure>
    <time_frame>at 2 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls since the last follow-up visit</measure>
    <time_frame>at 3 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain on the contralateral hip</measure>
    <time_frame>at 3 months after randomization</time_frame>
    <description>Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain on the contralateral hip</measure>
    <time_frame>at 1 year after randomization</time_frame>
    <description>Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain on the contralateral hip</measure>
    <time_frame>at 2 years after randomization</time_frame>
    <description>Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain on the contralateral hip</measure>
    <time_frame>at 3 years after randomization</time_frame>
    <description>Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">812</enrollment>
  <condition>Femoral Neck Fractures</condition>
  <arm_group>
    <arm_group_label>Preventive fixation of the contralateral femoral neck</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mini-invasive preventive fixation of the contralateral femoral neck : 6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No fixation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)</intervention_name>
    <description>6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients</description>
    <arm_group_label>Preventive fixation of the contralateral femoral neck</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women and men&#xD;
&#xD;
          -  80 years or older&#xD;
&#xD;
          -  operated on for a femoral neck fracture&#xD;
&#xD;
          -  presenting one, or more, added clinical risk factor of hip fracture*&#xD;
&#xD;
          -  a fragility fracture in the past five years&#xD;
&#xD;
          -  a history of fall in the past 12 months (not considering the fall that led to the&#xD;
             present fracture)&#xD;
&#xD;
          -  a very high risk of falling: use of psychoactive medication or impaired vision or&#xD;
             impaired neuromuscular function&#xD;
&#xD;
          -  BMI lower than 20kg/m2&#xD;
&#xD;
          -  giving her/his consent.&#xD;
&#xD;
          -  affiliated to the social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of a contralateral proximal femoral fracture&#xD;
&#xD;
          -  history of a surgical operation of the contralateral proximal femur&#xD;
&#xD;
          -  ongoing infection (bone or soft-tissue) on the contralateral hip&#xD;
&#xD;
          -  contraindication of MIPF of the contralateral hip&#xD;
&#xD;
          -  non ambulatory patients&#xD;
&#xD;
          -  patients already included in the study&#xD;
&#xD;
          -  patients with contraindication to the medical devices under evaluation&#xD;
&#xD;
          -  patients not suitable for a surgical procedure (including not suitable for an&#xD;
             anaesthetic)&#xD;
&#xD;
          -  patients with a benign or malignant bone lesion of the contralateral femur&#xD;
&#xD;
          -  patients included in another clinical research which could directly have an effect on&#xD;
             the femoral neck bone strength&#xD;
&#xD;
          -  patients presenting with a grade 4 Kellgren-Lawrence osteoarthritis of the&#xD;
             contralateral hip and reporting significant clinical symptoms&#xD;
&#xD;
          -  patients with an life expectancy of less than 3 months&#xD;
&#xD;
          -  patients with a legal representative (tutorship or guardianship) and insane patients&#xD;
             will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David Biau</last_name>
    <phone>+331 58 41 30 37</phone>
    <email>david.biau@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu RESCHE-RIGON, Pr</last_name>
    <phone>0142499742</phone>
    <phone_ext>0142499742</phone_ext>
    <email>matthieu.resche-rigon@univ-paris-diderot.fr</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 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>
  <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/NCT04408053
org study id: APHP180585
nct id: NCT04408053
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In France, the annual incidence of hip fracture is about 80 000 with more than 75% of these
      fractures occurring in patients aged 80 years old or more. About 10% percent of patients
      presenting with a hip fracture will sustain a contralateral hip fracture, most within 3
      years. The consequences of a hip fracture are dramatic: 20% of patients die in the first year
      and less than half those who survive regain their previous level of function. Hip fractures
      are invariably associated with chronic pain, reduced mobility, disability, and an increasing
      degree of dependence. The efficacy of pharmacological treatments to prevent a contralateral
      hip fracture is marginal and postponed and compliance is known to be poor.

      Osteoporosis is associated with cortical thinning and trabecular bone loss. Therefore, the
      mini-invasive preventive fixation (MIPF) of the contralateral femoral neck is appealing. The
      effect is immediate and compliance is certain. Morbidity is minimal because it is performed
      during the same operation as the fixation of the femoral neck fracture.

      The main objective of this study is to determine whether the mini-invasive preventive
      fixation (MIPF) of the contralateral femoral neck in patients having a femoral neck fracture
      is superior to no fixation regarding the occurrence of a contralateral hip fracture within 3
      years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cumulative incidence of a contralateral fracture of the proximal femur
time frame: at 3 years after randomization
measure: Mortality
time frame: within 3 years after randomization
measure: Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason
time frame: within 3 years after randomization
measure: Patient's autonomy
time frame: at 3 months after randomization
description: Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
measure: Patient's autonomy
time frame: at 1 year after randomization
description: Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
measure: Patient's autonomy
time frame: at 2 years after randomization
description: Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
measure: Patient's autonomy
time frame: at 3 years after randomization
description: Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
measure: Patient's function
time frame: at 3 months after randomization
description: Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
measure: Patient's function
time frame: at 1 year after randomization
description: Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
measure: Patient's function
time frame: at 2 years after randomization
description: Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
measure: Patient's function
time frame: at 3 years after randomization
description: Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
measure: Proportion of patients receiving an antiosteoporotic treatment
time frame: at 3 months after randomization
measure: Number of falls since the last follow-up visit
time frame: at 3 months after randomization
measure: Number of falls since the last follow-up visit
time frame: at 1 year after randomization
measure: Number of falls since the last follow-up visit
time frame: at 2 years after randomization
measure: Number of falls since the last follow-up visit
time frame: at 3 years after randomization
measure: Pain on the contralateral hip
time frame: at 3 months after randomization
description: Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).
measure: Pain on the contralateral hip
time frame: at 1 year after randomization
description: Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).
measure: Pain on the contralateral hip
time frame: at 2 years after randomization
description: Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).
measure: Pain on the contralateral hip
time frame: at 3 years after randomization
description: Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).
arm group label: Preventive fixation of the contralateral femoral neck
arm group type: Experimental
description: Mini-invasive preventive fixation of the contralateral femoral neck : 6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients
arm group label: No fixation
arm group type: No Intervention
intervention type: Device
intervention name: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)
description: 6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients
arm group label: Preventive fixation of the contralateral femoral neck
criteria: 
gender: All
minimum age: 80 Years
maximum age: N/A
healthy volunteers: No
last name: David Biau
phone: +331 58 41 30 37
email: david.biau@aphp.fr
last name: Matthieu RESCHE-RIGON, Pr
phone: 0142499742
phone ext: 0142499742
email: matthieu.resche-rigon@univ-paris-diderot.fr
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures
sharing ipd: Undecided