<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/NCT04494672</url>
  </required_header>
  <id_info>
    <org_study_id>ORL-ORT-015</org_study_id>
    <nct_id>NCT04494672</nct_id>
  </id_info>
  <brief_title>A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System</brief_title>
  <official_title>Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christian Candrian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ente Ospedaliero Cantonale, Bellinzona</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head&#xD;
      without additional radiation. It automatically detects the used implant and its position&#xD;
      relative to the femoral head, helping the surgeon to achieve an optimal proximal screw&#xD;
      positioning in the femoral head. The investigators want to verify if with the addition of the&#xD;
      ADAPT system the investigators can improve screw placement and reduce surgery time and&#xD;
      radiation exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a 2-arm randomized controlled trial comparing intramedullary nailing of&#xD;
      proximal fracture of the femur (AO classified as 31 A1.3 , 31 A2.1, 31 A2.2 31 A2.3, 31 A3.1,&#xD;
      31 A3.2, 31 A3.3) performed with the ADAPT system (arm-A) and those performed without&#xD;
      (arm-B).&#xD;
&#xD;
      The ADAPT system has been developed with the aim to reduce the rate of complications in&#xD;
      intramedullary nailing and its usefulness has been previously explored only in two&#xD;
      underpowered randomized controlled trials. Thanks to the possibility to track screw placement&#xD;
      in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in&#xD;
      order to minimize radiation exposure, surgical time, and rate of complications.&#xD;
&#xD;
      All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano&#xD;
      satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and&#xD;
      randomly allocated (allocation ratio 1:1) to receive preoperatively:&#xD;
&#xD;
        -  Intramedullary nailing with ADAPT system (arm-A)&#xD;
&#xD;
        -  Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating&#xD;
           the results will be blinded to the assigned group.&#xD;
&#xD;
      The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data&#xD;
      about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and&#xD;
      radiation exposure time will be collected.&#xD;
&#xD;
      Fracture healing, and rate of complications (cut-through and cut out) will be evaluated&#xD;
      during all the follow-up visits, alongside VAS and a functional evaluation of the injured hip&#xD;
      through the Oxford Hip score.&#xD;
&#xD;
      All treatment related adverse events will be reported up to follow-up visit 4, i.e. up to 12&#xD;
      ± 1 months.&#xD;
&#xD;
      Every patient will be involved in the trial for 1 year. The expected time to complete the&#xD;
      trial is 4 years: 3 years for patient enrolment and 1 year to complete the last follow-up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2024</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TAD (tip to apex) index at the post-operative X-Ray control prior discharge</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge.&#xD;
The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time of the procedure</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative blood loss</measure>
    <time_frame>during the surgery</time_frame>
    <description>intraoperative blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative radiation time</measure>
    <time_frame>during the surgery</time_frame>
    <description>intraoperative radiation time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>The satisfaction NRS is a self-assessment scale in which surgeons rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>non-union</measure>
    <time_frame>at 6 weeks, 3 months, 6 months and 1-year</time_frame>
    <description>fracture not alligned</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cut-through rate</measure>
    <time_frame>at 6 weeks, 3 months, 6 months and 1-year</time_frame>
    <description>cut-through rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cut-out rate</measure>
    <time_frame>at 6 weeks, 3 months, 6 months and 1-year</time_frame>
    <description>cut-out rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>at 6 weeks, 3 months, 6 months and 1-year</time_frame>
    <description>Visual pain analogue scale, [from 0 (no pain) to 10 (worst pain)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]</measure>
    <time_frame>at 6 weeks, 3 months, 6 months and 1-year</time_frame>
    <description>Hip function</description>
  </secondary_outcome>
  <other_outcome>
    <measure>re-fracture rates</measure>
    <time_frame>at 6 weeks, 3 months, 6 months and 1-year</time_frame>
    <description>re-fracture rates</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Femoral Fracture</condition>
  <arm_group>
    <arm_group_label>Intramedullary nailing with ADAPT system (arm-A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A commercial product, namely ADAPT will be used as investigation product in arm-A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intramedullary nailing without ADAPT system (arm-B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intramedullary nailing with ADAPT system</intervention_name>
    <description>Stryker ADAPT®system (ADAPT, Stryker Leibinger GmbH &amp; Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively</description>
    <arm_group_label>Intramedullary nailing with ADAPT system (arm-A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intramedullary nailing without ADAPT system</intervention_name>
    <description>Intramedullary nailing without ADAPT system</description>
    <arm_group_label>Intramedullary nailing without ADAPT system (arm-B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing unilateral primary intramedullary nailing at the Ospedale&#xD;
             Regionale di Lugano.&#xD;
&#xD;
          -  Patients aged 50-85 years old.&#xD;
&#xD;
          -  Patients with a BMI &gt;18 and &lt;35.&#xD;
&#xD;
          -  Patients able to provide informed consent and follow all the study procedures as&#xD;
             indicated by the protocol.&#xD;
&#xD;
          -  Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31&#xD;
             A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other clinically significant concomitant disease states (e.g. renal failure, major&#xD;
             hepatic dysfunction, life-threatening cardiovascular disease, etc..).&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse.&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant.&#xD;
&#xD;
          -  Previous enrolment into the current study.&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Candrian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ente Ospedaliero Cantonale, Bellinzona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Candrian, MD</last_name>
    <phone>0041918117029</phone>
    <email>RicercaOrtopedia.ORL@eoc.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Christian Candrian</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Candrian, Prof.Dr.med</last_name>
      <phone>+41 (0) 91 811 61 23</phone>
      <email>christian.candrian@eoc.ch</email>
    </contact>
    <contact_backup>
      <last_name>Gianluigi Capone, Dr.</last_name>
      <email>gianluigi.capone@eoc.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ente Ospedaliero Cantonale, Bellinzona</investigator_affiliation>
    <investigator_full_name>Christian Candrian</investigator_full_name>
    <investigator_title>Prof. Dr. Med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>not foreseen</ipd_description>
  </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/NCT04494672
org study id: ORL-ORT-015
nct id: NCT04494672
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head
      without additional radiation. It automatically detects the used implant and its position
      relative to the femoral head, helping the surgeon to achieve an optimal proximal screw
      positioning in the femoral head. The investigators want to verify if with the addition of the
      ADAPT system the investigators can improve screw placement and reduce surgery time and
      radiation exposure.
This study is a 2-arm randomized controlled trial comparing intramedullary nailing of
      proximal fracture of the femur (AO classified as 31 A1.3 , 31 A2.1, 31 A2.2 31 A2.3, 31 A3.1,
      31 A3.2, 31 A3.3) performed with the ADAPT system (arm-A) and those performed without
      (arm-B).

      The ADAPT system has been developed with the aim to reduce the rate of complications in
      intramedullary nailing and its usefulness has been previously explored only in two
      underpowered randomized controlled trials. Thanks to the possibility to track screw placement
      in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in
      order to minimize radiation exposure, surgical time, and rate of complications.

      All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano
      satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and
      randomly allocated (allocation ratio 1:1) to receive preoperatively:

        -  Intramedullary nailing with ADAPT system (arm-A)

        -  Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating
           the results will be blinded to the assigned group.

      The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data
      about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and
      radiation exposure time will be collected.

      Fracture healing, and rate of complications (cut-through and cut out) will be evaluated
      during all the follow-up visits, alongside VAS and a functional evaluation of the injured hip
      through the Oxford Hip score.

      All treatment related adverse events will be reported up to follow-up visit 4, i.e. up to 12
      ± 1 months.

      Every patient will be involved in the trial for 1 year. The expected time to complete the
      trial is 4 years: 3 years for patient enrolment and 1 year to complete the last follow-up
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: TAD (tip to apex) index at the post-operative X-Ray control prior discharge
time frame: immediately after the surgery
description: The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge.
The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.
measure: time of the procedure
time frame: immediately after the surgery
description: time
measure: intraoperative blood loss
time frame: during the surgery
description: intraoperative blood loss
measure: intraoperative radiation time
time frame: during the surgery
description: intraoperative radiation time
measure: surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
time frame: immediately after the surgery
description: The satisfaction NRS is a self-assessment scale in which surgeons rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery
measure: non-union
time frame: at 6 weeks, 3 months, 6 months and 1-year
description: fracture not alligned
measure: cut-through rate
time frame: at 6 weeks, 3 months, 6 months and 1-year
description: cut-through rate
measure: cut-out rate
time frame: at 6 weeks, 3 months, 6 months and 1-year
description: cut-out rate
measure: VAS
time frame: at 6 weeks, 3 months, 6 months and 1-year
description: Visual pain analogue scale, [from 0 (no pain) to 10 (worst pain)]
measure: Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]
time frame: at 6 weeks, 3 months, 6 months and 1-year
description: Hip function
measure: re-fracture rates
time frame: at 6 weeks, 3 months, 6 months and 1-year
description: re-fracture rates
arm group label: Intramedullary nailing with ADAPT system (arm-A)
arm group type: Experimental
description: A commercial product, namely ADAPT will be used as investigation product in arm-A
arm group label: Intramedullary nailing without ADAPT system (arm-B)
arm group type: Active Comparator
description: No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B
intervention type: Procedure
intervention name: Intramedullary nailing with ADAPT system
description: Stryker ADAPT®system (ADAPT, Stryker Leibinger GmbH & Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively
arm group label: Intramedullary nailing with ADAPT system (arm-A)
intervention type: Procedure
intervention name: Intramedullary nailing without ADAPT system
description: Intramedullary nailing without ADAPT system
arm group label: Intramedullary nailing without ADAPT system (arm-B)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christian Candrian, MD
role: Principal Investigator
affiliation: Ente Ospedaliero Cantonale, Bellinzona
last name: Christian Candrian, MD
phone: 0041918117029
email: RicercaOrtopedia.ORL@eoc.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Ente Ospedaliero Cantonale, Bellinzona
investigator full name: Christian Candrian
investigator title: Prof. Dr. Med.
mesh term: Fractures, Bone
mesh term: Femoral Fractures
sharing ipd: No
ipd description: not foreseen