xml: <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/NCT06024304</url>
    </required_header>
    <id_info>
      <org_study_id>ORTHO-22-INTERTAN</org_study_id>
      <nct_id>NCT06024304</nct_id>
    </id_info>
    <brief_title>InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery</brief_title>
    <official_title>Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Paul E. Matuszewski</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kentucky</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 goal of this pilot, patient blinded randomized trial is to develop a mechanistic&#xD;
        understanding of gait following fixation of unstable intertrochanteric hip fractures and&#xD;
        return to function and pain control. The guiding hypothesis that will be tested in a&#xD;
        subsequent clinicial trial is that the InterTAN when compared to standard lag-screw&#xD;
        cephalomedullary nails will have decreased post operative pain, earlier return to symmetric&#xD;
        weight bearing, and quicker return to pre-injury functioning levels.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim 1: Determine the feasibility of conducting a randomized trial assessing gait mechanics as&#xD;
        well as outcomes following unstable intertrochanteric femur fractures treated with&#xD;
        cephalomedullary nails. This will be achieved by performing a pilot randomized trial&#xD;
        comparing the InterTAN versus a single-screw design cephalomedullary nail (SSCMN).&#xD;
        Deliverable: Preliminary data to support a larger randomized trial powered on either&#xD;
        mechanical assessments or patient reported outcomes. Feasibility of conducting comprehensive&#xD;
        biomechanical and patient related outcome measurements in the geriatric hip fracture&#xD;
        population.&#xD;
  &#xD;
        Aim 2: Determine the pathway to return to function and symmetric weight bearing. Load bearing&#xD;
        will be assessed through insole monitoring during their inpatient stay and 2-weeks post-op.&#xD;
        Additionally, analysis will be performed to measure gait for hip motion, loading, strength&#xD;
        and functional assessments at 6,12, and 26 weeks post-op. Patients will also be assessed at&#xD;
        1-year for reported function as well. Hypothesis: Patients in the InterTAN group will have&#xD;
        faster return to symmetrical weight bearing/motion and earlier return to function.&#xD;
        Deliverable: Longitudinal data assessing return to function and weight bearing in&#xD;
        intertrochanteric femur fractures.&#xD;
  &#xD;
        Aim 3: Determine if use of the InterTAN device when compared to SSCMN results in decreased&#xD;
        pain following unstable intertrochanteric femur fractures. Patients will be enrolled in a&#xD;
        prospective trial with standardized pain control regimen, assessing patients for pain during&#xD;
        their hospital stay using Area Under the Curve Analysis of Visual Analogue Pain Scores at 24,&#xD;
        48 and 72 hours. Similarly, opioid usage in morphine milligram equivalents will be assessed.&#xD;
        Pain will be assessed at follow-up visits 6, 12, 26, 52 weeks. Hypothesis: The InterTAN will&#xD;
        result in decreased pain in the immediate post-operative period and in sub-acute&#xD;
        post-operative period.&#xD;
  &#xD;
        Aim 4: Determine if the use of the InterTAN device when compared to SSCMN results in&#xD;
        decreased healthcare utilization. Participation with therapy, hospital length of stay,&#xD;
        discharge disposition, and time-spent in rehabilitation facility will be assessed.&#xD;
        Hypothesis: Patients in the InterTAN group will be more likely to be discharged home,&#xD;
        participate with therapy more, have decreased length of stay in both inpatient and outpatient&#xD;
        units. Deliverable: Data to inform the power analysis for a larger prospective clinical&#xD;
        trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</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>
      <intervention_model_description>Pilot, patient blinded randomized trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in self-reported physical function</measure>
      <time_frame>2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months</time_frame>
      <description>Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in self-reported pain</measure>
      <time_frame>2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months</time_frame>
      <description>Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Questionnaire is a 56 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates increased interference due to pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Functional Independence Measure</measure>
      <time_frame>2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months</time_frame>
      <description>The Functional Independence Measure (FIM) is a tool used to measure the level of disability as well as the change in patient status. FI is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain assessment</measure>
      <time_frame>2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months</time_frame>
      <description>Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in weight bearing</measure>
      <time_frame>2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months</time_frame>
      <description>The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric during their physical therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Visual Analog Pain Score</measure>
      <time_frame>2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months</time_frame>
      <description>The visual analog pain score is a horizontal line with a scale ranging from 0 to 10 where a higher number indicates more pain.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Fracture of Hip</condition>
    <arm_group>
      <arm_group_label>Trigen InterTan</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith &amp; Nephew.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Synthes TFNA</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Synthes TFNA</intervention_name>
      <description>Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.</description>
      <arm_group_label>Synthes TFNA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Trigen InterTAN</intervention_name>
      <description>Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.</description>
      <arm_group_label>Trigen InterTan</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-pathologic fractures&#xD;
  &#xD;
            -  OTA/AO classification 31A2, 31A3 fractures&#xD;
  &#xD;
            -  Ability to participate in 4-MET equivalent activities without ambulatory assistance&#xD;
               prior to injury&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to consent&#xD;
  &#xD;
            -  Inability to participate in follow-up activities&#xD;
  &#xD;
            -  History of chronic pain / current opioid treatment&#xD;
  &#xD;
            -  Pre-injury ambulatory status requiring assistance device&#xD;
  &#xD;
            -  Neurological condition altering gait or sensation (e.g. History of stroke with altered&#xD;
               gait, peripheral neuropathy).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paul Matuszewski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paul E Matuszewski, MD</last_name>
      <phone>(859) 323-5533</phone>
      <email>pmatuszewski@uky.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Matthew Eubank</last_name>
      <phone>(859) 323-5533</phone>
      <email>mseuba01@uky.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 13, 2022</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Paul E. Matuszewski</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Surgical Fixation</keyword>
    <keyword>Cephalomedullary nail</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024304
  org study id: ORTHO-22-INTERTAN
  nct id: NCT06024304
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this pilot, patient blinded randomized trial is to develop a mechanistic
        understanding of gait following fixation of unstable intertrochanteric hip fractures and
        return to function and pain control. The guiding hypothesis that will be tested in a
        subsequent clinicial trial is that the InterTAN when compared to standard lag-screw
        cephalomedullary nails will have decreased post operative pain, earlier return to symmetric
        weight bearing, and quicker return to pre-injury functioning levels.
  Aim 1: Determine the feasibility of conducting a randomized trial assessing gait mechanics as
        well as outcomes following unstable intertrochanteric femur fractures treated with
        cephalomedullary nails. This will be achieved by performing a pilot randomized trial
        comparing the InterTAN versus a single-screw design cephalomedullary nail (SSCMN).
        Deliverable: Preliminary data to support a larger randomized trial powered on either
        mechanical assessments or patient reported outcomes. Feasibility of conducting comprehensive
        biomechanical and patient related outcome measurements in the geriatric hip fracture
        population.
  
        Aim 2: Determine the pathway to return to function and symmetric weight bearing. Load bearing
        will be assessed through insole monitoring during their inpatient stay and 2-weeks post-op.
        Additionally, analysis will be performed to measure gait for hip motion, loading, strength
        and functional assessments at 6,12, and 26 weeks post-op. Patients will also be assessed at
        1-year for reported function as well. Hypothesis: Patients in the InterTAN group will have
        faster return to symmetrical weight bearing/motion and earlier return to function.
        Deliverable: Longitudinal data assessing return to function and weight bearing in
        intertrochanteric femur fractures.
  
        Aim 3: Determine if use of the InterTAN device when compared to SSCMN results in decreased
        pain following unstable intertrochanteric femur fractures. Patients will be enrolled in a
        prospective trial with standardized pain control regimen, assessing patients for pain during
        their hospital stay using Area Under the Curve Analysis of Visual Analogue Pain Scores at 24,
        48 and 72 hours. Similarly, opioid usage in morphine milligram equivalents will be assessed.
        Pain will be assessed at follow-up visits 6, 12, 26, 52 weeks. Hypothesis: The InterTAN will
        result in decreased pain in the immediate post-operative period and in sub-acute
        post-operative period.
  
        Aim 4: Determine if the use of the InterTAN device when compared to SSCMN results in
        decreased healthcare utilization. Participation with therapy, hospital length of stay,
        discharge disposition, and time-spent in rehabilitation facility will be assessed.
        Hypothesis: Patients in the InterTAN group will be more likely to be discharged home,
        participate with therapy more, have decreased length of stay in both inpatient and outpatient
        units. Deliverable: Data to inform the power analysis for a larger prospective clinical
        trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pilot, patient blinded randomized trial
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in self-reported physical function
  time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
  description: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
  measure: Change in self-reported pain
  time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
  description: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Questionnaire is a 56 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates increased interference due to pain.
  measure: Change in Functional Independence Measure
  time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
  description: The Functional Independence Measure (FIM) is a tool used to measure the level of disability as well as the change in patient status. FI is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
  measure: Change in pain assessment
  time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
  description: Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''
  measure: Change in weight bearing
  time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
  description: The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric during their physical therapy.
  measure: Change in Visual Analog Pain Score
  time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
  description: The visual analog pain score is a horizontal line with a scale ranging from 0 to 10 where a higher number indicates more pain.
  arm group label: Trigen InterTan
  arm group type: Active Comparator
  description: Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith & Nephew.
  arm group label: Synthes TFNA
  arm group type: Active Comparator
  description: Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes.
  intervention type: Device
  intervention name: Synthes TFNA
  description: Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.
  arm group label: Synthes TFNA
  intervention type: Device
  intervention name: Trigen InterTAN
  description: Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.
  arm group label: Trigen InterTan
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Paul Matuszewski, MD
  role: Principal Investigator
  affiliation: University of Kentucky
  last name: Paul E Matuszewski, MD
  phone: (859) 323-5533
  email: pmatuszewski@uky.edu
  last name: Matthew Eubank
  phone: (859) 323-5533
  email: mseuba01@uky.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Paul E. Matuszewski
  investigator title: Associate Professor
  mesh term: Hip Fractures
  sharing ipd: No