<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/NCT03261544</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00082717</org_study_id>
    <nct_id>NCT03261544</nct_id>
  </id_info>
  <brief_title>Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?</brief_title>
  <official_title>Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the functional outcomes in patients undergoing&#xD;
      proximal femur resection and reconstruction with an endoprosthesis, based on the abductor&#xD;
      muscle repair technique. The investigators hypothesize that those patients who receive&#xD;
      reattachment of the abductors directly into the prosthesis will have better functional&#xD;
      outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective,&#xD;
      and reproducible method to assess abductor function at clinical post-operative visits through&#xD;
      plain radiographs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients treated for proximal femur replacements at Duke University Medical Center by&#xD;
      Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify&#xD;
      retrospective patients using the above mentioned CPT codes. Individual chart review of the&#xD;
      electronic medical record will then be used to identify those receiving a proximal femur&#xD;
      replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300&#xD;
      charts, the investigators plan to consent 25 subjects who have return appointments scheduled.&#xD;
      The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>The Musculoskeletal Tumor Society (MSTS) score</measure>
    <time_frame>up to 24 months postoperatively</time_frame>
    <description>The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>up to 24 months postoperatively</time_frame>
    <description>The Harris Hip Score (HHS) is a clinician-based outcome measure that is frequently used for the evaluation of patients following a Total Hip Arthroplasty (THA). The survey has ten questions and scores ranging from 0-100, with higher scores representing less dysfunction and better outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.</measure>
    <time_frame>up to 24 months postoperatively</time_frame>
    <description>The adverse event form records the occurence of implant-related complications that occur during study participation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait Analysis as reported on the study's case report form</measure>
    <time_frame>up to 24 months postoperatively</time_frame>
    <description>Motion data collected from gait analysis testing will be evaluated with OpenCap.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sarcoma</condition>
  <condition>Bone Metastases</condition>
  <condition>Proximal Femur Replacement</condition>
  <arm_group>
    <arm_group_label>Proximal Femur Replacement</arm_group_label>
    <description>The proximal femur is a common site for primary bone sarcomas and metastatic disease. The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Proximal Femur Replacement</intervention_name>
    <description>The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.</description>
    <arm_group_label>Proximal Femur Replacement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated for proximal femur replacements at Duke University Medical Center by&#xD;
        Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify&#xD;
        retrospective patients using the above mentioned CPT codes. Individual chart review of the&#xD;
        electronic medical record will then be used to identify those receiving a proximal femur&#xD;
        replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300&#xD;
        charts, the investigators plan to consent 25 subjects who have return appointments&#xD;
        scheduled. The investigators also plan to consent 25 preoperative patients, for a total of&#xD;
        50 subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-ambulatory before or after the procedure&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, have not or likely will not complete&#xD;
             at least some portion of the investigator's recommended follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Eward, MD, DVM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Sachs, MS</last_name>
    <phone>9196609849</phone>
    <email>elizabeth.sachs@duke.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sachs</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</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>Sarcoma</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/NCT03261544
org study id: Pro00082717
nct id: NCT03261544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the functional outcomes in patients undergoing
      proximal femur resection and reconstruction with an endoprosthesis, based on the abductor
      muscle repair technique. The investigators hypothesize that those patients who receive
      reattachment of the abductors directly into the prosthesis will have better functional
      outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective,
      and reproducible method to assess abductor function at clinical post-operative visits through
      plain radiographs.
Patients treated for proximal femur replacements at Duke University Medical Center by
      Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify
      retrospective patients using the above mentioned CPT codes. Individual chart review of the
      electronic medical record will then be used to identify those receiving a proximal femur
      replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300
      charts, the investigators plan to consent 25 subjects who have return appointments scheduled.
      The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.
observational model: Cohort
time perspective: Prospective
measure: The Musculoskeletal Tumor Society (MSTS) score
time frame: up to 24 months postoperatively
description: The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
measure: Harris Hip Score
time frame: up to 24 months postoperatively
description: The Harris Hip Score (HHS) is a clinician-based outcome measure that is frequently used for the evaluation of patients following a Total Hip Arthroplasty (THA). The survey has ten questions and scores ranging from 0-100, with higher scores representing less dysfunction and better outcomes.
measure: Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.
time frame: up to 24 months postoperatively
description: The adverse event form records the occurence of implant-related complications that occur during study participation.
measure: Gait Analysis as reported on the study's case report form
time frame: up to 24 months postoperatively
description: Motion data collected from gait analysis testing will be evaluated with OpenCap.
arm group label: Proximal Femur Replacement
description: The proximal femur is a common site for primary bone sarcomas and metastatic disease. The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.
intervention type: Procedure
intervention name: Proximal Femur Replacement
description: The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.
arm group label: Proximal Femur Replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: No
last name: William Eward, MD, DVM
role: Principal Investigator
affiliation: Duke University
last name: Elizabeth Sachs, MS
phone: 9196609849
email: elizabeth.sachs@duke.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Sarcoma