<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/NCT03240484</url>
  </required_header>
  <id_info>
    <org_study_id>20170312</org_study_id>
    <nct_id>NCT03240484</nct_id>
  </id_info>
  <brief_title>Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement</brief_title>
  <official_title>Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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>
      The purpose of the study is to explore the long term functional status of people who have had&#xD;
      both a spinal fusion procedure and a total hip replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to explore the long term functional status of people who have had&#xD;
      both a spinal fusion procedure and a total hip replacement. Studies have found that those who&#xD;
      have received spinal fusion may have worse outcomes following a total hip replacement than&#xD;
      those who have not received a spinal fusion. The information obtained from this study will&#xD;
      allow surgeons and researchers to better understand why some who've had a spine fusion have&#xD;
      more complications post total hip replacement compared to those who did not have spinal&#xD;
      fusion surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant positioning</measure>
    <time_frame>6months or greater post-operative</time_frame>
    <description>Radiographic assessment (x-ray cup orientation measurements)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip dysfunction and osteoarthritis outcome score (HOOS)</measure>
    <time_frame>6months or greater post-operative</time_frame>
    <description>Disease-specific quality of life measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Hip Score</measure>
    <time_frame>6months or greater post-operative</time_frame>
    <description>Disease-specific quality of life measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 Questionnaire</measure>
    <time_frame>6months or greater post-operative</time_frame>
    <description>Patient-reported overall quality of life measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry low back disability questionnaire</measure>
    <time_frame>6months or greater post-operative</time_frame>
    <description>Assessment of low back pain</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Spinal Fusion</condition>
  <condition>Total Hip Replacement</condition>
  <arm_group>
    <arm_group_label>Spine Fusion and Total Hip Replacement</arm_group_label>
    <description>Any patient who has undergone spine fusion (SF) and total hip arthroplasty (THA). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total Hip Replacement Group</arm_group_label>
    <description>Any patient who has had THA only (no spine fusion surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spine Fusion Only Group</arm_group_label>
    <description>Any patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>X-Ray Imaging</intervention_name>
    <description>X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.</description>
    <arm_group_label>Spine Fusion Only Group</arm_group_label>
    <arm_group_label>Spine Fusion and Total Hip Replacement</arm_group_label>
    <arm_group_label>Total Hip Replacement Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait Analysis</intervention_name>
    <description>Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.</description>
    <arm_group_label>Spine Fusion and Total Hip Replacement</arm_group_label>
    <arm_group_label>Total Hip Replacement Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 70 patients who underwent total hip arthroplasty (THA) and spine fusion (SF)&#xD;
        surgery will be called by the surgeon or research team and asked if they wish to&#xD;
        participate in the study. A second group of approximately 45 patients who have only had a&#xD;
        THA (and no SF) will serve as a comparison group. A third group of approximately 45&#xD;
        patients who have only had an SF surgery (and no THA) will also be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to come to the Civic Campus for a surgical follow-up visit&#xD;
&#xD;
          -  Speaks English and/or French&#xD;
&#xD;
          -  Group 1 patients must have had a spine fusion (SF) and total hip arthroplasty (THA)&#xD;
&#xD;
          -  Group 2 patients must have had a total hip replacement (THA) and no history of spine&#xD;
             fusion (SF)&#xD;
&#xD;
          -  Group 3 patients must have had a spine fusion (SF) and no history of total hip&#xD;
             arthroplasty (THA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient does not meet all 'inclusion' criteria&#xD;
&#xD;
          -  Patient is unable to answer questionnaires&#xD;
&#xD;
          -  Unable to get x-rays for other medical reasons&#xD;
&#xD;
          -  Severe dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wade Gofton, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meaghan Dufresne</last_name>
    <phone>613-737-8899</phone>
    <email>meadufresne@ohri.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Research Manager</last_name>
    <phone>613-737-8920</phone>
    <email>jdobransky@ohri.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Manager</last_name>
      <phone>613-737-8920</phone>
    </contact>
    <investigator>
      <last_name>Wade Gofton, MD FRCSC MEd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Beaule, MD FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>George Grammatopoulos, BMBBS DPhil Oxon MRCS FRCS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthew Coyle, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mario Lamontagne, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe Phan, MD PhD FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ottawa Hospital Research Institute</investigator_affiliation>
    <investigator_full_name>Wade Gofton</investigator_full_name>
    <investigator_title>Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03240484
org study id: 20170312
nct id: NCT03240484
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to explore the long term functional status of people who have had
      both a spinal fusion procedure and a total hip replacement.
The purpose of the study is to explore the long term functional status of people who have had
      both a spinal fusion procedure and a total hip replacement. Studies have found that those who
      have received spinal fusion may have worse outcomes following a total hip replacement than
      those who have not received a spinal fusion. The information obtained from this study will
      allow surgeons and researchers to better understand why some who've had a spine fusion have
      more complications post total hip replacement compared to those who did not have spinal
      fusion surgery.
observational model: Case-Control
time perspective: Prospective
measure: Implant positioning
time frame: 6months or greater post-operative
description: Radiographic assessment (x-ray cup orientation measurements)
measure: Hip dysfunction and osteoarthritis outcome score (HOOS)
time frame: 6months or greater post-operative
description: Disease-specific quality of life measure
measure: Oxford Hip Score
time frame: 6months or greater post-operative
description: Disease-specific quality of life measure
measure: SF-12 Questionnaire
time frame: 6months or greater post-operative
description: Patient-reported overall quality of life measure
measure: Oswestry low back disability questionnaire
time frame: 6months or greater post-operative
description: Assessment of low back pain
arm group label: Spine Fusion and Total Hip Replacement
description: Any patient who has undergone spine fusion (SF) and total hip arthroplasty (THA). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.
arm group label: Total Hip Replacement Group
description: Any patient who has had THA only (no spine fusion surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.
arm group label: Spine Fusion Only Group
description: Any patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires.
intervention type: Diagnostic Test
intervention name: X-Ray Imaging
description: X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
arm group label: Spine Fusion Only Group
arm group label: Spine Fusion and Total Hip Replacement
arm group label: Total Hip Replacement Group
intervention type: Other
intervention name: Gait Analysis
description: Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.
arm group label: Spine Fusion and Total Hip Replacement
arm group label: Total Hip Replacement Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wade Gofton, MD, FRCSC
role: Principal Investigator
affiliation: The Ottawa Hospital Research Institute
last name: Meaghan Dufresne
phone: 613-737-8899
email: meadufresne@ohri.ca
last name: Research Manager
phone: 613-737-8920
email: jdobransky@ohri.ca
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Ottawa Hospital Research Institute
investigator full name: Wade Gofton
investigator title: Orthopaedic Surgeon
sharing ipd: No