<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/NCT02204007</url>
  </required_header>
  <id_info>
    <org_study_id>14-555</org_study_id>
    <nct_id>NCT02204007</nct_id>
  </id_info>
  <brief_title>Real Time 3D Imaging and Surrogate Bone Model</brief_title>
  <official_title>Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observer-blinded prospective randomized clinical trial to define the efficacy of a&#xD;
      new technology developed at the Cleveland Clinic to improve the positioning of the acetabular&#xD;
      shell in total hip arthroplasty.The proposed study will enroll patients that have consented&#xD;
      to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This&#xD;
      treatment is standard of care. Patients will receive standard of care pre- and post-operative&#xD;
      care and placement of standard of care implants all of which are commercially available and&#xD;
      FDA approved for general use for the clinical indications used in these patients. The only&#xD;
      difference in treatment between the groups will be the use of a surrogate bone model to help&#xD;
      assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic&#xD;
      testing performed specifically related to this study consists of obtaining one pre-operative&#xD;
      and one post-operative CT scan. The post-operative scan is to be performed within two weeks&#xD;
      of surgery.&#xD;
&#xD;
      The investigators predict that those patients with 3D imaging and bone model will have better&#xD;
      acetabular shell placement than those with standard preoperative planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The plan is enroll 44 subjects (22 in the standard surgery group and 22 in the experimental&#xD;
      surgical group) into this randomized clinical trial. All subjects will have the standard of&#xD;
      care indications for THA and will give informed consent for both the surgery and&#xD;
      participation in this study. Enrollment will occur as part of the routine office evaluation&#xD;
      and will be obtained by the treating surgeon or by the research assistant. Four surgeons&#xD;
      (Wael Barsoum, Trevor Murray, Carlos Higuera, and Michael Bloomfield) with surgical&#xD;
      experience in total hip arthroplasty will perform the procedures in this study. All subjects&#xD;
      within each surgeon's practice who qualify for participation in this study will be&#xD;
      approached. Subjects will be enrolled at least 10 days prior to the date of surgery. Ten days&#xD;
      is the minimum time necessary to obtain a pre-operative CT scan for surgical planning and to&#xD;
      manufacture the surrogate bone model. Patients who are not approached during regular office&#xD;
      visits will be contacted by phone and if they are interested, they will be scheduled to&#xD;
      arrive to the radiology department to sign the informed consent and receive the preoperative&#xD;
      CT scan. Subjects will be randomized into either the experimental or control group at the&#xD;
      time of consent by the study coordinator. Subjects in the experimental group will have their&#xD;
      pre-operative planning done using the 3D surgical simulator and surrogate bone model will be&#xD;
      available for the surgeon during surgery. Subjects in the control group will have their&#xD;
      pre-operative planning done using plain film x-ray and two-dimensional (2D) templates.&#xD;
&#xD;
      Eligible subjects for inclusion in the study will be able to receive a pelvic CT scan at the&#xD;
      Cleveland Clinic. Additionally, we will obtain standard of care pre- and post-operative&#xD;
      x-rays (AP view). For subjects randomized into the experimental group, their CT scan DICOM&#xD;
      images will be uploaded into the Cleveland Clinic developed surgical simulator specifically&#xD;
      designed for THA at least 10 days prior to surgery. For each experimental subject, the&#xD;
      Cleveland Clinic pre-operative planning software will be used to define the optimal size and&#xD;
      location of the acetabular components (acetabular shell, and the ultra-high molecular weight&#xD;
      polyethylene bearing - UHMWPE). The treating surgeon will virtually place the implant in the&#xD;
      simulator software. The specification for shell placement will vary depending on the&#xD;
      subject's individual pathology and pelvic morphology, but is expected to fall within the&#xD;
      range of 10-35 degrees of anteversion and 30-50 degrees of abduction.&#xD;
&#xD;
      In the control group, each surgeon will use their standard methods of pre-operative planning&#xD;
      using the pre-operative x-rays. To prepare the acetabulum and place the implants on the day&#xD;
      of surgery, surgeons will use standard surgical alignment instruments provided by the&#xD;
      manufacturer of the implant. For the experimental group, the surgeon will use CT scan and a&#xD;
      3D preoperative planning software to place the implants virtually. The surgeons are provided&#xD;
      with a surrogate bone model with a fabricated acetabular implant placed in the same&#xD;
      orientation as was planned in the surgical simulator software, and will use standard surgical&#xD;
      instruments provided by the manufacturer of the implant.&#xD;
&#xD;
      The images obtained from the post-operative CT scans will be uploaded into the simulator&#xD;
      software for 3D reconstruction. The 3D image of the post-operative pelvis with the implants&#xD;
      will be superimposed onto the image of the pre-operative pelvis with the virtually placed&#xD;
      implants. Using measurement tools within the software we will compare the position of the&#xD;
      actual acetabular component placed in the patient with the desired position specified by the&#xD;
      plan. The measurements that will be made are for angular orientations in 3D space&#xD;
      (anteversion and inclination). Measurements are accurate to within a fraction of a degree.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Small number of subjects&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acetabular Shell Version and Inclination</measure>
    <time_frame>within 2 weeks of surgery</time_frame>
    <description>A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version &amp; inclination measured in degrees) of the acetabular shell</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative Time</measure>
    <time_frame>time of surgery</time_frame>
    <description>Duration of the surgical case</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>3D imaging, surrogate bone model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D imaging &amp; surrogate bone model</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Preoperative Imaging</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receiving standard of care preoperative planning prior to total hip arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D imaging &amp; surrogate bone model</intervention_name>
    <description>3D imaging &amp; surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging</description>
    <arm_group_label>3D imaging, surrogate bone model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects to be included in this protocol will be adult males and females of all races&#xD;
             and socioeconomic status meeting the following criteria:&#xD;
&#xD;
          -  Primary, unilateral Total hip arthroplasty (THA)&#xD;
&#xD;
          -  18 to 85 years old at time of surgery&#xD;
&#xD;
          -  Able to get a pre- and post-operative CT scan at the Cleveland Clinic Main Campus at&#xD;
             least 10 days prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant metal in the joint that results in metal artifact on the pre--operative CT&#xD;
             scan, thereby compromising the ability to visualize the acetabulum on the&#xD;
             pre-operative simulator.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Condition deemed by physician or medical staff to be non-conducive to patient's&#xD;
             ability to complete the study, or a potential risk to the patient's health and&#xD;
             well-being.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Higuera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alison Klika, MS</last_name>
    <role>Study Director</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.dsm.com/markets/medical/en_US/home.html</url>
    <description>Medical Device Materials</description>
  </link>
  <reference>
    <citation>Codsi MJ, Bennetts C, Gordiev K, Boeck DM, Kwon Y, Brems J, Powell K, Iannotti JP. Normal glenoid vault anatomy and validation of a novel glenoid implant shape. J Shoulder Elbow Surg. 2008 May-Jun;17(3):471-8. doi: 10.1016/j.jse.2007.08.010. Epub 2008 Mar 7.</citation>
    <PMID>18328741</PMID>
  </reference>
  <reference>
    <citation>Scalise JJ, Bryan J, Polster J, Brems JJ, Iannotti JP. Quantitative analysis of glenoid bone loss in osteoarthritis using three-dimensional computed tomography scans. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):328-35. doi: 10.1016/j.jse.2007.07.013. Epub 2008 Jan 22.</citation>
    <PMID>18218326</PMID>
  </reference>
  <reference>
    <citation>Scalise JJ, Codsi MJ, Bryan J, Iannotti JP. The three-dimensional glenoid vault model can estimate normal glenoid version in osteoarthritis. J Shoulder Elbow Surg. 2008 May-Jun;17(3):487-91. doi: 10.1016/j.jse.2007.09.006. Epub 2008 Feb 20.</citation>
    <PMID>18282721</PMID>
  </reference>
  <reference>
    <citation>Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Nov;90(11):2438-45. doi: 10.2106/JBJS.G.01341.</citation>
    <PMID>18978413</PMID>
  </reference>
  <reference>
    <citation>Eisler T, Svensson O, Tengstrom A, Elmstedt E. Patient expectation and satisfaction in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4):457-62. doi: 10.1054/arth.2002.31245.</citation>
    <PMID>12066276</PMID>
  </reference>
  <reference>
    <citation>Furnes O, Lie SA, Espehaug B, Vollset SE, Engesaeter LB, Havelin LI. Hip disease and the prognosis of total hip replacements. A review of 53,698 primary total hip replacements reported to the Norwegian Arthroplasty Register 1987-99. J Bone Joint Surg Br. 2001 May;83(4):579-86. doi: 10.1302/0301-620x.83b4.11223.</citation>
    <PMID>11380136</PMID>
  </reference>
  <reference>
    <citation>Older J. Charnley low-friction arthroplasty: a worldwide retrospective review at 15 to 20 years. J Arthroplasty. 2002 Sep;17(6):675-80. doi: 10.1054/arth.2002.31973.</citation>
    <PMID>12216018</PMID>
  </reference>
  <reference>
    <citation>Phillips CB, Barrett JA, Losina E, Mahomed NN, Lingard EA, Guadagnoli E, Baron JA, Harris WH, Poss R, Katz JN. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. J Bone Joint Surg Am. 2003 Jan;85(1):20-6. doi: 10.2106/00004623-200301000-00004.</citation>
    <PMID>12533567</PMID>
  </reference>
  <reference>
    <citation>Parvizi J, Wade FA, Rapuri V, Springer BD, Berry DJ, Hozack WJ. Revision hip arthroplasty for late instability secondary to polyethylene wear. Clin Orthop Relat Res. 2006 Jun;447:66-9. doi: 10.1097/01.blo.0000218751.14989.a6.</citation>
    <PMID>16672896</PMID>
  </reference>
  <reference>
    <citation>Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92.</citation>
    <PMID>12377909</PMID>
  </reference>
  <reference>
    <citation>Dorr LD, Wolf AW, Chandler R, Conaty JP. Classification and treatment of dislocations of total hip arthroplasty. Clin Orthop Relat Res. 1983 Mar;(173):151-8.</citation>
    <PMID>6825326</PMID>
  </reference>
  <reference>
    <citation>McCollum DE, Gray WJ. Dislocation after total hip arthroplasty. Causes and prevention. Clin Orthop Relat Res. 1990 Dec;(261):159-70.</citation>
    <PMID>2245542</PMID>
  </reference>
  <reference>
    <citation>Robinson RP, Simonian PT, Gradisar IM, Ching RP. Joint motion and surface contact area related to component position in total hip arthroplasty. J Bone Joint Surg Br. 1997 Jan;79(1):140-6. doi: 10.1302/0301-620x.79b1.6842.</citation>
    <PMID>9020463</PMID>
  </reference>
  <reference>
    <citation>Mahomed NN, Barrett JA, Katz JN, Phillips CB, Losina E, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Rates and outcomes of primary and revision total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2003 Jan;85(1):27-32. doi: 10.2106/00004623-200301000-00005.</citation>
    <PMID>12533568</PMID>
  </reference>
  <reference>
    <citation>Hafez MA, Chelule KL, Seedhom BB, Sherman KP. Computer-assisted total knee arthroplasty using patient-specific templating. Clin Orthop Relat Res. 2006 Mar;444:184-92. doi: 10.1097/01.blo.0000201148.06454.ef.</citation>
    <PMID>16446589</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>December 20, 2016</results_first_submitted>
  <results_first_submitted_qc>February 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 29, 2017</results_first_posted>
  <last_update_submitted>February 15, 2017</last_update_submitted>
  <last_update_submitted_qc>February 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acetabular Shell</keyword>
  <keyword>Total Hip Arthroplasty</keyword>
  <keyword>3D imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>3D Imaging, Surrogate Bone Model</title>
          <description>3D imaging &amp; surrogate bone model&#xD;
3D imaging &amp; surrogate bone model: 3D imaging &amp; surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care Preoperative Imaging</title>
          <description>Patients receiving standard of care preoperative planning prior to total hip arthroplasty.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Surgery Canceled</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>3D Imaging, Surrogate Bone Model</title>
          <description>3D imaging &amp; surrogate bone model&#xD;
3D imaging &amp; surrogate bone model: 3D imaging &amp; surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care Preoperative Imaging</title>
          <description>Patients receiving standard of care preoperative planning prior to total hip arthroplasty.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.4" lower_limit="44" upper_limit="80"/>
                    <measurement group_id="B2" value="58.6" lower_limit="41" upper_limit="82"/>
                    <measurement group_id="B3" value="62.0" lower_limit="41" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acetabular Shell Version and Inclination</title>
        <description>A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version &amp; inclination measured in degrees) of the acetabular shell</description>
        <time_frame>within 2 weeks of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3D Imaging, Surrogate Bone Model</title>
            <description>3D imaging &amp; surrogate bone model&#xD;
3D imaging &amp; surrogate bone model: 3D imaging &amp; surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Preoperative Imaging</title>
            <description>Patients receiving standard of care preoperative planning prior to total hip arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Acetabular Shell Version and Inclination</title>
          <description>A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version &amp; inclination measured in degrees) of the acetabular shell</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Inclination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" lower_limit="34" upper_limit="54"/>
                    <measurement group_id="O2" value="39.3" lower_limit="27" upper_limit="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anteversion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1" lower_limit="9" upper_limit="48"/>
                    <measurement group_id="O2" value="23.3" lower_limit="9" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Time</title>
        <description>Duration of the surgical case</description>
        <time_frame>time of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3D Imaging, Surrogate Bone Model</title>
            <description>3D imaging &amp; surrogate bone model&#xD;
3D imaging &amp; surrogate bone model: 3D imaging &amp; surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Preoperative Imaging</title>
            <description>Patients receiving standard of care preoperative planning prior to total hip arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Time</title>
          <description>Duration of the surgical case</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.9" lower_limit="76" upper_limit="179"/>
                    <measurement group_id="O2" value="151.2" lower_limit="82" upper_limit="291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>3D Imaging, Surrogate Bone Model</title>
          <description>3D imaging &amp; surrogate bone model&#xD;
3D imaging &amp; surrogate bone model: 3D imaging &amp; surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care Preoperative Imaging</title>
          <description>Patients receiving standard of care preoperative planning prior to total hip arthroplasty.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Carlos A Higuera, MD</name_or_title>
      <organization>Cleveland Clinic Foundation</organization>
      <phone>2166361136</phone>
      <email>higuerc@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02204007
org study id: 14-555
nct id: NCT02204007
lead sponsor: 
has dmc: Yes
This is an observer-blinded prospective randomized clinical trial to define the efficacy of a
      new technology developed at the Cleveland Clinic to improve the positioning of the acetabular
      shell in total hip arthroplasty.The proposed study will enroll patients that have consented
      to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This
      treatment is standard of care. Patients will receive standard of care pre- and post-operative
      care and placement of standard of care implants all of which are commercially available and
      FDA approved for general use for the clinical indications used in these patients. The only
      difference in treatment between the groups will be the use of a surrogate bone model to help
      assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic
      testing performed specifically related to this study consists of obtaining one pre-operative
      and one post-operative CT scan. The post-operative scan is to be performed within two weeks
      of surgery.

      The investigators predict that those patients with 3D imaging and bone model will have better
      acetabular shell placement than those with standard preoperative planning.
The plan is enroll 44 subjects (22 in the standard surgery group and 22 in the experimental
      surgical group) into this randomized clinical trial. All subjects will have the standard of
      care indications for THA and will give informed consent for both the surgery and
      participation in this study. Enrollment will occur as part of the routine office evaluation
      and will be obtained by the treating surgeon or by the research assistant. Four surgeons
      (Wael Barsoum, Trevor Murray, Carlos Higuera, and Michael Bloomfield) with surgical
      experience in total hip arthroplasty will perform the procedures in this study. All subjects
      within each surgeon's practice who qualify for participation in this study will be
      approached. Subjects will be enrolled at least 10 days prior to the date of surgery. Ten days
      is the minimum time necessary to obtain a pre-operative CT scan for surgical planning and to
      manufacture the surrogate bone model. Patients who are not approached during regular office
      visits will be contacted by phone and if they are interested, they will be scheduled to
      arrive to the radiology department to sign the informed consent and receive the preoperative
      CT scan. Subjects will be randomized into either the experimental or control group at the
      time of consent by the study coordinator. Subjects in the experimental group will have their
      pre-operative planning done using the 3D surgical simulator and surrogate bone model will be
      available for the surgeon during surgery. Subjects in the control group will have their
      pre-operative planning done using plain film x-ray and two-dimensional (2D) templates.

      Eligible subjects for inclusion in the study will be able to receive a pelvic CT scan at the
      Cleveland Clinic. Additionally, we will obtain standard of care pre- and post-operative
      x-rays (AP view). For subjects randomized into the experimental group, their CT scan DICOM
      images will be uploaded into the Cleveland Clinic developed surgical simulator specifically
      designed for THA at least 10 days prior to surgery. For each experimental subject, the
      Cleveland Clinic pre-operative planning software will be used to define the optimal size and
      location of the acetabular components (acetabular shell, and the ultra-high molecular weight
      polyethylene bearing - UHMWPE). The treating surgeon will virtually place the implant in the
      simulator software. The specification for shell placement will vary depending on the
      subject's individual pathology and pelvic morphology, but is expected to fall within the
      range of 10-35 degrees of anteversion and 30-50 degrees of abduction.

      In the control group, each surgeon will use their standard methods of pre-operative planning
      using the pre-operative x-rays. To prepare the acetabulum and place the implants on the day
      of surgery, surgeons will use standard surgical alignment instruments provided by the
      manufacturer of the implant. For the experimental group, the surgeon will use CT scan and a
      3D preoperative planning software to place the implants virtually. The surgeons are provided
      with a surrogate bone model with a fabricated acetabular implant placed in the same
      orientation as was planned in the surgical simulator software, and will use standard surgical
      instruments provided by the manufacturer of the implant.

      The images obtained from the post-operative CT scans will be uploaded into the simulator
      software for 3D reconstruction. The 3D image of the post-operative pelvis with the implants
      will be superimposed onto the image of the pre-operative pelvis with the virtually placed
      implants. Using measurement tools within the software we will compare the position of the
      actual acetabular component placed in the patient with the desired position specified by the
      plan. The measurements that will be made are for angular orientations in 3D space
      (anteversion and inclination). Measurements are accurate to within a fraction of a degree.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Acetabular Shell Version and Inclination
time frame: within 2 weeks of surgery
description: A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version & inclination measured in degrees) of the acetabular shell
measure: Operative Time
time frame: time of surgery
description: Duration of the surgical case
arm group label: 3D imaging, surrogate bone model
arm group type: Experimental
description: 3D imaging & surrogate bone model
arm group label: Standard of Care Preoperative Imaging
arm group type: No Intervention
description: Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
intervention type: Device
intervention name: 3D imaging & surrogate bone model
description: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging
arm group label: 3D imaging, surrogate bone model
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos Higuera, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Alison Klika, MS
role: Study Director
affiliation: The Cleveland Clinic
facility: 
country: United States
url: http://www.dsm.com/markets/medical/en_US/home.html
description: Medical Device Materials
citation: Codsi MJ, Bennetts C, Gordiev K, Boeck DM, Kwon Y, Brems J, Powell K, Iannotti JP. Normal glenoid vault anatomy and validation of a novel glenoid implant shape. J Shoulder Elbow Surg. 2008 May-Jun;17(3):471-8. doi: 10.1016/j.jse.2007.08.010. Epub 2008 Mar 7.
PMID: 18328741
citation: Scalise JJ, Bryan J, Polster J, Brems JJ, Iannotti JP. Quantitative analysis of glenoid bone loss in osteoarthritis using three-dimensional computed tomography scans. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):328-35. doi: 10.1016/j.jse.2007.07.013. Epub 2008 Jan 22.
PMID: 18218326
citation: Scalise JJ, Codsi MJ, Bryan J, Iannotti JP. The three-dimensional glenoid vault model can estimate normal glenoid version in osteoarthritis. J Shoulder Elbow Surg. 2008 May-Jun;17(3):487-91. doi: 10.1016/j.jse.2007.09.006. Epub 2008 Feb 20.
PMID: 18282721
citation: Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Nov;90(11):2438-45. doi: 10.2106/JBJS.G.01341.
PMID: 18978413
citation: Eisler T, Svensson O, Tengstrom A, Elmstedt E. Patient expectation and satisfaction in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4):457-62. doi: 10.1054/arth.2002.31245.
PMID: 12066276
citation: Furnes O, Lie SA, Espehaug B, Vollset SE, Engesaeter LB, Havelin LI. Hip disease and the prognosis of total hip replacements. A review of 53,698 primary total hip replacements reported to the Norwegian Arthroplasty Register 1987-99. J Bone Joint Surg Br. 2001 May;83(4):579-86. doi: 10.1302/0301-620x.83b4.11223.
PMID: 11380136
citation: Older J. Charnley low-friction arthroplasty: a worldwide retrospective review at 15 to 20 years. J Arthroplasty. 2002 Sep;17(6):675-80. doi: 10.1054/arth.2002.31973.
PMID: 12216018
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PMID: 12533567
citation: Parvizi J, Wade FA, Rapuri V, Springer BD, Berry DJ, Hozack WJ. Revision hip arthroplasty for late instability secondary to polyethylene wear. Clin Orthop Relat Res. 2006 Jun;447:66-9. doi: 10.1097/01.blo.0000218751.14989.a6.
PMID: 16672896
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PMID: 12377909
citation: Dorr LD, Wolf AW, Chandler R, Conaty JP. Classification and treatment of dislocations of total hip arthroplasty. Clin Orthop Relat Res. 1983 Mar;(173):151-8.
PMID: 6825326
citation: McCollum DE, Gray WJ. Dislocation after total hip arthroplasty. Causes and prevention. Clin Orthop Relat Res. 1990 Dec;(261):159-70.
PMID: 2245542
citation: Robinson RP, Simonian PT, Gradisar IM, Ching RP. Joint motion and surface contact area related to component position in total hip arthroplasty. J Bone Joint Surg Br. 1997 Jan;79(1):140-6. doi: 10.1302/0301-620x.79b1.6842.
PMID: 9020463
citation: Mahomed NN, Barrett JA, Katz JN, Phillips CB, Losina E, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Rates and outcomes of primary and revision total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2003 Jan;85(1):27-32. doi: 10.2106/00004623-200301000-00005.
PMID: 12533568
citation: Hafez MA, Chelule KL, Seedhom BB, Sherman KP. Computer-assisted total knee arthroplasty using patient-specific templating. Clin Orthop Relat Res. 2006 Mar;444:184-92. doi: 10.1097/01.blo.0000201148.06454.ef.
PMID: 16446589
responsible party type: Sponsor
mesh term: Arthritis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed
point of contact: 