<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/NCT03031964</url>
  </required_header>
  <id_info>
    <org_study_id>#16-1030</org_study_id>
    <nct_id>NCT03031964</nct_id>
  </id_info>
  <brief_title>Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup</brief_title>
  <official_title>Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate patients receiving a multihole revision acetabular implant for total&#xD;
      hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of&#xD;
      the implanted prosthesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4&#xD;
      weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at&#xD;
      each site will identify, recruit, and prospectively follow the 60 patients at his/her site.&#xD;
      Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for&#xD;
      revision, Paprosky classification, native femoral head measurement (mm) etc. will be&#xD;
      collected preoperatively. The study coordinator will contact patients prior to each visit to&#xD;
      ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation&#xD;
      (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition,&#xD;
      patients will be assessed for any complications (e.g., dislocation, emergency department&#xD;
      visits, infection, reoperation, etc.). Patients will complete the Hip disability and&#xD;
      Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific&#xD;
      question regarding groin pain) and a pain assessment. In the event that a patient has&#xD;
      relocated and/or refuses to return to the office for the 5-year visit, a script will be sent&#xD;
      to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All&#xD;
      data will be entered and maintained in RedCap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Closed the single investigator initiated study at request of Stryker, to begin collecting as a&#xD;
    multicenter study.&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">January 2022</completion_date>
  <primary_completion_date type="Actual">January 2022</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>survivorship of a multihole revision acetabular cup</measure>
    <time_frame>10 years</time_frame>
    <description>evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes of multihole revision acetabular cup</measure>
    <time_frame>10 years</time_frame>
    <description>determine clinical outcomes with VR-12 surveys</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional outcomes of multihole revision acetabular cup</measure>
    <time_frame>10 years</time_frame>
    <description>determine functional outcomes with HOOS surveys</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assess pain levels in patients who receive multihole revision acetabular cup</measure>
    <time_frame>10 years</time_frame>
    <description>determine level of pain with pain assessments</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Complications Arthroplasty</condition>
  <arm_group>
    <arm_group_label>revision multihole acetabular cup</arm_group_label>
    <description>Revision total hip arthroplasty using multihole revision acetabular cup</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>revision multihole acetabular cup</intervention_name>
    <description>post market study of multi hole revision acetabular cup</description>
    <arm_group_label>revision multihole acetabular cup</arm_group_label>
    <other_name>Stryker restoration anatomic shell</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring a revision total hip arthroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients requiring revision total hip replacement of the acetabular component or&#xD;
             complicated primary total hip replacement.&#xD;
&#xD;
          2. Femoral stem (either retained or replaced) is a compatible Stryker stem.&#xD;
&#xD;
          3. Patient is willing to comply with follow-up requirements (e.g. will return for&#xD;
             long-term follow-up visits)&#xD;
&#xD;
          4. Age: 18-85 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has a BMI &gt; 40&#xD;
&#xD;
          2. Exclude revision for infection&#xD;
&#xD;
          3. Patient is undergoing bilateral THA surgery or had prior hip arthroplasty on&#xD;
             contralateral side less than 6 months from date of surgery&#xD;
&#xD;
          4. Patient has history of radiation therapy&#xD;
&#xD;
          5. Patient has known diagnosis of renal disease&#xD;
&#xD;
          6. Patient has known diagnosis of osteoporosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Higuera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</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>
  <reference>
    <citation>Jafari SM, Bender B, Coyle C, Parvizi J, Sharkey PF, Hozack WJ. Do tantalum and titanium cups show similar results in revision hip arthroplasty? Clin Orthop Relat Res. 2010 Feb;468(2):459-65. doi: 10.1007/s11999-009-1090-5.</citation>
    <PMID>19809857</PMID>
  </reference>
  <reference>
    <citation>Kremers HM, Howard JL, Loechler Y, Schleck CD, Harmsen WS, Berry DJ, Cabanela ME, Hanssen AD, Pagnano MW, Trousdale RT, Lewallen DG. Comparative long-term survivorship of uncemented acetabular components in revision total hip arthroplasty. J Bone Joint Surg Am. 2012 Jun 20;94(12):e82. doi: 10.2106/JBJS.K.00549.</citation>
    <PMID>22717834</PMID>
  </reference>
  <reference>
    <citation>Unger AS, Lewis RJ, Gruen T. Evaluation of a porous tantalum uncemented acetabular cup in revision total hip arthroplasty: clinical and radiological results of 60 hips. J Arthroplasty. 2005 Dec;20(8):1002-9. doi: 10.1016/j.arth.2005.01.023.</citation>
    <PMID>16376255</PMID>
  </reference>
  <reference>
    <citation>Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.</citation>
    <PMID>23927907</PMID>
  </reference>
  <reference>
    <citation>Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.</citation>
    <PMID>17403800</PMID>
  </reference>
  <reference>
    <citation>Silverton CD, Rosenberg AG, Sheinkop MB, Kull LR, Galante JO. Revision total hip arthroplasty using a cementless acetabular component. Technique and results. Clin Orthop Relat Res. 1995 Oct;(319):201-8.</citation>
    <PMID>7554631</PMID>
  </reference>
  <reference>
    <citation>Petrera P, Rubash HE. Revision Total Hip Arthroplasty: The Acetabular Component. J Am Acad Orthop Surg. 1995 Jan;3(1):15-21. doi: 10.5435/00124635-199501000-00003.</citation>
    <PMID>10790649</PMID>
  </reference>
  <reference>
    <citation>Klika AK, Murray TG, Darwiche H, Barsoum WK. Options for acetabular fixation surfaces. J Long Term Eff Med Implants. 2007;17(3):187-92. doi: 10.1615/jlongtermeffmedimplants.v17.i3.20.</citation>
    <PMID>19023943</PMID>
  </reference>
  <reference>
    <citation>Ramappa M, Bajwa A, Kulkarni A, McMurtry I, Port A. Early results of a new highly porous modular acetabular cup in revision arthroplasty. Hip Int. 2009 Jul-Sep;19(3):239-44. doi: 10.1177/112070000901900309.</citation>
    <PMID>19876878</PMID>
  </reference>
  <reference>
    <citation>Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. Bone response to a novel highly porous surface in a canine implantable chamber. J Biomed Mater Res B Appl Biomater. 2004 Nov 15;71(2):387-91. doi: 10.1002/jbm.b.30104.</citation>
    <PMID>15389510</PMID>
  </reference>
  <reference>
    <citation>Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x.</citation>
    <PMID>8163974</PMID>
  </reference>
  <reference>
    <citation>Claus AM, Engh CA Jr, Sychterz CJ, Xenos JS, Orishimo KF, Engh CA Sr. Radiographic definition of pelvic osteolysis following total hip arthroplasty. J Bone Joint Surg Am. 2003 Aug;85(8):1519-26. doi: 10.2106/00004623-200308000-00013.</citation>
    <PMID>12925632</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Carlos Higuera-Rueda</investigator_full_name>
    <investigator_title>Staff 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/NCT03031964
org study id: #16-1030
nct id: NCT03031964
lead sponsor: 
has dmc: No
This study will evaluate patients receiving a multihole revision acetabular implant for total
      hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of
      the implanted prosthesis.
Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4
      weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at
      each site will identify, recruit, and prospectively follow the 60 patients at his/her site.
      Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for
      revision, Paprosky classification, native femoral head measurement (mm) etc. will be
      collected preoperatively. The study coordinator will contact patients prior to each visit to
      ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation
      (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition,
      patients will be assessed for any complications (e.g., dislocation, emergency department
      visits, infection, reoperation, etc.). Patients will complete the Hip disability and
      Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific
      question regarding groin pain) and a pain assessment. In the event that a patient has
      relocated and/or refuses to return to the office for the 5-year visit, a script will be sent
      to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All
      data will be entered and maintained in RedCap.
observational model: Cohort
time perspective: Prospective
measure: survivorship of a multihole revision acetabular cup
time frame: 10 years
description: evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis
measure: Clinical outcomes of multihole revision acetabular cup
time frame: 10 years
description: determine clinical outcomes with VR-12 surveys
measure: functional outcomes of multihole revision acetabular cup
time frame: 10 years
description: determine functional outcomes with HOOS surveys
measure: assess pain levels in patients who receive multihole revision acetabular cup
time frame: 10 years
description: determine level of pain with pain assessments
arm group label: revision multihole acetabular cup
description: Revision total hip arthroplasty using multihole revision acetabular cup
intervention type: Device
intervention name: revision multihole acetabular cup
description: post market study of multi hole revision acetabular cup
arm group label: revision multihole acetabular cup
other name: Stryker restoration anatomic shell
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Carlos Higuera, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Jafari SM, Bender B, Coyle C, Parvizi J, Sharkey PF, Hozack WJ. Do tantalum and titanium cups show similar results in revision hip arthroplasty? Clin Orthop Relat Res. 2010 Feb;468(2):459-65. doi: 10.1007/s11999-009-1090-5.
PMID: 19809857
citation: Kremers HM, Howard JL, Loechler Y, Schleck CD, Harmsen WS, Berry DJ, Cabanela ME, Hanssen AD, Pagnano MW, Trousdale RT, Lewallen DG. Comparative long-term survivorship of uncemented acetabular components in revision total hip arthroplasty. J Bone Joint Surg Am. 2012 Jun 20;94(12):e82. doi: 10.2106/JBJS.K.00549.
PMID: 22717834
citation: Unger AS, Lewis RJ, Gruen T. Evaluation of a porous tantalum uncemented acetabular cup in revision total hip arthroplasty: clinical and radiological results of 60 hips. J Arthroplasty. 2005 Dec;20(8):1002-9. doi: 10.1016/j.arth.2005.01.023.
PMID: 16376255
citation: Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.
PMID: 23927907
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PMID: 17403800
citation: Silverton CD, Rosenberg AG, Sheinkop MB, Kull LR, Galante JO. Revision total hip arthroplasty using a cementless acetabular component. Technique and results. Clin Orthop Relat Res. 1995 Oct;(319):201-8.
PMID: 7554631
citation: Petrera P, Rubash HE. Revision Total Hip Arthroplasty: The Acetabular Component. J Am Acad Orthop Surg. 1995 Jan;3(1):15-21. doi: 10.5435/00124635-199501000-00003.
PMID: 10790649
citation: Klika AK, Murray TG, Darwiche H, Barsoum WK. Options for acetabular fixation surfaces. J Long Term Eff Med Implants. 2007;17(3):187-92. doi: 10.1615/jlongtermeffmedimplants.v17.i3.20.
PMID: 19023943
citation: Ramappa M, Bajwa A, Kulkarni A, McMurtry I, Port A. Early results of a new highly porous modular acetabular cup in revision arthroplasty. Hip Int. 2009 Jul-Sep;19(3):239-44. doi: 10.1177/112070000901900309.
PMID: 19876878
citation: Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. Bone response to a novel highly porous surface in a canine implantable chamber. J Biomed Mater Res B Appl Biomater. 2004 Nov 15;71(2):387-91. doi: 10.1002/jbm.b.30104.
PMID: 15389510
citation: Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x.
PMID: 8163974
citation: Claus AM, Engh CA Jr, Sychterz CJ, Xenos JS, Orishimo KF, Engh CA Sr. Radiographic definition of pelvic osteolysis following total hip arthroplasty. J Bone Joint Surg Am. 2003 Aug;85(8):1519-26. doi: 10.2106/00004623-200308000-00013.
PMID: 12925632
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Carlos Higuera-Rueda
investigator title: Staff Surgeon
sharing ipd: No