<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/NCT02237482</url>
  </required_header>
  <id_info>
    <org_study_id>539-06</org_study_id>
    <nct_id>NCT02237482</nct_id>
  </id_info>
  <brief_title>Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery</brief_title>
  <official_title>Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to compare the proximal migration of the tantalum design (TM) with a&#xD;
      cemented cup used in conjunction with bone allografting in cases with major bone loss. A&#xD;
      group of patients with good periacetabular bone stock are included to analyse the differences&#xD;
      between the tantalum and titanium design regarding risk of loosening and differences in&#xD;
      clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and&#xD;
      rotation of the revision cups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acetabular component loosening is often associated with periacetabular bone loss. Different&#xD;
      approaches are described to address the bone defects in acetabular revision surgery. Several&#xD;
      authors have reported inferior results when uncemented Titanium alloys and older porous&#xD;
      coated designs are used in acetabular revisions with significant bone loss. Cemented fixation&#xD;
      of the revision cup with impaction bone grafting (BIG), introduced more than three decades&#xD;
      ago has today a thorough documentation. The Tantalum designs, with inherent properties such&#xD;
      as high volumetric porosity, low modulus of elasticity and high friction against the bone,&#xD;
      have been suggested to improve the fixation of the acetabular component. Several authors have&#xD;
      been reporting promising short- and medium-term results using the TM designs in acetabular&#xD;
      revisions with large periacetabular bone defects. Proximal migration measured with&#xD;
      radiostereometry (RSA) has been suggested to predict risk for late aseptic loosening in hip&#xD;
      prosthesis surgery. This study was primarily to compare the proximal migration of the&#xD;
      tantalum design with a cemented cup used in conjunction with bone allografting in cases with&#xD;
      major bone loss. A group of patients with good periacetabular bone stock are included to&#xD;
      analyse the differences between the tantalum and titanium design. RSA is used to accurately&#xD;
      measure migration and rotation of the revision cups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2006</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proximal migration measured with RSA</measure>
    <time_frame>24 month postoperatively.</time_frame>
    <description>All patients have been recruited (operated on) by end of December 2011. Our primary intention is to follow all patients a minimum of two years with RSA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome measures</measure>
    <time_frame>first two years postoperatively</time_frame>
    <description>Harris Hip Score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Re-revision due to aseptic loosening or radiographical loosening</measure>
    <time_frame>minimum13 years postoperative</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>EuroQol 5D</measure>
    <time_frame>first two years postoperatively.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Prosthesis Loosening</condition>
  <arm_group>
    <arm_group_label>Small periacetabular bone defects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with cup loosening and small periacetabular bone defects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Large periacetabular bone defects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with cup loosening and large periacetabular bone defects</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trilogy cup</intervention_name>
    <arm_group_label>Small periacetabular bone defects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trabecular metal cup (TM)</intervention_name>
    <arm_group_label>Large periacetabular bone defects</arm_group_label>
    <arm_group_label>Small periacetabular bone defects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ZCA cup</intervention_name>
    <arm_group_label>Large periacetabular bone defects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients with a loose acetabular component, undergoing revision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient not able to understand the intention of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan Kärrholm, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Borlin N, Rohrl SM, Bragdon CR. RSA wear measurements with or without markers in total hip arthroplasty. J Biomech. 2006;39(9):1641-50. doi: 10.1016/j.jbiomech.2005.05.004. Epub 2005 Jun 28.</citation>
    <PMID>15990104</PMID>
  </reference>
  <reference>
    <citation>Cuckler JM. Management strategies for acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4 Suppl 1):153-6. doi: 10.1054/arth.2002.32811.</citation>
    <PMID>12068428</PMID>
  </reference>
  <reference>
    <citation>Lakstein D, Backstein D, Safir O, Kosashvili Y, Gross AE. Trabecular Metal cups for acetabular defects with 50% or less host bone contact. Clin Orthop Relat Res. 2009 Sep;467(9):2318-24. doi: 10.1007/s11999-009-0772-3. Epub 2009 Mar 10.</citation>
    <PMID>19277803</PMID>
  </reference>
  <reference>
    <citation>Schreurs BW, Keurentjes JC, Gardeniers JW, Verdonschot N, Slooff TJ, Veth RP. Acetabular revision with impacted morsellised cancellous bone grafting and a cemented acetabular component: a 20- to 25-year follow-up. J Bone Joint Surg Br. 2009 Sep;91(9):1148-53. doi: 10.1302/0301-620X.91B9.21750.</citation>
    <PMID>19721038</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Maziar Mohaddes Ardebili</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prosthesis Failure</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/NCT02237482
org study id: 539-06
nct id: NCT02237482
lead sponsor: 
has dmc: No
This study is intended to compare the proximal migration of the tantalum design (TM) with a
      cemented cup used in conjunction with bone allografting in cases with major bone loss. A
      group of patients with good periacetabular bone stock are included to analyse the differences
      between the tantalum and titanium design regarding risk of loosening and differences in
      clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and
      rotation of the revision cups.
Acetabular component loosening is often associated with periacetabular bone loss. Different
      approaches are described to address the bone defects in acetabular revision surgery. Several
      authors have reported inferior results when uncemented Titanium alloys and older porous
      coated designs are used in acetabular revisions with significant bone loss. Cemented fixation
      of the revision cup with impaction bone grafting (BIG), introduced more than three decades
      ago has today a thorough documentation. The Tantalum designs, with inherent properties such
      as high volumetric porosity, low modulus of elasticity and high friction against the bone,
      have been suggested to improve the fixation of the acetabular component. Several authors have
      been reporting promising short- and medium-term results using the TM designs in acetabular
      revisions with large periacetabular bone defects. Proximal migration measured with
      radiostereometry (RSA) has been suggested to predict risk for late aseptic loosening in hip
      prosthesis surgery. This study was primarily to compare the proximal migration of the
      tantalum design with a cemented cup used in conjunction with bone allografting in cases with
      major bone loss. A group of patients with good periacetabular bone stock are included to
      analyse the differences between the tantalum and titanium design. RSA is used to accurately
      measure migration and rotation of the revision cups.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proximal migration measured with RSA
time frame: 24 month postoperatively.
description: All patients have been recruited (operated on) by end of December 2011. Our primary intention is to follow all patients a minimum of two years with RSA.
measure: Patient reported outcome measures
time frame: first two years postoperatively
description: Harris Hip Score
measure: Re-revision due to aseptic loosening or radiographical loosening
time frame: minimum13 years postoperative
measure: EuroQol 5D
time frame: first two years postoperatively.
arm group label: Small periacetabular bone defects
arm group type: Experimental
description: Patients with cup loosening and small periacetabular bone defects
arm group label: Large periacetabular bone defects
arm group type: Experimental
description: Patients with cup loosening and large periacetabular bone defects
intervention type: Device
intervention name: Trilogy cup
arm group label: Small periacetabular bone defects
intervention type: Device
intervention name: Trabecular metal cup (TM)
arm group label: Large periacetabular bone defects
arm group label: Small periacetabular bone defects
intervention type: Device
intervention name: ZCA cup
arm group label: Large periacetabular bone defects
criteria: 
gender: All
minimum age: N/A
maximum age: 85 Years
healthy volunteers: No
last name: Johan Kärrholm, Professor
role: Study Director
affiliation: Sahlgrenska University Hospital, Sweden
facility: 
country: Sweden
citation: Borlin N, Rohrl SM, Bragdon CR. RSA wear measurements with or without markers in total hip arthroplasty. J Biomech. 2006;39(9):1641-50. doi: 10.1016/j.jbiomech.2005.05.004. Epub 2005 Jun 28.
PMID: 15990104
citation: Cuckler JM. Management strategies for acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4 Suppl 1):153-6. doi: 10.1054/arth.2002.32811.
PMID: 12068428
citation: Lakstein D, Backstein D, Safir O, Kosashvili Y, Gross AE. Trabecular Metal cups for acetabular defects with 50% or less host bone contact. Clin Orthop Relat Res. 2009 Sep;467(9):2318-24. doi: 10.1007/s11999-009-0772-3. Epub 2009 Mar 10.
PMID: 19277803
citation: Schreurs BW, Keurentjes JC, Gardeniers JW, Verdonschot N, Slooff TJ, Veth RP. Acetabular revision with impacted morsellised cancellous bone grafting and a cemented acetabular component: a 20- to 25-year follow-up. J Bone Joint Surg Br. 2009 Sep;91(9):1148-53. doi: 10.1302/0301-620X.91B9.21750.
PMID: 19721038
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Maziar Mohaddes Ardebili
investigator title: M.D.
mesh term: Prosthesis Failure