xml: <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/NCT05981222</url>
    </required_header>
    <id_info>
      <org_study_id>2019-397-04</org_study_id>
      <nct_id>NCT05981222</nct_id>
    </id_info>
    <brief_title>Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients</brief_title>
    <acronym>OMC</acronym>
    <official_title>Biomechanical-matched Titanium Cages(Osteo Match) Versus PEEK Cages in Osteoporotic Lumbar Spine: a Multicenter, Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a multicenter, prospective cohort study. The osteoporotic patients requiring&#xD;
        posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up.&#xD;
        The patients undergoing LIF with the biomechanical-matched 3D-printed titanium cages (Osteo&#xD;
        Match) are compared with those using routine PEEK cages. The hypothesis is that the use of&#xD;
        Osteo Match cages can reduce the rate of cage subsidence and increase the rate of lumbar&#xD;
        fusion in osteoporotic patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Interbody fusion cages are widely used for the surgical treatment of degenerative lumbar&#xD;
        diseases, which can stabilize the spine and promote solid fusion. However, because of&#xD;
        population aging and the high rate of osteoporosis in the elderly with lumbar degenerative&#xD;
        diseases, the cage subsidence and failure of fusion have been frequently reported. The&#xD;
        biomechanical strength (such as elasticity modulus) of routine PEEK cages is mismatched with&#xD;
        osteoporotic bone, leading to cage subsidence and nonunion.&#xD;
  &#xD;
        The 3D-printed porous titanium alloy cages have been proved to have advantages in speeding up&#xD;
        and enhancing the lumbar fusion over conventional PEEK cages. However, most of the titanium&#xD;
        cages still have much higher biomechanical strength than the osteoporotic bone. The new&#xD;
        titanium cages named Osteo Match has been first clinically used in Peking University Third&#xD;
        Hospital in China. The elastic modulus of Osteo Match cage is matched with that of lumbar&#xD;
        spine with different degrees of osteoporosis. Therefore, we hypothesize that patients&#xD;
        undergoing LIF with Osteo Match cages can achieve lower rate of cage subsidence and higher&#xD;
        rate of lumbar fusion than those using PEEK cages.&#xD;
  &#xD;
        The osteoporotic patients requiring posterior lumbar interbody fusion with cages are&#xD;
        prospectively enrolled and followed up. The researchers will invite appropriate patients to&#xD;
        participate in the study after their surgical plans are determined. General patients data are&#xD;
        collected after informed consent, such as age, gender, weight, height, bone mineral density&#xD;
        (measured by DXA, CT Hounsfield units, or QCT), detailed surgical plans, and etc. They are&#xD;
        followed up at 3, 6, 12, and 24 months according to our clinical routine, including lumbar&#xD;
        x-ray, CTand certain questions about the clinical outcomes.&#xD;
  &#xD;
        The patients used Osteo Match cages are compared with those using conventional PEEK cages.&#xD;
        The primary endpoints are the subsidence rate and fusion rate at 6 months follow-up. The&#xD;
        secondary endpoints are the subsidence rate and fusion rate at other time point of follow-up&#xD;
        , and the clinical outcomes(ODI/JOA/VAS) at every follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</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>Cage subsidence rate</measure>
      <time_frame>6 months</time_frame>
      <description>The presence of cage subsidence &gt; 2mm at x-ray or CT images.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fusion rate</measure>
      <time_frame>6 months</time_frame>
      <description>The presence of continuous fusion mass at bone graft site in CT scans and absence of intervertebral mobility on lateral flextion-extension x-ray images.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Osteoporosis</condition>
    <condition>Degenerative Lumbar Disease</condition>
    <condition>Degeneration Spine</condition>
    <arm_group>
      <arm_group_label>Osteo Match cage</arm_group_label>
      <description>Patients undergoing posterior lumbar interbody fusion with Osteo Match Cages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Peek Cage</arm_group_label>
      <description>Patients undergoing posterior lumbar interbody fusion with PEEK Cages</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The osteoporotic patients requiring lumbar interbody fusion with cages for lumbar&#xD;
          degenerative diseases are invited to participate in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged≥ 50 years old&#xD;
  &#xD;
            -  lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such&#xD;
               as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis.&#xD;
  &#xD;
            -  no response to nonoperative treatment of at least 3 months&#xD;
  &#xD;
            -  osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA,&#xD;
               QCTor CT Hounsfield units&#xD;
  &#xD;
            -  requiring lumbar interbody fusion with cages within L3-S1&#xD;
  &#xD;
            -  the type of fusion cage has been chosen by the patients&#xD;
  &#xD;
            -  informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the surgical plan includes any unconventional techniques used to strengthen the&#xD;
               fixation, such as augmentation of the pedicle screw with bone cement&#xD;
  &#xD;
            -  lumbar spondylolisthesis of ≥II degree&#xD;
  &#xD;
            -  lumbar scoliosis of &gt;20° or imbalance of spinal alignment&#xD;
  &#xD;
            -  history of lumbar fusion surgery&#xD;
  &#xD;
            -  cervical myelopathy, thoracic spinal stenosis, motor neuron disease,tuberculosis of&#xD;
               spine,spinal tumor&#xD;
  &#xD;
            -  vertebral fracture within interbody fusion segement&#xD;
  &#xD;
            -  ASA of ≥IV&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Weishi Li</last_name>
      <role>Study Chair</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Zou D, Yue L, Fan Z, Zhao Y, Leng H, Sun Z, Li W. Biomechanical Analysis of Lumbar Interbody Fusion Cages With Various Elastic Moduli in Osteoporotic and Non-osteoporotic Lumbar Spine: A Finite Element Analysis. Global Spine J. 2023 May 3:21925682231166612. doi: 10.1177/21925682231166612. Online ahead of print.</citation>
      <PMID>37132375</PMID>
    </reference>
    <reference>
      <citation>McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26.</citation>
      <PMID>29496624</PMID>
    </reference>
    <reference>
      <citation>Li P, Jiang W, Yan J, Hu K, Han Z, Wang B, Zhao Y, Cui G, Wang Z, Mao K, Wang Y, Cui F. A novel 3D printed cage with microporous structure and in vivo fusion function. J Biomed Mater Res A. 2019 Jul;107(7):1386-1392. doi: 10.1002/jbm.a.36652. Epub 2019 Mar 18.</citation>
      <PMID>30724479</PMID>
    </reference>
    <reference>
      <citation>Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948.</citation>
      <PMID>26378363</PMID>
    </reference>
    <reference>
      <citation>Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.</citation>
      <PMID>31725127</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Osteoporosis</keyword>
    <keyword>Cage subsidence</keyword>
    <keyword>Lumbar fusion</keyword>
    <keyword>Osteo Match</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981222
  org study id: 2019-397-04
  nct id: NCT05981222
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, prospective cohort study. The osteoporotic patients requiring
        posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up.
        The patients undergoing LIF with the biomechanical-matched 3D-printed titanium cages (Osteo
        Match) are compared with those using routine PEEK cages. The hypothesis is that the use of
        Osteo Match cages can reduce the rate of cage subsidence and increase the rate of lumbar
        fusion in osteoporotic patients.
  Interbody fusion cages are widely used for the surgical treatment of degenerative lumbar
        diseases, which can stabilize the spine and promote solid fusion. However, because of
        population aging and the high rate of osteoporosis in the elderly with lumbar degenerative
        diseases, the cage subsidence and failure of fusion have been frequently reported. The
        biomechanical strength (such as elasticity modulus) of routine PEEK cages is mismatched with
        osteoporotic bone, leading to cage subsidence and nonunion.
  
        The 3D-printed porous titanium alloy cages have been proved to have advantages in speeding up
        and enhancing the lumbar fusion over conventional PEEK cages. However, most of the titanium
        cages still have much higher biomechanical strength than the osteoporotic bone. The new
        titanium cages named Osteo Match has been first clinically used in Peking University Third
        Hospital in China. The elastic modulus of Osteo Match cage is matched with that of lumbar
        spine with different degrees of osteoporosis. Therefore, we hypothesize that patients
        undergoing LIF with Osteo Match cages can achieve lower rate of cage subsidence and higher
        rate of lumbar fusion than those using PEEK cages.
  
        The osteoporotic patients requiring posterior lumbar interbody fusion with cages are
        prospectively enrolled and followed up. The researchers will invite appropriate patients to
        participate in the study after their surgical plans are determined. General patients data are
        collected after informed consent, such as age, gender, weight, height, bone mineral density
        (measured by DXA, CT Hounsfield units, or QCT), detailed surgical plans, and etc. They are
        followed up at 3, 6, 12, and 24 months according to our clinical routine, including lumbar
        x-ray, CTand certain questions about the clinical outcomes.
  
        The patients used Osteo Match cages are compared with those using conventional PEEK cages.
        The primary endpoints are the subsidence rate and fusion rate at 6 months follow-up. The
        secondary endpoints are the subsidence rate and fusion rate at other time point of follow-up
        , and the clinical outcomes(ODI/JOA/VAS) at every follow-up.
  observational model: Cohort
  time perspective: Prospective
  measure: Cage subsidence rate
  time frame: 6 months
  description: The presence of cage subsidence > 2mm at x-ray or CT images.
  measure: Fusion rate
  time frame: 6 months
  description: The presence of continuous fusion mass at bone graft site in CT scans and absence of intervertebral mobility on lateral flextion-extension x-ray images.
  arm group label: Osteo Match cage
  description: Patients undergoing posterior lumbar interbody fusion with Osteo Match Cages
  arm group label: Peek Cage
  description: Patients undergoing posterior lumbar interbody fusion with PEEK Cages
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Weishi Li
  role: Study Chair
  affiliation: Peking University Third Hospital
  facility: 
  country: China
  citation: Zou D, Yue L, Fan Z, Zhao Y, Leng H, Sun Z, Li W. Biomechanical Analysis of Lumbar Interbody Fusion Cages With Various Elastic Moduli in Osteoporotic and Non-osteoporotic Lumbar Spine: A Finite Element Analysis. Global Spine J. 2023 May 3:21925682231166612. doi: 10.1177/21925682231166612. Online ahead of print.
  PMID: 37132375
  citation: McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26.
  PMID: 29496624
  citation: Li P, Jiang W, Yan J, Hu K, Han Z, Wang B, Zhao Y, Cui G, Wang Z, Mao K, Wang Y, Cui F. A novel 3D printed cage with microporous structure and in vivo fusion function. J Biomed Mater Res A. 2019 Jul;107(7):1386-1392. doi: 10.1002/jbm.a.36652. Epub 2019 Mar 18.
  PMID: 30724479
  citation: Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948.
  PMID: 26378363
  citation: Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.
  PMID: 31725127
  responsible party type: Sponsor
  mesh term: Osteoporosis
  sharing ipd: Undecided