<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/NCT04466397</url>
  </required_header>
  <id_info>
    <org_study_id>Liuzhongjun-1</org_study_id>
    <nct_id>NCT04466397</nct_id>
  </id_info>
  <brief_title>Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant</brief_title>
  <official_title>Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant: a New &quot;Implant-bone&quot; Interface Fusion Concept for Large Bone Defects Treatment</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>
    <has_dmc>No</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 aim of this study was to investigate the simply use of three-dimensional (3D) printed&#xD;
      individualized porous implants in the absence of autogenous/allogeneic bone graft or any&#xD;
      osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and&#xD;
      systematically study its long-term therapeutic effect and osseointegration characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A selection of fifty-eight patients with large bone defects caused by tumor, infection or&#xD;
      trauma received the individualized porous implants treatment, and two typical cases were&#xD;
      chosen for detailed study. Further, the large segmental femur defect model of sheep was&#xD;
      utilized to study the osseointegration characteristics of the individualized porous implants&#xD;
      in 1, 3, 6 months after implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biomechanical stability</measure>
    <time_frame>Immediate after the bone defect reconstruction.</time_frame>
    <description>Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomechanical stability</measure>
    <time_frame>2 months after the bone defect reconstruction.</time_frame>
    <description>Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomechanical stability</measure>
    <time_frame>5 months after the bone defect reconstruction.</time_frame>
    <description>Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomechanical stability</measure>
    <time_frame>8 months after the bone defect reconstruction.</time_frame>
    <description>Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomechanical stability</measure>
    <time_frame>14 months after the bone defect reconstruction.</time_frame>
    <description>Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomechanical stability</measure>
    <time_frame>20 months after the bone defect reconstruction.</time_frame>
    <description>Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Osseointegration</measure>
    <time_frame>Immediate after the bone defect reconstruction.</time_frame>
    <description>Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osseointegration</measure>
    <time_frame>2 months after the bone defect reconstruction.</time_frame>
    <description>Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osseointegration</measure>
    <time_frame>5 months after the bone defect reconstruction.</time_frame>
    <description>Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osseointegration</measure>
    <time_frame>8 months after the bone defect reconstruction.</time_frame>
    <description>Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osseointegration</measure>
    <time_frame>14 months after the bone defect reconstruction.</time_frame>
    <description>Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osseointegration</measure>
    <time_frame>20 months after the bone defect reconstruction.</time_frame>
    <description>Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Large Bone Defects</condition>
  <arm_group>
    <arm_group_label>3D printed implants reconstruction group</arm_group_label>
    <description>The patients with large bone defects who treated by 3D printed individualized porous implants</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D printed individualized porous implants</intervention_name>
    <description>Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.</description>
    <arm_group_label>3D printed implants reconstruction group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with bone tumor or bone infection who are diagnosed with large bone defects&#xD;
        after receiving surgery in our Peking University Third Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Large bone defects (&gt;4cm) in spine, limb bone and hip joint caused by tumor, infection&#xD;
             or other pathogenesis received the individualized porous implants treatment.Exclusion&#xD;
             Criteria:&#xD;
&#xD;
          -  Bone defects less than 4cm long.&#xD;
&#xD;
          -  Bone defects treated by other methods ,such as ilizarov technique, masquelet technique&#xD;
             or Ti mesh.&#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>Zhongjun Liu, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Teng Zhang, PhD</last_name>
    <phone>8613385347899</phone>
    <email>zhangtengdoc@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teng Zhang, PhD</last_name>
      <phone>8613385347899</phone>
      <email>zhangtengdoc@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>large bone defects</keyword>
  <keyword>3D printed individualized porous implant</keyword>
  <keyword>&quot;implant-bone&quot; interface fusion</keyword>
  <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/NCT04466397
org study id: Liuzhongjun-1
nct id: NCT04466397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the simply use of three-dimensional (3D) printed
      individualized porous implants in the absence of autogenous/allogeneic bone graft or any
      osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and
      systematically study its long-term therapeutic effect and osseointegration characteristics.
A selection of fifty-eight patients with large bone defects caused by tumor, infection or
      trauma received the individualized porous implants treatment, and two typical cases were
      chosen for detailed study. Further, the large segmental femur defect model of sheep was
      utilized to study the osseointegration characteristics of the individualized porous implants
      in 1, 3, 6 months after implantation.
observational model: Case-Only
time perspective: Retrospective
measure: Biomechanical stability
time frame: Immediate after the bone defect reconstruction.
description: Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
measure: Biomechanical stability
time frame: 2 months after the bone defect reconstruction.
description: Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
measure: Biomechanical stability
time frame: 5 months after the bone defect reconstruction.
description: Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
measure: Biomechanical stability
time frame: 8 months after the bone defect reconstruction.
description: Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
measure: Biomechanical stability
time frame: 14 months after the bone defect reconstruction.
description: Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
measure: Biomechanical stability
time frame: 20 months after the bone defect reconstruction.
description: Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.
measure: Osseointegration
time frame: Immediate after the bone defect reconstruction.
description: Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
measure: Osseointegration
time frame: 2 months after the bone defect reconstruction.
description: Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
measure: Osseointegration
time frame: 5 months after the bone defect reconstruction.
description: Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
measure: Osseointegration
time frame: 8 months after the bone defect reconstruction.
description: Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
measure: Osseointegration
time frame: 14 months after the bone defect reconstruction.
description: Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
measure: Osseointegration
time frame: 20 months after the bone defect reconstruction.
description: Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.
arm group label: 3D printed implants reconstruction group
description: The patients with large bone defects who treated by 3D printed individualized porous implants
intervention type: Device
intervention name: 3D printed individualized porous implants
description: Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.
arm group label: 3D printed implants reconstruction group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Zhongjun Liu, Bachelor
role: Principal Investigator
affiliation: Peking University Third Hospital
last name: Teng Zhang, PhD
phone: 8613385347899
email: zhangtengdoc@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No