<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/NCT04481269</url>
  </required_header>
  <id_info>
    <org_study_id>20200718</org_study_id>
    <nct_id>NCT04481269</nct_id>
  </id_info>
  <brief_title>A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device</brief_title>
  <official_title>A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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 study is a prospective, randomized, controlled, double-arm, non-inferiority study that&#xD;
      will be carried out in China. It aims to compare two implant systems (the research group uses&#xD;
      surface-modified composite coated orthopedic implants, and controls group using conventional&#xD;
      orthopedic implants) safety and effectiveness. A total of 240 patients were recruited. The&#xD;
      recruited patients are randomly divided into groups at a ratio of 1:1 to ensure that the&#xD;
      distribution of patients in the treatment group and the control group is consistent. Patients&#xD;
      will receive clinical follow-up in the 1, 3, 6, 9 and 12 months postoperatively. The main&#xD;
      indicator for evaluation is the postoperative infection rate, and the secondary indicators&#xD;
      include the SF-12 scoring scale, EQ-5D patient questionnaire score, fracture healing,&#xD;
      malunion, nonunion incidence in the 12th month after surgery, and skin and soft tissue&#xD;
      complications Symptom incidence rate. The follow-up data will be used to determine the main&#xD;
      safety and effectiveness of the new surface modified composite coated orthopedic implant&#xD;
      system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>post-operation infection rate</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-12 score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fracture union, malunion, nonunion rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases</condition>
  <arm_group>
    <arm_group_label>Research Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Research group uses surface-modified composite coated orthopedic implants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Controls group uses conventional orthopedic implants</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surface-modified composite coated orthopedic implants</intervention_name>
    <description>The surface-modified composite coated orthopedic implants have the capacity of high binding strength, high tissue-inducing activity and intelligent bacteria-resistance. The implant devices are expected to be used in the prevention and treatment of plant-related infections in orthopedic surgeries.</description>
    <arm_group_label>Research Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>conventional orthopedic implants</intervention_name>
    <description>conventional orthopedic implants</description>
    <arm_group_label>Controls Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Limb fracture group criteria&#xD;
&#xD;
               1. Age 18-75 years old, no gender limit&#xD;
&#xD;
               2. The preoperative diagnosis is clearly Anderson-Gustilo type III open fracture&#xD;
                  patient&#xD;
&#xD;
               3. Postoperative diagnosis stage is IIIA or IIIB patients with open fracture&#xD;
&#xD;
               4. The subject understands the meaning of this project, volunteers to be the&#xD;
                  subject, and signs to be informed consent&#xD;
&#xD;
          -  Joint replacement group criteria&#xD;
&#xD;
               1. Age 40-75 years old, no gender limit&#xD;
&#xD;
               2. The patient is clearly diagnosed as degenerative osteoarthritis before the&#xD;
                  operation, and the postoperative diagnosis is the same as before the operation&#xD;
&#xD;
               3. Patients can tolerate implantation operation&#xD;
&#xD;
               4. The subject understands the meaning of this project, volunteers to be the&#xD;
                  subject, and signs to be informed consent&#xD;
&#xD;
          -  Spine patients group criteria&#xD;
&#xD;
               1. Age 40-75 years old, no gender limit&#xD;
&#xD;
               2. Before surgery, it is clearly diagnosed as degenerative spine disease and spine&#xD;
                  requiring intervertebral fusion&#xD;
&#xD;
               3. Patients can tolerate implantation operation&#xD;
&#xD;
               4. The subject understands the meaning of this project, volunteers to be the&#xD;
                  subject, and signs to be informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. The subject is pregnant or breastfeeding, or a woman of childbearing age does not&#xD;
             agree to take effective contraceptive measures during the period 2. Closed fractures&#xD;
             or pathological fractures (such as primary or metastatic tumors) 3. Patients with&#xD;
             symptoms of compartment syndrome 4. According to Gustilo-Anderson classification of&#xD;
             open fractures into type I and type II patients 5. Multiple injuries, determined by&#xD;
             the researcher to be unsuitable for research 6. The patient is allergic to metal&#xD;
             plants 7. Combined with certain medical diseases, it is determined by the investigator&#xD;
             to be unsuitable for the study, for example metabolic bone disease, sequelae of polio,&#xD;
             poor bone quality, poor bone healing 8. The patient has participated in other clinical&#xD;
             trials in the past 3 months 9. The patient has contraindications to anesthesia and&#xD;
             surgery 10. Patients with congenital malformations, local or systemic infections, skin&#xD;
             diseases 11. The patient is currently receiving chemotherapy or radiotherapy, systemic&#xD;
             corticosteroid, long-term use of sedative and hypnotics (using more than 3 consecutive&#xD;
             months) or non-steroidal anti-inflammatory drugs (continuous use for more than 3&#xD;
             months) 12. The patient's compliance is poor, and the research staff determines that&#xD;
             it cannot be completed according to the research plan. No consent for voluntary&#xD;
             participation in clinical research was provided.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Fractures, Open</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/NCT04481269
org study id: 20200718
nct id: NCT04481269
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, randomized, controlled, double-arm, non-inferiority study that
      will be carried out in China. It aims to compare two implant systems (the research group uses
      surface-modified composite coated orthopedic implants, and controls group using conventional
      orthopedic implants) safety and effectiveness. A total of 240 patients were recruited. The
      recruited patients are randomly divided into groups at a ratio of 1:1 to ensure that the
      distribution of patients in the treatment group and the control group is consistent. Patients
      will receive clinical follow-up in the 1, 3, 6, 9 and 12 months postoperatively. The main
      indicator for evaluation is the postoperative infection rate, and the secondary indicators
      include the SF-12 scoring scale, EQ-5D patient questionnaire score, fracture healing,
      malunion, nonunion incidence in the 12th month after surgery, and skin and soft tissue
      complications Symptom incidence rate. The follow-up data will be used to determine the main
      safety and effectiveness of the new surface modified composite coated orthopedic implant
      system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: post-operation infection rate
time frame: 12 months
measure: SF-12 score
time frame: 12 months
measure: EQ-5D score
time frame: 12 months
measure: fracture union, malunion, nonunion rate
time frame: 12 months
arm group label: Research Group
arm group type: Experimental
description: Research group uses surface-modified composite coated orthopedic implants
arm group label: Controls Group
arm group type: Active Comparator
description: Controls group uses conventional orthopedic implants
intervention type: Device
intervention name: Surface-modified composite coated orthopedic implants
description: The surface-modified composite coated orthopedic implants have the capacity of high binding strength, high tissue-inducing activity and intelligent bacteria-resistance. The implant devices are expected to be used in the prevention and treatment of plant-related infections in orthopedic surgeries.
arm group label: Research Group
intervention type: Device
intervention name: conventional orthopedic implants
description: conventional orthopedic implants
arm group label: Controls Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Spinal Diseases
mesh term: Fractures, Open