<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/NCT02968693</url>
  </required_header>
  <id_info>
    <org_study_id>20150801c</org_study_id>
    <nct_id>NCT02968693</nct_id>
  </id_info>
  <brief_title>Drug Delivery Devices for Osteomyelitis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yulin Orthopedics Hospital of Chinese and Western Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yulin Orthopedics Hospital of Chinese and Western Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of&#xD;
      the lower extremities were included in the retrospective investigation. The patients were&#xD;
      assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate&#xD;
      and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological&#xD;
      parameters, eradication of infection, rate of infection recurrence and reoperation rate were&#xD;
      evaluated during the follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>complications after first-stage surgery.</measure>
    <time_frame>through study completion, an average of 24 months.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>local infection recurrence after first-stage surgery.</measure>
    <time_frame>through study completion, an average of 24 months.</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Osteomyelitis</condition>
  <arm_group>
    <arm_group_label>combination therapy group</arm_group_label>
    <description>antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PMMA group</arm_group_label>
    <description>antibiotic-loaded polymethyl methacrylate and Vancomycin</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>antibiotic-loaded calcium sulfate</intervention_name>
    <description>To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets.</description>
    <arm_group_label>combination therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>antibiotic-loaded polymethyl methacrylate</intervention_name>
    <description>One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely.</description>
    <arm_group_label>PMMA group</arm_group_label>
    <arm_group_label>combination therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>Vancomycin powder was added into the combination therapy group and PMMA groups</description>
    <arm_group_label>PMMA group</arm_group_label>
    <arm_group_label>combination therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Between April 2011 and April 2015, fifty-one patients requiring surgical treatment for&#xD;
        chronic post-traumatic/postoperative osteomyelitis of the lower extremities were enrolled&#xD;
        in a retrospective and control study in our hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The retrospective study included patients with chronic post-traumatic or postoperative&#xD;
             osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute&#xD;
             post-traumatic or postoperative osteomyelitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other kinds of osteomyelitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yulin Orthopedics Hospital of Chinese and Western Medicine</name>
      <address>
        <city>Yulin</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yulin Orthopedics Hospital of Chinese and Western Medicine</investigator_affiliation>
    <investigator_full_name>Shanchao Luo</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteomyelitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
    <mesh_term>Polymethyl Methacrylate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <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/NCT02968693
org study id: 20150801c
nct id: NCT02968693
lead sponsor: 
has dmc: No
Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of
      the lower extremities were included in the retrospective investigation. The patients were
      assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate
      and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological
      parameters, eradication of infection, rate of infection recurrence and reoperation rate were
      evaluated during the follow-up.
observational model: Case-Control
time perspective: Retrospective
measure: complications after first-stage surgery.
time frame: through study completion, an average of 24 months.
measure: local infection recurrence after first-stage surgery.
time frame: through study completion, an average of 24 months.
arm group label: combination therapy group
description: antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
arm group label: PMMA group
description: antibiotic-loaded polymethyl methacrylate and Vancomycin
intervention type: Device
intervention name: antibiotic-loaded calcium sulfate
description: To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets.
arm group label: combination therapy group
intervention type: Device
intervention name: antibiotic-loaded polymethyl methacrylate
description: One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely.
arm group label: PMMA group
arm group label: combination therapy group
intervention type: Drug
intervention name: Vancomycin
description: Vancomycin powder was added into the combination therapy group and PMMA groups
arm group label: PMMA group
arm group label: combination therapy group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 68 Years
healthy volunteers: No
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Yulin Orthopedics Hospital of Chinese and Western Medicine
investigator full name: Shanchao Luo
investigator title: Director
mesh term: Osteomyelitis
mesh term: Anti-Bacterial Agents
mesh term: Vancomycin
mesh term: Antibiotics, Antitubercular
mesh term: Polymethyl Methacrylate
mesh term: Calcium
sharing ipd: No