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/NCT05990816</url>
    </required_header>
    <id_info>
      <org_study_id>cbdemirkan</org_study_id>
      <nct_id>NCT05990816</nct_id>
    </id_info>
    <brief_title>Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty</brief_title>
    <official_title>Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bezmialem Vakif University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bezmialem Vakif University</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this observational study is to asses the natural course of blood homocysteine&#xD;
        levels in patients who underwent primary total joint arthroplasty surgery. The main&#xD;
        question[s] it aims to answer are:&#xD;
  &#xD;
          -  İs homocysteine a good marker for determining periprosthetic joint infection ?&#xD;
  &#xD;
          -  İs homocysteine more sensitive marker for periprosthetic joint infections ?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2024</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>Homocysteine</measure>
      <time_frame>6 months</time_frame>
      <description>Homocysteine levels in patient blood works</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Joint Prosthesis; Complications, Infection or Inflammation</condition>
    <arm_group>
      <arm_group_label>Arthroplasty Patients</arm_group_label>
      <description>Only one group that consist patients who underwent primary total joint arthroplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood works for homocysteine levels</intervention_name>
      <description>In a single patient group of 80 people, the natural course of homocysteine after total joint arthroplasty will be examined by blood work analyzes at the 1,2,3,4 and 6th weeks after operation</description>
      <arm_group_label>Arthroplasty Patients</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood Test for Homocysteine Levels Assessment&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Healty volunteers who have undergone uneventful primary total joint arthroplasty&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People who have undergone Total Knee Arthroplasty operation&#xD;
  &#xD;
            -  People who have undergone Total Hip Arthroplasty operation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People who have undergone total knee arthroplasty operation and developed a&#xD;
               periprosthetic joint infection&#xD;
  &#xD;
            -  People who have undergone total hip arthroplasty operation and developed a&#xD;
               periprosthetic joint infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bezmialem Vakif University</name>
        <address>
          <city>Istanbul</city>
          <zip>34140</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Mouravas H, Verettas D, Kazakos K, Xarhas K, Panagiotou N, Ellinas P. Homocysteine and its relationship to deep venous thrombosis in patients undergoing total knee or hip arthroplasty. Hippokratia. 2010 Jul;14(3):185-8.</citation>
      <PMID>20981167</PMID>
    </reference>
    <reference>
      <citation>Watanabe N, Ogawa T, Takada R, Amano Y, Jinno T, Koga H, Yoshii T, Okawa A, Miyatake K. Association of osteoporosis and high serum homocysteine levels with intraoperative periprosthetic fracture during total hip arthroplasty: a propensity-score matching analysis. Arch Orthop Trauma Surg. 2023 Jul 19. doi: 10.1007/s00402-023-04989-6. Online ahead of print.</citation>
      <PMID>37468711</PMID>
    </reference>
    <results_reference>
      <citation>Azboy I, Catal B, Basarir K, Mutlu M, Bilgen OF, Parvizi J. The Natural Course of Serum D-Dimer, C-Reactive Protein, and Erythrocyte Sedimentation Rate Levels After Uneventful Primary Total Joint Arthroplasty. J Arthroplasty. 2021 Sep;36(9):3118-3122. doi: 10.1016/j.arth.2021.04.031. Epub 2021 Apr 30.</citation>
      <PMID>34088567</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
      <investigator_full_name>Cemil Burak DEMİRKIRAN</investigator_full_name>
      <investigator_title>Resident Doctor</investigator_title>
    </responsible_party>
    <keyword>periprosthetic joint infection</keyword>
    <keyword>diagnosis</keyword>
    <keyword>natural course</keyword>
    <keyword>total joint arthroplasty.</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <!-- 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/NCT05990816
  org study id: cbdemirkan
  nct id: NCT05990816
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to asses the natural course of blood homocysteine
        levels in patients who underwent primary total joint arthroplasty surgery. The main
        question[s] it aims to answer are:
  
          -  İs homocysteine a good marker for determining periprosthetic joint infection ?
  
          -  İs homocysteine more sensitive marker for periprosthetic joint infections ?
  observational model: Cohort
  time perspective: Prospective
  measure: Homocysteine
  time frame: 6 months
  description: Homocysteine levels in patient blood works
  arm group label: Arthroplasty Patients
  description: Only one group that consist patients who underwent primary total joint arthroplasty
  intervention type: Diagnostic Test
  intervention name: Blood works for homocysteine levels
  description: In a single patient group of 80 people, the natural course of homocysteine after total joint arthroplasty will be examined by blood work analyzes at the 1,2,3,4 and 6th weeks after operation
  arm group label: Arthroplasty Patients
  Blood Test for Homocysteine Levels Assessment
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  citation: Mouravas H, Verettas D, Kazakos K, Xarhas K, Panagiotou N, Ellinas P. Homocysteine and its relationship to deep venous thrombosis in patients undergoing total knee or hip arthroplasty. Hippokratia. 2010 Jul;14(3):185-8.
  PMID: 20981167
  citation: Watanabe N, Ogawa T, Takada R, Amano Y, Jinno T, Koga H, Yoshii T, Okawa A, Miyatake K. Association of osteoporosis and high serum homocysteine levels with intraoperative periprosthetic fracture during total hip arthroplasty: a propensity-score matching analysis. Arch Orthop Trauma Surg. 2023 Jul 19. doi: 10.1007/s00402-023-04989-6. Online ahead of print.
  PMID: 37468711
  citation: Azboy I, Catal B, Basarir K, Mutlu M, Bilgen OF, Parvizi J. The Natural Course of Serum D-Dimer, C-Reactive Protein, and Erythrocyte Sedimentation Rate Levels After Uneventful Primary Total Joint Arthroplasty. J Arthroplasty. 2021 Sep;36(9):3118-3122. doi: 10.1016/j.arth.2021.04.031. Epub 2021 Apr 30.
  PMID: 34088567
  responsible party type: Principal Investigator
  investigator affiliation: Bezmialem Vakif University
  investigator full name: Cemil Burak DEMİRKIRAN
  investigator title: Resident Doctor
  mesh term: Inflammation