<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/NCT04486040</url>
  </required_header>
  <id_info>
    <org_study_id>GrucaTH</org_study_id>
    <nct_id>NCT04486040</nct_id>
  </id_info>
  <brief_title>Closed Suction Drainage After Revision Hip Arthroplasty</brief_title>
  <official_title>Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof A Gruca Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof A Gruca Teaching 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>
      Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided&#xD;
      in to two groups with or without drainage. All patients was assessed with ultrasonography on&#xD;
      3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed&#xD;
      after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion&#xD;
      criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure,&#xD;
      thromboembolism in past history. At the end of operation information of drainage was get out&#xD;
      from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the&#xD;
      joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein,&#xD;
      erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was&#xD;
      taken on 3rd day after surgery and Harris Hip Score 6 weeks after.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2016</start_date>
  <completion_date type="Actual">March 13, 2020</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hematoma size</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Level of fluid at endoprosthesis neck in ultrasonography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin level</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Hemoglobin level after surgery on 1st and 3rd day after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Assessing blood loss with use of Gross formula</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reinfection</measure>
    <time_frame>2 years after surgery</time_frame>
    <description>Number of patients with infection after surgery performed in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Soft tissue hematoma</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Note hematoma formation in soft tissue after surgery (ultrasonography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein level</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Level of C-reactive protein after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion</measure>
    <time_frame>5-14 days after surgery</time_frame>
    <description>Number of patients who need blood transfusion after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Level of pain after surgery, 1- no pain; 10- &quot;the worst pain you ever had&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>Clinical outcome after surgery, 0-100 points; 100 points the best score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Drainage group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with drainage after hip revision arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-drainage group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients without drainage after hip revision arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Drainage</intervention_name>
    <description>Use of the suction drainage after hip revision arthroplasty</description>
    <arm_group_label>Drainage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No-drainage</intervention_name>
    <description>Patients without drainage after surgery</description>
    <arm_group_label>No-drainage group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aseptic loosening,&#xD;
&#xD;
          -  head or insert damage,&#xD;
&#xD;
          -  girdlestone hip&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  septic loosening,&#xD;
&#xD;
          -  primary or secondary coagulopathy,&#xD;
&#xD;
          -  renal or hepatic failure,&#xD;
&#xD;
          -  thromboembolism in past history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pawel Bartosz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof A Gruca Teaching Hospital</investigator_affiliation>
    <investigator_full_name>Bartosz Paweł</investigator_full_name>
    <investigator_title>M.D., Ph.D. Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hip</keyword>
  <keyword>Revision</keyword>
  <keyword>Arthroplasty</keyword>
  <keyword>Drainage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_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/NCT04486040
org study id: GrucaTH
nct id: NCT04486040
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided
      in to two groups with or without drainage. All patients was assessed with ultrasonography on
      3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed
      after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after
      surgery.
Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion
      criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure,
      thromboembolism in past history. At the end of operation information of drainage was get out
      from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the
      joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein,
      erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was
      taken on 3rd day after surgery and Harris Hip Score 6 weeks after.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hematoma size
time frame: 3 days after surgery
description: Level of fluid at endoprosthesis neck in ultrasonography
measure: Hemoglobin level
time frame: 3 days after surgery
description: Hemoglobin level after surgery on 1st and 3rd day after surgery
measure: Blood loss
time frame: 1 day after surgery
description: Assessing blood loss with use of Gross formula
measure: Reinfection
time frame: 2 years after surgery
description: Number of patients with infection after surgery performed in the study
measure: Soft tissue hematoma
time frame: 3 days after surgery
description: Note hematoma formation in soft tissue after surgery (ultrasonography)
measure: C-reactive protein level
time frame: 3 days after surgery
description: Level of C-reactive protein after surgery
measure: Blood transfusion
time frame: 5-14 days after surgery
description: Number of patients who need blood transfusion after surgery
measure: Visual Analog Scale
time frame: 3 days after surgery
description: Level of pain after surgery, 1- no pain; 10- "the worst pain you ever had"
measure: Harris Hip Score
time frame: 6 weeks after surgery
description: Clinical outcome after surgery, 0-100 points; 100 points the best score
arm group label: Drainage group
arm group type: Active Comparator
description: Patients with drainage after hip revision arthroplasty
arm group label: No-drainage group
arm group type: Active Comparator
description: Patients without drainage after hip revision arthroplasty
intervention type: Procedure
intervention name: Drainage
description: Use of the suction drainage after hip revision arthroplasty
arm group label: Drainage group
intervention type: Procedure
intervention name: No-drainage
description: Patients without drainage after surgery
arm group label: No-drainage group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pawel Bartosz
role: Principal Investigator
affiliation: Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock
responsible party type: Principal Investigator
investigator affiliation: Prof A Gruca Teaching Hospital
investigator full name: Bartosz Paweł
investigator title: M.D., Ph.D. Principal Investigator
mesh term: Osteoarthritis, Hip
sharing ipd: No