<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/NCT04469166</url>
  </required_header>
  <id_info>
    <org_study_id>HMU/Sherwan 10</org_study_id>
    <nct_id>NCT04469166</nct_id>
  </id_info>
  <brief_title>Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up</brief_title>
  <official_title>Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hawler Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hawler Medical 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>
      This study is randomized controlled trial with 5 years follow up and involved 101 patients&#xD;
      divided in two groups; group A in which tourniquet was used in total knee arthroplasty while&#xD;
      group B in which tourniquet was not used. All these patients were analyzed for the clinical&#xD;
      and functional outcome measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, investigators have primary outcome measures and secondary outcome measures&#xD;
      which were assessed in multiple periods to see the effects of using tourniquet in total knee&#xD;
      arthroplasty on the clinical and functional outcomes with follow up of 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blinded study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Knee society score</measure>
    <time_frame>This score was assessed at 5 years postoperatively</time_frame>
    <description>Knee society score for functional outcome which will be low in poor function and high in best function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee injury and osteoarthritis outcome scores</measure>
    <time_frame>This score was assessed at 5 years post-operatively</time_frame>
    <description>Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS for thigh pain</measure>
    <time_frame>This score was assessed at 1st day post-operatively</time_frame>
    <description>Visual analogue scale for thigh pain which will be high in more pain and low in less pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post operative complications</measure>
    <time_frame>These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.</time_frame>
    <description>The complications can occurred after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Use of Tourniquet in Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Tourniquet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of tourniquet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No tourniquet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of no tourniquet</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tourniquet</intervention_name>
    <description>Use of tourniquet</description>
    <arm_group_label>Tourniquet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No tourniquet</intervention_name>
    <description>No use of tourniquet</description>
    <arm_group_label>No tourniquet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade 3 and 4 osteoarthritis&#xD;
&#xD;
          -  age 55-80 years&#xD;
&#xD;
          -  patients agree to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or&#xD;
             lumbosacral spinal stenosis.&#xD;
&#xD;
          -  Hip pathology like osteoarthritis or fractures&#xD;
&#xD;
          -  Neuromuscular disorders&#xD;
&#xD;
          -  Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.&#xD;
&#xD;
          -  Previous knee surgery or knee infection&#xD;
&#xD;
          -  Peripheral vascular disease&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Hemoglobin less than 12 gram/deciliter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hawler Medical University</investigator_affiliation>
    <investigator_full_name>Sherwan Ahmed Ali Hamawandi</investigator_full_name>
    <investigator_title>Assistant professor of orthopedic surgery</investigator_title>
  </responsible_party>
  <keyword>Tourniquet</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Clinical outcomes</keyword>
  <keyword>Functional outcomes</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Upon the publication of our study, I will decide to share my patients data</ipd_description>
  </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/NCT04469166
org study id: HMU/Sherwan 10
nct id: NCT04469166
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is randomized controlled trial with 5 years follow up and involved 101 patients
      divided in two groups; group A in which tourniquet was used in total knee arthroplasty while
      group B in which tourniquet was not used. All these patients were analyzed for the clinical
      and functional outcome measures.
In this study, investigators have primary outcome measures and secondary outcome measures
      which were assessed in multiple periods to see the effects of using tourniquet in total knee
      arthroplasty on the clinical and functional outcomes with follow up of 5 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double blinded study
measure: Knee society score
time frame: This score was assessed at 5 years postoperatively
description: Knee society score for functional outcome which will be low in poor function and high in best function
measure: Knee injury and osteoarthritis outcome scores
time frame: This score was assessed at 5 years post-operatively
description: Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function
measure: VAS for thigh pain
time frame: This score was assessed at 1st day post-operatively
description: Visual analogue scale for thigh pain which will be high in more pain and low in less pain
measure: Post operative complications
time frame: These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.
description: The complications can occurred after surgery
arm group label: Tourniquet
arm group type: Active Comparator
description: Group of tourniquet
arm group label: No tourniquet
arm group type: Active Comparator
description: Group of no tourniquet
intervention type: Procedure
intervention name: tourniquet
description: Use of tourniquet
arm group label: Tourniquet
intervention type: Procedure
intervention name: No tourniquet
description: No use of tourniquet
arm group label: No tourniquet
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Hawler Medical University
investigator full name: Sherwan Ahmed Ali Hamawandi
investigator title: Assistant professor of orthopedic surgery
sharing ipd: Undecided
ipd description: Upon the publication of our study, I will decide to share my patients data