<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/NCT02203045</url>
  </required_header>
  <id_info>
    <org_study_id>12-0648</org_study_id>
    <nct_id>NCT02203045</nct_id>
  </id_info>
  <brief_title>Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty</brief_title>
  <official_title>Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colorado Joint Replacement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centura Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this study is to determine the effects of intraoperative tourniquet use&#xD;
      during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet&#xD;
      (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During&#xD;
      the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity&#xD;
      while the contralateral lower extremity undergoes TKA without the use of a tourniquet&#xD;
      (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in&#xD;
      TKA to improve visualization of the surgical field and limit blood loss. However, studies&#xD;
      suggest that tourniquet use may be associated with higher rates of medical complications and&#xD;
      poor functional outcomes, including increased swelling, decreased muscle strength and altered&#xD;
      neuromuscular activity. We will measure strength, voluntary muscle activation, and other&#xD;
      functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs&#xD;
      after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities&#xD;
      in the NOTQT group will demonstrate improved strength and performance when compared to lower&#xD;
      extremities in the TQT group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">August 2014</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>Change from baseline in Quadriceps Muscle Force</measure>
    <time_frame>Pre-operative, 3 weeks and 3 months post-operative</time_frame>
    <description>NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Balance testing</measure>
    <time_frame>Pre-operatively, 3 weeks and 3 months post-operative</time_frame>
    <description>Patients will be asked to perform a test of unilateral balance ability. Patients will place both hands on their hips before assuming a single limb stance. Patients will attempt to hold this position for a maximum time of 60 seconds, although timing will stop if patients ever place both feet on the ground, if the non-stance leg braces against the stance leg to control balance, or if hands are removed from the hips to regain balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Isometric Hamstring Strength</measure>
    <time_frame>Pre-operatively, 3 weeks and 3 months post-operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline from Voluntary Quadriceps Activation</measure>
    <time_frame>Pre-operative, 3 weeks and 3 months post-operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Range of Motion</measure>
    <time_frame>Pre-operatively, 3 weeks and 3 months post-operatively</time_frame>
    <description>Knee flexion and extension range of motion (ROM) will be quantified using a standard long-arm goniometer with the patient lying in supine. Knee flexion ROM will be defined as the angle of maximal active bending of the knee. Knee extension ROM will be the angle of maximal straightening while the patient's heel is propped on a 10cm wooden block. If hyperextension is achieved, then the degrees of extension beyond zero will be recorded as a negative value.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Radiographic Examination</measure>
    <time_frame>1 to 2 months post surgery</time_frame>
    <description>Radiographic examination will be used to provide preliminary data on rates of fracture and tibiofemoral joint malalignment specific to the use of tourniquet during surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Deep Vein Thrombosis Formation</measure>
    <time_frame>48- 72 hours post operative</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative blood loss</measure>
    <time_frame>48 hours post surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Lower extremity edema</measure>
    <time_frame>48- 72 hours postoperative</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Verbal analog scale pain assessment</measure>
    <time_frame>Pre-Operative, 3 weeks and 3 months post-operative</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Tourniquet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (&gt;200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non- tourniquet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (&gt;200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <arm_group_label>Non- tourniquet</arm_group_label>
    <arm_group_label>Tourniquet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no neurological, vascular or cardiac problems that limit function or any unstable&#xD;
             orthopaedic conditions that limit functional performance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Dennis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado Joint Replacement</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Stevens-Lapsley, MPT and PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ray Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado Joint Replacement</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Joint Replacement</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>May 13, 2015</last_update_submitted>
  <last_update_submitted_qc>May 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT02203045
org study id: 12-0648
nct id: NCT02203045
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The overall goal of this study is to determine the effects of intraoperative tourniquet use
      during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet
      (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During
      the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity
      while the contralateral lower extremity undergoes TKA without the use of a tourniquet
      (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in
      TKA to improve visualization of the surgical field and limit blood loss. However, studies
      suggest that tourniquet use may be associated with higher rates of medical complications and
      poor functional outcomes, including increased swelling, decreased muscle strength and altered
      neuromuscular activity. We will measure strength, voluntary muscle activation, and other
      functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs
      after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities
      in the NOTQT group will demonstrate improved strength and performance when compared to lower
      extremities in the TQT group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in Quadriceps Muscle Force
time frame: Pre-operative, 3 weeks and 3 months post-operative
description: NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA
measure: Change from Baseline in Balance testing
time frame: Pre-operatively, 3 weeks and 3 months post-operative
description: Patients will be asked to perform a test of unilateral balance ability. Patients will place both hands on their hips before assuming a single limb stance. Patients will attempt to hold this position for a maximum time of 60 seconds, although timing will stop if patients ever place both feet on the ground, if the non-stance leg braces against the stance leg to control balance, or if hands are removed from the hips to regain balance.
measure: Change from Baseline in Isometric Hamstring Strength
time frame: Pre-operatively, 3 weeks and 3 months post-operative
measure: Change from Baseline from Voluntary Quadriceps Activation
time frame: Pre-operative, 3 weeks and 3 months post-operative
measure: Change from Baseline in Range of Motion
time frame: Pre-operatively, 3 weeks and 3 months post-operatively
description: Knee flexion and extension range of motion (ROM) will be quantified using a standard long-arm goniometer with the patient lying in supine. Knee flexion ROM will be defined as the angle of maximal active bending of the knee. Knee extension ROM will be the angle of maximal straightening while the patient's heel is propped on a 10cm wooden block. If hyperextension is achieved, then the degrees of extension beyond zero will be recorded as a negative value.
measure: Radiographic Examination
time frame: 1 to 2 months post surgery
description: Radiographic examination will be used to provide preliminary data on rates of fracture and tibiofemoral joint malalignment specific to the use of tourniquet during surgery.
measure: Deep Vein Thrombosis Formation
time frame: 48- 72 hours post operative
measure: Postoperative blood loss
time frame: 48 hours post surgery
measure: Lower extremity edema
time frame: 48- 72 hours postoperative
measure: Verbal analog scale pain assessment
time frame: Pre-Operative, 3 weeks and 3 months post-operative
arm group label: Tourniquet
arm group type: Active Comparator
description: All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.
arm group label: Non- tourniquet
arm group type: Experimental
description: All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.
intervention type: Other
intervention name: Total Knee Arthroplasty
arm group label: Non- tourniquet
arm group label: Tourniquet
criteria: 
gender: All
minimum age: N/A
maximum age: 75 Years
healthy volunteers: No
last name: Douglas Dennis, MD
role: Principal Investigator
affiliation: Colorado Joint Replacement
last name: Jennifer Stevens-Lapsley, MPT and PhD
role: Study Director
affiliation: University of Colorado, Denver
last name: Ray Kim, MD
role: Principal Investigator
affiliation: Colorado Joint Replacement
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis