<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/NCT03823573</url>
  </required_header>
  <id_info>
    <org_study_id>P1102-16</org_study_id>
    <nct_id>NCT03823573</nct_id>
  </id_info>
  <brief_title>Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty</brief_title>
  <official_title>Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ignacio Aguado Maestro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital del Río Hortega</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>
      Patients undergoing total knee arthroplasty will follow two different rehabilitation&#xD;
      protocols. In one of them, they will start walking the day of surgery and discharged on a 48&#xD;
      hours basis. On the other one, start walking 3 days after surgery and discharged on a 96&#xD;
      hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and&#xD;
      overall complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomization will be performed concealed the day before surgery. Tranexamic acid will be&#xD;
      used in both groups. Rapid recovery group will not be using a drain, whereas the standard&#xD;
      protocol group will have one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain: Morphine clorhydrate shots requested by the patient</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of shots requested and administered to the patient after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>6 months</time_frame>
    <description>Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasonography incidence of deep vein thrombosis</measure>
    <time_frame>4 weeks-8 weeks</time_frame>
    <description>Incidence of deep vein thrombosis measured by ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall score given by the patient to the knee replacement process</measure>
    <time_frame>6 months</time_frame>
    <description>Satisfaction with the protocol. Subjective measure by the patient from 0 (bad) to 10 (best) with the surgery process.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infection</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>48 hours</time_frame>
    <description>Haemoglobin drop</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxford Knee Score pre op and post op</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in Oxford Knee Scores postoperatively and preoperatively</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Fast Track</condition>
  <condition>Tranexamic Acid Adverse Reaction</condition>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Rapid recovery protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>They will start walking the day of surgery. Levobupivacain 5mg/ml will be placed in the knee tissues. Tranexamic acid inside the knee. No drains.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classic protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They will start walking 3 days after surgery. Levobupivacain 5 mg/ml will be placed in the femoral nerve. Tranexamic acid inside the knee. A Redon drain will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walk within 24 hours</intervention_name>
    <description>Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.</description>
    <arm_group_label>Classic protocol</arm_group_label>
    <arm_group_label>Rapid recovery protocol</arm_group_label>
    <other_name>Drain</other_name>
    <other_name>Discharge the day after walking</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Knee osteoarthritis willing to undergo total knee arthroplasty&#xD;
&#xD;
          -  Age 55-79&#xD;
&#xD;
          -  Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hipersensibility to any of the components used&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Pulmonary embolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario del Río Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 10, 2020</last_update_submitted>
  <last_update_submitted_qc>October 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Río Hortega</investigator_affiliation>
    <investigator_full_name>Ignacio Aguado Maestro</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>fast track</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>tranexamic acid</keyword>
  <keyword>drain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03823573
org study id: P1102-16
nct id: NCT03823573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients undergoing total knee arthroplasty will follow two different rehabilitation
      protocols. In one of them, they will start walking the day of surgery and discharged on a 48
      hours basis. On the other one, start walking 3 days after surgery and discharged on a 96
      hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and
      overall complications.
Randomization will be performed concealed the day before surgery. Tranexamic acid will be
      used in both groups. Rapid recovery group will not be using a drain, whereas the standard
      protocol group will have one.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Pain: Morphine clorhydrate shots requested by the patient
time frame: 24 hours
description: Number of shots requested and administered to the patient after surgery
measure: Range of Motion
time frame: 6 months
description: Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
measure: Ultrasonography incidence of deep vein thrombosis
time frame: 4 weeks-8 weeks
description: Incidence of deep vein thrombosis measured by ultrasound
measure: Overall score given by the patient to the knee replacement process
time frame: 6 months
description: Satisfaction with the protocol. Subjective measure by the patient from 0 (bad) to 10 (best) with the surgery process.
measure: Infection
time frame: 1 year
description: Incidence of infection
measure: Blood loss
time frame: 48 hours
description: Haemoglobin drop
measure: Oxford Knee Score pre op and post op
time frame: 6 months
description: Difference in Oxford Knee Scores postoperatively and preoperatively
arm group label: Rapid recovery protocol
arm group type: Experimental
description: They will start walking the day of surgery. Levobupivacain 5mg/ml will be placed in the knee tissues. Tranexamic acid inside the knee. No drains.
arm group label: Classic protocol
arm group type: Active Comparator
description: They will start walking 3 days after surgery. Levobupivacain 5 mg/ml will be placed in the femoral nerve. Tranexamic acid inside the knee. A Redon drain will be used.
intervention type: Behavioral
intervention name: Walk within 24 hours
description: Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
arm group label: Classic protocol
arm group label: Rapid recovery protocol
other name: Drain
other name: Discharge the day after walking
criteria: 
gender: All
minimum age: 55 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital del Río Hortega
investigator full name: Ignacio Aguado Maestro
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No