<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/NCT03028779</url>
  </required_header>
  <id_info>
    <org_study_id>MaisonneuveRH2</org_study_id>
    <nct_id>NCT03028779</nct_id>
  </id_info>
  <brief_title>Implementation of Fast-track Surgery Program for Total Hip and Knee Replacement and the Evaluation of the Risks and Benefits for the Patient</brief_title>
  <official_title>Implementation of Fast-track Surgery Program for Total Hip and Knee Replacement and the Evaluation of the Risks and Benefits for the Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maisonneuve-Rosemont Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maisonneuve-Rosemont Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implementation of Fast-track surgery for total hip replacement and total knee replacement and&#xD;
      evaluation of the risks and benefits for the patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of the study is to evaluate the risk and the possible implementation of the&#xD;
      project of the total knee (TKR) or hip (THR) replacement in a fast track setting. The&#xD;
      specifics features of such a study are to introduce intervention modalities and care rapidly&#xD;
      to minimize and prevent all known complications associated with THR or TKR.&#xD;
&#xD;
      Following a total hip replacement (THR), the length of stay is usually 1 to 3 days and 3 to 5&#xD;
      days for a total knee replacement (TKR). The investigators have developed a new protocol with&#xD;
      intensive care giving the possibility to return home in less than 24 hours and want to&#xD;
      evaluate the feasibility and security of such a protocol.&#xD;
&#xD;
      To evaluate the security and feasibility of this protocol the investigators want to recruit&#xD;
      150 participants who will agree to enroll in this study.The investigators will evaluate these&#xD;
      variables; number of complications occuring within the 12 months fallowing the surgery,&#xD;
      number of readmission post-surgery, pain control efficiency, number of blood transfusion&#xD;
      needed, length of wound spread, patient satisfaction and the cost of the program&#xD;
      implementation. The investigators want to identify the success and failure factors to&#xD;
      optimise the program afterwards.&#xD;
&#xD;
      In order to achieve the evaluation, the investigators will compare the data obtain from the&#xD;
      150 patients to the data retrieved in the medical files of the patients that already had the&#xD;
      same usual intervention in the past, with the standard length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>All complications related with the surgery from pre-surgery to 1 year after the surgery:&#xD;
-Adverse events classification using (Clavien-Dindo Scale) Complication meaning the number of : blood loss/transfusion, wound infection, pain control, dressing problems, leg discrepancy, falls, unexpected fallow up phone calls to the assistant, hospital readmission after discharge, neurological impairment (example; drop foot), range of motion impairment following surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The cost of the outpatient procedure evaluation for the TKR or THR</measure>
    <time_frame>1 year</time_frame>
    <description>Estimation of the surgery costs and post surgery costs will be evaluated (procedure, surgery time, medication, lab test etc...) Costs for the hospital such as the cost for the surgery and their complications Costs outside the hospital such as the medication and the cost associated with the lost of productivity Lost of productivity; Work Productivity and Activity Impairment test (WPAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health outcome before surgery at medical evaluation</measure>
    <time_frame>before surgery at medical evaluation up to 3 months before surgery</time_frame>
    <description>EQ 5D health questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health outcome 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>EQ 5D health questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient sex</measure>
    <time_frame>up to 3 month before surgery</time_frame>
    <description>Patient sex; men or women Surgery date: (yyyy/mm/dd) Name of the surgeon Height in meters weight in kg BMI in kg/m2 Health and medical history Physical status score (ASA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient date of birth</measure>
    <time_frame>up to 3 months before surgery</time_frame>
    <description>Patient date of birth Surgery date: (yyyy/mm/dd) Name of the surgeon Height in meters weight in kg BMI in kg/m2 Health and medical history Physical status score (ASA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgery Date</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Surgery date (yyyy/mm/dd) Name of the surgeon Height in meters weight in kg BMI in kg/m2 Health and medical history Physical status score (ASA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Name of surgeon</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Name of the surgeon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>up to 3 months before surgery</time_frame>
    <description>BMI in kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health and medical history</measure>
    <time_frame>up to 3 months before surgery</time_frame>
    <description>Health and medical history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical status score (ASA)</measure>
    <time_frame>up to 3 months before surgery</time_frame>
    <description>Physical status score (ASA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgery Time</measure>
    <time_frame>The day of surgery</time_frame>
    <description>Evaluation of the surgery length in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of prosthesis</measure>
    <time_frame>The day of surgery</time_frame>
    <description>The type of prosthesis Total Knee Replacement (TKR) or Total Hip Replacement (THR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operated side; left or right leg</measure>
    <time_frame>The day of surgery, when patient arrives in OR</time_frame>
    <description>The side on which the patient is having the TKR(total knee replacement) or THR (total hip replacement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of blood in mL loss during surgery</measure>
    <time_frame>Day of the surgery after closing of the surgical site</time_frame>
    <description>Quantity in mL of blood loss during surgery, measured after closing the surgical site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time the patient arrives on the treatment floor</measure>
    <time_frame>The day of surgery when the patient arrives on treatment floor</time_frame>
    <description>The time in hours and minutes at which the patient arrives on the treatment floor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss in dressing before discharge in %</measure>
    <time_frame>Day of the surgery before discharge from hospital up to 24h after surgery</time_frame>
    <description>Percentage evaluation of the quantity of blood in the dressing, where on the dressing, the type of dressing and the aspect of the dressing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at discharged from the hospital</measure>
    <time_frame>Day of surgery,at discharge time up to 24h after surgery</time_frame>
    <description>The time in hours and minutes at which the patient leaves the hospital after discharged from hospital care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of failure to discharge</measure>
    <time_frame>through study completion up to 2 years</time_frame>
    <description>The number of failure to discharge patient according to the discharged criterias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score before surgery (VAS)</measure>
    <time_frame>Before surgery at the medical evaluation pre surgery</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score after surgery in recovery room (VAS)</measure>
    <time_frame>Day of surgery, after surgery in recovery room, day 0</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten in recovery room, day 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score after surgery on treatment floor before discharge (VAS)</measure>
    <time_frame>Day of surgery before discharge</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score 1-3 days after surgery (VAS)</measure>
    <time_frame>1-3 day after surgery</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score 4 to 6 weeks after surgery (VAS)</measure>
    <time_frame>4 to 6 weeks after surgery</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score 10 to 12 weeks after surgery (VAS)</measure>
    <time_frame>10-12 weeks after surgery</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score 6 months after surgery (VAS)</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score one year after surgery (VAS)</measure>
    <time_frame>one year after surgery</time_frame>
    <description>Pain evaluation using the visual analog scale (VAS) zero to ten</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of hemoglobin outcome before surgery</measure>
    <time_frame>Before surgery at the medical evaluation pre surgery up to 3 months before surgery</time_frame>
    <description>Blood test done by nurse evaluating the level in g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of hemoglobin outcome after surgery</measure>
    <time_frame>Day of surgery, when the patient arrives in the recovery room</time_frame>
    <description>Blood test done by nurse evaluating the level on g/L ,when the patient arrives in recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of hemoglobin outcome 3 to 4 days after surgery</measure>
    <time_frame>3 to 4 days after surgery</time_frame>
    <description>Blood test done by nurse evaluating the level of hemoglobine on g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of post surgery symptoms in recovery room</measure>
    <time_frame>Day of surgery, when the patient arrives in the recovery room</time_frame>
    <description>Evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of post surgery symptoms on treatment floor</measure>
    <time_frame>Day of surgery, when patient arrives on treatment floor</time_frame>
    <description>subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of post surgery symptoms before discharge</measure>
    <time_frame>Day of surgery, before discharge up to 24h after srugery</time_frame>
    <description>subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure outcome before surgery at the medical evaluation pre surgery</measure>
    <time_frame>before surgery at the medical evaluation pre surgery</time_frame>
    <description>Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse outcome before surgery at the medical evaluation pre surgery</measure>
    <time_frame>before surgery at the medical evaluation pre surgery</time_frame>
    <description>Measure of the pulse in bpm&#xD;
Measure of the oral temperature in Celcius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturation outcome before surgery at the medical evaluation pre surgery</measure>
    <time_frame>before surgery at the medical evaluation pre surgery</time_frame>
    <description>measure of saturation in % with index finger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature outcome before surgery at the medical evaluation pre surgery</measure>
    <time_frame>Before surgery at the medical evaluation pre surgery</time_frame>
    <description>Measure of oral temperature in Celsius with thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure outcome in recovery room</measure>
    <time_frame>Day of surgery,when patient arrives in recovery room</time_frame>
    <description>Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse outcome in recovery room</measure>
    <time_frame>Day of surgery, when patient arrives in recovery room</time_frame>
    <description>Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturation outcome in recovery room</measure>
    <time_frame>Day of surgery, when patient arrives in recovery room</time_frame>
    <description>Measure of saturation in % with index finger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature outcome in recovery room</measure>
    <time_frame>Day of surgery, when patient arrives in recovery room</time_frame>
    <description>Measure of oral temperature in Celsius with thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure outcome before discharge</measure>
    <time_frame>Day of surgery, before discharge up to 24hours after surgery</time_frame>
    <description>Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse outcome before discharge</measure>
    <time_frame>Day of surgery, before discharge up to 24hours after surgery</time_frame>
    <description>Measure of pulse in bpm Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturation outcome before discharge</measure>
    <time_frame>Day of surgery, before discharge up to 24hours after surgery</time_frame>
    <description>Measure of saturation in % with index finger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature outcome before discharge</measure>
    <time_frame>Day of surgery before discharge up to 24hours after surgery</time_frame>
    <description>Measure of the oral temperature in Celsius with thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure outcome at home 1 to 2 days after surgery</measure>
    <time_frame>at home 1 to 2 days after surgery</time_frame>
    <description>Measure of blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse outcome at home 1 to 2 days after surgery</measure>
    <time_frame>at home 1 to 2 days after surgery</time_frame>
    <description>Measure of the pulse in bpm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturation outcome at home 1 to 2 days after surgery</measure>
    <time_frame>at home 1 to 2 days after surgery</time_frame>
    <description>Measure of saturation in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature outcome at home 1 to 2 days after surgery</measure>
    <time_frame>at home 1 to 2 days after surgery</time_frame>
    <description>Measure of the oral temperature in Celsius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of big toe extension of the operated limb in recovery room</measure>
    <time_frame>Day of surgery, when patient arrives in recovery room</time_frame>
    <description>Neurological assesment myotomes evaluation; extension of the big toe of the operated limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of plantarflexion of the operated limb in recovery room</measure>
    <time_frame>Day of surgery, when patient arrives in recovery room</time_frame>
    <description>Neurological assesment Myotomes evaluation; plantarflexion of the operated limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of dorsiflexion of the operated limb in recovery room</measure>
    <time_frame>Day of surgery, when patient arrives in recovery room</time_frame>
    <description>Neurological assesment, myotomes evaluation; platarflexion of the operated limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatomes evaluation of the operated lower limb on treatment floor</measure>
    <time_frame>Day of the surgery, on treatment floor 4-6 hours after surgery</time_frame>
    <description>Dermatomes; all lower limbs L2 to S1-S2 if normal and comparable to other limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional evaluation outcome SF-36 at the medical evaluation before surgery</measure>
    <time_frame>Before surgery at medical evaluation up to 3 months before surgery</time_frame>
    <description>SF-36 health score questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional evaluation outcome, health score (SF-36) 6 months after surgery</measure>
    <time_frame>6months after surgery</time_frame>
    <description>SF-36 health score questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional evaluation outcome hip disability and osteoarthritis outcome score (HOOS) at medical evaluation before surgery</measure>
    <time_frame>Before surgery at medical evaluation up to 3 months before surgery</time_frame>
    <description>HOOS; hip disability and osteoarthritis outcome score questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional evaluation outcome HOOS 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>HOOS; hip disability and osteoarthritis outcome score questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional evaluation outcome, knee disability and osteoarthritis outcome score (KOOS) at medical evaluation before surgery</measure>
    <time_frame>Before surgery at medical evaluation up to 3 months before surgery</time_frame>
    <description>KOOS; knee disability and osteoarthritis outcome score questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional evaluation outcome KOOS 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>KOOS; knee disability and osteoarthritis outcome score questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip at medical evaluation</measure>
    <time_frame>Before surgery at medical evaluation up to 3 months before surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip on treatment floor</measure>
    <time_frame>Day of surgery, 4-6 hours after surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip 3 days after surgery</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip 4-6 weeks after surgery</measure>
    <time_frame>4-6 weeks after surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip 10-12 weeks after surgery</measure>
    <time_frame>10-12 weeks after surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion outcome of the knee or hip 1 year after surgery</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Straight leg raise (SLR) outcome after surgery</measure>
    <time_frame>3-4 hours after surgery</time_frame>
    <description>Measure of the height of the leg from the bed to the heel in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walk outcome before surgery at at medical evaluation</measure>
    <time_frame>Before surgery at at medical evaluation up to 3 months before surgery</time_frame>
    <description>Timed up and go (TUG) test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walk outcome 40 meters walk test at medical evaluation</measure>
    <time_frame>Before surgery at medical evaluation up to 3 months before surgery</time_frame>
    <description>Measure of time on m /s to walk 40 meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walk outcome 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Timed up and go (TUG) test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walk outcome 40 meters walk test 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Measure of time on m /s to walk 40 meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stairs climb outcome day of surgery</measure>
    <time_frame>Day of surgery before discharge up to 24hours after surgery</time_frame>
    <description>Stair climb test; how much time it takes in seconds to go up and down a flight of stairs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stairs climb outcome 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Stair climb test; how much time it takes in seconds to go up and down a flight of stairs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Orthopedic Procedure</condition>
  <arm_group>
    <arm_group_label>Fast-track total hip or knee arthroplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Be able to return patient home on the same day of a total hip or knee surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fast-track Total Hip and knee arthroplasty</intervention_name>
    <description>To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours</description>
    <arm_group_label>Fast-track total hip or knee arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient understanding the conditions of the study and ready to participate for the&#xD;
             duration of the study&#xD;
&#xD;
          2. Patient able to give their informed consent&#xD;
&#xD;
          3. Aged between 18 and 75 years&#xD;
&#xD;
          4. Patient needing a primary total hip or knee replacement (not associated with unusual&#xD;
             treatment such as bone graft, osteotomy, revision implant, etc.&#xD;
&#xD;
          5. The patient as a family member or a companion available the day of the pre-op&#xD;
             evaluation, the day of surgery and at home after the surgery for a week fallowing the&#xD;
             surgery&#xD;
&#xD;
          6. Women in age to procreate have to accept to add another contraception method one month&#xD;
             fallowing the intake of Emend/ Aprepitant received pre-surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Living further than 50 Km from Maisonneuve-Rosemont Hospital&#xD;
&#xD;
          2. Lack of services offered by the CLSC (home health care services) in their area&#xD;
&#xD;
          3. BMI over 40&#xD;
&#xD;
          4. Psychiatric desease limiting the participation in the study&#xD;
&#xD;
          5. Pregnancy&#xD;
&#xD;
          6. The need of long therm urinary foley post-op&#xD;
&#xD;
          7. Allergies to sulfinamide or to the other medications intended in the protocol&#xD;
&#xD;
          8. Presenting a cognitive impairment or a communication problem preventing the&#xD;
             realisation of the protocol&#xD;
&#xD;
          9. The patient has had a pulmonary embolism or veinous thromboembolism in the past year&#xD;
&#xD;
         10. Necessitating a long therm anticoagulation therapy&#xD;
&#xD;
         11. Under corticotherapy or has received a systemic corticotherapy in the past year&#xD;
             (unless a positive confirmation of a cortrosyn test done before the surgery)&#xD;
&#xD;
         12. Subject with a systemic involvement(diabetic, cardiac, renal, hematologic, etc.)&#xD;
             necessitating special perisurgical care (intensive care unit, multiples transfusions,&#xD;
             dialysis, etc.)&#xD;
&#xD;
         13. Inflammatory or tumoral joint disease ( rheumatoid arthritis, lupus, etc.)&#xD;
&#xD;
         14. Subject presenting a coagulation problem increasing their bleeding risk per and post&#xD;
             surgery (ie : thrombocytopenia, hemophilia, etc.)&#xD;
&#xD;
         15. Subject presenting a locomotion problem ,other then to the joint to be replaced,&#xD;
             enforcing functional limitations keeping them from mobilizing without technical or&#xD;
             physical aid&#xD;
&#xD;
         16. Presenting neurological or balance disorder&#xD;
&#xD;
         17. Having a living space incompatible with post-surgery home care&#xD;
&#xD;
         18. Under treatment with a medication substrate or strong inhibitor of CYP3A4&#xD;
&#xD;
         19. Subject with Clcr &lt; 30 ml/min ( Cockcroft-Gault formula)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maisonneuve-Rosemont Hospital</investigator_affiliation>
    <investigator_full_name>Pascal André Vendittoli</investigator_full_name>
    <investigator_title>Orthopedist</investigator_title>
  </responsible_party>
  <keyword>Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)</keyword>
  <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/NCT03028779
org study id: MaisonneuveRH2
nct id: NCT03028779
lead sponsor: 
has dmc: No
Implementation of Fast-track surgery for total hip replacement and total knee replacement and
      evaluation of the risks and benefits for the patients.
The primary goal of the study is to evaluate the risk and the possible implementation of the
      project of the total knee (TKR) or hip (THR) replacement in a fast track setting. The
      specifics features of such a study are to introduce intervention modalities and care rapidly
      to minimize and prevent all known complications associated with THR or TKR.

      Following a total hip replacement (THR), the length of stay is usually 1 to 3 days and 3 to 5
      days for a total knee replacement (TKR). The investigators have developed a new protocol with
      intensive care giving the possibility to return home in less than 24 hours and want to
      evaluate the feasibility and security of such a protocol.

      To evaluate the security and feasibility of this protocol the investigators want to recruit
      150 participants who will agree to enroll in this study.The investigators will evaluate these
      variables; number of complications occuring within the 12 months fallowing the surgery,
      number of readmission post-surgery, pain control efficiency, number of blood transfusion
      needed, length of wound spread, patient satisfaction and the cost of the program
      implementation. The investigators want to identify the success and failure factors to
      optimise the program afterwards.

      In order to achieve the evaluation, the investigators will compare the data obtain from the
      150 patients to the data retrieved in the medical files of the patients that already had the
      same usual intervention in the past, with the standard length of stay.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: 1 year
description: All complications related with the surgery from pre-surgery to 1 year after the surgery:
-Adverse events classification using (Clavien-Dindo Scale) Complication meaning the number of : blood loss/transfusion, wound infection, pain control, dressing problems, leg discrepancy, falls, unexpected fallow up phone calls to the assistant, hospital readmission after discharge, neurological impairment (example; drop foot), range of motion impairment following surgery.
measure: The cost of the outpatient procedure evaluation for the TKR or THR
time frame: 1 year
description: Estimation of the surgery costs and post surgery costs will be evaluated (procedure, surgery time, medication, lab test etc...) Costs for the hospital such as the cost for the surgery and their complications Costs outside the hospital such as the medication and the cost associated with the lost of productivity Lost of productivity; Work Productivity and Activity Impairment test (WPAI)
measure: Health outcome before surgery at medical evaluation
time frame: before surgery at medical evaluation up to 3 months before surgery
description: EQ 5D health questionnaire
measure: Health outcome 6 months after surgery
time frame: 6 months after surgery
description: EQ 5D health questionnaire
measure: Patient sex
time frame: up to 3 month before surgery
description: Patient sex; men or women Surgery date: (yyyy/mm/dd) Name of the surgeon Height in meters weight in kg BMI in kg/m2 Health and medical history Physical status score (ASA)
measure: Patient date of birth
time frame: up to 3 months before surgery
description: Patient date of birth Surgery date: (yyyy/mm/dd) Name of the surgeon Height in meters weight in kg BMI in kg/m2 Health and medical history Physical status score (ASA)
measure: Surgery Date
time frame: Day of surgery
description: Surgery date (yyyy/mm/dd) Name of the surgeon Height in meters weight in kg BMI in kg/m2 Health and medical history Physical status score (ASA)
measure: Name of surgeon
time frame: Day of surgery
description: Name of the surgeon
measure: BMI
time frame: up to 3 months before surgery
description: BMI in kg/m2
measure: Health and medical history
time frame: up to 3 months before surgery
description: Health and medical history
measure: Physical status score (ASA)
time frame: up to 3 months before surgery
description: Physical status score (ASA)
measure: Surgery Time
time frame: The day of surgery
description: Evaluation of the surgery length in minutes
measure: Type of prosthesis
time frame: The day of surgery
description: The type of prosthesis Total Knee Replacement (TKR) or Total Hip Replacement (THR)
measure: Operated side; left or right leg
time frame: The day of surgery, when patient arrives in OR
description: The side on which the patient is having the TKR(total knee replacement) or THR (total hip replacement)
measure: Quantity of blood in mL loss during surgery
time frame: Day of the surgery after closing of the surgical site
description: Quantity in mL of blood loss during surgery, measured after closing the surgical site.
measure: The time the patient arrives on the treatment floor
time frame: The day of surgery when the patient arrives on treatment floor
description: The time in hours and minutes at which the patient arrives on the treatment floor
measure: Blood loss in dressing before discharge in %
time frame: Day of the surgery before discharge from hospital up to 24h after surgery
description: Percentage evaluation of the quantity of blood in the dressing, where on the dressing, the type of dressing and the aspect of the dressing.
measure: Time at discharged from the hospital
time frame: Day of surgery,at discharge time up to 24h after surgery
description: The time in hours and minutes at which the patient leaves the hospital after discharged from hospital care.
measure: Number of failure to discharge
time frame: through study completion up to 2 years
description: The number of failure to discharge patient according to the discharged criterias
measure: Pain score before surgery (VAS)
time frame: Before surgery at the medical evaluation pre surgery
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Pain score after surgery in recovery room (VAS)
time frame: Day of surgery, after surgery in recovery room, day 0
description: Pain evaluation using the visual analog scale (VAS) zero to ten in recovery room, day 0
measure: Pain score after surgery on treatment floor before discharge (VAS)
time frame: Day of surgery before discharge
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Pain score 1-3 days after surgery (VAS)
time frame: 1-3 day after surgery
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Pain score 4 to 6 weeks after surgery (VAS)
time frame: 4 to 6 weeks after surgery
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Pain score 10 to 12 weeks after surgery (VAS)
time frame: 10-12 weeks after surgery
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Pain score 6 months after surgery (VAS)
time frame: 6 months after surgery
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Pain score one year after surgery (VAS)
time frame: one year after surgery
description: Pain evaluation using the visual analog scale (VAS) zero to ten
measure: Level of hemoglobin outcome before surgery
time frame: Before surgery at the medical evaluation pre surgery up to 3 months before surgery
description: Blood test done by nurse evaluating the level in g/L
measure: Level of hemoglobin outcome after surgery
time frame: Day of surgery, when the patient arrives in the recovery room
description: Blood test done by nurse evaluating the level on g/L ,when the patient arrives in recovery room.
measure: Level of hemoglobin outcome 3 to 4 days after surgery
time frame: 3 to 4 days after surgery
description: Blood test done by nurse evaluating the level of hemoglobine on g/L
measure: Presence of post surgery symptoms in recovery room
time frame: Day of surgery, when the patient arrives in the recovery room
description: Evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches.
measure: Presence of post surgery symptoms on treatment floor
time frame: Day of surgery, when patient arrives on treatment floor
description: subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches
measure: Presence of post surgery symptoms before discharge
time frame: Day of surgery, before discharge up to 24h after srugery
description: subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches
measure: Blood pressure outcome before surgery at the medical evaluation pre surgery
time frame: before surgery at the medical evaluation pre surgery
description: Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius
measure: Pulse outcome before surgery at the medical evaluation pre surgery
time frame: before surgery at the medical evaluation pre surgery
description: Measure of the pulse in bpm
Measure of the oral temperature in Celcius
measure: Saturation outcome before surgery at the medical evaluation pre surgery
time frame: before surgery at the medical evaluation pre surgery
description: measure of saturation in % with index finger
measure: Temperature outcome before surgery at the medical evaluation pre surgery
time frame: Before surgery at the medical evaluation pre surgery
description: Measure of oral temperature in Celsius with thermometer
measure: Blood pressure outcome in recovery room
time frame: Day of surgery,when patient arrives in recovery room
description: Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius
measure: Pulse outcome in recovery room
time frame: Day of surgery, when patient arrives in recovery room
description: Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius
measure: Saturation outcome in recovery room
time frame: Day of surgery, when patient arrives in recovery room
description: Measure of saturation in % with index finger
measure: Temperature outcome in recovery room
time frame: Day of surgery, when patient arrives in recovery room
description: Measure of oral temperature in Celsius with thermometer
measure: Blood pressure outcome before discharge
time frame: Day of surgery, before discharge up to 24hours after surgery
description: Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius
measure: Pulse outcome before discharge
time frame: Day of surgery, before discharge up to 24hours after surgery
description: Measure of pulse in bpm Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius
measure: Saturation outcome before discharge
time frame: Day of surgery, before discharge up to 24hours after surgery
description: Measure of saturation in % with index finger
measure: Temperature outcome before discharge
time frame: Day of surgery before discharge up to 24hours after surgery
description: Measure of the oral temperature in Celsius with thermometer
measure: Blood pressure outcome at home 1 to 2 days after surgery
time frame: at home 1 to 2 days after surgery
description: Measure of blood pressure in mmHg
measure: Pulse outcome at home 1 to 2 days after surgery
time frame: at home 1 to 2 days after surgery
description: Measure of the pulse in bpm
measure: Saturation outcome at home 1 to 2 days after surgery
time frame: at home 1 to 2 days after surgery
description: Measure of saturation in %
measure: Temperature outcome at home 1 to 2 days after surgery
time frame: at home 1 to 2 days after surgery
description: Measure of the oral temperature in Celsius
measure: Presence of big toe extension of the operated limb in recovery room
time frame: Day of surgery, when patient arrives in recovery room
description: Neurological assesment myotomes evaluation; extension of the big toe of the operated limb.
measure: Presence of plantarflexion of the operated limb in recovery room
time frame: Day of surgery, when patient arrives in recovery room
description: Neurological assesment Myotomes evaluation; plantarflexion of the operated limb.
measure: Presence of dorsiflexion of the operated limb in recovery room
time frame: Day of surgery, when patient arrives in recovery room
description: Neurological assesment, myotomes evaluation; platarflexion of the operated limb
measure: Dermatomes evaluation of the operated lower limb on treatment floor
time frame: Day of the surgery, on treatment floor 4-6 hours after surgery
description: Dermatomes; all lower limbs L2 to S1-S2 if normal and comparable to other limb.
measure: Functional evaluation outcome SF-36 at the medical evaluation before surgery
time frame: Before surgery at medical evaluation up to 3 months before surgery
description: SF-36 health score questionnaire
measure: Functional evaluation outcome, health score (SF-36) 6 months after surgery
time frame: 6months after surgery
description: SF-36 health score questionnaire
measure: Functional evaluation outcome hip disability and osteoarthritis outcome score (HOOS) at medical evaluation before surgery
time frame: Before surgery at medical evaluation up to 3 months before surgery
description: HOOS; hip disability and osteoarthritis outcome score questionnaire
measure: Functional evaluation outcome HOOS 6 months after surgery
time frame: 6 months after surgery
description: HOOS; hip disability and osteoarthritis outcome score questionnaire
measure: Functional evaluation outcome, knee disability and osteoarthritis outcome score (KOOS) at medical evaluation before surgery
time frame: Before surgery at medical evaluation up to 3 months before surgery
description: KOOS; knee disability and osteoarthritis outcome score questionnaire
measure: Functional evaluation outcome KOOS 6 months after surgery
time frame: 6 months after surgery
description: KOOS; knee disability and osteoarthritis outcome score questionnaire
measure: Range of motion outcome of the knee or hip at medical evaluation
time frame: Before surgery at medical evaluation up to 3 months before surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Range of motion outcome of the knee or hip on treatment floor
time frame: Day of surgery, 4-6 hours after surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Range of motion outcome of the knee or hip 3 days after surgery
time frame: 3 days after surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Range of motion outcome of the knee or hip 4-6 weeks after surgery
time frame: 4-6 weeks after surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Range of motion outcome of the knee or hip 10-12 weeks after surgery
time frame: 10-12 weeks after surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Range of motion outcome of the knee or hip 6 months after surgery
time frame: 6 months after surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Range of motion outcome of the knee or hip 1 year after surgery
time frame: 1 year after surgery
description: Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer
measure: Straight leg raise (SLR) outcome after surgery
time frame: 3-4 hours after surgery
description: Measure of the height of the leg from the bed to the heel in centimeters
measure: Walk outcome before surgery at at medical evaluation
time frame: Before surgery at at medical evaluation up to 3 months before surgery
description: Timed up and go (TUG) test
measure: Walk outcome 40 meters walk test at medical evaluation
time frame: Before surgery at medical evaluation up to 3 months before surgery
description: Measure of time on m /s to walk 40 meters
measure: Walk outcome 6 months after surgery
time frame: 6 months after surgery
description: Timed up and go (TUG) test
measure: Walk outcome 40 meters walk test 6 months after surgery
time frame: 6 months after surgery
description: Measure of time on m /s to walk 40 meters
measure: Stairs climb outcome day of surgery
time frame: Day of surgery before discharge up to 24hours after surgery
description: Stair climb test; how much time it takes in seconds to go up and down a flight of stairs.
measure: Stairs climb outcome 6 months after surgery
time frame: 6 months after surgery
description: Stair climb test; how much time it takes in seconds to go up and down a flight of stairs
arm group label: Fast-track total hip or knee arthroplasty
arm group type: Experimental
description: Be able to return patient home on the same day of a total hip or knee surgery.
intervention type: Procedure
intervention name: Fast-track Total Hip and knee arthroplasty
description: To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours
arm group label: Fast-track total hip or knee arthroplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Maisonneuve-Rosemont Hospital
investigator full name: Pascal André Vendittoli
investigator title: Orthopedist
sharing ipd: No