Implementation of Fast-track Surgery Program for Total Hip and Knee Replacement and the Evaluation of the Risks and Benefits for the Patient

Study Overview
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Brief Summary
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Implementation of Fast-track surgery for total hip replacement and total knee replacement and evaluation of the risks and benefits for the patients.

Detailed Description
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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.

Official Title
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Implementation of Fast-track Surgery Program for Total Hip and Knee Replacement and the Evaluation of the Risks and Benefits for the Patient

Conditions
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Orthopedic Procedure

Intervention / Treatment
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* Procedure: Fast-track Total Hip and knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient understanding the conditions of the study and ready to participate for the duration of the study Patient able to give their informed consent Aged between 18 and 75 years Patient needing a primary total hip or knee replacement (not associated with unusual treatment such as bone graft, osteotomy, revision implant, etc. The patient as a family member or a companion available the day of the pre-op evaluation, the day of surgery and at home after the surgery for a week fallowing the surgery Women in age to procreate have to accept to add another contraception method one month fallowing the intake of Emend/ Aprepitant received pre-surgery. Exclusion Criteria: Living further than 50 Km from Maisonneuve-Rosemont Hospital Lack of services offered by the CLSC (home health care services) in their area BMI over 40 Psychiatric desease limiting the participation in the study Pregnancy The need of long therm urinary foley post-op Allergies to sulfinamide or to the other medications intended in the protocol Presenting a cognitive impairment or a communication problem preventing the realisation of the protocol The patient has had a pulmonary embolism or veinous thromboembolism in the past year Necessitating a long therm anticoagulation therapy Under corticotherapy or has received a systemic corticotherapy in the past year (unless a positive confirmation of a cortrosyn test done before the surgery) Subject with a systemic involvement(diabetic, cardiac, renal, hematologic, etc.) necessitating special perisurgical care (intensive care unit, multiples transfusions, dialysis, etc.) Inflammatory or tumoral joint disease ( rheumatoid arthritis, lupus, etc.) Subject presenting a coagulation problem increasing their bleeding risk per and post surgery (ie : thrombocytopenia, hemophilia, etc.) Subject presenting a locomotion problem ,other then to the joint to be replaced, enforcing functional limitations keeping them from mobilizing without technical or physical aid Presenting neurological or balance disorder Having a living space incompatible with post-surgery home care Under treatment with a medication substrate or strong inhibitor of CYP3A4 Subject with Clcr < 30 ml/min ( Cockcroft-Gault formula)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast-track total hip or knee arthroplasty<br>Be able to return patient home on the same day of a total hip or knee surgery. | Procedure: Fast-track Total Hip and knee arthroplasty<br>* To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure outcome before surgery at the medical evaluation pre surgery | Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius | before surgery at the medical evaluation pre surgery | 
| Pulse outcome before surgery at the medical evaluation pre surgery | Measure of the pulse in bpm Measure of the oral temperature in Celcius | before surgery at the medical evaluation pre surgery | 
| Saturation outcome before surgery at the medical evaluation pre surgery | measure of saturation in % with index finger | before surgery at the medical evaluation pre surgery | 
| Temperature outcome before surgery at the medical evaluation pre surgery | Measure of oral temperature in Celsius with thermometer | Before surgery at the medical evaluation pre surgery | 
| Blood pressure outcome in recovery room | Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius | Day of surgery,when patient arrives in recovery room | 
| Pulse outcome in recovery room | Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius | Day of surgery, when patient arrives in recovery room | 
| Saturation outcome in recovery room | Measure of saturation in % with index finger | Day of surgery, when patient arrives in recovery room | 
| Temperature outcome in recovery room | Measure of oral temperature in Celsius with thermometer | Day of surgery, when patient arrives in recovery room | 
| Blood pressure outcome before discharge | Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius | Day of surgery, before discharge up to 24hours after surgery | 
| Pulse outcome before discharge | Measure of pulse in bpm Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius | Day of surgery, before discharge up to 24hours after surgery | 
| Saturation outcome before discharge | Measure of saturation in % with index finger | Day of surgery, before discharge up to 24hours after surgery | 
| Temperature outcome before discharge | Measure of the oral temperature in Celsius with thermometer | Day of surgery before discharge up to 24hours after surgery | 
| Blood pressure outcome at home 1 to 2 days after surgery | Measure of blood pressure in mmHg | at home 1 to 2 days after surgery | 
| Pulse outcome at home 1 to 2 days after surgery | Measure of the pulse in bpm | at home 1 to 2 days after surgery | 
| Saturation outcome at home 1 to 2 days after surgery | Measure of saturation in % | at home 1 to 2 days after surgery | 
| Temperature outcome at home 1 to 2 days after surgery | Measure of the oral temperature in Celsius | at home 1 to 2 days after surgery | 
| Presence of big toe extension of the operated limb in recovery room | Neurological assesment myotomes evaluation; extension of the big toe of the operated limb. | Day of surgery, when patient arrives in recovery room | 
| Presence of plantarflexion of the operated limb in recovery room | Neurological assesment Myotomes evaluation; plantarflexion of the operated limb. | Day of surgery, when patient arrives in recovery room | 
| Presence of dorsiflexion of the operated limb in recovery room | Neurological assesment, myotomes evaluation; platarflexion of the operated limb | Day of surgery, when patient arrives in recovery room | 
| Dermatomes evaluation of the operated lower limb on treatment floor | Dermatomes; all lower limbs L2 to S1-S2 if normal and comparable to other limb. | Day of the surgery, on treatment floor 4-6 hours after surgery | 
| Functional evaluation outcome SF-36 at the medical evaluation before surgery | SF-36 health score questionnaire | Before surgery at medical evaluation up to 3 months before surgery | 
| Functional evaluation outcome, health score (SF-36) 6 months after surgery | SF-36 health score questionnaire | 6months after surgery | 
| Functional evaluation outcome hip disability and osteoarthritis outcome score (HOOS) at medical evaluation before surgery | HOOS; hip disability and osteoarthritis outcome score questionnaire | Before surgery at medical evaluation up to 3 months before surgery | 
| Functional evaluation outcome HOOS 6 months after surgery | HOOS; hip disability and osteoarthritis outcome score questionnaire | 6 months after surgery | 
| Functional evaluation outcome, knee disability and osteoarthritis outcome score (KOOS) at medical evaluation before surgery | KOOS; knee disability and osteoarthritis outcome score questionnaire | Before surgery at medical evaluation up to 3 months before surgery | 
| Functional evaluation outcome KOOS 6 months after surgery | KOOS; knee disability and osteoarthritis outcome score questionnaire | 6 months after surgery | 
| Range of motion outcome of the knee or hip at medical evaluation | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | Before surgery at medical evaluation up to 3 months before surgery | 
| Range of motion outcome of the knee or hip on treatment floor | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | Day of surgery, 4-6 hours after surgery | 
| Range of motion outcome of the knee or hip 3 days after surgery | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | 3 days after surgery | 
| Range of motion outcome of the knee or hip 4-6 weeks after surgery | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | 4-6 weeks after surgery | 
| Range of motion outcome of the knee or hip 10-12 weeks after surgery | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | 10-12 weeks after surgery | 
| Range of motion outcome of the knee or hip 6 months after surgery | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | 6 months after surgery | 
| Range of motion outcome of the knee or hip 1 year after surgery | Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer | 1 year after surgery | 
| Straight leg raise (SLR) outcome after surgery | Measure of the height of the leg from the bed to the heel in centimeters | 3-4 hours after surgery | 
| Walk outcome before surgery at at medical evaluation | Timed up and go (TUG) test | Before surgery at at medical evaluation up to 3 months before surgery | 
| Walk outcome 40 meters walk test at medical evaluation | Measure of time on m /s to walk 40 meters | Before surgery at medical evaluation up to 3 months before surgery | 
| Walk outcome 6 months after surgery | Timed up and go (TUG) test | 6 months after surgery | 
| Walk outcome 40 meters walk test 6 months after surgery | Measure of time on m /s to walk 40 meters | 6 months after surgery | 
| Stairs climb outcome day of surgery | Stair climb test; how much time it takes in seconds to go up and down a flight of stairs. | Day of surgery before discharge up to 24hours after surgery | 
| Stairs climb outcome 6 months after surgery | Stair climb test; how much time it takes in seconds to go up and down a flight of stairs | 6 months after surgery | 
| The cost of the outpatient procedure evaluation for the TKR or THR | 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) | 1 year | 
| Health outcome before surgery at medical evaluation | EQ 5D health questionnaire | before surgery at medical evaluation up to 3 months before surgery | 
| Health outcome 6 months after surgery | EQ 5D health questionnaire | 6 months after surgery | 
| Patient sex | 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) | up to 3 month before surgery | 
| Patient date of birth | 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) | up to 3 months before surgery | 
| Surgery Date | 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) | Day of surgery | 
| Name of surgeon | Name of the surgeon | Day of surgery | 
| BMI | BMI in kg/m2 | up to 3 months before surgery | 
| Health and medical history | Health and medical history | up to 3 months before surgery | 
| Physical status score (ASA) | Physical status score (ASA) | up to 3 months before surgery | 
| Surgery Time | Evaluation of the surgery length in minutes | The day of surgery | 
| Type of prosthesis | The type of prosthesis Total Knee Replacement (TKR) or Total Hip Replacement (THR) | The day of surgery | 
| Operated side; left or right leg | The side on which the patient is having the TKR(total knee replacement) or THR (total hip replacement) | The day of surgery, when patient arrives in OR | 
| Quantity of blood in mL loss during surgery | Quantity in mL of blood loss during surgery, measured after closing the surgical site. | Day of the surgery after closing of the surgical site | 
| The time the patient arrives on the treatment floor | The time in hours and minutes at which the patient arrives on the treatment floor | The day of surgery when the patient arrives on treatment floor | 
| Blood loss in dressing before discharge in % | Percentage evaluation of the quantity of blood in the dressing, where on the dressing, the type of dressing and the aspect of the dressing. | Day of the surgery before discharge from hospital up to 24h after surgery | 
| Time at discharged from the hospital | The time in hours and minutes at which the patient leaves the hospital after discharged from hospital care. | Day of surgery,at discharge time up to 24h after surgery | 
| Number of failure to discharge | The number of failure to discharge patient according to the discharged criterias | through study completion up to 2 years | 
| Pain score before surgery (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | Before surgery at the medical evaluation pre surgery | 
| Pain score after surgery in recovery room (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten in recovery room, day 0 | Day of surgery, after surgery in recovery room, day 0 | 
| Pain score after surgery on treatment floor before discharge (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | Day of surgery before discharge | 
| Pain score 1-3 days after surgery (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | 1-3 day after surgery | 
| Pain score 4 to 6 weeks after surgery (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | 4 to 6 weeks after surgery | 
| Pain score 10 to 12 weeks after surgery (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | 10-12 weeks after surgery | 
| Pain score 6 months after surgery (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | 6 months after surgery | 
| Pain score one year after surgery (VAS) | Pain evaluation using the visual analog scale (VAS) zero to ten | one year after surgery | 
| Level of hemoglobin outcome before surgery | Blood test done by nurse evaluating the level in g/L | Before surgery at the medical evaluation pre surgery up to 3 months before surgery | 
| Level of hemoglobin outcome after surgery | Blood test done by nurse evaluating the level on g/L ,when the patient arrives in recovery room. | Day of surgery, when the patient arrives in the recovery room | 
| Level of hemoglobin outcome 3 to 4 days after surgery | Blood test done by nurse evaluating the level of hemoglobine on g/L | 3 to 4 days after surgery | 
| Presence of post surgery symptoms in recovery room | Evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches. | Day of surgery, when the patient arrives in the recovery room | 
| Presence of post surgery symptoms on treatment floor | subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches | Day of surgery, when patient arrives on treatment floor | 
| Presence of post surgery symptoms before discharge | subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches | Day of surgery, before discharge up to 24h after srugery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)