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

Maisonneuve-Rosemont Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

150

Conditions

Orthopedic Procedure

Interventions

Fast-track Total Hip and knee arthroplastyPROCEDURE

To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient understanding the conditions of the study and ready to participate for the duration of the study 2. Patient able to give their informed consent 3. Aged between 18 and 75 years 4. Patient needing a primary total hip or knee replacement (not associated with unusual treatment such as bone graft, osteotomy, revision implant, etc. 5. 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 6. 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: 1. Living further than 50 Km from Maisonneuve-Rosemont Hospital 2. Lack of services offered by the CLSC (home health care services) in their area 3. BMI over 40 4. Psychiatric desease limiting the participation in the study 5. Pregnancy 6. The need of long therm urinary foley post-op 7. Allergies to sulfinamide or to the other medications intended in the protocol 8. Presenting a cognitive impairment or a communication problem preventing the realisation of the protocol 9. The patient has had a pulmonary embolism or veinous thromboembolism in the past year 10. Necessitating a long therm anticoagulation therapy 11. Under corticotherapy or has received a systemic corticotherapy in the past year (unless a positive confirmation of a cortrosyn test done before the surgery) 12. Subject with a systemic involvement(diabetic, cardiac, renal, hematologic, etc.) necessitating special perisurgical care (intensive care unit, multiples transfusions, dialysis, etc.) 13. Inflammatory or tumoral joint disease ( rheumatoid arthritis, lupus, etc.) 14. Subject presenting a coagulation problem increasing their bleeding risk per and post surgery (ie : thrombocytopenia, hemophilia, etc.) 15. 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 16. Presenting neurological or balance disorder 17. Having a living space incompatible with post-surgery home care 18. Under treatment with a medication substrate or strong inhibitor of CYP3A4 19. Subject with Clcr \< 30 ml/min ( Cockcroft-Gault formula)

Locations (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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)

Time frame: 1 year

Health outcome before surgery at medical evaluation

EQ 5D health questionnaire

Time frame: before surgery at medical evaluation up to 3 months before surgery

Health outcome 6 months after surgery

EQ 5D health questionnaire

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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)

Time frame: Day of surgery

Name of surgeon

Name of the surgeon

Time frame: Day of surgery

BMI

BMI in kg/m2

Time frame: up to 3 months before surgery

Health and medical history

Time frame: up to 3 months before surgery

Physical status score (ASA)

Time frame: up to 3 months before surgery

Surgery Time

Evaluation of the surgery length in minutes

Time frame: The day of surgery

Type of prosthesis

The type of prosthesis Total Knee Replacement (TKR) or Total Hip Replacement (THR)

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: through study completion up to 2 years

Pain score before surgery (VAS)

Pain evaluation using the visual analog scale (VAS) zero to ten

Time frame: 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

Time frame: 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

Time frame: Day of surgery before discharge

Pain score 1-3 days after surgery (VAS)

Pain evaluation using the visual analog scale (VAS) zero to ten

Time frame: 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

Time frame: 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

Time frame: 10-12 weeks after surgery

Pain score 6 months after surgery (VAS)

Pain evaluation using the visual analog scale (VAS) zero to ten

Time frame: 6 months after surgery

Pain score one year after surgery (VAS)

Pain evaluation using the visual analog scale (VAS) zero to ten

Time frame: one year after surgery

Level of hemoglobin outcome before surgery

Blood test done by nurse evaluating the level in g/L

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Day of surgery, before discharge up to 24h after srugery

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day of surgery, when patient arrives in recovery room

Saturation outcome in recovery room

Measure of saturation in % with index finger

Time frame: Day of surgery, when patient arrives in recovery room

Temperature outcome in recovery room

Measure of oral temperature in Celsius with thermometer

Time frame: 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

Time frame: 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

Time frame: Day of surgery, before discharge up to 24hours after surgery

Saturation outcome before discharge

Measure of saturation in % with index finger

Time frame: Day of surgery, before discharge up to 24hours after surgery

Temperature outcome before discharge

Measure of the oral temperature in Celsius with thermometer

Time frame: 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

Time frame: at home 1 to 2 days after surgery

Pulse outcome at home 1 to 2 days after surgery

Measure of the pulse in bpm

Time frame: at home 1 to 2 days after surgery

Saturation outcome at home 1 to 2 days after surgery

Measure of saturation in %

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3-4 hours after surgery

Walk outcome before surgery at at medical evaluation

Timed up and go (TUG) test

Time frame: 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

Time frame: Before surgery at medical evaluation up to 3 months before surgery

Walk outcome 6 months after surgery

Timed up and go (TUG) test

Time frame: 6 months after surgery

Walk outcome 40 meters walk test 6 months after surgery

Measure of time on m /s to walk 40 meters

Time frame: 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.

Time frame: 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

Time frame: 6 months after surgery