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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Orthopedic Procedure
• Intervention / Treatment: Procedure: Fast-track Total Hip and knee arthroplasty

Detailed Description

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
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast-track total hip or knee arthroplasty; 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; To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)
• Other Study ID Numbers: MaisonneuveRH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No