Clinical trial NCT03028779: 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: Implementation of Fast-track Surgery Program for Total Hip and Knee Replacement and the Evaluation of the Risks and Benefits for the Patient
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthopedic Procedure
Keywords: Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 year
Secondary outcomes:
measure: The cost of the outpatient procedure evaluation for the TKR or THR
timeFrame: 1 year
measure: Health outcome before surgery at medical evaluation
timeFrame: before surgery at medical evaluation up to 3 months before surgery
measure: Health outcome 6 months after surgery
timeFrame: 6 months after surgery
measure: Patient sex
timeFrame: up to 3 month before surgery
measure: Patient date of birth
timeFrame: up to 3 months before surgery
measure: Surgery Date
timeFrame: Day of surgery
measure: Name of surgeon
timeFrame: Day of surgery
measure: BMI
timeFrame: up to 3 months before surgery
measure: Health and medical history
timeFrame: up to 3 months before surgery
measure: Physical status score (ASA)
timeFrame: up to 3 months before surgery
measure: Surgery Time
timeFrame: The day of surgery
measure: Type of prosthesis
timeFrame: The day of surgery
measure: Operated side; left or right leg
timeFrame: The day of surgery, when patient arrives in OR
measure: Quantity of blood in mL loss during surgery
timeFrame: Day of the surgery after closing of the surgical site
measure: The time the patient arrives on the treatment floor
timeFrame: The day of surgery when the patient arrives on treatment floor
measure: Blood loss in dressing before discharge in %
timeFrame: Day of the surgery before discharge from hospital up to 24h after surgery
measure: Time at discharged from the hospital
timeFrame: Day of surgery,at discharge time up to 24h after surgery
measure: Number of failure to discharge
timeFrame: through study completion up to 2 years
measure: Pain score before surgery (VAS)
timeFrame: Before surgery at the medical evaluation pre surgery
measure: Pain score after surgery in recovery room (VAS)
timeFrame: Day of surgery, after surgery in recovery room, day 0
measure: Pain score after surgery on treatment floor before discharge (VAS)
timeFrame: Day of surgery before discharge
measure: Pain score 1-3 days after surgery (VAS)
timeFrame: 1-3 day after surgery
measure: Pain score 4 to 6 weeks after surgery (VAS)
timeFrame: 4 to 6 weeks after surgery
measure: Pain score 10 to 12 weeks after surgery (VAS)
timeFrame: 10-12 weeks after surgery
measure: Pain score 6 months after surgery (VAS)
timeFrame: 6 months after surgery
measure: Pain score one year after surgery (VAS)
timeFrame: one year after surgery
measure: Level of hemoglobin outcome before surgery
timeFrame: Before surgery at the medical evaluation pre surgery up to 3 months before surgery
measure: Level of hemoglobin outcome after surgery
timeFrame: Day of surgery, when the patient arrives in the recovery room
measure: Level of hemoglobin outcome 3 to 4 days after surgery
timeFrame: 3 to 4 days after surgery
measure: Presence of post surgery symptoms in recovery room
timeFrame: Day of surgery, when the patient arrives in the recovery room
measure: Presence of post surgery symptoms on treatment floor
timeFrame: Day of surgery, when patient arrives on treatment floor
measure: Presence of post surgery symptoms before discharge
timeFrame: Day of surgery, before discharge up to 24h after srugery
measure: Blood pressure outcome before surgery at the medical evaluation pre surgery
timeFrame: before surgery at the medical evaluation pre surgery
measure: Pulse outcome before surgery at the medical evaluation pre surgery
timeFrame: before surgery at the medical evaluation pre surgery
measure: Saturation outcome before surgery at the medical evaluation pre surgery
timeFrame: before surgery at the medical evaluation pre surgery
measure: Temperature outcome before surgery at the medical evaluation pre surgery
timeFrame: Before surgery at the medical evaluation pre surgery
measure: Blood pressure outcome in recovery room
timeFrame: Day of surgery,when patient arrives in recovery room
measure: Pulse outcome in recovery room
timeFrame: Day of surgery, when patient arrives in recovery room
measure: Saturation outcome in recovery room
timeFrame: Day of surgery, when patient arrives in recovery room
measure: Temperature outcome in recovery room
timeFrame: Day of surgery, when patient arrives in recovery room
measure: Blood pressure outcome before discharge
timeFrame: Day of surgery, before discharge up to 24hours after surgery
measure: Pulse outcome before discharge
timeFrame: Day of surgery, before discharge up to 24hours after surgery
measure: Saturation outcome before discharge
timeFrame: Day of surgery, before discharge up to 24hours after surgery
measure: Temperature outcome before discharge
timeFrame: Day of surgery before discharge up to 24hours after surgery
measure: Blood pressure outcome at home 1 to 2 days after surgery
timeFrame: at home 1 to 2 days after surgery
measure: Pulse outcome at home 1 to 2 days after surgery
timeFrame: at home 1 to 2 days after surgery
measure: Saturation outcome at home 1 to 2 days after surgery
timeFrame: at home 1 to 2 days after surgery
measure: Temperature outcome at home 1 to 2 days after surgery
timeFrame: at home 1 to 2 days after surgery
measure: Presence of big toe extension of the operated limb in recovery room
timeFrame: Day of surgery, when patient arrives in recovery room
measure: Presence of plantarflexion of the operated limb in recovery room
timeFrame: Day of surgery, when patient arrives in recovery room
measure: Presence of dorsiflexion of the operated limb in recovery room
timeFrame: Day of surgery, when patient arrives in recovery room
measure: Dermatomes evaluation of the operated lower limb on treatment floor
timeFrame: Day of the surgery, on treatment floor 4-6 hours after surgery
measure: Functional evaluation outcome SF-36 at the medical evaluation before surgery
timeFrame: Before surgery at medical evaluation up to 3 months before surgery
measure: Functional evaluation outcome, health score (SF-36) 6 months after surgery
timeFrame: 6months after surgery
measure: Functional evaluation outcome hip disability and osteoarthritis outcome score (HOOS) at medical evaluation before surgery
timeFrame: Before surgery at medical evaluation up to 3 months before surgery
measure: Functional evaluation outcome HOOS 6 months after surgery
timeFrame: 6 months after surgery
measure: Functional evaluation outcome, knee disability and osteoarthritis outcome score (KOOS) at medical evaluation before surgery
timeFrame: Before surgery at medical evaluation up to 3 months before surgery
measure: Functional evaluation outcome KOOS 6 months after surgery
timeFrame: 6 months after surgery
measure: Range of motion outcome of the knee or hip at medical evaluation
timeFrame: Before surgery at medical evaluation up to 3 months before surgery
measure: Range of motion outcome of the knee or hip on treatment floor
timeFrame: Day of surgery, 4-6 hours after surgery
measure: Range of motion outcome of the knee or hip 3 days after surgery
timeFrame: 3 days after surgery
measure: Range of motion outcome of the knee or hip 4-6 weeks after surgery
timeFrame: 4-6 weeks after surgery
measure: Range of motion outcome of the knee or hip 10-12 weeks after surgery
timeFrame: 10-12 weeks after surgery
measure: Range of motion outcome of the knee or hip 6 months after surgery
timeFrame: 6 months after surgery
measure: Range of motion outcome of the knee or hip 1 year after surgery
timeFrame: 1 year after surgery
measure: Straight leg raise (SLR) outcome after surgery
timeFrame: 3-4 hours after surgery
measure: Walk outcome before surgery at at medical evaluation
timeFrame: Before surgery at at medical evaluation up to 3 months before surgery
measure: Walk outcome 40 meters walk test at medical evaluation
timeFrame: Before surgery at medical evaluation up to 3 months before surgery
measure: Walk outcome 6 months after surgery
timeFrame: 6 months after surgery
measure: Walk outcome 40 meters walk test 6 months after surgery
timeFrame: 6 months after surgery
measure: Stairs climb outcome day of surgery
timeFrame: Day of surgery before discharge up to 24hours after surgery
measure: Stairs climb outcome 6 months after surgery
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
References: