Orthopedic ProcedureNCT03028779
Implementation of Fast-track Surgery Program for Total Hip and Knee Replacement and the Evaluation of the Risks and Benefits for the Patient
A study testing Fast-track Total Hip and knee arthroplasty in people with Orthopedic Procedure, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Implementation of Fast-track surgery for total hip replacement and total knee replacement and evaluation of the risks and benefits for the patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Procedure
- What is being tested?
- Fast-track Total Hip and knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Implementation of Fast-track surgery for total hip replacement and total knee replacement and evaluation of the risks and benefits for the patients.
Read the 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.
- Conditions
- Orthopedic Procedure
- Being tested
- Fast-track Total Hip and knee arthroplasty
- Keywords
- Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-track Total Hip and knee arthroplastyProcedure or surgery
To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Fast-track total hip or knee arthroplasty | Experimental | Be able to return patient home on the same day of a total hip or knee surgery. Receives: Procedure: Fast-track Total Hip and knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (72)
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)
Measured: 1 year
Health outcome before surgery at medical evaluation
EQ 5D health questionnaire
Measured: before surgery at medical evaluation up to 3 months before surgery
Health outcome 6 months after surgery
EQ 5D health questionnaire
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day of surgery
Name of surgeon
Name of the surgeon
Measured: Day of surgery
BMI
BMI in kg/m2
Measured: up to 3 months before surgery
Health and medical history
Health and medical history
Measured: up to 3 months before surgery
Physical status score (ASA)
Physical status score (ASA)
Measured: up to 3 months before surgery
Surgery Time
Evaluation of the surgery length in minutes
Measured: The day of surgery
Type of prosthesis
The type of prosthesis Total Knee Replacement (TKR) or Total Hip Replacement (THR)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: through study completion up to 2 years
Pain score before surgery (VAS)
Pain evaluation using the visual analog scale (VAS) zero to ten
Measured: 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
Measured: 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
Measured: Day of surgery before discharge
Pain score 1-3 days after surgery (VAS)
Pain evaluation using the visual analog scale (VAS) zero to ten
Measured: 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
Measured: 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
Measured: 10-12 weeks after surgery
Pain score 6 months after surgery (VAS)
Pain evaluation using the visual analog scale (VAS) zero to ten
Measured: 6 months after surgery
Pain score one year after surgery (VAS)
Pain evaluation using the visual analog scale (VAS) zero to ten
Measured: one year after surgery
Level of hemoglobin outcome before surgery
Blood test done by nurse evaluating the level in g/L
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day of surgery, when patient arrives in recovery room
Saturation outcome in recovery room
Measure of saturation in % with index finger
Measured: Day of surgery, when patient arrives in recovery room
Temperature outcome in recovery room
Measure of oral temperature in Celsius with thermometer
Measured: 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
Measured: 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
Measured: Day of surgery, before discharge up to 24hours after surgery
Saturation outcome before discharge
Measure of saturation in % with index finger
Measured: Day of surgery, before discharge up to 24hours after surgery
Temperature outcome before discharge
Measure of the oral temperature in Celsius with thermometer
Measured: 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
Measured: at home 1 to 2 days after surgery
Pulse outcome at home 1 to 2 days after surgery
Measure of the pulse in bpm
Measured: at home 1 to 2 days after surgery
Saturation outcome at home 1 to 2 days after surgery
Measure of saturation in %
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3-4 hours after surgery
Walk outcome before surgery at at medical evaluation
Timed up and go (TUG) test
Measured: 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
Measured: Before surgery at medical evaluation up to 3 months before surgery
Walk outcome 6 months after surgery
Timed up and go (TUG) test
Measured: 6 months after surgery
Walk outcome 40 meters walk test 6 months after surgery
Measure of time on m /s to walk 40 meters
Measured: 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.
Measured: 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
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionSep 2019
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal André Vendittoli, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028779
- Sponsor's protocol ID
- MaisonneuveRH2
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2016
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03028779
- Acronym / sponsor ID
- MaisonneuveRH2
- Conditions
- Orthopedic Procedure
- Keywords
- Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fast-track total hip or knee arthroplasty | Experimental | Procedure: Fast-track Total Hip and knee arthroplastyBe able to return patient home on the same day of a total hip or knee surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-track Total Hip and knee arthroplastyTo be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours | Procedure or surgery | Fast-track total hip or knee arthroplasty |
Primary outcome
Number of participants with adverse events
Time frame: 1 year
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.
72 secondary outcomes
The cost of the outpatient procedure evaluation for the TKR or THR
Time frame: 1 year
Health outcome before surgery at medical evaluation
Time frame: before surgery at medical evaluation up to 3 months before surgery
Health outcome 6 months after surgery
Time frame: 6 months after surgery
Patient sex
Time frame: up to 3 month before surgery
Patient date of birth
Time frame: up to 3 months before surgery
Surgery Date
Time frame: Day of surgery
Name of surgeon
Time frame: Day of surgery
BMI
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
Time frame: The day of surgery
Type of prosthesis
Time frame: The day of surgery
Operated side; left or right leg
Time frame: The day of surgery, when patient arrives in OR
Quantity of blood in mL loss during surgery
Time frame: Day of the surgery after closing of the surgical site
The time 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 %
Time frame: Day of the surgery before discharge from hospital up to 24h after surgery
Time at discharged from the hospital
Time frame: Day of surgery,at discharge time up to 24h after surgery
Number of failure to discharge
Time frame: through study completion up to 2 years
Pain score before surgery (VAS)
Time frame: Before surgery at the medical evaluation pre surgery
Pain score after surgery in recovery room (VAS)
Time frame: Day of surgery, after surgery in recovery room, day 0
Pain score after surgery on treatment floor before discharge (VAS)
Time frame: Day of surgery before discharge
Pain score 1-3 days after surgery (VAS)
Time frame: 1-3 day after surgery
Pain score 4 to 6 weeks after surgery (VAS)
Time frame: 4 to 6 weeks after surgery
Pain score 10 to 12 weeks after surgery (VAS)
Time frame: 10-12 weeks after surgery
Pain score 6 months after surgery (VAS)
Time frame: 6 months after surgery
Pain score one year after surgery (VAS)
Time frame: one year after surgery
Level of hemoglobin outcome before surgery
Time frame: Before surgery at the medical evaluation pre surgery up to 3 months before surgery
Level of hemoglobin outcome after surgery
Time frame: Day of surgery, when the patient arrives in the recovery room
Level of hemoglobin outcome 3 to 4 days after surgery
Time frame: 3 to 4 days after surgery
Presence of post surgery symptoms in recovery room
Time frame: Day of surgery, when the patient arrives in the recovery room
Presence of post surgery symptoms on treatment floor
Time frame: Day of surgery, when patient arrives on treatment floor
Presence of post surgery symptoms before discharge
Time frame: Day of surgery, before discharge up to 24h after srugery
Blood pressure outcome before surgery at the medical evaluation pre surgery
Time frame: before surgery at the medical evaluation pre surgery
Pulse outcome before surgery at the medical evaluation pre surgery
Time frame: before surgery at the medical evaluation pre surgery
Saturation outcome before surgery at the medical evaluation pre surgery
Time frame: before surgery at the medical evaluation pre surgery
Temperature outcome before surgery at the medical evaluation pre surgery
Time frame: Before surgery at the medical evaluation pre surgery
Blood pressure outcome in recovery room
Time frame: Day of surgery,when patient arrives in recovery room
Pulse outcome in recovery room
Time frame: Day of surgery, when patient arrives in recovery room
Saturation outcome in recovery room
Time frame: Day of surgery, when patient arrives in recovery room
Temperature outcome in recovery room
Time frame: Day of surgery, when patient arrives in recovery room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-track Total Hip and knee arthroplasty in people with Orthopedic Procedure, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.