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Active, not recruitingNCT03028779Updated Mar 17, 2023

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

An interventional study of Fast-track Total Hip and knee arthroplasty in Orthopedic Procedure, sponsored by Maisonneuve-Rosemont Hospital. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Maisonneuve-Rosemont Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Orthopedic Procedure

Keywords

  • Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)
03

In context

Lead sponsor

Maisonneuve-Rosemont Hospital is the lead sponsor of 70 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureFast-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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Health outcome before surgery at medical evaluation

    EQ 5D health questionnaire

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

  3. Health outcome 6 months after surgery

    EQ 5D health questionnaire

    Time frame: 6 months after surgery

  4. 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

  5. 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)

    Time frame: up to 3 months before surgery

  6. 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

  7. Name of surgeon

    Name of the surgeon

    Time frame: Day of surgery

  8. BMI

    BMI in kg/m2

    Time frame: up to 3 months before surgery

  9. Health and medical history

    Health and medical history

    Time frame: up to 3 months before surgery

  10. Physical status score (ASA)

    Physical status score (ASA)

    Time frame: up to 3 months before surgery

  11. Surgery Time

    Evaluation of the surgery length in minutes

    Time frame: The day of surgery

  12. Type of prosthesis

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

    Time frame: The day of surgery

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. Pain score 6 months after surgery (VAS)

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

    Time frame: 6 months after surgery

  26. Pain score one year after surgery (VAS)

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

    Time frame: one year after surgery

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. Saturation outcome in recovery room

    Measure of saturation in % with index finger

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

  40. Temperature outcome in recovery room

    Measure of oral temperature in Celsius with thermometer

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

  41. 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

  42. 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

  43. Saturation outcome before discharge

    Measure of saturation in % with index finger

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

  44. 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

  45. 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

  46. 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

  47. Saturation outcome at home 1 to 2 days after surgery

    Measure of saturation in %

    Time frame: at home 1 to 2 days after surgery

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. Functional evaluation outcome, health score (SF-36) 6 months after surgery

    SF-36 health score questionnaire

    Time frame: 6months after surgery

  55. 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

  56. Functional evaluation outcome HOOS 6 months after surgery

    HOOS; hip disability and osteoarthritis outcome score questionnaire

    Time frame: 6 months after surgery

  57. 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

  58. Functional evaluation outcome KOOS 6 months after surgery

    KOOS; knee disability and osteoarthritis outcome score questionnaire

    Time frame: 6 months after surgery

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. Walk outcome 6 months after surgery

    Timed up and go (TUG) test

    Time frame: 6 months after surgery

  70. 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

  71. 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

  72. 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

07

Study locations

1 site
  • Hôpital Maisonneuve-Rosemont
    Montreal, Quebec H1T 2M4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03028779
Lead sponsor
Maisonneuve-Rosemont Hospital
Responsible party
Pascal André Vendittoli (Orthopedist, Maisonneuve-Rosemont Hospital) — Principal investigator
First posted
Jan 23, 2017
Start date
Nov 2016
Primary completion
Sep 2019
Completion
Sep 2025 (estimated)
Last update
Mar 17, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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