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

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ClinicalTrials.gov Identifier: NCT03028779
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Pascal André Vendittoli, Maisonneuve-Rosemont Hospital

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.

Condition or disease Intervention/treatment Phase
Orthopedic Procedure Procedure: Fast-track Total Hip and knee arthroplasty Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. The cost of the outpatient procedure evaluation for the TKR or THR [ Time Frame: 1 year ]
    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)

  2. Health outcome before surgery at medical evaluation [ Time Frame: before surgery at medical evaluation up to 3 months before surgery ]
    EQ 5D health questionnaire

  3. Health outcome 6 months after surgery [ Time Frame: 6 months after surgery ]
    EQ 5D health questionnaire

  4. Patient sex [ Time Frame: up to 3 month before surgery ]
    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)

  5. Patient date of birth [ Time Frame: up to 3 months before surgery ]
    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)

  6. Surgery Date [ Time Frame: Day of surgery ]
    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)

  7. Name of surgeon [ Time Frame: Day of surgery ]
    Name of the surgeon

  8. BMI [ Time Frame: up to 3 months before surgery ]
    BMI in kg/m2

  9. Health and medical history [ Time Frame: up to 3 months before surgery ]
    Health and medical history

  10. Physical status score (ASA) [ Time Frame: up to 3 months before surgery ]
    Physical status score (ASA)

  11. Surgery Time [ Time Frame: The day of surgery ]
    Evaluation of the surgery length in minutes

  12. Type of prosthesis [ Time Frame: The day of surgery ]
    The type of prosthesis Total Knee Replacement (TKR) or Total Hip Replacement (THR)

  13. Operated side; left or right leg [ Time Frame: The day of surgery, when patient arrives in OR ]
    The side on which the patient is having the TKR(total knee replacement) or THR (total hip replacement)

  14. Quantity of blood in mL loss during surgery [ Time Frame: Day of the surgery after closing of the surgical site ]
    Quantity in mL of blood loss during surgery, measured after closing the surgical site.

  15. The time the patient arrives on the treatment floor [ Time Frame: The day of surgery when the patient arrives on treatment floor ]
    The time in hours and minutes at which the patient arrives on the treatment floor

  16. Blood loss in dressing before discharge in % [ Time Frame: Day of the surgery before discharge from hospital up to 24h after surgery ]
    Percentage evaluation of the quantity of blood in the dressing, where on the dressing, the type of dressing and the aspect of the dressing.

  17. Time at discharged from the hospital [ Time Frame: Day of surgery,at discharge time up to 24h after surgery ]
    The time in hours and minutes at which the patient leaves the hospital after discharged from hospital care.

  18. Number of failure to discharge [ Time Frame: through study completion up to 2 years ]
    The number of failure to discharge patient according to the discharged criterias

  19. Pain score before surgery (VAS) [ Time Frame: Before surgery at the medical evaluation pre surgery ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  20. Pain score after surgery in recovery room (VAS) [ Time Frame: Day of surgery, after surgery in recovery room, day 0 ]
    Pain evaluation using the visual analog scale (VAS) zero to ten in recovery room, day 0

  21. Pain score after surgery on treatment floor before discharge (VAS) [ Time Frame: Day of surgery before discharge ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  22. Pain score 1-3 days after surgery (VAS) [ Time Frame: 1-3 day after surgery ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  23. Pain score 4 to 6 weeks after surgery (VAS) [ Time Frame: 4 to 6 weeks after surgery ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  24. Pain score 10 to 12 weeks after surgery (VAS) [ Time Frame: 10-12 weeks after surgery ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  25. Pain score 6 months after surgery (VAS) [ Time Frame: 6 months after surgery ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  26. Pain score one year after surgery (VAS) [ Time Frame: one year after surgery ]
    Pain evaluation using the visual analog scale (VAS) zero to ten

  27. Level of hemoglobin outcome before surgery [ Time Frame: Before surgery at the medical evaluation pre surgery up to 3 months before surgery ]
    Blood test done by nurse evaluating the level in g/L

  28. Level of hemoglobin outcome after surgery [ Time Frame: Day of surgery, when the patient arrives in the recovery room ]
    Blood test done by nurse evaluating the level on g/L ,when the patient arrives in recovery room.

  29. Level of hemoglobin outcome 3 to 4 days after surgery [ Time Frame: 3 to 4 days after surgery ]
    Blood test done by nurse evaluating the level of hemoglobine on g/L

  30. Presence of post surgery symptoms in recovery room [ Time Frame: Day of surgery, when the patient arrives in the recovery room ]
    Evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches.

  31. Presence of post surgery symptoms on treatment floor [ Time Frame: Day of surgery, when patient arrives on treatment floor ]
    subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches

  32. Presence of post surgery symptoms before discharge [ Time Frame: Day of surgery, before discharge up to 24h after srugery ]
    subjective evaluation of the symptoms after surgery such as syncope, dizziness, nausea, vomit, headaches

  33. Blood pressure outcome before surgery at the medical evaluation pre surgery [ Time Frame: 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

  34. Pulse outcome before surgery at the medical evaluation pre surgery [ Time Frame: before surgery at the medical evaluation pre surgery ]

    Measure of the pulse in bpm

    Measure of the oral temperature in Celcius


  35. Saturation outcome before surgery at the medical evaluation pre surgery [ Time Frame: before surgery at the medical evaluation pre surgery ]
    measure of saturation in % with index finger

  36. Temperature outcome before surgery at the medical evaluation pre surgery [ Time Frame: Before surgery at the medical evaluation pre surgery ]
    Measure of oral temperature in Celsius with thermometer

  37. Blood pressure outcome in recovery room [ Time Frame: Day of surgery,when patient arrives 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

  38. Pulse outcome in recovery room [ Time Frame: Day of surgery, when patient arrives in recovery room ]
    Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius

  39. Saturation outcome in recovery room [ Time Frame: Day of surgery, when patient arrives in recovery room ]
    Measure of saturation in % with index finger

  40. Temperature outcome in recovery room [ Time Frame: Day of surgery, when patient arrives in recovery room ]
    Measure of oral temperature in Celsius with thermometer

  41. Blood pressure outcome before discharge [ Time Frame: Day of surgery, before discharge up to 24hours after surgery ]
    Measure of blood pressure in mmHg Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius

  42. Pulse outcome before discharge [ Time Frame: Day of surgery, before discharge up to 24hours after surgery ]
    Measure of pulse in bpm Measure of the pulse in bpm Measure of saturation in % Measure of the oral temperature in Celcius

  43. Saturation outcome before discharge [ Time Frame: Day of surgery, before discharge up to 24hours after surgery ]
    Measure of saturation in % with index finger

  44. Temperature outcome before discharge [ Time Frame: Day of surgery before discharge up to 24hours after surgery ]
    Measure of the oral temperature in Celsius with thermometer

  45. Blood pressure outcome at home 1 to 2 days after surgery [ Time Frame: at home 1 to 2 days after surgery ]
    Measure of blood pressure in mmHg

  46. Pulse outcome at home 1 to 2 days after surgery [ Time Frame: at home 1 to 2 days after surgery ]
    Measure of the pulse in bpm

  47. Saturation outcome at home 1 to 2 days after surgery [ Time Frame: at home 1 to 2 days after surgery ]
    Measure of saturation in %

  48. Temperature outcome at home 1 to 2 days after surgery [ Time Frame: at home 1 to 2 days after surgery ]
    Measure of the oral temperature in Celsius

  49. Presence of big toe extension of the operated limb in recovery room [ Time Frame: Day of surgery, when patient arrives in recovery room ]
    Neurological assesment myotomes evaluation; extension of the big toe of the operated limb.

  50. Presence of plantarflexion of the operated limb in recovery room [ Time Frame: Day of surgery, when patient arrives in recovery room ]
    Neurological assesment Myotomes evaluation; plantarflexion of the operated limb.

  51. Presence of dorsiflexion of the operated limb in recovery room [ Time Frame: Day of surgery, when patient arrives in recovery room ]
    Neurological assesment, myotomes evaluation; platarflexion of the operated limb

  52. Dermatomes evaluation of the operated lower limb on treatment floor [ Time Frame: Day of the surgery, on treatment floor 4-6 hours after surgery ]
    Dermatomes; all lower limbs L2 to S1-S2 if normal and comparable to other limb.

  53. Functional evaluation outcome SF-36 at the medical evaluation before surgery [ Time Frame: Before surgery at medical evaluation up to 3 months before surgery ]
    SF-36 health score questionnaire

  54. Functional evaluation outcome, health score (SF-36) 6 months after surgery [ Time Frame: 6months after surgery ]
    SF-36 health score questionnaire

  55. Functional evaluation outcome hip disability and osteoarthritis outcome score (HOOS) at medical evaluation before surgery [ Time Frame: Before surgery at medical evaluation up to 3 months before surgery ]
    HOOS; hip disability and osteoarthritis outcome score questionnaire

  56. Functional evaluation outcome HOOS 6 months after surgery [ Time Frame: 6 months after surgery ]
    HOOS; hip disability and osteoarthritis outcome score questionnaire

  57. Functional evaluation outcome, knee disability and osteoarthritis outcome score (KOOS) at medical evaluation before surgery [ Time Frame: Before surgery at medical evaluation up to 3 months before surgery ]
    KOOS; knee disability and osteoarthritis outcome score questionnaire

  58. Functional evaluation outcome KOOS 6 months after surgery [ Time Frame: 6 months after surgery ]
    KOOS; knee disability and osteoarthritis outcome score questionnaire

  59. Range of motion outcome of the knee or hip at medical evaluation [ Time Frame: Before surgery at medical evaluation up to 3 months before surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  60. Range of motion outcome of the knee or hip on treatment floor [ Time Frame: Day of surgery, 4-6 hours after surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  61. Range of motion outcome of the knee or hip 3 days after surgery [ Time Frame: 3 days after surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  62. Range of motion outcome of the knee or hip 4-6 weeks after surgery [ Time Frame: 4-6 weeks after surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  63. Range of motion outcome of the knee or hip 10-12 weeks after surgery [ Time Frame: 10-12 weeks after surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  64. Range of motion outcome of the knee or hip 6 months after surgery [ Time Frame: 6 months after surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  65. Range of motion outcome of the knee or hip 1 year after surgery [ Time Frame: 1 year after surgery ]
    Range of motion (ROM) of the knee or hip in degrees in flexion using a goniometer

  66. Straight leg raise (SLR) outcome after surgery [ Time Frame: 3-4 hours after surgery ]
    Measure of the height of the leg from the bed to the heel in centimeters

  67. Walk outcome before surgery at at medical evaluation [ Time Frame: Before surgery at at medical evaluation up to 3 months before surgery ]
    Timed up and go (TUG) test

  68. Walk outcome 40 meters walk test at medical evaluation [ Time Frame: Before surgery at medical evaluation up to 3 months before surgery ]
    Measure of time on m /s to walk 40 meters

  69. Walk outcome 6 months after surgery [ Time Frame: 6 months after surgery ]
    Timed up and go (TUG) test

  70. Walk outcome 40 meters walk test 6 months after surgery [ Time Frame: 6 months after surgery ]
    Measure of time on m /s to walk 40 meters

  71. Stairs climb outcome day of surgery [ Time Frame: Day of surgery before discharge up to 24hours after surgery ]
    Stair climb test; how much time it takes in seconds to go up and down a flight of stairs.

  72. Stairs climb outcome 6 months after surgery [ Time Frame: 6 months after surgery ]
    Stair climb test; how much time it takes in seconds to go up and down a flight of stairs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028779


Contacts
Layout table for location contacts
Contact: Pascal-André Vendittoli, Orthopedist 514-246-0068 pa.vendittoli@me.com
Contact: Karina Pellei, Physiotherapist 514-252-3400 ext 1676 kpellei.hmr@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Hôpital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Pascal-André Vendittoli, Orthopedist    514-246-0068    pa.vendittoli@me.com   
Contact: Karina Pellei, Physiotherapist    514-252-3400 ext 1676    kpellei.hmr@ssss.gouv.qc.ca   
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital

Layout table for additonal information
Responsible Party: Pascal André Vendittoli, Orthopedist, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT03028779     History of Changes
Other Study ID Numbers: MaisonneuveRH2
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pascal André Vendittoli, Maisonneuve-Rosemont Hospital:
Outpatient,fast-track, arthroplasty, Total knee arthroplasty (TKA), Total hip Arthroplasty (THA)