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

NCT ID: NCT03028779

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2025-09-30

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.

Conditions

Orthopedic Procedure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fast-track total hip or knee arthroplasty

Be able to return patient home on the same day of a total hip or knee surgery.

Group Type: EXPERIMENTAL

Fast-track Total Hip and knee arthroplasty

Intervention Type: PROCEDURE

To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours

Interventions

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pascal André Vendittoli

Orthopedist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

MaisonneuveRH2

Identifier Type: -

Identifier Source: org_study_id