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

NCT03028779 | Unknown

• 1 other identifier: MaisonneuveRH2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Procedure

Keywords

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

Outcome Measures

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.

  1 year

Secondary Outcomes (72)

• The cost of the outpatient procedure evaluation for the TKR or THR

  1 year

• Health outcome before surgery at medical evaluation

  before surgery at medical evaluation up to 3 months before surgery

• Health outcome 6 months after surgery

  6 months after surgery

• Patient sex

  up to 3 month before surgery

• Patient date of birth

  up to 3 months before surgery

Study Arms (1)

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.

Procedure: Fast-track Total Hip and knee arthroplasty

Interventions

Fast-track Total Hip and knee arthroplasty PROCEDURE

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

Fast-track total hip or knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedist

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 23, 2017
• Study Start: November 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2025
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)