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

Maisonneuve-Rosemont Hospital1 个研究点分布在 1 个国家目标入组 150 人2016年11月

适应症Orthopedic Procedure

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Orthopedic Procedure
发起方: Maisonneuve-Rosemont Hospital
入组人数: 150
试验地点: 1
主要终点: Number of participants with adverse events
状态: 进行中（未招募）
最后更新: 3年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Implementation of Fast-track surgery for total hip replacement and total knee replacement and evaluation of the risks and benefits for the patients.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2016年11月

结束日期

2025年9月

最后更新

3年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Maisonneuve-Rosemont Hospital

责任方

Principal Investigator

主要研究者

Pascal André Vendittoli

Orthopedist

Maisonneuve-Rosemont Hospital

入排标准

入选标准

•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.

排除标准

•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
•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)

结局指标

主要结局

Number of participants with adverse events

时间窗: 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.

次要结局

Health outcome before surgery at medical evaluation(before surgery at medical evaluation up to 3 months before surgery)
BMI(up to 3 months before surgery)
Health and medical history(up to 3 months before surgery)
Type of prosthesis(The day of surgery)
Surgery Date(Day of surgery)
Name of surgeon(Day of surgery)
Quantity of blood in mL loss during surgery(Day of the surgery after closing of the surgical site)
Blood loss in dressing before discharge in %(Day of the surgery before discharge from hospital up to 24h after surgery)
Time at discharged from the hospital(Day of surgery,at discharge time up to 24h after surgery)
Pain score after surgery in recovery room (VAS)(Day of surgery, after surgery in recovery room, day 0)
Pain score 4 to 6 weeks after surgery (VAS)(4 to 6 weeks after surgery)
The cost of the outpatient procedure evaluation for the TKR or THR(1 year)
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)
Surgery Time(The day of surgery)
Operated side; left or right leg(The day of surgery, when patient arrives in OR)
Pain score before surgery (VAS)(Before surgery at the medical evaluation pre surgery)
Presence of post surgery symptoms on treatment floor(Day of surgery, when patient arrives on treatment floor)
Pulse outcome before surgery at the medical evaluation pre surgery(before surgery at the medical evaluation pre surgery)
Physical status score (ASA)(up to 3 months before surgery)
The time the patient arrives on the treatment floor(The day of surgery when the patient arrives on treatment floor)
Number of failure to discharge(through study completion up to 2 years)
Pain score 1-3 days after surgery (VAS)(1-3 day after surgery)
Pain score one year after surgery (VAS)(one year after surgery)
Level of hemoglobin outcome 3 to 4 days after surgery(3 to 4 days after surgery)
Presence of post surgery symptoms in recovery room(Day of surgery, when the patient arrives in the recovery room)
Saturation outcome before surgery at the medical evaluation pre surgery(before surgery at the medical evaluation pre surgery)
Saturation outcome in recovery room(Day of surgery, when patient arrives in recovery room)
Temperature outcome at home 1 to 2 days after surgery(at home 1 to 2 days after surgery)
Pain score 6 months after surgery (VAS)(6 months after surgery)
Temperature outcome before surgery at the medical evaluation pre surgery(Before surgery at the medical evaluation pre surgery)
Pulse outcome in recovery room(Day of surgery, when patient arrives in recovery room)
Blood pressure outcome at home 1 to 2 days after surgery(at home 1 to 2 days after surgery)
Pulse outcome at home 1 to 2 days after surgery(at home 1 to 2 days after surgery)
Functional evaluation outcome hip disability and osteoarthritis outcome score (HOOS) at medical evaluation before surgery(Before surgery at medical evaluation up to 3 months before surgery)
Range of motion outcome of the knee or hip 6 months after surgery(6 months after surgery)
Pain score after surgery on treatment floor before discharge (VAS)(Day of surgery before discharge)
Blood pressure outcome before surgery at the medical evaluation pre surgery(before surgery at the medical evaluation pre surgery)
Blood pressure outcome in recovery room(Day of surgery,when patient arrives in recovery room)
Temperature outcome in recovery room(Day of surgery, when patient arrives in recovery room)
Blood pressure outcome before discharge(Day of surgery, before discharge up to 24hours after surgery)
Saturation outcome before discharge(Day of surgery, before discharge up to 24hours after surgery)
Temperature outcome before discharge(Day of surgery before discharge up to 24hours after surgery)
Presence of plantarflexion of the operated limb in recovery room(Day of surgery, when patient arrives in recovery room)
Functional evaluation outcome SF-36 at the medical evaluation before surgery(Before surgery at medical evaluation up to 3 months before surgery)
Functional evaluation outcome, knee disability and osteoarthritis outcome score (KOOS) at medical evaluation before surgery(Before surgery at medical evaluation up to 3 months before surgery)
Range of motion outcome of the knee or hip on treatment floor(Day of surgery, 4-6 hours after surgery)
Range of motion outcome of the knee or hip 3 days after surgery(3 days after surgery)
Straight leg raise (SLR) outcome after surgery(3-4 hours after surgery)
Pain score 10 to 12 weeks after surgery (VAS)(10-12 weeks after surgery)
Level of hemoglobin outcome before surgery(Before surgery at the medical evaluation pre surgery up to 3 months before surgery)
Level of hemoglobin outcome after surgery(Day of surgery, when the patient arrives in the recovery room)
Presence of post surgery symptoms before discharge(Day of surgery, before discharge up to 24h after srugery)
Pulse outcome before discharge(Day of surgery, before discharge up to 24hours after surgery)
Saturation outcome at home 1 to 2 days after surgery(at home 1 to 2 days after surgery)
Walk outcome 6 months after surgery(6 months after surgery)
Stairs climb outcome day of surgery(Day of surgery before discharge up to 24hours after surgery)
Stairs climb outcome 6 months after surgery(6 months after surgery)
Presence of big toe extension of the operated limb in recovery room(Day of surgery, when patient arrives in recovery room)
Range of motion outcome of the knee or hip 10-12 weeks after surgery(10-12 weeks after surgery)
Range of motion outcome of the knee or hip 1 year after surgery(1 year after surgery)
Presence of dorsiflexion of the operated limb in recovery room(Day of surgery, when patient arrives in recovery room)
Dermatomes evaluation of the operated lower limb on treatment floor(Day of the surgery, on treatment floor 4-6 hours after surgery)
Functional evaluation outcome, health score (SF-36) 6 months after surgery(6months after surgery)
Functional evaluation outcome HOOS 6 months after surgery(6 months after surgery)
Functional evaluation outcome KOOS 6 months after surgery(6 months after surgery)
Range of motion outcome of the knee or hip at medical evaluation(Before surgery at medical evaluation up to 3 months before surgery)
Range of motion outcome of the knee or hip 4-6 weeks after surgery(4-6 weeks after surgery)
Walk outcome before surgery at at medical evaluation(Before surgery at at medical evaluation up to 3 months before surgery)
Walk outcome 40 meters walk test at medical evaluation(Before surgery at medical evaluation up to 3 months before surgery)
Walk outcome 40 meters walk test 6 months after surgery(6 months after surgery)