Total Knee Arthroplasty: Fast Track Protocol is the Future?

Study Overview
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Brief Summary
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Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

Detailed Description
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The aim of this protocol is to compare standard care and fast track total knee arthroplasties. The fast track care consists of: preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients antalgic protocol administered only orally early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position. The standard care consists of usual antalgic and physiotherapy post-operative care: Antalgic protocol consist in intravenous drugs the first physiotherapy session is the day after surgery.

Official Title
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Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee, Arthropathy of Knee

Intervention / Treatment
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* Procedure: fast track care protocol
* Procedure: standard care protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty BMI < 32 Time up ang go test </= 12 seconds American Society of Anesthesiologists physical status classification system (ASA) </= 2 preoperative hemoglobin (HB) >13 g/dl patients eligible for spinal anesthesia presence of a care-giver Exclusion Criteria: psychiatric diseases preoperative use of crutches ASA > 3 preoperative HB < 13 g/dl

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fast track total knee arthroplasties<br>patients treated using fast track care protocol | Procedure: fast track care protocol<br>* fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.<br>|
| Active Comparator: standard care total knee arthroplasties<br>patients treated using standard care protocol | Procedure: standard care protocol<br>* standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early functional outcomes | Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day. This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results. | Third post operative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital staying | The collection of hospital stay for each patient. The fast track expecting hospital stay is three days. | Third day after surgery | 
| Incidence of early major complications | The collection of acute infection and early fracture | Third day after surgery | 
| Number of transfusions | the collection of number of transfusions during hospital staying | Third day after surgery | 
| Analgesic consumption | The request for analgesic rescue in relation to fast track standard analgesic scheme | Third day after surgery | 
| Knee Society Score (KSS) at 6 weeks | The collection of functional outcomes score KSS at 6 weeks. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor. | 6 weeks after surgery | 
| Knee Society Score (KSS) at third month | The collection of functional outcomes score KSS at third month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor. | third month after surgery | 
| Knee Society Score (KSS) at sixth month | The collection of functional outcomes score KSS at sixth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor. | sixth month after surgery | 
| Knee Society Score (KSS) at twelfth month | The collection of functional outcomes score KSS at twelfth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor. | twelfth month after surgery | 
| Oxford Score (OS) at 6 weeks | The collection of functional outcomes score OS at 6 weeks. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | 6 weeks after surgery | 
| Oxford Score (OS) at third month | The collection of functional outcomes score OS at third month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | third month after surgery | 
| Oxford Score (OS) at sixth month | The collection of functional outcomes score OS at sixth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | sixth month after surgery | 
| Oxford Score (OS) at twelfth month | The collection of functional outcomes score OS at twelfth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | twelfth month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fast track care, total knee arthroplasty