Total Hip Arthroplasty: Fast Track Protocol is the Future?

Study Overview
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Brief Summary
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Fast-track total hip arthroplasty (THA) 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 hip 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 hip 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 Functional Outcomes and Hospital Stay Of Total Hip Arthroplasty

Conditions
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Hip Osteoarthritis, Arthropathy of Hip

Intervention / Treatment
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* Procedure: Fast Track Protocol
* Procedure: Standard Care Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients affected by hip osteoarthritis, eligible for primary total hip 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: 70 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
Interventional Model Description: The study aims to evaluate the effectiveness of a fast track protocol , which consists of an innovative analgesic therapy scheme and a rapid rehabilitation protocol, and a standard care protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fast Track Protocol<br>Patients treated using Fast Track Care Protocol | Procedure: Fast Track Protocol<br>* Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol<br>|
| Active Comparator: Standard Protocol<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 56, where 56 indicates worst 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 post operative day | 
| 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 | 
| Harris Hip Score (HHS) at 6 weeks | The collection of functional outcomes HHS at 6 weeks. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes. | 6 weeks after surgery | 
| Harris Hip Score (HHS) at third month | The collection of functional outcomes HHS at third month. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes | third month after surgery | 
| Harris Hip Score (HHS) at sixth month | The collection of functional outcomes HHS at sixth month. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes | sixth month after surgery | 
| Harris Hip Score (HHS) at twelfth month twelfth | The collection of functional outcomes HHS at twelfth month. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes | twelfth month after surgery | 
| WOMAC at 6 weeks | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes. | 6 weeks after surgery | 
| WOMAC at third month | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes. | Third month after surgery | 
| WOMAC at sixth month | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes. | Sixth month after surgery | 
| WOMAC at twelfth month | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less 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 hip arthroplasty