Hip Osteoarthritis, Arthropathy of Hip
Conditions
Keywords
fast track care, total hip arthroplasty
Brief summary
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
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.
Interventions
PROCEDUREFast Track Protocol
Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol
PROCEDUREStandard Care Protocol
Standard Care Protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early functional outcomes | Third post operative day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early major complications | Third day after surgery | The collection of acute infection and early fracture |
| Number of transfusions | Third day after surgery | the collection of number of transfusions during hospital staying |
| Analgesic consumption | Third day after surgery | The request for analgesic rescue in relation to fast track standard analgesic scheme |
| Harris Hip Score (HHS) at 6 weeks | 6 weeks after surgery | 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. |
| Harris Hip Score (HHS) at third month | third month after surgery | 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 |
| hospital staying | Third post operative day | The collection of hospital stay for each patient. The fast track expecting hospital stay is three days. |
| Harris Hip Score (HHS) at twelfth month twelfth | twelfth month after surgery | 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 |
| WOMAC at 6 weeks | 6 weeks after surgery | 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. |
| WOMAC at third month | Third month after surgery | 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. |
| WOMAC at sixth month | Sixth month after surgery | 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. |
| WOMAC at twelfth month | twelfth month after surgery | 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. |
| Harris Hip Score (HHS) at sixth month | sixth month after surgery | 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 |
Countries
Italy
Outcome results
None listed