Total Hip Arthroplasty: Fast Track Protocol is the Future?

Not Applicable

Completed

• Conditions: Arthropathy of Hip; Hip Osteoarthritis

• Registration Number: NCT03875976
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Primary Completion: 2021-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Analgesic consumption	Third day after surgery	The request for analgesic rescue in relation to fast track standard analgesic scheme
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.
hospital staying	Third post operative day	The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
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
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
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
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 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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italia, Italy