Fast Track Total Hip Arthroplasty vs Standard Care

Not Applicable

Completed

• Conditions: Hip Osteoarthritis; Hip Pain Chronic
• Interventions: Procedure: fast track care protocol; Procedure: standard care protocol

• Registration Number: NCT04211987
• 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: 2018-03-13
• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-26
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
• BMI < 32
• 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

Arm && Interventions

Group	Intervention	Description
Fast track care protocol	fast track care protocol	patients treated using fast track care protocol
Standard care protocol	standard care protocol	patients treated using standard care protocol

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 50, where 50 indicates better functional results.

Secondary Outcome Measures

Name	Time	Method
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)	12 months after surgery	The collection of functional outcomes score HHS at 12 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: \<70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	12 months after surgery	The collection of functional outcomes score Womac at 12 months after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.; The collection of functional outcomes score Womac at 12 months after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzli; 🇮🇹 Bologna, Italy