Fast Track Total Hip Arthroplasty vs Standard Care

Overview

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.

Full Title of Study: “Evaluation of Functional Rehabilitation Fast Track Total Hip Arthroplasty vs Standard Care: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

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

  • Procedure: fast track care protocol
    • fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.
  • Procedure: standard care protocol
    • standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.

Arms, Groups and Cohorts

  • Active Comparator: Fast track care protocol
    • patients treated using fast track care protocol
  • Active Comparator: Standard care protocol
    • patients treated using standard care protocol

Clinical Trial Outcome Measures

Primary Measures

  • Early functional outcomes
    • Time Frame: 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 Measures

  • hospital staying
    • Time Frame: 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)
    • Time Frame: 6 weeks after surgery
    • The collection of functional outcomes score HHS at 6 weeks. 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. The collection of functional outcomes score HHS at 6 weeks. 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. The collection of functional outcomes score HHS at 6 weeks. 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.
  • Harris Hip Score (HHS)
    • Time Frame: 3 months after surgery
    • The collection of functional outcomes score HHS at 3 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
  • Harris Hip Score (HHS)
    • Time Frame: 6 months after surgery
    • The collection of functional outcomes score HHS at 6 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.
  • Harris Hip Score (HHS)
    • Time Frame: 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)
    • Time Frame: 6 weeks after surgery
    • The collection of functional outcomes score Womac at 6 weeks 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.
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    • Time Frame: 3 months after surgery
    • The collection of functional outcomes score Womac at 3 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.
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    • Time Frame: 6 months after surgery
    • The collection of functional outcomes score Womac at 6 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.
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Istituto Ortopedico Rizzoli
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dante Dallari, Principal Investigator, Istituto Ortopedico Rizzoli

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