Fast Track Total Hip Arthroplasty vs Standard Care

Hip Osteoarthritis Clinical Trial

— FastTrack-H  

Official title:

Evaluation of Functional Rehabilitation Fast Track Total Hip Arthroplasty vs Standard Care: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211987
• Other study ID #: 14-19
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: January 25, 2021

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 25, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Hip Pain Chronic
• Osteoarthritis, Hip

Intervention

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.
• standard care protocol
standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 50, where 50 indicates better functional results.	Third post operative day
Secondary	hospital staying	The collection of hospital stay for each patient. The fast track expecting hospital stay is three days	Third post operative day
Secondary	Harris Hip Score (HHS)	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.	6 weeks after surgery
Secondary	Harris Hip Score (HHS)	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	3 months after surgery
Secondary	Harris Hip Score (HHS)	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.	6 months after surgery
Secondary	Harris Hip Score (HHS)	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.	12 months after surgery
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	6 weeks after surgery
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	3 months after surgery
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	6 months after surgery
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	12 months after surgery