FastTrack-H: Fast Track Total Hip Arthroplasty vs Standard Care

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Unknown status

CT.gov ID

NCT04211987

Collaborator

(none)

Enrollment

Location

Arms

45.6

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis Hip Pain Chronic	Procedure: fast track care protocol Procedure: standard care protocol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 13, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fast track care protocol patients treated using fast track care protocol	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.
Active Comparator: Standard care protocol patients treated using standard care 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.

Arm

Intervention/Treatment

Active Comparator: Fast track care protocol

patients treated using fast track care protocol

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.

Active Comparator: Standard care protocol

patients treated using standard care 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.

Outcome Measures

Primary Outcome Measures

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

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) [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) [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) [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) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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