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NCT Number: NCT04211987

Fast Track Total Hip Arthroplasty vs Standard Care

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Hip Pain Chronic Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzli

Bologna, 40136, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fast track care protocol

Procedure

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

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: FastTrack-H

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 26, 2019
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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