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Clinical Trials/NCT03875976
NCT03875976
Completed
Not Applicable

Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on Functional Outcomes and Hospital Stay Of Total Hip Arthroplasty

Istituto Ortopedico Rizzoli1 site in 1 country90 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
90
Locations
1
Primary Endpoint
Early functional outcomes
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dante Dallari, MD

MD

Istituto Ortopedico Rizzoli

Eligibility Criteria

Inclusion Criteria

  • patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
  • BMI \< 32
  • Time up ang go test \</= 12 seconds
  • 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
  • preoperative HB \< 13 g/dl

Outcomes

Primary Outcomes

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 56, where 56 indicates worst functional results.

Secondary Outcomes

  • Analgesic consumption(Third day after surgery)
  • WOMAC at sixth month(Sixth month after surgery)
  • hospital staying(Third post operative day)
  • Incidence of early major complications(Third day after surgery)
  • Number of transfusions(Third day after surgery)
  • Harris Hip Score (HHS) at 6 weeks(6 weeks after surgery)
  • Harris Hip Score (HHS) at third month(third month after surgery)
  • Harris Hip Score (HHS) at sixth month(sixth month after surgery)
  • Harris Hip Score (HHS) at twelfth month twelfth(twelfth month after surgery)
  • WOMAC at 6 weeks(6 weeks after surgery)
  • WOMAC at third month(Third month after surgery)
  • WOMAC at twelfth month(twelfth month after surgery)

Study Sites (1)

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