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Clinical Trials/NCT03869996
NCT03869996
Recruiting
Not Applicable

Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty

Istituto Ortopedico Rizzoli1 site in 1 country64 target enrollmentFebruary 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
64
Locations
1
Primary Endpoint
Early functional outcomes
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Fast-track total knee arthroplasty (TKA) 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 knee 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 knee 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
February 25, 2019
End Date
November 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients affected by knee osteoarthritis, eligible for primary total knee 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 50, where 50 indicates better functional results.

Secondary Outcomes

  • hospital staying(Third day after surgery)
  • Number of transfusions(Third day after surgery)
  • Analgesic consumption(Third day after surgery)
  • Knee Society Score (KSS) at third month(third month after surgery)
  • Knee Society Score (KSS) at sixth month(sixth month after surgery)
  • Knee Society Score (KSS) at twelfth month(twelfth month after surgery)
  • Oxford Score (OS) at 6 weeks(6 weeks after surgery)
  • Incidence of early major complications(Third day after surgery)
  • Oxford Score (OS) at sixth month(sixth month after surgery)
  • Knee Society Score (KSS) at 6 weeks(6 weeks after surgery)
  • Oxford Score (OS) at third month(third month after surgery)
  • Oxford Score (OS) at twelfth month(twelfth month after surgery)

Study Sites (1)

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