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Recruiting NCT03869996

Total Knee Arthroplasty: Fast Track Protocol is the Future?

No phase Interventional Osteoarthritis, Knee Arthropathy of Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fast track care protocol, standard care protocol.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Arthropathy of Knee. Basic parameters: 18 years — 78 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Early functional outcomes [Time frame: Third post operative day]
Secondary outcome measures (12)
  • hospital staying [Time frame: Third day after surgery]
  • Incidence of early major complications [Time frame: Third day after surgery]
  • Number of transfusions [Time frame: Third day after surgery]
  • Analgesic consumption [Time frame: Third day after surgery]
  • Knee Society Score (KSS) at 6 weeks [Time frame: 6 weeks after surgery]
  • Knee Society Score (KSS) at third month [Time frame: third month after surgery]
  • Knee Society Score (KSS) at sixth month [Time frame: sixth month after surgery]
  • Knee Society Score (KSS) at twelfth month [Time frame: twelfth month after surgery]
  • Oxford Score (OS) at 6 weeks [Time frame: 6 weeks after surgery]
  • Oxford Score (OS) at third month [Time frame: third month after surgery]
  • Oxford Score (OS) at sixth month [Time frame: sixth month after surgery]
  • Oxford Score (OS) at twelfth month [Time frame: twelfth month after surgery]

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
  • ASA > 3
  • preoperative HB < 13 g/dl

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • Istituto Ortopedico Rizzli — Bologna

Identifiers

NCT: NCT03869996 · 0001094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗