Clinical trial NCT03869996: Total Knee Arthroplasty: Fast Track Protocol is the Future?
Official title: Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Arthropathy of Knee
Keywords: fast track care
total knee arthroplasty
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Early functional outcomes
timeFrame: Third post operative day
Secondary outcomes:
measure: hospital staying
timeFrame: Third day after surgery
measure: Incidence of early major complications
timeFrame: Third day after surgery
measure: Number of transfusions
timeFrame: Third day after surgery
measure: Analgesic consumption
timeFrame: Third day after surgery
measure: Knee Society Score (KSS) at 6 weeks
timeFrame: 6 weeks after surgery
measure: Knee Society Score (KSS) at third month
timeFrame: third month after surgery
measure: Knee Society Score (KSS) at sixth month
timeFrame: sixth month after surgery
measure: Knee Society Score (KSS) at twelfth month
timeFrame: twelfth month after surgery
measure: Oxford Score (OS) at 6 weeks
timeFrame: 6 weeks after surgery
measure: Oxford Score (OS) at third month
timeFrame: third month after surgery
measure: Oxford Score (OS) at sixth month
timeFrame: sixth month after surgery
measure: Oxford Score (OS) at twelfth month
timeFrame: twelfth month after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Cesare Stagni, MD
role: PRINCIPAL_INVESTIGATOR
References: