Total Knee Arthroplasty: Fast Track Protocol is the Future? (FastTrack-G)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Arthropathy of Knee; Osteoarthritis, Knee

Treatments: Procedure: fast track care protocol; Procedure: standard care protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03869996

0001094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

fast track total knee arthroplasties

Active Comparator group

Description:

patients treated using fast track care protocol

Treatment:

Procedure: fast track care protocol

standard care total knee arthroplasties

Active Comparator group

Description:

patients treated using standard care protocol

Treatment:

Procedure: standard care protocol