Total Knee Arthroplasty: Fast Track Protocol is the Future?

Osteoarthritis, Knee Clinical Trial

— FastTrack-G  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03869996
• Other study ID #: 0001094
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Martina Rocchi, MD
• Phone: 00393338705057
• Email: martina.rocchi[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early functional outcomes	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.	Third post operative day
Secondary	hospital staying	The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.	Third day after surgery
Secondary	Incidence of early major complications	The collection of acute infection and early fracture	Third day after surgery
Secondary	Number of transfusions	the collection of number of transfusions during hospital staying	Third day after surgery
Secondary	Analgesic consumption	The request for analgesic rescue in relation to fast track standard analgesic scheme	Third day after surgery
Secondary	Knee Society Score (KSS) at 6 weeks	The collection of functional outcomes score KSS at 6 weeks. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.	6 weeks after surgery
Secondary	Knee Society Score (KSS) at third month	The collection of functional outcomes score KSS at third month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.	third month after surgery
Secondary	Knee Society Score (KSS) at sixth month	The collection of functional outcomes score KSS at sixth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.	sixth month after surgery
Secondary	Knee Society Score (KSS) at twelfth month	The collection of functional outcomes score KSS at twelfth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.	twelfth month after surgery
Secondary	Oxford Score (OS) at 6 weeks	The collection of functional outcomes score OS at 6 weeks. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.	6 weeks after surgery
Secondary	Oxford Score (OS) at third month	The collection of functional outcomes score OS at third month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.	third month after surgery
Secondary	Oxford Score (OS) at sixth month	The collection of functional outcomes score OS at sixth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.	sixth month after surgery
Secondary	Oxford Score (OS) at twelfth month	The collection of functional outcomes score OS at twelfth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.	twelfth month after surgery