Total Knee Arthroplasty: Fast Track Protocol is the Future?

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; Arthropathy of Knee
• Interventions: Procedure: standard care protocol; Procedure: fast track care protocol

• Registration Number: NCT03869996
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study Start: 2019-02-25
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care total knee arthroplasties	standard care protocol	patients treated using standard care protocol
fast track total knee arthroplasties	fast track care protocol	patients treated using fast track care protocol

Primary Outcome Measures

Name	Time	Method
Early functional outcomes	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 Outcome Measures

Name	Time	Method
hospital staying	Third day after surgery	The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
Number of transfusions	Third day after surgery	the collection of number of transfusions during hospital staying
Analgesic consumption	Third day after surgery	The request for analgesic rescue in relation to fast track standard analgesic scheme
Knee Society Score (KSS) at third month	third month after surgery	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.
Knee Society Score (KSS) at sixth month	sixth month after surgery	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.
Knee Society Score (KSS) at twelfth month	twelfth month after surgery	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.
Oxford Score (OS) at 6 weeks	6 weeks after surgery	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.
Incidence of early major complications	Third day after surgery	The collection of acute infection and early fracture
Oxford Score (OS) at sixth month	sixth month after surgery	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.
Knee Society Score (KSS) at 6 weeks	6 weeks after surgery	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.
Oxford Score (OS) at third month	third month after surgery	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.
Oxford Score (OS) at twelfth month	twelfth month after surgery	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzli; 🇮🇹 Bologna, Italy