RecruitingNot ApplicableNCT03869996

Total Knee Arthroplasty: Fast Track Protocol is the Future?

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

64 participants

Start Date

Feb 25, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 78 Years

Plain Language Summary

Simplified for easier understanding

This study compares a "fast-track" enhanced recovery protocol versus standard care for patients undergoing total knee replacement (TKR) surgery for knee osteoarthritis. Fast-track protocols involve coordinated, multimodal approaches — including optimized anesthesia, aggressive pain management, early mobilization, and streamlined care pathways — designed to get patients moving and home faster, with less pain and fewer complications. Participants are randomized to fast-track or conventional care. Outcomes measured include time to achieve mobilization milestones, length of hospital stay, pain levels, and complication rates. This study tests whether fast-track protocols are safe and effective in an Italian hospital setting. You may be eligible if: - You have knee osteoarthritis and are scheduled for primary total knee replacement - Your BMI is less than 32 - You can complete a simple timed mobility test in 12 seconds or less - Your anesthesia risk classification is ASA 2 or below - Your pre-operative hemoglobin is above 13 g/dL - You are eligible for spinal anesthesia and have a caregiver at home You may NOT be eligible if: - You have a psychiatric condition - You currently need crutches before the surgery - Your anesthesia risk is ASA 3 or higher - Your pre-operative hemoglobin is below 13 g/dL - You are between 18 and 78 years old (maximum age applies) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREfast 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.

PROCEDUREstandard care protocol

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


Locations(1)

Istituto Ortopedico Rizzli

Bologna, Italy

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NCT03869996


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