Actively Recruiting

Phase Not Applicable
Age: 18Years - 78Years
All Genders
Healthy Volunteers
ID03869996

Randomized Study Comparing Fast Track and Standard Care Protocols for Functional Outcomes and Hospital Stay after Total Knee Arthroplasty

Led by Istituto Ortopedico Rizzoli · Updated on 2025-01-16

64

Participants Needed

1

Research Sites

348 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two approaches for total knee arthroplasty (TKA) in patients with knee osteoarthritis: a fast-track protocol and standard care. The fast-track protocol aims to reduce surgical stress and improve recovery by using optimized logistics, education, and evidence-based treatments. The study evaluates differences in functional and subjective outcomes, length of hospital stay, number of blood transfusions, and pain medication use. The fast-track care includes a preoperative educational session led by an orthopedic surgeon, anesthesiologist, and physiotherapist to explain the surgery and recovery process. Pain control uses oral medications only, and rehabilitation begins early with the physiotherapist helping the patient stand on the day of surgery. In contrast, the standard care uses intravenous pain medications and starts physiotherapy the day after surgery, without the preoperative education and intensive early rehabilitation. Participants will be monitored for early functional outcomes on the third day after surgery. Researchers will assess recovery progress, hospital stay duration, pain management, and transfusion needs. The study includes adults aged 18 to 78 with knee osteoarthritis undergoing primary TKA, and participation requires a caregiver. The total involvement spans from preoperative preparation through the immediate postoperative period with close observation of functional results.

CONDITIONS

Official Title

Total Knee Arthroplasty: Fast Track Protocol is the Future?

Who Can Participate

Age: 18Years - 78Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty
  • Body mass index (BMI) less than 32
  • Timed Up and Go test result of 12 seconds or less
  • American Society of Anesthesiologists (ASA) physical status classification of 2 or lower
  • Preoperative hemoglobin level greater than 13 g/dl
  • Eligible for spinal anesthesia
  • Presence of a caregiver to assist during recovery
Not Eligible

You will not qualify if you...

  • Psychiatric diseases
  • Preoperative use of crutches
  • American Society of Anesthesiologists (ASA) physical status classification greater than 3
  • Preoperative hemoglobin level less than 13 g/dl

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzli

Bologna, Italy, 40136

Actively Recruiting

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Research Team

M

Martina Rocchi, MD

C

Cesare Stagni, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Frequently Asked Questions

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Randomized Study Comparing Fast Track and Standard Care Protocols for Functional Outcomes and Hospital Stay after Total Knee Arthroplasty | DecenTrialz