Actively Recruiting
Randomised Controlled Study Comparing Fast Track and Standard Care Protocols on Functional Outcomes and Hospital Stay in Total Knee Arthroplasty
Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-22
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing fast track and standard care protocols for total knee arthroplasty (TKA) in patients with knee osteoarthritis. The study aims to evaluate differences in functional outcomes, hospital stay duration, number of transfusions, and pain medication use after surgery. Fast track TKA focuses on reducing surgical stress and improving recovery through optimized care. The fast track protocol includes preoperative education from an orthopedic surgeon, anesthesiologist, and physiotherapist to prepare patients for surgery and recovery. Pain management is done with oral medications only, and early rehabilitation starts the day of surgery with physiotherapist-assisted standing. The standard care group receives intravenous pain medications and begins physiotherapy the day after surgery. Participants will be monitored for early functional outcomes on the third day after surgery, including hospital stay length, complications, transfusions, and analgesic use. Knee function will also be assessed using the Knee Society Score and Oxford Score at 6 weeks, 3, 6, and 12 months post-surgery. The study tracks recovery progress and compares benefits between the two care approaches.
CONDITIONS
Brief Title
Total Knee Arthroplasty: Fast Track Protocol is the Future?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty
- Body mass index (BMI) less than 32
- Time up and go test of 12 seconds or less
- American Society of Anesthesiologists (ASA) physical status classification of 2 or less
- Preoperative hemoglobin level greater than 13 g/dl
- Eligible for spinal anesthesia
- Presence of a caregiver to assist during recovery
You will not qualify if you...
- Presence of psychiatric diseases
- Preoperative use of crutches
- American Society of Anesthesiologists (ASA) classification greater than 3
- Preoperative hemoglobin level less than 13 g/dl
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay up to 3 days after surgery
Participants undergo total knee arthroplasty using either the fast track care protocol or the standard care protocol. Fast track care includes preoperative education, oral pain management, and early rehabilitation starting the day of surgery. Standard care includes usual intravenous pain management and physiotherapy starting the day after surgery.
Surgery day plus daily visits until discharge around the third day after surgery
Duration - Up to 12 months
Participants are followed up to assess functional outcomes and recovery after surgery.
Visits at 6 weeks, 3 months, 6 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzli
Bologna, Italy, 40136
Actively Recruiting
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
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