Actively Recruiting
Computer-Assisted Surgery vs Standard Surgical Technique in Total Knee Replacement: Comparison of Clinical and Functional Outcomes
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-22
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical methods for patients needing total knee replacement surgery. The study compares the standard conventional technique with a newer computer-assisted navigation technique. The goal is to assess differences in clinical and functional outcomes, surgical bleeding, and healthcare costs such as surgery duration and hospital stay. This research involves 160 patients split evenly between the two surgery types. Participants will undergo either conventional total knee arthroplasty or computer-assisted total knee arthroplasty using imageless computer guidance. The comparison includes monitoring both surgical processes and recovery. Patients are randomly assigned to one of the two groups, and the study is conducted with single masking. Throughout the study, participants will be evaluated using the Knee Society Score, WOMAC index, and pain scales from enrollment until 12 months after surgery. Secondary measures include surgical time, complications, blood loss, transfusions, and length of hospital stay. The study spans from enrollment through discharge and a 12-month follow-up period to assess outcomes and safety.
CONDITIONS
Brief Title
CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant
- Males and females aged 65 45
- Willingness to participate in the study
- Acquisition of informed consent to participate
You will not qualify if you...
- Patients unable to understand or give consent for participation
- Refusal to participate or to sign informed consent
- Known or suspected nickel allergy
- Pregnant women or women of childbearing age who cannot exclude pregnancy
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 - Up to 4 weeks
Participants undergo either conventional or computer-assisted total knee arthroplasty surgery followed by immediate post-operative care.
1 surgical procedure day and visits until hospital discharge
Duration - 12 months
Participants are monitored for clinical and functional outcomes, complications, and recovery for 12 months after surgery.
Follow-up visits over 12 months post-operative
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy
Actively Recruiting
Research Team
D
Dallari (M.D.)
H
Haddad (M.D.)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here