Actively Recruiting
ROSA Knee Intraoperative Planning Flexibility Study
Led by Zimmer Biomet · Updated on 2026-04-08
80
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
CONDITIONS
Official Title
ROSA Knee Intraoperative Planning Flexibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 20 years and over
- Skeletally matured
- Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form
You will not qualify if you...
- Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
- Is septic, has an active infection or has osteomyelitis at the affected joint
- Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Is known to be pregnant
- Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
- Has a known sensitivity or allergy to one or more of the implanted materials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
Research Team
N
Noriko Sugawara
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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