Status:
RECRUITING
ROSA Knee Intraoperative Planning Flexibility Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteo Arthritis Knee
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Brief Summary
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)...
Detailed Description
The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's op...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05966519
Start Date
January 5 2024
End Date
January 1 2028
Last Update
December 27 2024
Active Locations (1)
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1
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582