ROSA Knee Intraoperative Planning Flexibility Study
NCT05966519 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80
Last updated 2026-04-08
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) 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
- Osteo Arthritis Knee
- Rheumatoid Arthritis
Interventions
- DEVICE
-
Total Knee Replacement (TKR)
Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Principal Investigators
-
Yasuharu Nakashima · Kyushu University
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-05
- Primary Completion
- 2027-01-31
- Completion
- 2029-01-31
- FDA Device
- Yes
Countries
- Japan
Study Locations
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