Tests a surgical robot's intraoperative planning during knee replacement surgery
Checks whether a surgical robot can adjust bone cuts during knee replacement in adults.
Plain-language title generated from the registry record
Registry title: ROSA Knee Intraoperative Planning Flexibility Study
Key facts
- Where
- Fukuoka, JapanSee the site
Where in Japan
- Kyushu University HospitalFukuoka, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zimmer Biomet
- Trial code
- NCT05966519
- Record updated
- 8 April 2026
- Original description
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.Read full original descriptionShow less
ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study
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.
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 any concomitant disease which is likely to jeopardize the functioning or success of the implant; Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails; 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 a known sensitivity or allergy to one or more of the implanted materials; Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft; Is known to be pregnant.