Using a robotic system to adjust knee surgery in real-time
Official title: ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study
Run by Zimmer Biomet · NCT05966519 · Data updated 2026-11-12
This study is testing if a robotic system can help make real-time adjustments during knee surgery to improve outcomes for patients getting total knee replacements.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 1 site (Fukuoka, Fukuoka) |
| Status | Recruiting |
| Started | January 5, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2029 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT05966519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20 and over who are scheduled for total knee arthroplasty using the ROSA Knee System.
✕Probably not a fit
Patients with serious bone defects, active infections, or other significant health issues that could compromise surgery outcomes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of the ROSA Knee System, an orthopedic surgical assist robot, in providing intraoperative adjustments during total knee arthroplasty (TKA) based on real-time feedback from soft tissue conditions. A total of 80 patients will be enrolled at Kyushu University Hospital, with a follow-up period of two years to assess surgical outcomes. The study will document the accuracy of the robot's adjustments and their alignment with the surgeon's preferred techniques, focusing on various endpoints including kinematic analysis and patient-reported outcomes.
Why it matters
Potential benefit: If successful, this approach could enhance the precision of knee surgeries, leading to improved patient outcomes and satisfaction.
How similar studies have gone: While robotic assistance in orthopedic surgery is gaining traction, this specific approach to intraoperative adjustments based on real-time feedback is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Kyushu University Hospital
Fukuoka, Fukuoka, Japan Recruiting
Study contacts
- Principal investigator: Yasuharu Nakashima — Kyushu University
- Study coordinator: Noriko Sugawara
- Email: noriko.sugawara@zimmerbiomet.com
- Phone: +81-3-6402-6600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.