NCT05966519Recruiting
ROSA Knee Intraoperative Planning Flexibility Study
ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 5 Jan 2024
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05966519
What you commit to
- Study type: Observational
- Planned participants: 80
- From 5 Jan 2024 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
- Is known to be pregnant
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.