NCT05966519 ROSA Knee Intraoperative Planning Flexibility Study
| NCT ID | NCT05966519 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Osteo Arthritis Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-01-05 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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.
Eligibility 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
Contact & Investigator
Yasuharu Nakashima
PRINCIPAL INVESTIGATOR
Kyushu University
Frequently Asked Questions
Who can join the NCT05966519 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05966519 currently recruiting?
Yes, NCT05966519 is actively recruiting participants. Contact the research team at noriko.sugawara@zimmerbiomet.com for enrollment information.
Where is the NCT05966519 trial being conducted?
This trial is being conducted at Fukuoka, Japan.
Who is sponsoring the NCT05966519 clinical trial?
NCT05966519 is sponsored by Zimmer Biomet. The principal investigator is Yasuharu Nakashima at Kyushu University. The trial plans to enroll 80 participants.