CompletedNot Applicable

ROSA® Knee System V1.5 Pilot Study

New Zealand40 participantsStarted 2025-02-25

Plain-language summary

This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed. The primary objectives will be assessed by measuring: 1. Intra-operative complications 2. Verification that the device performs as intended 3. Overall surgeon satisfaction with the instrumentation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is a minimum of 18 years of age * Independent of study participation, patient is a candidate for primary total knee arthroplasty using commercially available and compatible implants in accordance with product labeling * Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form Exclusion Criteria: * Patient is currently participating in any other surgical intervention studies or pain management studies * Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) * Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System

Timeframe: Intra-operative observations, with immediate post-operative documentation and reporting period.

Trial details

NCT IDNCT07009912

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-17

View on ClinicalTrials.gov More Knee Arthroplasty, Total trials