ROSA® Knee System V1.5 Pilot Study

Launched by ZIMMER BIOMET · May 29, 2025

Keywords

ClinConnect Summary

The ROSA® Knee System V1.5 Pilot Study is a research project designed to test the safety and usability of a new version of the ROSA® Knee System, which is a robotic tool used during knee surgery for patients with knee osteoarthritis and other joint diseases. The main goal of this study is to see how well the robotic system works during surgery and to understand how satisfied surgeons are with its performance. This study is not yet recruiting participants, but it will include adults aged 18 and older who are scheduled for a total knee replacement surgery.

To participate, patients must be eligible for knee surgery using standard implants and be willing to sign a consent form. However, individuals who are pregnant, currently participating in other related studies, or have had previous knee surgery on the same knee cannot take part. Participants can expect to help provide important information that may lead to improvements in robotic knee surgery, while also ensuring that the system is safe for future use.

Gender

ALL

Eligibility criteria

• 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