A Single-arm, Monocentric, Cross-sectional, Pilot Study Evaluating Updated Features for The ROSA® Knee System, v1.5, in Patients Undergoing Primary Total Knee Arthroplasty
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
New Zealand
Kensington Private Hospital
RECRUITING
Kensington
Contact Information
Primary
Sabine Montenegro
sabine.montenegro@zimmerbiomet.com
+61 437 814 806
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2026-02
Participants
Target number of participants: 40
Treatments
Experimental: Experimental: Zimmer Biomet ROSA® Knee System, v1.5
This study will include a single-arm of patients who qualify for robotic-assisted (RA) total knee arthroplasty (TKA) with the ROSA® Knee System and are planned to receive commercially available and compatible implants.
Related Therapeutic Areas
Sponsors
Leads: Zimmer Biomet