NCT05391828

Persona MC vs PS RCT With ROSA

Randomized Control Trial Comparing Zimmer Biomet Persona Medial Congruent Versus Posterior Stabilized Total Knee Arthroplasty for Treatment of Knee Arthritis Using the ROSA Knee System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, controlled study comparing two total knee implant devices, Persona medial congruent (MC) vs posterior stabilized (PS). These surgeries will be performed using the ROSA robotic system. Patients will be followed up to 5 years.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design	TKA will be performed using the MC Bearing Design. The MC bearing provides medial stability and lateral mobility to facilitate more natural motion.
DEVICE	Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design	TKA will be performed using the PS Bearing Design. The PS bearings are designed to provide ±1.5 degrees varus/valgus constraint and ± 5.5 degrees internal/external rotation constraint.

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-05-26
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study