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Persona MC vs PS RCT With ROSA

NCT05391828 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Vinay Aggarwal, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391828 on ClinicalTrials.gov