RecruitingNot ApplicableNCT05391828

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

Sponsor

NYU Langone Health

Enrollment

200 participants

Start Date

Sep 27, 2023

Study Type

INTERVENTIONAL

Conditions

Total Knee Arthroplasty

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Patients ≥18 years of age
Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System.
Patient is willing to cooperate and follow study protocol and visit schedule
Subject has access to a device is capable of pairing to the Apple Watch, supporting application updates and is compatible with the mymobility App.

Exclusion Criteria6

Patient is pregnant
Patient is unable to provide written consent
Revision TKA
History of prior infection in the affected knee
History of prior open surgery with significant hardware in place on the affected knee (i.e. prior distal femur or proximal tibia fracture or osteotomy)
Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

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Interventions

DEVICEZimmer-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.

DEVICEZimmer-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.