Persona MC vs PS RCT With ROSA

NYU Langone Health

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Device: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design; Device: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design

Study type: Interventional

Funder types: Other

Identifiers

NCT05391828

22-00033

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥18 years of age
2. Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System.
3. Patient is willing to cooperate and follow study protocol and visit schedule
4. 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 criteria

1. Patient is pregnant
2. Patient is unable to provide written consent
3. Revision TKA
4. History of prior infection in the affected knee
5. 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)
6. Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface design

Experimental group

Treatment:

Device: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design

Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing design

Active Comparator group

Treatment:

Device: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design