Recruiting

Persona MC vs. PS

Sponsor:

NYU Langone Health

Code:

NCT05391828

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design

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

Study Details

Brief 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

Study ID

NCT05391828

Start date

Sep 27, 2023

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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.

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.

Primary outcome measure

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Baseline ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Week 6 ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Month 3 ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Year 1 ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Year 2 ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Year 5 ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Year 10 ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Year 20 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Baseline ]
  • Forgotten Joint Score (FJS) [ Time Frame: Week 6 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Month 3 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Year 1 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Year 2 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Year 5 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Year 10 ]
  • Forgotten Joint Score (FJS) [ Time Frame: Year 20 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Baseline ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Week 6 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Month 3 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Year 1 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Year 2 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Year 5 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Year 10 ]
  • European Quality of Life Five Dimension (EQ-5D) Score [ Time Frame: Year 20 ]

Central Contacts and Locations

Central contacts

Vinay Aggarwal, MD

202 250 0679Vinay.Aggarwal@nyulangone.org

Daniel Waren

954 559 2251Daniel.Waren@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Vinay Aggarwal

202-250-0679Vinay.Aggarwal@nyulangone.org

More Information

Sponsor

NYU Langone Health

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-29.