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Recruiting NCT05391828

Persona MC vs PS RCT With ROSA

No phase Interventional Total Knee Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design, Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Change in Average gait speed [Time frame: Baseline, Year 2]
  • Change in Average daily step count [Time frame: Baseline, Year 2]
  • Change in Average daily flight count [Time frame: Baseline, Year 2]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05391828 · 22-00033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗