Persona MC vs PS RCT With ROSA

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05391828
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 27, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Vinay Aggarwal
[email protected]
202-250-0679

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

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