Persona MC vs PS RCT With ROSA

Last updated: September 24, 2024
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Replacement

Treatment

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

Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design

Clinical Study ID

NCT05391828
22-00033
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥18 years of age

  2. Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis orinflammatory 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, supportingapplication updates and is compatible with the mymobility App.

Exclusion

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 affectedknee (i.e. prior distal femur or proximal tibia fracture or osteotomy)

  6. Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design
Phase:
Study Start date:
September 27, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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