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NCT05391828 | RECRUITING | Total Knee Arthroplasty

Persona MC vs PS RCT With ROSA
Sponsor:

NYU Langone Health

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.

Condition or disease

Total Knee Arthroplasty

Intervention/treatment

Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design

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

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-09-27
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Persona MC vs PS RCT With ROSA

Location Details

NCT05391828

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How to Participate

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Locations

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016