NCT05391828NARecruiting
Persona MC vs PS RCT With ROSA
NYU Langone Health
Start Date
9/27/2023
Completion Date
12/1/2028
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
Age Range: 18 years to No maximum
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
Interventions
DEVICE
Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design
DEVICE
Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design
Conditions
Total Knee Arthroplasty
Locations
NYU Langone Health
New York, New York 10016
United States