Status:
RECRUITING
Persona MC vs PS RCT With ROSA
Lead Sponsor:
NYU Langone Health
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
NA
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. Pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05391828
Start Date
September 27 2023
End Date
December 1 2026
Last Update
July 30 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016