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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Vinay Aggarwal, MD
Vinay.Aggarwal@nyulangone.org
202 250 0679
Backup
Daniel Waren
Daniel.Waren@nyulangone.org
954 559 2251
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health