Persona MC vs PS RCT With ROSA

Launched by NYU LANGONE HEALTH · May 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different types of knee implants used during total knee replacement surgery. The goal is to compare the Persona medial congruent (MC) implant with the posterior stabilized (PS) implant, both of which will be placed using the ROSA robotic system. By participating in this study, patients will help researchers understand which implant may work better for those with arthritis in their knees. The trial is currently looking for participants who are 18 years or older and are scheduled for this type of surgery.

To be eligible, participants should be diagnosed with osteoarthritis or inflammatory arthritis and must be willing to follow the study guidelines and attend scheduled visits. It's important to note that individuals who are pregnant, unable to give consent, or have had certain previous surgeries on the affected knee cannot participate. Those who join the trial will be monitored for up to five years to see how well the different implants perform and how they affect recovery and mobility. This study aims to provide valuable information that could improve knee replacement outcomes in the future.

Gender

ALL

Eligibility 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