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Persona MC vs PS RCT With ROSA

RECRUITINGN/ASponsored by NYU Langone Health
Actively Recruiting
PhaseN/A
SponsorNYU Langone Health
Started2023-09-27
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

ArthritisTotal Knee Arthroplasty

Locations1 site

NYU Langone Health
New York, New York, 10016
Vinay Aggarwal202-250-0679Vinay.Aggarwal@nyulangone.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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