| NCT ID | NCT05391828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-09-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-09-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Patients will be followed up to 5 years.
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
Contact & Investigator
Vinay Aggarwal, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05391828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05391828 currently recruiting?
Yes, NCT05391828 is actively recruiting participants. Contact the research team at Vinay.Aggarwal@nyulangone.org for enrollment information.
Where is the NCT05391828 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05391828 clinical trial?
NCT05391828 is sponsored by NYU Langone Health. The principal investigator is Vinay Aggarwal, MD at NYU Langone Health. The trial plans to enroll 200 participants.