Comparing two types of knee implants using robotic assistance
Official title: 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
Run by NYU Langone Health · NCT05391828 · Data updated 2026-11-12
This study is testing which of two different knee implants works better for patients getting knee replacement surgery with the help of a robotic system.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 27, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2028 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT05391828 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled for elective primary total knee arthroplasty due to osteoarthritis or inflammatory arthritis.
✕Probably not a fit
Patients who may not benefit from this study include those with a history of prior knee infections, revision surgeries, or specific preoperative diagnoses such as post-traumatic arthritis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized, controlled study that compares two different total knee implant devices: the Persona medial congruent (MC) and the posterior stabilized (PS) designs. The surgeries will be performed using the ROSA robotic system, which aims to enhance precision and outcomes in knee arthroplasty. Patients will be monitored for up to five years to assess the effectiveness and safety of each implant type. The study seeks to determine which implant provides better results for patients undergoing total knee arthroplasty.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and recovery for patients undergoing total knee arthroplasty.
How similar studies have gone: Other studies have shown success with robotic-assisted knee surgeries, indicating a promising approach in this area.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Vinay Aggarwal, MD — NYU Langone Health
- Study coordinator: Vinay Aggarwal, MD
- Email: Vinay.Aggarwal@nyulangone.org
- Phone: 202 250 0679
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.