Comparing two types of knee implants using robotic assistance
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
NA · NYU Langone Health · NCT05391828
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05391828 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success with robotic-assisted knee surgeries, indicating a promising approach in this area.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Knee Arthroplasty