Robotic-Assisted Knee Replacement Designs for Total Knee Replacement

Overseen By Vinay Aggarwal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Revision TKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of knee implants to determine which performs better for individuals needing a total knee replacement due to osteoarthritis or inflammatory arthritis. Surgeons will use a robotic system called ROSA, and patient follow-up will last up to 5 years. The trial compares the Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design with the Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design. Prospective participants should have osteoarthritis or inflammatory arthritis and plan to undergo knee replacement surgery using the ROSA system. Participants must also have access to a device compatible with the mymobility App. As an unphased trial, this study provides a unique opportunity to advance knee replacement technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these knee implant devices are safe for total knee replacement?

Previous studies on the Zimmer-Biomet Persona Medial Congruent (MC) knee implant have shown that patients generally feel satisfied and experience good stability. Research indicates that this knee design fits well and supports natural knee movement, suggesting it is usually well-tolerated by patients.

For the Zimmer-Biomet Persona Posterior-Stabilized (PS) knee implant, research also shows positive results. Studies report that it performs well over the long term and remains durable, with patients experiencing significant improvements even after many years.

Both knee implants are designed for better fit and function, helping to reduce side effects. They emphasize stability and comfort, which are crucial for patient safety and satisfaction. Overall, evidence suggests that both implants are safe and effective for knee replacement surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about robotic-assisted knee replacement designs because they could offer more precision than traditional methods. Unlike standard knee replacements that rely heavily on the surgeon's skill and experience, these robotic-assisted techniques use advanced technology to ensure better alignment and fitting of the knee components. The Zimmer-Biomet Persona Medial Congruent (MC) design focuses on replicating the knee's natural movement, while the Persona Posterior-Stabilized (PS) design aims to enhance stability during knee extension. These innovations might lead to quicker recovery times and improved long-term outcomes for patients needing total knee arthroplasty.

What evidence suggests that these knee implant designs are effective for total knee replacement?

This trial will compare two different designs for total knee arthroplasty (TKA). Research has shown that the Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design, which participants in this trial may receive, holds promise for knee replacement. Early results indicate it provides good pain relief and improved knee joint movement. Patients have reported greater satisfaction compared to those with standard knee implants.

For the Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design, another option in this trial, studies have demonstrated strong short-term results, with implants designed for better fit and function. Long-term evidence suggests these implants last well, working effectively for at least 15 years. Both designs aim to improve stability and personalized fit, leading to better outcomes for knee replacement patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Vinay Aggarwal, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a knee replacement due to osteoarthritis or inflammatory arthritis and are willing to follow the study's protocol. They must be scheduled for surgery using the ROSA robotic system and have access to a device that works with an Apple Watch and mymobility App.

Inclusion Criteria

Subject has access to a device capable of pairing to the Apple Watch, supporting application updates, and compatible with the mymobility App.

I am scheduled for a knee replacement due to arthritis using the ROSA Knee System.

I am willing to follow the study's rules and visit schedule.

Exclusion Criteria

I have had major knee surgery with metal implants.

I have been diagnosed with arthritis, bone death, or a fracture due to injury before surgery.

I have had an infection in my knee before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Total Knee Arthroplasty (TKA) performed using either a posterior stabilized or medial congruent design with the ROSA robotic system

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design
• Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design

Trial Overview The study compares two types of knee implant devices: Persona Medial Congruent (MC) versus Posterior-Stabilized (PS), both performed with the ROSA robotic system. Participants will be monitored for up to five years after their surgeries.

How Is the Trial Designed?

Group I: Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface design Experimental Treatment 1 Intervention

Group II: Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing design Active Control 1 Intervention

Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Persona Medial Congruent Bearing for:

• Total knee replacement for varus osteoarthritis
• Primary total knee arthroplasty

Approved in United States as Persona Medial Congruent Bearing for:

• Total knee replacement for varus osteoarthritis
• Primary total knee arthroplasty

Approved in Canada as Persona Medial Congruent Bearing for:

• Total knee replacement for varus osteoarthritis
• Primary total knee arthroplasty

Approved in Japan as Persona Medial Congruent Bearing for:

• Total knee replacement for varus osteoarthritis
• Primary total knee arthroplasty

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Patients who received medial pivot (MP) total knee arthroplasty (TKA) reported significantly higher satisfaction scores (Forgotten Joint Score-12) compared to those who received posterior-stabilized (PS) TKA, indicating better perceived outcomes.

Although there was no significant difference in range of motion (ROM) improvement between the two groups at various postoperative intervals, the MP-TKA design may enhance patient satisfaction due to its more natural knee movement and stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Comparison of a Medial Pivot and Posterior-Stabilized Total Knee Arthroplasty With Respect to Patient-Reported and Radiographic Outcomes. Samy, DA., Wolfstadt, JI., Vaidee, I., et al.[2019]

Digital templates designed for guiding total alloplastic joint replacement surgery were successfully used in six patients, showing high accuracy in bone trimming and prosthesis placement with a mean error of only 1.139±0.183 mm compared to preoperative plans.

The use of these templates not only improved the precision of the surgery but also ensured the safety of vital anatomical structures, such as the skull base and inferior alveolar neurovascular bundle, preventing any injuries during the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of digital templates to guide total alloplastic joint replacement surgery with biomet standard replacement system. Bai, G., He, D., Yang, C., et al.[2016]

In a study of 91 knees from 85 patients who received the Persona® implant for total knee arthroplasty, the implant showed a low revision rate of 2.19% and good clinical outcomes after an average follow-up of 5.9 years.

Patients reported high functional scores, with a mean Oxford Knee Score of 44.21 and a mean range of motion of 120.8º, indicating effective pain relief and improved mobility post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results of a new personalized knee implant for total knee arthroplasty: implant survivorship and patient-reported outcome after five years' follow-up. Dauder Gallego, C., Moreno Fenoll, IB., Patiño Contreras, JL., et al.[2022]

Patient-specific instrumentation (PSI) technology for knee replacement surgery allows for more precise planning and execution, leading to reduced surgical tray usage and improved predictability of component sizes, as demonstrated in a study of 88 patients.

The use of PSI resulted in more accurate alignment of knee components during surgery, although some intraoperative adjustments were still necessary, indicating that while PSI is promising, further development is needed for optimal soft tissue balancing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total and unicompartmental knee replacement. Patient-specific Instrumentation]. Köster, G., Biró, C.[2018]

The Persona Knee implant system demonstrated high safety and efficacy in total knee arthroplasty, with a 2-year survival rate of 99% and only one revision due to infection among 146 surgeries performed.

Patient-reported outcomes significantly improved post-surgery, with the Oxford Knee Score increasing from an average of 22.1 to 41.8, indicating enhanced pain relief, function, and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. Mathijssen, NMC., Verburg, H., London, NJ., et al.[2020]

In a study of 190 patients undergoing simultaneous bilateral total knee replacement, both the anterior-posterior-glide and rotating-platform Low Contact Stress mobile-bearing prostheses showed comparable postoperative outcomes, with mean knee scores of 89.4 and 88.6, respectively, after an average follow-up of 6.4 years.

Both prosthesis types demonstrated favorable safety profiles, with no cases of aseptic loosening or significant wear, although there were isolated incidents of nerve palsies in both groups, indicating that while complications can occur, they are relatively rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of anterior-posterior-glide and rotating-platform low contact stress mobile-bearing total knee arthroplasties. Kim, YH., Kim, JS.[2019]

The study compared the amount of bone removed during femoral box osteotomy for three total knee arthroplasty designs and found that the Persona design consistently required less bone resection than the Vanguard and Sigma PS designs across all implant sizes.

This suggests that when choosing a posterior stabilized knee implant, selecting the Persona model may be beneficial as it preserves more distal femoral bone, although the clinical implications of this finding need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of differences in bone removal during femoral box osteotomy for primary total knee arthroplasty. Graceffa, A., Indelli, PF., Basnett, K., et al.[2020]

In a study of 105 patients undergoing total knee arthroplasty, ultracongruent (UC) tibial inserts demonstrated significantly better functional outcomes compared to cruciate retaining (CR) inserts over a 2-year follow-up period, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index and Modified Knee Society Score.

Despite the improved functional scores with UC inserts, gait analysis showed no significant differences in foot pressure and step length between the two designs, indicating that the enhanced outcomes were not related to changes in gait parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait Parameters and Functional Outcomes After Total Knee Arthroplasty Using Persona Knee System With Cruciate Retaining and Ultracongruent Knee Inserts. Rajgopal, A., Aggarwal, K., Khurana, A., et al.[2018]

In a study of 30 total knee arthroplasty procedures using Zimmer patient-specific instrumentation (PSI), significant discrepancies were found between the planned bone cuts and the actual alignment achieved during surgery, with errors exceeding 3° in 3% of femoral and 17% of tibial components.

The findings suggest that reliance on Zimmer PSI without real-time verification of alignment could lead to increased malalignment rates in knee surgeries, highlighting the need for further validation and objective assessment methods before routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific instrumentation for total knee arthroplasty does not match the pre-operative plan as assessed by intra-operative computer-assisted navigation. Scholes, C., Sahni, V., Lustig, S., et al.[2021]

Citations

1. zimmerbiomet.com zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/knee/persona-knee-system/persona-medial-congruent-bearing-design-rationale.pdf

Persona Medial Congruent Bearing Design Rationale The concave medial tibial plateau and a more rigid meniscus provide stability. Healthy Knee: Stability and Motion. Historically, many TKA implant designs have.

2. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/knee/persona-the-personalized-knee/1211.3-GLBL-en%20Persona%20Primary%20Clinical%20Summary.pdf

Persona ® The Personalized Knee ® Clinical Summary Additionally, the MC bearing scored higher in patient satisfaction as compared to CR. Mid-flexion stability in the anteroposterior plane is achieved with a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7987930/

A Medial Congruent Polyethylene Offers Satisfactory Early ... An MC bearing provided similar or improved early pain, ROM, KOOS, PROMIS-10, FJS-12, and patient satisfaction as compared with standard bearings in TKA.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03568123

A Comparison of the Persona Total Knee Arthroplasty ... Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352344125000196

A Comparison of Medial-congruent, Ultracongruent, and ... The aim of this study was to compare medial-congruent (MC), ultracongruent (UC), and cruciate-retaining (CR) TKA utilizing a single CR total knee system.

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-knee-system.html

Persona® The Personalized Knee Our most comprehensive knee system, including anatomically accurate components with finer increments to help surgeons personalize the fit for each patient.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03568123

A Comparison of the Persona Total Knee Arthroplasty ... The purpose of the proposed Randomized Clinical Trial (RCT) is to evaluate the outcome and safety of a newly designed polyethylene bearing by comparing it with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113639/

Medial Congruent and Medial Pivot Inserts in Total Knee ... The aim of this scoping review on medial-stabilized TKA inserts—medial congruent (MC) and medial pivot (MP)—is to focus on their clinical ...