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

Trial Summary

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 data supports the effectiveness of the treatment Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design for total knee replacement?

Research shows that the Persona knee implant system, which includes the Zimmer-Biomet Persona Medial Congruent Bearing, has positive patient-reported outcomes and good implant survivorship up to two years after surgery. Additionally, midterm results indicate that this personalized knee implant offers improved functional outcomes and a higher range of motion five years post-surgery. ^{1 2 3 4 5}

Is the Persona knee implant system generally safe for use in total knee replacement surgeries?

The Persona knee implant system, used in total knee replacement surgeries, has been studied for patient outcomes and implant durability up to two years after surgery, suggesting it is generally safe for use in humans. ^{1 2 5 6 7}

What makes the Zimmer-Biomet Persona knee replacement designs unique compared to other treatments?

The Zimmer-Biomet Persona knee replacement designs are unique because they offer personalized implant options that aim to better replicate the natural movement of the knee, potentially leading to improved functional outcomes and patient satisfaction. These designs include the Medial Congruent (MC) and Posterior-Stabilized (PS) bearings, which are tailored to enhance the range of motion and overall knee function. ^{1 2 4 8 9}

What is the purpose of this trial?

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.

Research Team

Vinay Aggarwal, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2020]

2. United States 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Application of digital templates to guide total alloplastic joint replacement surgery with biomet standard replacement system. [2016]

4. France 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. [2022]

5. Germany 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. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Analysis of differences in bone removal during femoral box osteotomy for primary total knee arthroplasty. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

[Total and unicompartmental knee replacement. Patient-specific Instrumentation]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2019]