Knee Replacement Types for Osteoarthritis

(MP-Persona Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: Failed arthroplasty, Hip OA, others

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

Compensation: Varies

Number of Visits: 3

Duration: Intra-operative

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. However, an increasing number of patients are complaining about their TKA due to altered sensations between their previous joint and the implant. Although several designs have been proposed to improve these outcomes, the knee kinematics after TKA remains different from physiological kinematics. The Medial Pivot TKA design was introduced to closely mimic normal knee kinematics and create the natural feeling of the knee. This study is intended to evaluate the clinical effectiveness and ability to restore knee motion of two TKA devices: the Medial Pivot Persona TKA Zimmer design with the traditional Zimmer Persona Knee-PS. The investigator's hypothesis is that the Medial Pivot design will results in better patient outcomes and restore knee motion at natural parameters.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the Zimmer MP Persona and Zimmer Persona Knee-PS treatment unique for knee replacement in osteoarthritis?

The Zimmer MP Persona and Zimmer Persona Knee-PS treatments are unique because they use personalized implant designs that aim to optimize the fit and function of the knee replacement, potentially improving patient outcomes and implant longevity compared to standard designs. ^{1 2 3 4 5}

What data supports the effectiveness of the Zimmer MP Persona and Zimmer Persona Knee-PS treatment for knee replacement in osteoarthritis?

Research shows that the Persona knee implant system, which is part of the Zimmer treatment, has good patient-reported outcomes and implant survivorship up to two years after surgery. Additionally, customized posterior-stabilized knee replacements, similar to the Zimmer Persona Knee-PS, have high patient satisfaction and functional outcomes due to their patient-specific design. ^{1 2 6 7 8}

Who Is on the Research Team?

John Antoniou, MD, PhD

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with knee osteoarthritis who need a total knee replacement and can follow the study's procedures. They must understand and consent to the study, but cannot join if they have inflammatory arthritis, severe neurological or cardiovascular conditions, previous failed leg surgeries, severe hip OA, or recent leg trauma.

Inclusion Criteria

I am willing and able to follow all study requirements.

I understand the study's conditions and agree to participate.

I have osteoarthritis and am a good candidate for a total knee replacement.

Exclusion Criteria

I have severe arthritis, neurological, or heart conditions.

I have had a failed leg joint replacement or metal implants in my leg.

I have severe hip osteoarthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty (TKA) with either the Medial Pivot Persona TKA Zimmer design or the traditional Zimmer Persona Knee-PS.

Intra-operative

Initial Follow-up

Clinical follow-up visits and radiographic assessments are performed to monitor recovery and implant performance.

6 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for knee kinematics, muscle activation, and clinical outcomes at 1 and 2 years post-operatively.

2 years

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Zimmer MP Persona
• Zimmer Persona Knee-PS

Trial Overview The trial compares two types of total knee replacements: Zimmer MP Persona (a new design aiming to mimic natural knee motion) versus the traditional Zimmer Persona Knee-PS. The goal is to see which one gives better patient outcomes and more natural-feeling knee movement after surgery.

How Is the Trial Designed?

Group I: Zimmer MP Persona Experimental Treatment 1 Intervention

Zimmer MP Persona is total knee prosthesis intended to resurface the articulating surface of the femoral, tibial and patellar bones. It employs modular components between the tibial plates and articular surfaces and a medial congruent bearing manufactured from Vivacit-E Highly Crosslinked Polyethylene (HXPE). Persona® Medial Congruent Bearing is available in several sizes and offers up to a 13mm anterior lip height to provide greater anterior constraint and subluxation resistance. Can be used with a with both cruciate retaining and posterior stabilized femoral provisionals

Group II: Zimmer Persona Knee-PS Active Control 1 Intervention

Zimmer Biomet Persona® Knee-PS is a semiconstrained knee prosthesis that employs modular components between the tibial plates and articular surfaces. The device is intended to resurface the articulating surface of the femoral, tibial and patellar bones. The posterior stabilized (PS) femoral provisionals and components can be used with the PS or constrained posterior stabilized (CPS) bearings provisionals and components when the PCL is deficient and removed.The Persona Femur offers 21 distinct profiles, in 2 mm increments.

Group III: Healthy Participants Active Control 1 Intervention

The control group for the kinematic assessment

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Zimmer Biomet

Industry Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Montreal General Hospital

Collaborator

Trials

20

Recruited

10,400+

Jewish General Hospital

Collaborator

Trials

144

Recruited

283,000+

Published Research Related to This Trial

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 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]

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 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]

Citations

1. 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]

2. India pubmed.ncbi.nlm.nih.gov

Patient specific implants versus conventional implants in primary total knee arthroplasty: No significant difference in patient reported outcomes at 5 years. [2023]

3. 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]

4. Germany pubmed.ncbi.nlm.nih.gov

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

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

Patient Satisfaction, Functional Outcomes, and Survivorship in Patients with a Customized Posterior-Stabilized Total Knee Replacement. [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. Italy pubmed.ncbi.nlm.nih.gov

Pre-operative and post-operative kinematic analysis in total knee arthroplasty. A pilot study. [2020]

8. Ukraine pubmed.ncbi.nlm.nih.gov

[Endoprosthesis of the knee joint]. [2016]