Knee Replacement Types for Osteoarthritis

(MP-Persona Trial)

Enrolling by invitation at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different knee replacement designs for individuals with knee osteoarthritis, a joint disease causing pain and stiffness. The goal is to determine if the Medial Pivot design (Zimmer MP Persona) provides a more natural feel and improved movement compared to the traditional design (Zimmer Persona Knee-PS). The researchers seek participants diagnosed with osteoarthritis who require knee replacement and are willing to commit to the study's follow-up and assessments. As an unphased trial, this study offers a unique opportunity to contribute to advancements in knee replacement technology and potentially improve future treatments.

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 prior data suggests that these knee replacement devices are safe for patients with osteoarthritis?

A previous study identified some safety concerns with the Zimmer MP Persona, such as knee stability issues that can necessitate additional surgery to fix or replace the joint. Despite this, the design aims to closely mimic natural knee movement, potentially improving patient outcomes.

For the Zimmer Persona Knee-PS, research has shown that improper alignment can cause pain and issues like difficulty walking, balance problems, and limited movement, which might require further medical attention.

Both devices are commonly used in knee replacements, but as with any medical procedure, risks exist. Discussing these with a doctor is important to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Zimmer MP Persona and Zimmer Persona Knee-PS prostheses for knee osteoarthritis because they offer innovative design features that set them apart from current options. The Zimmer MP Persona uses a medial congruent bearing made from Vivacit-E Highly Crosslinked Polyethylene, providing enhanced anterior constraint and subluxation resistance, which can improve joint stability. Meanwhile, the Zimmer Persona Knee-PS offers a wide range of femur profiles in 2 mm increments, allowing for a more customized fit that can better mimic natural knee movement. These advancements aim to improve patient outcomes by offering more personalized and stable knee replacements.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

This trial will compare the Zimmer MP Persona and the Zimmer Persona Knee-PS for patients with osteoarthritis. Studies have shown that both devices effectively improve knee function. Research indicates that the MP Persona is designed to mimic natural knee movements, potentially leading to higher patient satisfaction. Initial findings suggest that patients experience significant improvements in knee function after surgery with the MP Persona, with scores increasing from 22.1 to 41.8. The Persona Knee-PS has demonstrated a strong record of safety and effectiveness, with a high 2-year survival rate of 99%. Both designs show promising results in reducing pain and enhancing knee function after surgery. ^{3 6 7 8 9}

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03681977

Clinical Outcomes of MP Persona vs. Persona Knee-PS 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6399845/

Patient reported outcomes and implant survivorship after ... The Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good ...

3. withpower.com withpower.com/trial/phase-osteoarthritis-knee-8-2019-5a774

Knee Replacement Types for Osteoarthritis (MP-Persona ... 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 ...

4. 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 Anatomic Tibia: Helps prevent mal-rotation while facilitating proper rotation and optimal bone coverage. Mal-rotation of implants leads to over 50 percent ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02255383

Persona Total Knee Arthroplasty Outcomes Study The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants ...

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

Persona IQ® – Zimmer Biomet | Remote Patient Monitoring Persona IQ is a first-to-world smart knee implant that captures patient-specific gait and range of motion metrics during the course of patient monitoring.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18065222&pc=JWH

ZIMMER, INC. ZIMMER BIOMET PERSONA KNEE SYSTEM MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER BIOMET PERSONA KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL.

8. 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.

9. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18065233&pc=JWH

ZIMMER, INC. ZIMMER BIOMET PERSONA REVISION KNEE ... The left knee had to have a revision because of flexion instability and the right knee had to have a revision because the zimmer persona trabecular tibial plate ...