Persona Partial Knee Replacement for Osteoarthritis

Not currently recruiting at 25 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Rheumatoid arthritis, Neurologic disorders, Osteomalacia, others

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

Compensation: Varies

Number of Visits: 8

Duration: Surgery and immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather data on the effectiveness of the Persona Partial Knee system, a type of knee implant, for individuals with osteoarthritis. The focus is on the implant's longevity and overall effectiveness. It suits those with osteoarthritis severe enough to consider knee replacement surgery. Participants should not have other joint diseases, infections, or conditions affecting knee stability. As an unphased trial, participation offers a chance to contribute to valuable research that could enhance future knee implant treatments.

Do I have to stop taking my current medications for the trial?

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 the Persona Partial Knee system is safe for osteoarthritis?

Research shows that the Persona Partial Knee system is generally safe and well-tolerated. Studies have found that using this system for knee joint repair or replacement yields good results with few complications. Specifically, the Persona Knee implant system demonstrated safety and effectiveness in similar procedures, achieving a 99% success rate over two years with only one follow-up surgery required to fix or replace the implant.

Additionally, patients using the Persona Partial Knee system reported improved knee function, scoring higher on tests measuring knee health and recovery. This indicates that the system not only performs well but is also safe to use. Overall, the evidence supports the safety of the Persona Partial Knee system for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard knee replacement surgeries that often involve replacing the entire knee joint, the Persona Partial Knee system offers a more targeted approach for osteoarthritis. This system is designed to replace only the damaged part of the knee, preserving healthy bone and tissue. Researchers are excited about this treatment because it can potentially lead to a quicker recovery, less pain, and more natural movement compared to a total knee replacement. By focusing on the specific area affected by osteoarthritis, the Persona Partial Knee system aims to offer a personalized fit and improved function, making it a promising option for patients with localized knee issues.

What evidence suggests that the Persona Partial Knee system is effective for osteoarthritis?

Research has shown that the Persona Partial Knee system, which participants in this trial will receive, holds promise for treating osteoarthritis. This system, used in knee replacements, has been linked to better patient-reported outcomes compared to other implants. It incorporates design features from an earlier knee implant that achieved a 98% success rate after 10 years and 90% after 20 years. Clinical data up to two years post-surgery indicate high patient satisfaction and effective performance. These findings suggest that the Persona Partial Knee system could be a reliable choice for those needing knee replacement due to osteoarthritis. ^{1 2 3 6 7}

Who Is on the Research Team?

Hillary Overholser

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a knee replacement due to conditions like osteoarthritis or tibial plateau fracture and are suitable for the Persona Partial Knee system. Participants must be able to follow the study plan and give informed consent. Those with severe bone or joint issues, certain neurological disorders, infections, inflammatory diseases, or pregnant women cannot join.

Inclusion Criteria

I am willing and able to follow the study's schedule and check-ups.

I am eligible for knee replacement surgery based on my doctor's assessment.

I am eligible for a Persona Partial Knee replacement outside of this study.

Exclusion Criteria

My bones are too weak to support a medical implant.

I have rheumatoid arthritis or another type of joint inflammation.

I have a joint that cannot straighten more than 15 degrees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative clinical evaluations prior to their partial knee arthroplasty

1-2 weeks

Treatment

Participants receive the Persona Partial Knee system

Surgery and immediate postoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Visits at 3 months, 1 year, and 2 years post-operatively

Long-term Follow-up

Optional continuation of follow-up assessment up to 10 years

10 years

Visits at 5 and 10 years post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Persona Partial Knee system

Trial Overview The study aims to collect data on how well the Persona Partial Knee system works in patients needing knee arthroplasty. It will look at how long the implant lasts (implant survivorship) and measure patient outcomes after surgery using this specific knee replacement device.

How Is the Trial Designed?

Group I: PPK subjects Experimental Treatment 1 Intervention

Subjects that receive the Persona Partial Knee system

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead 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

Published Research Related to This Trial

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03034811

Persona Partial Knee Clinical Outcomes Study The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858461/

Learning curve of Persona Partial Knee (PPK) arthroplasty This study investigated the learning curve of Persona Partial Knee (PPK) arthroplasty for primary medial UKA performed by a single, non-designer surgeon.

3. withpower.com withpower.com/trial/phase-arthritis-1-2017-eea29

Persona Partial Knee Replacement for Osteoarthritis The Persona knee system, used in total knee replacements, has shown promising early outcomes and improved patient-reported outcomes compared to other implants.

4. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-partial-knee.html

Persona Partial Knee Arthroplasty The Persona Partial Knee carries forward design elements of the Zimmer Miller Galante (M/G) Uni, which showed 98% survivorship at 10 years and 90% at 20 years.

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2470-y

Patient reported outcomes and implant survivorship after Total ... 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 ...

6. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/knee/persona-partial-knee/1739.4-GLBL-en%20Persona%20Partial%20Clinical%20Summary.pdf

Persona® Partial Knee Persona Partial patients scored significantly higher in the KOOS SF (Knee injury and Osteoarthritis ... Persona® Partial Knee Clinical Outcomes Study ANNUAL.

7. hal.science hal.science/hal-04490649/document

Safe and reliable clinical outcomes at 2 years of a fixed- ... This prospective multicentric study reported safe and reli- able early clinical outcomes of a newly designed fixed-bear- ing morphometric ...