Persona Partial Knee Replacement for Osteoarthritis

Recruiting at 23 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

643 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a knee implant called the Persona Partial Knee System in patients needing partial knee replacement. It aims to see how well the implant works and how long it lasts by tracking patients over time. The Persona® system is a newly launched implant designed for knee replacement with innovations intended for better function and higher flexibility.

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.

How is the Persona Partial Knee Replacement treatment different from other treatments for osteoarthritis?

The Persona Partial Knee Replacement is unique because it is a personalized implant designed to fit the patient's anatomy more closely, potentially leading to better movement and comfort compared to standard knee replacements. ^{1 2 3 4 5}

What data supports the effectiveness of the Persona Partial Knee Replacement treatment 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. This suggests that the personalized design of the Persona system may lead to better functional results and patient satisfaction. ^{1 2 3 4 6}

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 a joint that cannot straighten more than 15 degrees.

I have rheumatoid arthritis or another type of joint inflammation.

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

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]

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. 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]

2. Germany pubmed.ncbi.nlm.nih.gov

Promising early outcomes of a novel anatomic knee system. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Do the increment of femoral condyle curvature and the change of tibia shape improve clinical outcome in total knee arthroplasty? A propensity score matching analysis. [2021]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

Safe and reliable clinical outcomes at 2 years of a fixed-bearing partial knee arthroplasty with a morphometric tibial tray in a large worldwide population. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The INDUS knee prosthesis - Prospective multicentric trial of a posteriorly stabilized high-flex design: 2 years follow-up. [2021]