What is the mechanism of action of this treatment?

Common treatments for osteoarthritis (OA) include non-surgical options like NSAIDs, which reduce inflammation and pain, and duloxetine, which modulates pain perception. Surgical treatments, such as partial knee arthroplasty (e.g., the Persona Partial Knee System), involve replacing the damaged knee compartment with a prosthesis. This surgical approach alleviates pain and restores function by removing diseased tissue and providing a smooth, artificial surface for joint movement. These treatments are crucial for improving the quality of life in OA patients by reducing pain and enhancing mobility, especially when non-surgical treatments are insufficient.

What side effects are associated with this type of intervention?

The most common treatments for osteoarthritis, particularly surgical interventions like partial knee prosthesis implantation, can have several side effects. Surgical procedures, including arthroscopic partial meniscectomy, may lead to adverse events such as deep venous thrombosis, infection, pulmonary embolism, and, in rare cases, death. Non-surgical treatments like NSAIDs can cause gastrointestinal issues, cardiovascular risks, and other systemic side effects. Intra-articular injections, while providing short-term pain relief, are associated with risks like joint infection and potential cartilage damage. It is essential to discuss these risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several surgical treatments for osteoarthritis, including total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). These procedures involve the implantation of prosthetic devices to replace damaged knee compartments. The Persona Partial Knee System is an example of a partial knee prosthesis designed to replace only the affected compartments of the knee, preserving more of the patient's natural knee structure compared to total knee replacement. This approach aims to provide pain relief and improve function while maintaining more natural knee movement.

What other types of research exist?

Promising alternatives to the Persona Partial Knee System for osteoarthritis patients include the Oxford Unicompartmental Knee Replacement, which is reliable for medial knee compartment osteoarthritis and uses a minimally invasive technique. Additionally, the MBA Optetrak prosthetic implant is designed to minimize stress on high-density polyethylene and has shown good clinical and radiographic outcomes. For more comprehensive treatment, total knee arthroplasty options like the kinematic posterior cruciate ligament-retaining total knee replacements and the Kinematic Stabilizer total knee replacement have demonstrated long-term survivorship and patient satisfaction.

← Back to Search

Orthopedic Implant

Persona Partial Knee Replacement for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is at least 18 years of age

Be older than 18 years old

Must not have

Insufficient bone stock to provide adequate support and/or fixation to the prosthesis

Fixed flexion deformity (not passively correctable) of greater than 15 degrees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, typical side effects of knee replacement may include pain at the surgery site, swelling, stiffness in the knee joint, bleeding or blood clots. There could also be risks related to anesthesia during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My bones are too weak to support a medical implant.

Select...

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

Select...

I have rheumatoid arthritis or another type of joint inflammation.

Select...

I have infections that could spread to the surgery area.

Select...

I have weak or damaged tissue around my knee.

Select...

My knee ligaments are too weak to support a new device.

Select...

I am able to follow directions and cooperate with treatment.

Select...

My knee bends inward and cannot be straightened out manually beyond 15 degrees.

Select...

I do not have an infection, sepsis, or bone infection.

Select...

I have Charcot's disease.

Select...

I have deep damage in the weight-bearing area of my opposite joint.

Select...

I have issues with blood flow, muscle loss, or nerve and muscle diseases.

Select...

I have been diagnosed with osteomalacia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oxford Knee Score

Secondary study objectives

EQ-5D

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PPK subjectsExperimental Treatment1 Intervention

Subjects that receive the Persona Partial Knee system

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include non-surgical options like NSAIDs, which reduce inflammation and pain, and duloxetine, which modulates pain perception. Surgical treatments, such as partial knee arthroplasty (e.g., the Persona Partial Knee System), involve replacing the damaged knee compartment with a prosthesis. This surgical approach alleviates pain and restores function by removing diseased tissue and providing a smooth, artificial surface for joint movement. These treatments are crucial for improving the quality of life in OA patients by reducing pain and enhancing mobility, especially when non-surgical treatments are insufficient.

Developing an experimental model of early knee osteoarthritis after medial meniscus posterior root release: an in vivo study.UNICOMPARTMENTAL KNEE ARTHROPLASTY: CURRENT PERSPECTIVES AND TRENDS IN BRAZIL.