What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, especially those related to total knee arthroplasty, include NSAIDs, intraarticular glucocorticoids, and surgical interventions. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal impairment. Intraarticular glucocorticoids may lead to joint infection, cartilage damage, and systemic side effects like hyperglycemia. Surgical interventions, such as total knee arthroplasty, carry risks of infection, blood clots, implant loosening, and the need for revision surgery. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis, particularly focusing on joint replacement procedures like total knee arthroplasty (TKA). Implants such as the Persona Ti-Nidium are used in TKA to replace damaged knee joints, providing pain relief and improved function. Other FDA-approved treatments for osteoarthritis include nonsteroidal anti-inflammatory drugs (NSAIDs) for pain management, and intraarticular injections for temporary relief. While newer biological treatments and monoclonal antibodies have been investigated, they often face safety concerns and are not yet widely endorsed.

What other types of research exist?

Promising alternatives to the Persona Ti-Nidium implant for TKA in osteoarthritis patients include: 1) Titanium Niobium Nitride Mobile-Bearing Unicompartmental Knee Arthroplasty, which is hypoallergenic and shows comparable results to standard CoCr implants. 2) The Multigen Plus system with a ceramic femoral component, which has demonstrated good short-term outcomes in clinical studies. These options are particularly suitable for patients with metal allergies or those seeking advanced material technologies.

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Orthopedic Implant

Titanium Knee Implant for Knee Arthritis (TKA Trial)

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 of legal age and skeletally mature

Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface

Must not have

Patient is unwilling to sign the Informed Consent

Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the safety and effectiveness of the Persona Ti-Nidium implant in patients needing knee replacement surgery. The implant aims to improve movement and reduce pain by replacing damaged knee parts with an artificial joint. The study will follow patients for several years to assess long-term outcomes. The Persona® system is a newly launched implant designed for total knee replacement with innovations intended for better function and higher flexibility.

Who is the study for?

This trial is for adults with various knee conditions like osteoarthritis, rheumatoid arthritis, and chronic knee pain who need a total knee replacement. Participants must be able to consent and follow the study's procedures. Those with mental conditions affecting treatment adherence or at high risk as determined by the investigator are excluded.

What is being tested?

The Persona Ti-Nidium Total Knee System is being tested for its effectiveness and safety in total knee arthroplasty (knee replacement surgery). The study aims to assess how well this implant works over time in patients undergoing surgery.

What are the potential side effects?

While not explicitly listed, potential side effects may include pain at the surgical site, swelling, infection risks associated with surgeries, issues with implant fitting or durability, and possible allergic reactions to materials.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am an adult and my bones have stopped growing.

Select...

I am eligible for a knee replacement using specific materials based on my medical history and physical exam.

Exclusion Criteria

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

Select...

I am not willing to sign the Informed Consent.

Select...

I am not institutionalized, a known drug abuser, alcoholic, and I understand the study requirements.

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 (OKS)

Secondary study objectives

EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure

Knee Society Score (KSS) Expectations (pre and post op)

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: Persona Ti-NidiumExperimental Treatment1 Intervention

Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System

0 / 4Eligibility 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

The most common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and joint replacement surgery. NSAIDs, such as ibuprofen and naproxen, work by reducing inflammation and pain through the inhibition of cyclooxygenase enzymes (COX-1 and COX-2). Glucocorticoids, like prednisone, provide anti-inflammatory effects by suppressing the immune response and reducing inflammation in the joints. Joint replacement surgery, such as the Persona Ti-Nidium implant in total knee arthroplasty (TKA), involves replacing the damaged joint surfaces with artificial components, which helps restore function and alleviate pain. These treatments are crucial for OA patients as they address pain management, improve joint function, and enhance the quality of life.

Non-pharmacological and non-surgical interventions to manage patients with knee osteoarthritis: An umbrella review.