Titanium Knee Implant for Knee Arthritis

(TKA Trial)

Not currently recruiting at 6 trial locations

Overseen By Thorsten Seyler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infection, Osteoporosis, Neuromuscular disease, others

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

Compensation: Varies

Number of Visits: 10

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee implant, the Zimmer Biomet Persona Ti-Nidium Total Knee System, designed to help those with severe knee pain from arthritis or other joint issues. The study aims to evaluate the implant's effectiveness and safety for individuals needing a total knee replacement. It seeks participants with severe knee problems, such as rheumatoid arthritis or osteoarthritis, who are already candidates for knee replacement surgery. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future knee replacement options.

Do I need to stop 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 study team or your doctor.

What prior data suggests that the Zimmer Biomet Persona Ti-Nidium Total Knee System is safe for knee arthroplasty?

Research has shown that the Zimmer Biomet Persona Ti-Nidium Total Knee System is promising for knee replacements, particularly in terms of safety. Studies have focused on its use in patients with metal allergies, who have experienced results similar to those without allergies, suggesting the implant is well-tolerated.

The Persona knee implant system has been studied for up to five years, with patients reporting positive outcomes. This indicates that the implant is generally safe and effective. While any medical procedure carries some risk, the current data on this implant is encouraging for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zimmer Biomet Persona Ti-Nidium Total Knee System is unique because it uses a titanium-based implant specifically designed for knee arthritis. Unlike traditional knee implants, which are often made from a combination of metals like cobalt-chromium, this system features titanium, which is known for its excellent biocompatibility and lightweight properties. Researchers are excited about this treatment because titanium may offer improved integration with bone, potentially leading to better long-term outcomes and reduced wear compared to existing options. Additionally, the design of the Persona Ti-Nidium aims to provide a more personalized fit, enhancing comfort and joint function for patients.

What evidence suggests that the Zimmer Biomet Persona Ti-Nidium Total Knee System is effective for knee arthritis?

Research has shown that the Zimmer Biomet Persona Ti-Nidium Total Knee System, which participants in this trial will receive, is designed to improve knee movement in arthritis patients. Studies have found that this implant prevents misalignment, ensuring a proper fit and smoother joint movement. The special coating on the implant benefits individuals with metal allergies, providing results similar to traditional implants. Early findings suggest that this implant covers the bone more effectively, potentially improving knee function and reducing pain. Overall, the implant aims to offer a safer and more effective option for those needing knee replacements. ^{1 2 3 4 5}

Who Is on the Research Team?

Hillary Overholser

Principal Investigator

Zimmer Biomet Assoc Director

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am eligible for a specific knee replacement surgery.

Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document

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

Exclusion Criteria

Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)

Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study

Patient is currently participating in any other surgical intervention or pain management study

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 total knee arthroplasty

1-2 weeks

Treatment

Participants receive the Persona Ti-Nidium Total Knee System during total knee arthroplasty

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at Early Post-op, 6 months, 1 year, 2, 3, 5, 7, and 10 years post-operatively

10 years

Multiple visits over 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Zimmer Biomet Persona Ti-Nidium Total Knee System

Trial Overview 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.

How Is the Trial Designed?

Group I: Persona Ti-Nidium Experimental Treatment 1 Intervention

Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total 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/NCT04817969

Study Details | NCT04817969 | Persona Ti-Nidium Post- ... The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

2. 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 ...

3. withpower.com withpower.com/trial/phase-necrosis-5-2021-e066d

Titanium Knee Implant for Knee Arthritis (TKA Trial) This trial evaluates the safety and effectiveness of the Persona Ti-Nidium implant in patients needing knee replacement surgery. The implant aims to improve ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320431/

Hypoallergenic Knee Implant Usage and Clinical Outcomes The use of titanium niobium nitride-coated implants for primary knee osteoarthritis in self-reported metal hypersensitivity patients shows similar outcomes and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04817969?term=nidium&rank=1&checkSpell=

Persona Ti-Nidium Post-Market Clinical Follow-up The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.