240 Participants Needed

Titanium Knee Implant for Knee Arthritis

(TKA Trial)

Recruiting at 6 trial locations
CL
TN
MC
HB
JR
JC
MB
TS
Overseen ByThorsten Seyler, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Zimmer Biomet
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this 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 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.

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 data supports the effectiveness of the Titanium Knee Implant for Knee Arthritis treatment?

Research shows that the Persona knee implant system, which is part of the Zimmer Biomet Persona Ti-Nidium Total Knee System, has promising outcomes. Studies report good patient satisfaction and implant durability up to five years after surgery, indicating its effectiveness in improving knee function and quality of life for patients with knee arthritis.12345

Is the Titanium Knee Implant (Zimmer Biomet Persona Ti-Nidium Total Knee System) safe for humans?

The Persona knee implant system, used in total knee replacement surgeries, has been studied for up to five years, showing positive patient-reported outcomes and implant survivorship, indicating it is generally safe for humans.12367

How does the Zimmer Biomet Persona Ti-Nidium Total Knee System treatment differ from other treatments for knee arthritis?

The Zimmer Biomet Persona Ti-Nidium Total Knee System is unique because it is made entirely from titanium, which is beneficial for patients with metal allergies, unlike standard knee implants that often use alloys containing nickel, chromium, or cobalt.678910

Research Team

HO

Hillary Overholser

Principal Investigator

Zimmer Biomet Assoc Director

Eligibility Criteria

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.
See 1 more

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
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Timeline

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

Treatment Details

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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials
383
Recruited
67,800+
Dr. Nitin Goyal profile image

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos profile image

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

Findings from Research

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.
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.
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]

References

Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. [2020]
Midterm results of a new personalized knee implant for total knee arthroplasty: implant survivorship and patient-reported outcome after five years' follow-up. [2022]
Promising early outcomes of a novel anatomic knee system. [2020]
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]
Comparison of Biomechanical Gait Parameters and Patient-Reported Outcome in Patients After Total Knee Arthroplasty With the Use of Fixed-Bearing Medial Pivot and Multi-radius Design Implants-Retrospective Matched-Cohort Study. [2022]
Clinical Outcomes of the Lateral Trabecular Metal Total Ankle Replacement at a 5-Year Minimum Follow-up. [2023]
Fixed-Bearing Trabecular Metal Total Ankle Arthroplasty Using the Transfibular Approach for End-Stage Ankle Osteoarthritis: An International Non-Designer Multicenter Prospective Cohort Study. [2022]
Removal of a well-fixed trabecular metal monoblock tibial component. [2016]
Early clinical and radiological evaluation in patients with total ankle replacement performed by lateral approach and peroneal osteotomy. [2023]
Resurfacing knee arthroplasty in patients with allergic sensitivity to metals. [2006]