Titanium Knee Implant for Knee Arthritis
(TKA Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Zimmer Biomet

No Placebo Group

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.

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.

+2 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

+3 more

Participant Groups

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.

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