Knee Replacement for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+13 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?

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

Research Team

Kacy Arnold, RN, MBA

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults aged 18-75 with severe knee pain and disability due to conditions like osteoarthritis or rheumatoid arthritis, among others. Candidates must need a total knee replacement, be able to consent, and commit to follow-up evaluations. Exclusions include those in other studies, with certain bone/muscle diseases, previous knee replacements on the same side, or infections affecting the joint.

Inclusion Criteria

I am between 18 and 75 years old.

I am eligible for a knee replacement based on my doctor's assessment.

Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form

Exclusion Criteria

I have osteoporosis or a condition affecting my muscles or nerves that impacts my limb.

My joint is very unstable because of damaged ligaments.

I have had knee replacement surgery on the same side before.

Treatment Details

Interventions

• Zimmer Persona Total Knee System (Orthopedic Implant)

Trial Overview The study aims to collect data on the performance of Persona fixed bearing knee implants used in total knee arthroplasty (knee replacement surgery). It will focus on how long the implant lasts (implant survivorship) and how well it works clinically for patients who receive it.

Participant Groups

Group I: PERSONA TKA Experimental Treatment 1 Intervention

Primary total knee arthroplasty subjects that receive the Zimmer Persona 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