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New knee implant study aims to help arthritis sufferers walk Pain-Free

NCT ID NCT05787821

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study is testing the Persona knee implant in 760 people who need total knee replacement due to arthritis or other knee conditions. The goal is to see if the implant is safe and improves knee function and quality of life. Participants will be followed for several years after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Persona knee implant (a device for total knee replacement)
What this could lead to
If successful, this could confirm that the Persona knee implant is safe and improves knee function and quality of life for people needing knee replacement.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove the implant is better than others. Risks include typical surgery complications like infection, implant loosening, or ongoing pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 760 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is of legal age and skeletally mature 2. Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling Exclusion Criteria: 1. Patient is currently participating in any other surgical intervention or pain management study 2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent) 3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions 4. Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study 5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty 7. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint 8. Insufficient bone stock on femoral or tibial surfaces 9. Neuropathic arthropathy 10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 11. A stable, painless arthrodesis in a satisfactory functional position 12. Severe instability secondary to the absence of collateral ligament integrity 13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 14. Patient has a \> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique

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Conditions

The condition(s) this trial relates to.

arthritic joint disease avascular necrosis osteoarthritis osteoarthritis susceptibility 6 osteoarthritis, knee osteonecrosis polyarticular arthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Avascular necrosis Flexion deformity of knee Knee pain chronic Osteoarthritis, knee Polyarthritis Rheumatoid arthritis Traumatic arthritis Valgus deformity Varus deformity

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Denver Hip & Knee, Inc.

    Parker, Colorado, 80138, United States

  • Duke University

    Morrisville, North Carolina, 27560, United States

  • Foundation for Orthopaedic Research & Education

    Tampa, Florida, 33607, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Mississippi Sports Medicine and Orthopaedic Center

    Jackson, Mississippi, 39202, United States

  • NYU

    New York, New York, 11016, United States

  • New Mexico Orthopaedic Associates

    Albuquerque, New Mexico, 87110, United States

  • Northside Hospital, Inc.

    Atlanta, Georgia, 30342, United States

  • OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolina, 28207, United States

  • St. Francis Hospital & Heart Center

    Roslyn, New York, 11576, United States

  • Syracuse Orthopaedic Specialists

    DeWitt, New York, 13214, United States

  • U of L Health

    Louisville, Kentucky, 40202, United States

  • UT Health at Houston

    Houston, Texas, 77030, United States

  • UVA Health Orthopedic Center

    Charlottesville, Virginia, 22903, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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