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New knee implant under Long-Term review

NCT ID NCT02255383

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 737 people who received a Persona knee implant to see how long it lasts and how well it works. Participants are adults aged 18-75 with severe knee pain from conditions like arthritis or bone damage. The goal is to track implant survival and knee function over time.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

737 people

The number who actually took part.

Start date

Jul 2014

Expected to finish

Dec 2027

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.

Ages

18 to 75 years

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: * Patient 18-75 years of age, inclusive * Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee * Patient has participated in a study-related Informed Consent process * Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form * Patient is willing and able to complete scheduled study procedures and follow-up evaluations * Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling Exclusion Criteria: * Patient is currently participating in any other surgical intervention studies or pain management studies * Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint * Insufficient bone stock on femoral or tibial surfaces * Skeletal immaturity * Neuropathic arthropathy * Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb * Stable, painless arthrodesis in a satisfactory functional position * Severe instability secondary to the absence of collateral ligament integrity * Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin * Patient has a known or suspected sensitivity or allergy to one or more of the implant materials * Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) * Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

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Conditions

The condition(s) this trial relates to.

arthritic joint disease Genu Valgum osteoarthritis polyarticular arthritis rheumatoid arthritis

As listed by the trial registrant

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

Avascular necrosis of the femoral condyle Knee pain chronic Moderate varus, valgus or flexion deformities Osteoarthritis Polyarthritis Rheumatoid arthritis Traumatic arthritis

Contacts and locations

Locations

  • Colorado Joint Replacement

    Denver, Colorado, 80210, United States

  • Denver-Vail Orthopedics

    Parker, Colorado, 80134, United States

  • Henry County Orthopedics and Sports Medicine

    New Castle, Indiana, 47362, United States

  • Jordan Young Institute

    Virginia Beach, Virginia, 23462-1784, United States

  • Lindner Research Center

    Cincinnati, Ohio, 45219, United States

  • OrthoCarolina

    Charlotte, North Carolina, 28207, United States

  • Orthopaedic & Spine Center of the Rockies

    Fort Collins, Colorado, 80525, United States

  • Raleigh Orthopaedic Clinic

    Raleigh, North Carolina, 27612, United States

  • Rockford Orthopedic Associates

    Rockford, Illinois, 61114, United States

  • SportsMedicine Grant & Orthopaedic Associates

    Columbus, Ohio, 43215, United States

  • Tennessee Orthopaedic Foundation for Education and Research

    Knoxville, Tennessee, 37930, United States

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430, United States

  • UNC Department of Orthopaedics

    Chapel Hill, North Carolina, 27599-7055, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.