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New knee system aims to improve mobility after failed replacement

NCT ID NCT04821154

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new knee replacement system called Persona Revision for people who need a second knee replacement surgery. The goal is to see if it improves knee function, reduces pain, and is safe. About 380 adults will be followed for two years after surgery.

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 380 people

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

Started

Jun 2021

Expected to finish

Dec 2033

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

Patients in need of a primary or revision total knee procedure who receive Persona Revision Knee implants who meet all the inclusion criteria and none of the 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. Male or female of at least 18 years of age at the time of screening. 2. Signed an institutional review board approved informed consent. 3. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions. 4. Previous medical diagnosis/ history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU): 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis 2. Collagen disorders, and/or avascular necrosis of the femoral condyle 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy 4. Moderate valgus, varus, or flexion deformities 5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery 5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80. Exclusion Criteria: 1\) Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure. 3\) Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint. 4\) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis. 5\) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb. 6\) Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint. 7\) Severe instability of the affected joint secondary to the absence of collateral ligament integrity. 8\) Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening: 1. An ulcer of the skin 2. History of recurrent breakdown of the skin 3. Use of steroids 9\) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition. 10\) Pregnant or women planning to become pregnant during the time they will be participating in the study. 11\) Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure. 12\) Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.

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Conditions

The condition(s) this trial relates to.

collagenopathy Infections infectious disease osteoarthritis osteoarthritis, knee polyarticular arthritis rheumatoid arthritis

As listed by the trial registrant

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

Arthroplasty complications Infection Knee disease Knee osteoarthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Orthopaedic Specialists

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • Arthroplasty Foundation Inc.

    COMPLETED

    Louisville, Kentucky, 40220, United States

  • Ascension Providence Rochester Hospital

    RECRUITING

    Rochester, Michigan, 48307, United States

  • Bowen Hefley Orthopedics

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Community Foundation Medical Group

    WITHDRAWN

    Fresno, California, 93720, United States

  • Cornerstone Orthopaedics & Sports Medicine

    COMPLETED

    Superior, Colorado, 80027, United States

  • Jeff Yergler, LLC

    RECRUITING

    Granger, Indiana, 46530, United States

  • Michigan Orthopaedic Surgeons, PLLC

    RECRUITING

    Southfield, Michigan, 48076, United States

  • Orthopaedic Associates, Inc.

    COMPLETED

    Evansville, Indiana, 47710, United States

  • Orthopaedic Research Institute of New Jersey

    RECRUITING

    Chester, New Jersey, 07390, United States

  • Orthopedic Surgeons of Wisconsin, SC

    WITHDRAWN

    Wauwatosa, Wisconsin, 53222, United States

  • Penn Medicine/ Lancaster General Health

    COMPLETED

    Lancaster, Pennsylvania, 17602, United States

  • ROC Orthopedics

    COMPLETED

    Oregon City, Oregon, 97045, United States

  • TRIA Orthopaedic Center Research Institute

    COMPLETED

    Bloomington, Minnesota, 55431, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Thomas Aleto MD, PC

    WITHDRAWN

    Columbia, Missouri, 65201, United States

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