NCT04821154 · Zimmer Biomet
Persona Revision Knee System Outcomes
What this study is about
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a conducted at multiple hospitals, single-treatment group$1, consecutive series, reviewing past data group of participants study with forward-looking follow-up.
View original scientific description
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female of at least 18 years of age at the time of screening.
- Signed an institutional review board approved informed consent.
- 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.
- 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):
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
- Collagen disorders, and/or avascular necrosis of the femoral condyle
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities
- 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
- 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:
- An ulcer of the skin
- History of recurrent breakdown of the skin
- 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.
Where
- Fayetteville, Arkansas
- Little Rock, Arkansas
- Fresno, California
- Superior, Colorado
- Evansville, Indiana
- Granger, Indiana
- Louisville, Kentucky
- Rochester, Michigan
- Southfield, Michigan
- Bloomington, Minnesota
- Columbia, Missouri
- Chester, New Jersey
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations