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Evaluating the Persona Revision Knee System for knee surgeries

Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System

Observational Zimmer Biomet · NCT04821154

This study is testing how well the Persona Revision Knee System works for people who have had knee surgery to see if it helps them move better and feel safer after their operation.

Quick facts

Study typeObservational
Enrollment380 (estimated)
Ages18 Years and up
SexAll
SponsorZimmer Biomet Industry-sponsored
Locations16 sites (Fayetteville, Arkansas and 15 other locations)
Trial IDNCT04821154 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance, clinical benefits, and safety of the Persona Revision Knee System in patients who have undergone primary or revision total knee arthroplasty. It will utilize a multicenter, single-arm, consecutive series approach, retrospectively identifying eligible patients and inviting them for prospective follow-up at 1 to 5 years post-surgery. The primary endpoint will focus on improvements in knee function as measured by the Knee Society Clinical Rating System. A total of 20 sites will participate, with an enrollment cap of 380 patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific knee conditions requiring treatment with the Persona Revision Knee System.

Not a fit: Patients who do not have a history of knee conditions requiring the Persona Revision Knee System or those who are not eligible based on the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the Persona Revision Knee System, potentially improving outcomes for patients undergoing knee surgeries.

How similar studies have performed: Other studies evaluating similar knee arthroplasty systems have shown promising results, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fayetteville, Arkansas and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Arthroplasty ComplicationsInfectionKnee DiseaseKnee OsteoarthritisRevisionTotal KneeMedical DeviceSafety
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.