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Evaluating the Persona Knee Implant for Total Knee Replacement

Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation

Observational Zimmer Biomet · NCT05787821

This study is testing the Persona knee implant in people getting total knee replacement surgery to see how safe and effective it is over the next 10 years.

Quick facts

Study typeObservational
Enrollment760 (estimated)
Ages18 Years and up
SexAll
SponsorZimmer Biomet Industry-sponsored
Locations16 sites (Parker, Colorado and 15 other locations)
Trial IDNCT05787821 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety, performance, and clinical benefits of the Persona Total Knee System in patients undergoing primary total knee arthroplasty. It involves a multicenter data collection model where participants will undergo preoperative evaluations and will be followed for up to 10 years post-surgery. Clinical data will be collected through patient-reported outcomes and radiographic assessments to ensure the device meets its intended performance standards.

Who should consider this trial

Good fit: Ideal candidates include adults who are skeletally mature and qualify for primary or revision total knee arthroplasty based on their medical history and physical examination.

Not a fit: Patients currently involved in other surgical interventions or pain management studies, as well as pregnant individuals, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness and safety of total knee arthroplasty for patients suffering from knee pain and related conditions.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Parker, Colorado 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 Knee Pain ChronicOsteoarthritis, KneeRheumatoid ArthritisTraumatic ArthritisPolyarthritisVarus DeformityValgus DeformityFlexion Deformity of Knee
Last reviewed 2026-06-15 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.