Clinical Trials

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/13/23. Questions regarding updates should be directed to the study team contact.