Persona Total Knee Arthroplasty Outcomes Study

The study design is a prospective, multicenter, study of the commercially available Persona
fixed bearing knee implants. The study will require each site to obtain IRB approval prior to
study enrollment. All potential study subjects will be required to participate in the
Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee
arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6
weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.

The primary objective of this study is to obtain implant survivorship and clinical outcomes
data for the commercially available Persona fixed bearing implants used in primary total knee
arthroplasty. The assessments will include: implant survivorship based on removal of a study
device; safety based on incidence and frequency of adverse events; and clinical performance
measured by overall pain and function, quality of life data, radiographic parameters and
survivorship.

Inclusion Criteria:

- Patient 18-75 years of age, inclusive

- Patient qualifies for primary total knee arthroplasty based on physical exam and
medical history, including diagnosis of severe knee pain and disability due to at
least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the
femoral condyle; c) post-traumatic loss of joint configuration, particularly when
there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate
valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical
attempts that did not include partial or total knee arthroplasty of the ipsilateral
knee

- Patient has participated in a study-related Informed Consent process

- Patient is willing and able to provide written Informed Consent by signing and dating
the IRB or EC approved Informed Consent Form

- Patient is willing and able to complete scheduled study procedures and follow-up
evaluations

- Independent of study participation, patient is a candidate for commercially available
Persona fixed bearing knee components implanted in accordance with product labeling

Exclusion Criteria:

- Patient is currently participating in any other surgical intervention studies or pain
management studies

- Previous history of infection in the affected joint and/or other local/systemic
infection that may affect the prosthetic joint

- Insufficient bone stock on femoral or tibial surfaces

- Skeletal immaturity

- Neuropathic arthropathy

- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the
affected limb

- Stable, painless arthrodesis in a satisfactory functional position

- Severe instability secondary to the absence of collateral ligament integrity

- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent
breakdown of the skin

- Patient has a known or suspected sensitivity or allergy to one or more of the implant
materials

- Patient is pregnant or considered a member of a protected population (e.g., prisoner,
mentally incompetent, etc.)

- Patient has previously received partial or total knee arthroplasty for the ipsilateral
knee