Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

Osteoarthritis (OA) is the most common type of arthritis causing considerable
disability
across broad populations. The economic burden of arthritis, specifically
osteoarthritis is
enormous with an estimated cost of $60 billion in the United States and
expected to
increase to $100 billion by 2020.(1;2) The knee joint is the most common joint
to develop
OA and total knee arthroplasty (TKA) is the most frequently performed joint
arthroplasty
procedure for this condition.(3;4) With an increase in the prevalence of
arthritis, obesity,
and old age, a further demand for TKA is projected to increase substantially
over the next
few years. (5;6;7;8;9) In 2005, approximately 523,000 TKAs were performed
nationally.(10) The American Academy of Orthopedic Surgeons (AAOS) and Kurtz et
al,(11) have provided projections for future demand of TKA. In 2002, the AAOS
had
suggested an annual replacement load of 474,000 by the year 2030. In 2007,
Kurtz et
al,(11) described an annual demand of 3.5 million by 2030. While these
projections vary
widely, both suggest a strong increase in demand for TKA, prompting significant
interest
from surgeons, healthcare institutions and orthopedic device manufacturers
interested to
better understand the future technological and economic burden of TKA.
Although, TKA has demonstrated effectiveness with substantive and sustained
improvement in quality of life for individuals with moderate to severe
osteoarthritis,(12;13)
functional performance in patients 1 year after TKA remains lower than for
healthy adults,
with reports of an 18% slower walking speed, 51% slower stair-climbing speed,
and
deficits of nearly 40% in quadriceps strength.(14) Additionally, certain
limitations in knee
design systems require surgeons to accept compromises which can result in
surgical
inefficiencies and challenges in seizing desired outcomes.(15;16;17;18;19)
Patient
expectations and an ever emerging population with active lifestyle also add a
new
requirement and need for innovative designs that bring advantages over
traditional
implants. Personalized implants with critical features of natural movement,
contoured
shape, and unique anatomic and physiologic composition can address these
requirements. The current concepts in TKA warrant a personalized orthopedics
initiative
by offering a finer ability in identifying and precisely addressing the unique
needs of
patients. It is through this introduction of high fidelity implants,
morphologic designs and
intelligent instrumentation that each patient*s knee can be distinctively and
accurately
reconstructed, allowing for clinical outcomes to be better optimized.
Furthermore, such
personalized systems will empower the surgeon to advance performance by
providing a
leading design that efficiently accommodates surgeons* intraoperative needs with
minimizing surgical trade-offs and maximizing efficiency.
To address these clinical challenges and methodologically address new implant
characteristics, a prospective, multi-center, longitudinal data collection
model is being
proposed. The objective of this study is to determine clinical performance/
outcomes and
implant survivorship for commercially available Zimmer Persona knee implants
used in
primary total knee arthroplasty.

The objective of this study is to obtain clinical performance (outcomes) data
and
survivorship for commercially available Zimmer Persona knee implants implanted
in
primary total knee arthroplasty.

This is a prospective, multicenter, non-controlled clinical study designed to
facilitate the
collection and evaluation of pain, function, quality of life, radiographic
assessment, and
adverse event data. Up to 12 EMEA sites will contribute to this study with a
maximum of
600 implanted knees. Each Investigator will be skilled in total knee
arthroplasty and
experienced implanting the devices included in this study.
In order to avoid potential selection bias, each Investigator will offer study
participation to
each consecutive patient presenting as a candidate for primary total knee
arthroplasty
using the commercially available (CE marked and FDA cleared) Zimmer Persona knee
implants 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
5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years post-operative.

The Persona knee prosthesis used in primary total knee arthroplasty.

When used in accordance with product labeling, the risks associated with the
use of
Zimmer Persona knee implants are similar to those of standard,
metal-on-polyethylene
knee systems used for the same clinical indication or purpose.
A list of anticipated adverse device effects (ADE) can be found in the
Instruction For Use
of the system, a copy of which can be found in the Investigator Binder.