Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

a) Subject is male or female and between the ages of 22 and 80 years at the
time of consent, inclusive.
b) Subject was diagnosed with NIDJD and in the opinion of the Investigator,
their condition is consistent with the indications detailed in the Instructions
For Use.
c) Subject, in the opinion of the Investigator, is a suitable candidate for
cementless primary TKA using the devices described in this CIP with either
resurfaced or non-resurfaced patellae.
d) Subject that is willing to give voluntary, written informed consent to
participate in this clinical investigation and authorize the transfer of
his/her information to the Sponsor
e) Subject is currently not bedridden
f) Subject, in the opinion of the Investigator, is able to understand this
clinical investigation and is willing and able to perform all study procedures
and follow-up visits and co-operate with investigational procedures.
g) Subject is able to read, and comprehend the Informed Consent Document as
well as complete the required PROs in either English or one of the available
translations.

Exclusion Criteria

a) The Subject is a woman who is pregnant or lactating.
b) Contralateral knee has already been enrolled in this study
c) Subject had a contralateral amputation.
d) Previous partial knee replacement (unicompartmental, bicompartamental or
patellofemoral joint replacement), patellectomy, high tibial osteotomy or
primary TKA in affected knee.
e) Subject is currently diagnosed with radicular pain from the spine that
radiates into the limb to receive TKA.
f) Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three (3) months.
g) Subject is currently involved in any personal injury litigation,
medical-legal or worker*s compensation claims.
h) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in
the last 5 years) or has a psychological disorder that could affect their
ability to complete patient reported questionnaires or be compliant with
follow-up requirements.
i) Subject was diagnosed and is taking prescription medications to treat a
muscular disorder that limits mobility due to severe stiffness and pain such as
fibromyalgia or polymyalgia.
j) Subject has a significant neurological or musculoskeletal disorder(s) or
disease that may adversely affect gait or weight bearing (e.g., muscular
dystrophy, multiple sclerosis, Charcot disease).
k) Subject is suffering from inflammatory arthritis (e.g., rheumatoid
arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus
erythematosus, etc.).
l) Subject has a medical condition with less than five (5) years life
expectancy.
m) Uncontrolled gout