Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Complex Primary Total Knee Arthroplasty

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

a) Subject is male or female and between the ages of 22 and 80 years at the
time of consent, inclusive.
b) The decision to have knee replacement with the study device is regardless of
the research.
c) The devices are to be used according to the approved indications.
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 PROMs in either
English or one of the available translations.
h) Subject has not been diagnosed with an inflammatory arthritis (including
gout, rheumatoid, psoriatic etc.)

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, bicompartmental or
patellofemoral joint replacement) 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 his/her
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 activities (e.g.,
muscular dystrophy, multiple sclerosis, Charcot disease).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>There are two co-primary objectives; one regarding each tibial component<br /><br>configuration, fixed bearing (FB) and rotating platform (RP):<br /><br>1) Evaluate change from preoperative baseline to the 2 yr timepoint in patient<br /><br>reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB<br /><br>configuration.<br /><br>2) Evaluate change from preoperative baseline to the 2 yr timepoint in patient<br /><br>reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA RP<br /><br>configuration.</p><br>

Secondary Outcome Measures