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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Subject is male or female and between the ages of 22 and 80 years at the time
of consent, inclusive.
* Subject presents with a primary knee arthroplasty (primary TKA,
unicompartmental) or prior revision TKA that requires a revision procedure of
implanted tibial and/or femoral components.
* The decision to perform a knee revision with the study device is regardless
of the research.
* 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
* Subject is currently not bedridden
* The devices are to be used according to the approved indications.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.

Exclusion Criteria

* The Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study.
* Subject had a contralateral amputation.
* Subject is currently diagnosed with radicular pain from the spine that
radiates into the limb to receive RTKA.
* Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three (3) months.
* Subject is currently involved in any personal injury litigation,
medical-legal or worker's compensation claims.
* 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.
* 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.
* 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).
* Subject has a medical condition with less than five (5) years life expectancy
as determined by the Investigator.
* Uncontrolled gout

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There are two, co-primary objectives; one regarding each tibial component FB or<br /><br>RP:<br /><br>1) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis,<br /><br>with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS<br /><br>FB configuration.<br /><br>2) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis,<br /><br>with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS<br /><br>RP configuration.</p><br>

Secondary Outcome Measures