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Active Not Recruiting
NCT02839850
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Conditions: Osteoarthritis
Sex: All
Ages: 22 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 540
Sponsor: DePuy Orthopaedics
Location: Colorado Joint Replacement Denver Colorado
Summary
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Eligibility Criteria
Inclusion Criteria:
* Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* 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.
* 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
* 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.
* 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:
* The Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study .
* Subject had a contralateral amputation.
* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
* 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 their 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 (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
* Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
* Subject has a medical condition with less than five (5) years life expectancy.
* Uncontrolled gout
Source: ClinicalTrials.gov (NCT02839850). StuddyBuddy aggregates publicly available trial information.