14022 attune cementless rp clinical performance evaluation

Conditions: Osteoarthritis

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).

the secondary objectives of this study are: * evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: pkip (overall and sub-scores), koos (overall and sub-scores), aks and eq-5d-3l. * evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified vas pain score (discrete numbers rather than a continual scale) at 2yr. * evaluate type and frequency of adverse events * evaluate survivorship of the attune primary cementless tka system for the cr rp and ps rp configurations using kaplan-meier survival analysis at 2yr and 5yrs. * evaluate primary, cementless attune tka fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery. * evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.

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

Keywords: arthroplasty replacement knee function radiographic survivorship