This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).
This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees). This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care. Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).
Study Type
OBSERVATIONAL
Enrollment
200
Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP).
Rijnstate Hospital - Orthopaedic Department
Arnhem, Gelderland, Netherlands
Lievensberg Hospital Orthopaedic Department
Bergen op Zoom, North Brabant, Netherlands
Spaarne Hospital Orthopaedic Department
Hoofddorp, North Holland, Netherlands
HAGA Hospital Orthopaedic Department
The Hague, South Holland, Netherlands
KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points.
The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best.
Time frame: 6 Months Post-Operative minus Pre-Op
KOOS-PS change from baseline of the ATTUNE knee
The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best.
Time frame: Pre-Op (-90 days to day of surgery), 6 weeks (1 - 60 days), 3 months (61 - 137 days), 1 year (304 - 669 days), and 2 years (670 - 913 days) post-operative
Length of Hospital Stay
Collect days of hospitalization related to TKA procedure
Time frame: Immediate-post-operative: average 1 week
Annual Survivorship
A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant.
Time frame: 1 year (304 - 669 days), 2 years (670 - 913 days) post-operative
Type and frequency of Adverse Events (AEs) for all enrolled subjects
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
All Serious AEs must be reported to the Sponsor per protocol. All device-related and/or procedure-related AEs must be reported to the Sponsor per protocol.
Time frame: Day 0 - Post-Operative Day 913