Non-inflammatory Degenerative Joint Disease Clinical Trial
Official title:
Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty
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).
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