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The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.
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Inclusion criteria
The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These indications are stated below:
Patient selection factors to be considered include:
Exclusion criteria
The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are stated below:
Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
Relative contraindications include:
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Data sourced from clinicaltrials.gov
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