Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.
The purpose of this prospective clinical data collection is to document and compare the
performance and clinical outcomes between the Maxim® Knee System with Removable Molded Poly
Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.
FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159,
K010027. The data gathered will be collated and used to provide feedback to designing
engineers, support marketing efforts and answer potential questions from reimbursement
agencies.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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