AxioMed Spine Corporation (AxioMed), is planning to complete the clinical trial called FLD for the product Freedom Lumbar Disc (FLD) by december 2012. The aim is to compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc. The study analyzes the result of using the FLD device as an artificial lumbar disc. The study is currently recruiting with an estimated enrollment of 300 subjects.
The trial is being conducted in various locations of US. Subjects with DDD will be randomized to disc arthroplasty with the FLD device or a control device. The study official title is “An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease”.
Freedom Lumbar Disc is a one piece total disc replacement system. It is designed to achieve the geometry, motion, deformability, inherent stiffness and damping characteristics necessary to restore normal function to a spinal segment. A special plastic (silicone polycarbonate urethane polymer) is placed in between two metal plates. A metal cap locks into each plate.