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.
