Spinal Stenosis Study – Now Enrolling
The purpose of this research study is to demonstrate the safety and effectiveness of the coflex by comparing the results from subjects who undergo decompression surgery to those subjects who undergo decompression surgery plus the addition of the coflex, in the short and long term.
The standard of care decompression involves removal of tissue(s) that are narrowing the canals for the nerve or spinal cord, and can be performed through an open or minimally invasive approach. This will stop the spine from pressing on the nerves of the spine and should decrease or eliminate the cause of pain.
The coflex procedure involves the decompression surgery to remove the problem bone and tissue pressing on the spinal nerves, then implanting the study device through the lower back in the space between the affected vertebrae. No bone will be placed between the vertebrae. The coflex is designed to stabilize the vertebra while potentially still allowing some motion in that part of the spine. It is hoped that stabilizing the vertebra will decrease or eliminate the cause of pain.
Neither surgery is certain to decrease or eliminate the pain. The coflex surgery will be compared to decompression without additional stabilization in up to 500 persons. They will be in this study about ten years.