Fulcrum assisted soft stabilization system: a new concept in the surgical treatment of degenerative low back pain.

Study Design: An experimental study on cadaver spine and spine model for biomechanical evaluation of a novel dynamic stabilization device.

Objectives: First, to test the hypothesis that in dynamic stabilization of a lumbar spine using pedicle screws and ligament, addition of a fulcrum in front of the ligament can unload the disc. Second, to determine the relationship between the length and stiffness of the fulcrum and the ligament on disc unloading, lordosis and motion preservation.

Summary Of Background Data: Activity related low back pain may be attributable to abnormal disc loading or abnormal movement. Spinal fusion addresses both the mechanisms, but it has limitations. Soft stabilization with Graf ligament restricts abnormal movement but increases the disc pressure. The Dynesys system uses a plastic cylinder around the ligament to prevent overloading the disc, but it restricts extension and loses lordosis.

Methods: A novel dynamic stabilization system (fulcrum assisted soft stabilization or FASS) was developed in which a flexible fulcrum was placed in front of a ligament between the pedicle screws. It was hypothesized that the fulcrum should transform the compressive force of a ligament behind into a distraction force in front and unload the disc. Three spine models were developed using wooden blocks for vertebral bodies and neoprene rubber of different hardness for disc. Their load-deformation character was tested and compared with that of the cadaver spine in a spine tester. The spine model with the closest load-deformation property to cadaver spine was then tested for the effect of a FASS system, consisting of high density polythene rod as fulcrums and rubber "O" rings as ligaments. The disc pressure in the spine models were recorded with strain gauge in the center.

Results: Application of ligaments alone across the pedicle screws increased the disc pressure, produced a lordosis, and reduced the range of motion. Application of fulcrums reduced the disc pressure and maintained the lordosis. Increasing the fulcrum length resulted in progressive unloading of the disc but increased stiffness of the motion segment. As the fulcrum length approximated the height of the motion segment, the lordosis was lost, and the disc was completely unloaded. Decreasing the lateral bending stiffness of the fulcrum had minimal effect on disc unloading and motion-segment stiffness.

Conclusion: The novel FASS system can unload the disc, control the range of motion, and maintain lordosis. These parameters may be controlled with a suitable combination of ligament and fulcrum system. The study provides an indication toward the desirable biomechanical properties of the fulcrum and ligament for future development of a clinically applicable prototype.