Clinical Trials - SKOUT

SKOUT (Spineoplasty v. Kyphoplasty OUTcomes) Trial

We will be collecting clinical outcome information for the treatment of vertebral body defects with both the OptiMesh® bone containment and reinforcement system (Spineoplasty) and KyphX® system (Kyphoplasty). The OptiMesh system is made by Spineology and has U.S. Food and Drug Administration (FDA) clearance for this use. The KyphX system is made by Kyphon and has FDA clearance for this use. The vertebral bodies are the “stacked blocks” in the spine that carry the weight of the upper body. When the vertebral body fractures, the normal “load” is shifted, which can cause pain due to that load being placed on other structures. Similar to a fracture in the bones of an arm or leg, a vertebral body fracture will generally heal after several weeks. However, unlike a fractured arm, placing the body in an external brace (or cast) may not result in the degree of pain relief necessary to allow simple activities of daily living due to the pressure on the fractured vertebral body from simply sitting upright or standing. The OptiMesh system is a flexible mesh that is placed into the vertebral body through a small incision. Biologic bone graft materials are then injected and packed into the mesh. As the mesh is filled, the fracture may reduce, and the bone graft pack becomes a load bearing support within the vertebral body. This “internal bracing” of the vertebral body may result in pain relief and return to function.