A research study to determine the safety and effectiveness of the device
An alternative to spinal fusion surgery
Sibley Memorial Hospital is one of 30 hospitals nationwide to participate in the Premia Spine TOPS™ System clinical trial. An alternative to spinal fusion surgery, this procedure is being led by Sibley neurosurgeons, Joshua Ammerman, M.D., Joshua Wind, M.D. and Matthew Ammerman, M.D. The TOPS™ System is approved for use in Europe and several other countries around the world.
Qualifying patients will undergo a surgery to remove elements in the spine that are pressing on nerves. This is called decompression and is the first part of the surgery. Following the decompression, patients will be treated either with the TOPS™ System or with a fusion. A fusion permanently connects the two vertebral bones together and does not allow any movement. The TOPS™ System is intended to preserve normal motion, while still providing the needed stability in the spine.
The mechanical device, which is composed of two titanium plates that are connected by a polycarbonate urethane boot, is implanted in a procedure called 'posterior arthroplasty.' The device addresses two critical functions of the spine:
- Maintaining stability
- Preserving motion in all directions
Premia Spine TOPS™ System - How Does it Work?
The TOPS™ System is an alternative to traditional fusion surgery for patients suffering from moderate to severe lumbar spinal stenosis, with or without spondylolisthesis. The TOPS™ System is a mechanical device that is housed between two titanium plates, which allows axial rotation, lateral bending, extension, and flexion. The implant facilitates bending, straightening and twisting movements at the affected segment of the spine while blocking excessive posterior and anterior sagittal translation. The TOPS™ System uses four standard polyaxial pedicle screws for fixation to the vertebrae. The device is implanted via a traditional posterior surgical approach to stabilize the affected vertebrae and to replace the lamina and the facet joints that are removed, in whole or in part, during the surgical decompression.