http://www.surgicaldynamics.com/spine/ray_tfc/patient_info.html
Introduction This Patient Information Brochure was developed to help you make an informed decision about back surgery, specifically with the Ray TFC™ device or the Ray TFC™ Unite device.
What are the Ray TFC™ and Ray TFC™ Unite devices? There are two versions of the Ray Threaded Fusion Cage™ (Ray TFC™) Device. The standard Ray TFC™ device is a hollow threaded cylinder with holes. The Ray TFC™ Unite device is a hollow threaded cylinder with holes that has flattened sides. The flat sides of the Unite device allow the surgeon to place two devices in close proximity to each other. Both versions of the device are made of titanium metal alloy, which is compatible with the human body. At each end of the devices is an end cap made of the plastic ultra high molecular weight polyethylene. This plastic is also compatible with the human body. The devices are filled with bone taken from your hip. Depending on your doctor's preference or your spinal anatomy, two standard Ray TFC™ devices, two Ray TFC™ Unite devices, or one of each are to be implanted for each level of fusion along the spine.
Which Patients Might Benefit?
In your lower back, there are five moveable bones or vertebrae that make up the lumbar spine. Between each vertebra is a cushion-like material called a disc. All bending, twisting, and turning movements occur through the discs. Your disc can wear down (degenerate) or dry out and cause some of your disc spaces to collapse. This may produce leg and back pain.
Based on your examination, your doctor is considering spinal surgery using the Ray TFC™ device or Ray TFC™ Unite device. This is because your doctor has found that you have low back pain due to a condition called degenerative disc disease (DDD). The purpose of this surgery is to stabilize and fuse one or two disc spaces of your spine and relieve your pain.
Although your doctor is planning to use the Ray TFC™ device or Ray TFC™ Unite device for your condition, you should be aware that there are alternative treatments to this type of surgery. Non-operative alternative treatments may include, but are not limited to, physical therapy, medications, braces, chiropractic care, or exercise programs. In addition, there are alternative spinal fusion techniques. These include, but are not limited to, anterior lumbar interbody fusion (ALIF) procedures without instrumentation, combined anterior and posterolateral (360°) fusion procedures, anterior/anterolateral spinal systems (e.g. plate and screw systems), or posterior spinal systems (e.g. hook and rod systems). If you want information on these options, please discuss them with your doctor.
The Ray TFC™ device and Ray TFC™ Unite device are approved for use in patients with DDD. Your doctor will determine that you have DDD if you have back pain caused by disc degeneration, and if you have one of the following conditions: the disc has gotten thinner, the disc has moved out of its space, there is scarring of the tissue in the area, the surface that touches the disc is worn or changed, or there is more bone being formed on the vertebra. Your doctor confirms that you have these conditions by looking at radiographic evidence (X-rays, CT scan, MRI), and by looking at the history of your back problems. Patients with DDD may also have limited forward slippage of one vertebra over the other vertebra below (Grade I spondylolisthesis). The Ray TFC™ device or Ray TFC™ Unite device, filled with bone taken from your hip, may be implanted from the 2nd lumbar disc (L2) down to the sacrum. Only one or two disc spaces are to be fused. Patients being considered for this surgery should be skeletally mature (at least 18 years old) and have had at least six months of non-operative (conservative) treatment.
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Contraindications/Warnings
The Surgery
After Surgery
Potential Complications
Clinical Results
Glossary of Terms