Every year, thousands of patients worldwide undergo spinal fusions. This operation is performed for a variety of reasons, which include de-generative conditions, deformity, trauma, and finally, instability from other necessary procedures. The function of instrumentation with rods and screws is to act as and 'internal cast' to stabilize the vertebra until the fusion, or bony re-growth, can occur. Pedicle screws have been used for many decades to facilitate and ensure bone fusion. In the past 10 years, their documented benefits have led them to become what many consider the standard of care. Similarly, technological advancement of these implants resulted in a better recovery rate and a decrease in post-operative pain.

As a global leader in development of spinal solutions, Medtronic Sofamor Danek's main mission is to create new products that build on the advancements of past technology. TSRH-3D™ Spinal Instrumentation is the company's latest advancement of the most widely used spinal implant in the history of spinal surgery.

FAQ's
Q. Why would Spinal Surgery be necessary?
A. Approximately 50 million people are afflicted with back pain in the United States. Back pain in the most common reason that adults will seek medical care. Although most back pain can be managed with non-surgical therapy and exercises, there are more than 200,000 spinal surgeries performed in the US for the treatment of degenerative spinal disorders.

The causes of back pain in the lumbar spine are multi-factorial. They may include a herniated disc, degeneration of the facet joints between two or more adjacent vertebrae, enlargement of these joints producing pressure on the nerve roots that exit the spinal column adjacent to these joints, stenosis of the spinal canal, or patterns of instability such as spondylolisthesis, where one vertebrae slips forward on another.

Preoperative studies including x-rays, CT scans, and MRI's are commonly used to determine which of these factors are contributing to the symptoms that the patient may be experiencing. If a clear anatomic causative factor can be found, and if it matches the symptoms that the patient is having, then the patient may benefit from surgical treatment of their spinal problem.

If non-surgical treatment of the spinal condition is unsuccessful, the most common treatment for degenerative spinal disease is a decompression and fusion. The term "decompression" refers to the removal of bony and soft tissue structures that are placing pressure on the spinal canal and nerve roots in the lower back. This will often require that the facet joints between the vertebrae be partially removed. The facet joints are an important part of natural spinal stability. In addition, the patient may have pre-existing abnormal motion in the lumbar spine that requires that the surgeon perform a fusion during the same surgical procedure as a decompression. A fusion is created when one vertebrae grows together with the adjacent one, which increases the amount of stability in the spine and reduces the amount of back pain. Instrumentation such as the TSRH3-D™ has played a very large role in increasing post-operative stability and fusion rates in spine surgery. Today, pedicle screw based instrumentation is the preferred choice for fixation in the majority of spine surgeries. Each patient has a unique and specific cause for his or her back pain. This description of the decompression and fusion is an oversimplification of the process, and may or may not be the solution to each patient's unique problem.

Q. What type of deformity can be corrected with the TSRH-3D™ Spinal Instrumentation?
A. TSRH-3D™ Spinal Instrumentation System can be used to restore the normal contour the lumbar spine known as lordosis or "sway back." The restoration of this normal contour is an important part of relieving back pain and stabilizing the spine. In addition, this system allows for partial correction of spondylolisthesis, or a slippage of one vertebra forward on another. These 6 degrees of freedom give the surgeon the ultimate flexibility for correcting your deformity.

Q. How do the TSRH-3D™ Spinal Instrumentation system components work when treating thoracolumbar deformities?
A. The TSRH-3D™ Spinal Instrumentation system allows the surgeon to address the correction of a variety of degenerative conditions of the lumbar spine using a single instrumentation system. The advantages of the system include the ability to instrument the spine using multi-axial pedicle screws at each spinal level regardless of the extent of the deformity and then apply a corrective force in three dimensions and stabilize the spine for fusion.

Some of the unique features of the TSRH-3D™ Spinal Instrumentation system include:

Connections from any angle or any height.
Lateral offset washers and smooth screw posts allow for anatomic placement of pedicle screws and minimal rod contouring.
Malleable screw extenders that help guide the connectors to their proper alignment and allow engagement with the screws.
Adjustability of alignment with the construct in place prior to final tightening.
These unique features result in excellent correction and stability of the lumbar spine. The security of fixation that is provided by the TSRH-3D™ Spinal Instrumentation facilitates early mobilization of the patient while still providing the optimal environment for fusion of the spine.

Q. How many surgeons are performing this kind of surgery today?
A. Over 200,000 back surgeries are performed in the United States alone each year. Spinal instrumentation has become a routine part of surgery to treat all types of conditions of the thoracolumbar spine. As a result, the majority of surgeons that have a practice focused on the treatment of spinal disorders have become familiar and skilled with this type of spinal instrumentation.

Q. Are the results of surgery with spinal instrumentation better than with fusion surgery alone?
A. There is not an easy answer to this question since the results of surgery always depend upon the particular patient and the goals of the surgery. There is intuitive that implanting instrumentation will reduce the amount of motion between two adjacent vertebral segments that are trying to fuse together and that should increase the eventual fusion rate. For this reason, "instrumented fusions" are now considered by many surgeons to be the gold standard for a fusion, especially in complex spine surgeries.

Q. How would I know if surgery is right for my specific back condition and me?
A. In today's medical world, the patient is at the center of the decision making process. Ultimately, it is up to you to decide, with a lot of help from your doctor, whether or not spine surgery is right for you. Trying to make a decision about whether or not to have spine surgery can be an overwhelming process. How do you start to make this decision? Our recommendation is that you begin by learning as much as you can about why you need surgery, what kind of surgery you are going to have, and what this will mean to you and your family.

Having a complete understanding about the surgical process and what to expect will help to ease some of the anxiety that you will naturally have about this decision. It is best to go through a step-by-step process, beginning by educating yourself, that will guide you towards an informed, confident decision made jointly by you and your doctor about whether or not to have surgery.

History
The TSRH-3D™ Spinal Instrumentation is another step forward in the evolution of a pedicle screw instrumentation system that began as the original Texas Scottish Rite Hospital (TSRH) system of Variable Angle Screws and T-Bolts.

Pedicle screw fixation has made a profound contribution to the correction of spinal deformities in the thoracic, lumbar, and sacral spine. Pedicle screws are specially designed and manufactured bone screws that are placed through the pedicles of the spinal column into the vertebral body. Screws placed in this manner offer superior strength, purchase, and pull-out resistance, as compared to other forms of fixation in spine surgery. The ability to achieve pedicle fixation has allowed surgeons to obtain more secure fixation of the involved vertebral segments, which permits more powerful correction of deformity of the spine and reported better clinical outcomes.

The TSRH-3D™ Spinal Instrumentation System offers the next level of deformity correction by allowing a new level of dorsal adjustability. The unique connector design allows the surgeon to adjust the position of the connector dorsally, while allowing for the medial/lateral and saggital variability of the position of the bone screw placement. The 3-D connector provides the surgeon 6 degrees of freedom for the attachment of the spinal rods to the pedicle screws. Using this system, the surgeon can address virtually any deformity in the lumbar spine.