The degeneration of the spine is an all too common occurrence that develops with age and can lead to severe disability. Degenerative diseases of the lumbar spine, which encompass conditions such as spondylolisthesis, disc degeneration, and lumbar spinal stenosis, can cause debilitating symptoms such as pains in the lower back and extremities. The most prevalent spinal disease, lumbar spinal stenosis, affects more than two million people in the United States alone.
Typically, when less invasive treatments such as physical therapy, anti-inflammatory medications, and epidural steroid injections do not provide relief, a patient may elect to undergo decompression surgery. During this surgery, a small portion of the bone is removed to relieve pressure and pinching of the spinal nerves. After decompression surgery, the patient undergoes a fusion, which usually involves the fusing together of two or more vertebrae so that motion in the painful section of the spine is limited (this can also be done via bone graft). For years, decompression and fusion surgeries have remained the norm for surgical treatments of the spine.
Recently, however, a new medical device has become available which may be a viable alternative to fusion surgery. The Total Posterior Spine System (also known as the TOPS System) is a mechanical device that is implanted within the affected segment of the spine and can aid in the flexibility of the patient. Still in its infancy, the TOPS System, by Premia Spine, is currently undergoing clinical trials in the United States. Like any novel medical device, there are many questions surrounding its efficacy and complications, which only diligent research and studies can answer.
The Benefits of the Premia Spine Total Posterior Spine System
The Total Posterior Spine System is a mechanical implant device that replaces the bony and soft tissue that’s removed during spinal decompression surgery. The TOPS System is meant as an alternative to lumbar interbody fusion surgery, foregoing the need for a patient to have certain vertebrae segments fused together. There are different techniques used during traditional fusion surgeries for common degenerative spinal diseases, but the overall purpose is to create a solid bone (either through screws and solid rods and/or bone grafting) between the vertebrae, which eliminates movement between the bones, thus, reducing pain and irritation of the nerve root. Fusion surgery is considered to be a relatively effective treatment, with an approximate 5-10% risk that the fusion will fail. The risk that the patient’s pain will not be relieved is about 20% (also referred to as “failed back surgery syndrome”).
The TOPS System aims to treat patients diagnosed with common degenerative spinal diseases such as lumbar spinal stenosis (which occurs when the small joints between the vertebrae compress the spinal nerve roots in the lower back) and Grade 1 spondylolisthesis (which occurs when one vertebra “slips” over the one below it). The main difference between the TOPS System and traditional fusion surgery is that the TOPS device allows the patient physical stability and a greater range of movement in all directions. The device, which is composed of two titanium plates connected by a polycarbonate urethane boot and implanted in a procedure known as a “posterior arthroplasty,” is meant to enable the patient to enjoy normal physical activities without pain and with more flexibility.
Although not yet proven, the TOPS System may also be able to reduce the likelihood of subsequent problems in the spinal levels near the surgical site.
Are There Any Known Complications?
The TOPS System is currently approved for use in Europe and other countries throughout the world and is undergoing clinical studies in the United States. As part of an Investigational Device Exemption (IDE) study through the U.S. Food and Drug Administration, the TOPS System is available for a limited number of patients through certain participating hospitals and institutions. In order to qualify for the clinical trial, patients must be between the ages of 35 and 80 and they must have been diagnosed with either degenerative spondylolisthesis, moderate lumbar stenosis, or retrolisthesis (a slippage of the vertebra but unlike in spondylolisthesis, the vertebra slips backward, not forward). In addition, the potential participants must have had at least six months of failed non-surgical treatments to alleviate pain, such as physical therapy, anti-inflammatory medications, and epidural injections. The trial measures whether the patient experiences improvement in pain, disability, neurological issues, and flexibility of movement.
Since the clinical trials are relatively new and the number of participants is small, the long-term outcomes and overall results are still yet to be known. But because degenerative spinal diseases can cause severe pain and physical disability, the greatest risk of the TOPS System treatment, like all fusion surgeries, is the failure to alleviate pain. If the TOPS System fails to treat the patient’s symptoms, traditional fusion surgery may need to be conducted, or alternatively, non-surgical treatments may continue.
Secondly, like any treatment which involves a medical device, adverse reactions or events concerning the implant itself need to be studied. There have been no known, publicized device-related complications thus far, however, the general risks associated with implanting a foreign object in one’s body should be continually assessed. As of now, no lawsuits concerning the TOPS System have been filed.
Overall, Premia Spine’s Total Posterior Spine System is in an exciting stage of development in the United States. With clinical trials underway throughout the country, both patients and physicians have a ground-level opportunity to analyze and explore its risks and benefits. In light of the massive toll degenerative spinal diseases take on our population (and the unfortunate inability to avoid age-related degeneration), the TOPS System offers a potential alternative to traditional methods of treatments. However, the only way to know for certain is to follow the TOPS System’s clinical trials and monitor the long-term outcomes.