Spinal Fusion and Adjacent Segment Degeneration
New long-term data on the effect of lumbar total disc replacement on adjacent level degeneration reinforces outcomes from previous studies
CENTER VALLEY, Pa., May 8, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that Dr. Richard Guyer of the Center for Disc Replacement at Texas Back Institute presented the adjacent segment disease (ASD) outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) trial at the International Society for the Advancement of Spine Surgery Annual Meeting (April 12-14, 2017, Boca Raton, FL). The data reiterates the role of lumbar total disc replacement in delaying the progression of ASD, a common downstream complication associated with lumbar fusion. ASD furthers the societal burden imposed by degenerative disc disease, a condition responsible for 62 million physician visits per year and the number two reason – second only to the common cold – for lost work time. The trial found that at five years, the activL Artificial Disc had a protective effect on the progression of DDD at adjacent levels in 91.2% of patients.
According to Dr. Guyer, former president of the North American Spine Society (NASS), “These outcomes complement the large body of evidence already available reporting on the long-term adjacent outcomes following lumbar disc replacement. Previously, lumbar fusion had been reported to be responsible for a rate of ASD as high as 28.6% in patients with five-year follow-up.”
In 2008, Harrop et al. published a systematic review of lumbar disc replacement data and reported that in patients with three to 22 years of follow-up, total disc replacement resulted in a 9% adjacent segment degeneration rate, whereas lumbar fusion resulted in a 34% rate. Later, in 2012, Zigler et al. worked with Medical Metrics Incorporated (MMI) to conduct a post-hoc analysis on ProDisc-L IDE subjects and found a three-fold reduction in ASD rates between lumbar TDR and fusion at five years. MMI employed the same methods used in Zigler et al., 2012 to analyze the ASD outcomes from the activL Artificial Disc IDE trial.
Until recently, patient access to lumbar arthroplasty, or total disc replacement, for patients suffering from symptomatic degenerative disc disease has been a challenge due to the lack of coverage on many insurance policies. However, outcomes such as those presented by Dr. Guyer have caused payers to reconsider their policies.
In May, national insurer Humana, which is responsible for insuring more than six million American lives, overturned their coverage determination for lumbar total disc replacement. This policy change, along with others, resulted in now nearly one in two privately-insured Americans having access to lumbar disc replacement. Additional long-term evidence will likely cause more payers to reconsider their stance in the coming months.
A group of surgeon investigators from the activL Artificial Disc IDE trial are currently compiling the full outcomes of this ASD analysis and are expected to seek publication of the full data set later this year.
SOURCE Aesculap Implant Systems, LLC
Adjacent segment degeneration (ASD) is a condition that often occurs after a spinal fusion surgery. Adjacent segment degeneration affects the intervertebral joint(s) above and below the area of the spinal fusion surgery. Adjacent segment degeneration can occur anywhere along the spine.
Here is the clinical definition of Adjacent segment degeneration: A complication of spine surgery that can be seen on an x-ray, CT scan or MRI as changes in the motion segments above or below the surgery site.
No one knows for sure if spinal fusion surgery actually causes the adjacent segment degeneration. Of course there are many other factors at work in the development and progression of adjacent segment degeneration. For example, a 1999 study by Etebar published in the Journal of Neurosurgery looked at 125 spinal fusion patients in which rigid hardware was implanted to correct degenerative instability. The study found that post-menopausal women had an especially high risk for Adjacent segment degeneration!
What makes the Joints Degenerate when you have post Fusion Surgery Adjacent Segment Degeneration?
After a fusion surgery you will lose the ability to move your spine at the place where the spinal fusion procedure was done. This means you will no longer be able to bend forward, arch back, twist or tilt your spine at the specific level or levels fused by the surgery.
But that motion has to go somewhere in order to accommodate the things you do hundreds of times during a day, things like sitting, standing, walking, reaching, lifting and more.
Usually the motion goes to the joints next to or adjacent to the fusion surgery site.
You might say that adjacent segment degeneration is the result of extra wear and tear on the intervertebral joints above and below your surgery site. These joints now have to do double duty in order to make up for the immovable segments of your spine. Now they are subject to extra stress, and this will likely lead to degenerative changes.
Does Post Spinal fusion Adjacent Segment Degeneration Cause Pain?
While degenerative spinal changes associated with adjacent segment degeneration does show up on x-rays, they do not necessarily cause pain or other symptoms. Should symptoms emerge, however, your doctor may diagnose you with adjacent segment degeneration.
When Does Post Spinal fusion Adjacent Segment Degeneration Start?
Post Spinal fusion Adjacent Segment Degeneration takes time to develop. Studies evaluating the incidence of Post Spinal fusion Adjacent Segment Degeneration show that it may follow spinal surgery patients for up to 20 years. For example, studies show that people who have spinal fusion surgery when they are young most likely will develop Post Spinal fusion Adjacent Segment Degeneration as they age.
Will Post Spinal fusion Adjacent Segment Degeneration Add to My Medical Problems?
So what will your exact diagnosis be if changes are seen on your films after a spinal fusion? Unfortunately, there is not much research on this topic. A small study done in 1988 by Lee, published in Spine and involving 18 patients found that the most common type of degeneration in cases of Post Spinal fusion Adjacent Segment Degeneration was related to facet joint arthritis. Another study by Schlegel done in 1996, also published in Spine and involving 58 patients found incidences of spinal stenosis, disc herniation and spinal instability after spinal fusion surgery.
The good news is the presence of the degenerative changes in your spinal joints after a spinal fusion surgery does not necessarily mean you are not a candidate for Disc Replacement Surgery.
While some people do need a second surgery often Disc Replacement surgery can be done which will relieve the symptoms of Post Spinal fusion Adjacent Segment Degeneration and prevent further damage.
Disc Replacement Surgeon Dr. Karsten Ritter-Lang, with his team, presented a report on Outcomes for the Treatment of Degenerative Disc Disease in the Lumbar Spine Using Spinal Kinetics M6 Lumbar disc replacement implant at this year’s International Society for the Advancement of Spine Surgery, 15th Annual Conference.
This is the first clinical study to report on two year clinical and x-ray results of Artificial Disc Replacement surgery with the Spinal Kinetics M6 Disc Replacement implant. The results showed significantly decreased back pain, initial device safety and effectiveness when used for the treatment of lumbar degenerative disc disease at one or more lumbar spine levels
Artificial Disc Replacement technology has come a long way and thousands of spinal fusions are now being avoided. Improved artificial disc replacement implants now provide a natural “Quality of Motion” unlike the early ball-in-socket disc replacement designs.
So the question, Disc Replacement versus Fusion Surgery?
Some may ask, Why go through a Fusion Surgery when it is rarely even a good solution? Mostly because they will never be told about the option of Disc Replacement.
The Spinal Kinetics M6 is designed to replicate the structure and performance of a natural disc. Its innovative design incorporates an artificial nucleus to allow shock absorption and a woven fiber annulus for graded variable motion resistance in all directions.