In May 2009, the Bryan Cervical Artificial Disc received FDA approval.  This approval was previously written about in Dr. Sasso’s blog.  The cervical artificial disc provides an alternative spine surgical treatment for cervical degenerative disc disease.

Dr. Rick Sasso, a spine surgeon with Indiana Spine Group, has been a principal investigator in the studies with this spine surgical device – the Bryan Cervical Disc.  A few of abstracts of his published research studies regarding the cervical disc are available on the U.S. National Library of Medicine / National Institutes of Health web site. 

These include:

• Cervical kinematics after spinal fusion and bryan disc arthroplasty 
  
• Motion analysis of bryan cervical disc arthroplasty versus anterior discectomy and spinal fusion: results from a prospective, randomized, multicenter, clinical trial 
  

I was recently interviewed for a news story that announced the FDA approval of the Bryan™ Cervical Disc. The Bryan Cervical Disc is an artificial disc used in cervical arthroplasty. 

This story also appeared on their web site which generated a few reader’s comments/questions. This blog entry – will address some of those questions. 

Blogger question: Can it be used in the lower back?

The Bryan Cervical Disc can only be used in the cervical (neck area) spine. There are two FDA approved artificial discs for the lower back (lumbar spine). They are: CHARITE Artificial Disc, approved by the FDA in 2004 and the ProDisc. Artificial lumbar discs are a surgical option for some patients who are being treated for degenerative disc disease or other related spinal conditions. These links provides more information about the artificial lumbar disc - (article one and article two).

Blogger question: Does this work for someone who has had a fusion done 10 years ago?

The answer to this is no. When a spinal fusion is performed, two bones are “fused” together; meaning that they are attached. In that this procedure is done with the goal of a permanency – it can not really be undone to have cervical arthroplasty performed. 

In blog discussions about the cervical artificial disc, specifically the Bryan Cervical Disc, it was announced that this disc has now received FDA-approval.  One key advantage of cervical arthroplasty and the Bryan Cervical Disc is that patients maintain their natural neck motion as compared to a spinal fusion. (Spinal fusion is the current standard spine surgical treatment for degenerative disc disease.)  

A study that I participated in and co-authored, specifically evaluated the patient’s motion – comparing post-operative neck motion. Patients who received the Bryan Cervical Disc in cervical arthroplasty were compared to those that underwent a spinal fusion and anterior discectomy. 

In a prior blog, the recent FDA-approval of the Bryan Cervical Disc ™ was announced. One of the advantages of this device and cervical arthroplasty, as a spine surgical treatment for degenerative disc disease, is that patients can return to work and their normal activities in a relatively short period of time. Generally, this time period is quicker when compared to a spinal fusion – which is the current standard spine surgical treatment to this newer procedure and technology. At this time, spinal fusion is the standard surgical treatment.

A study recently published in Neurosurgery, concluded that patients that underwent cervical arthroplasty returned to work on average about three months sooner than those patients that underwent a spinal fusion and cervical discectomy. The patients who received the cervical artificial disc returned to work in a median time frame of 101 days following their spine surgery (cervical arthroplasty) as compared to 222 days in the group that underwent the spinal fusion and cervical discectomy.  

This blog entry will highlight Rapp Medical Systems Inc. | Medtronic Spinal & Biologics, a silver sponsor of Back Talk. Back Talk is the continuing medical education program that Indiana Spine Group is sponsoring for primary care physicians and practitioners. 
 

Rapp Medical Systems Inc. is a local medical product distributorship representing Medtronic Spinal and Biologics. Working with physicians, their mission is to provide superior products and service which will enable our physician partners to provide the highest level of patient care possible.

Medtronic Spinal and Biologics, is a division of Medtronic which focuses on spinal and  musculoskeletal therapies. Their key product areas include:

• Minimal Access Spine Technologies (MAST™) for treating painful conditions of the spine, such as degenerative disc disease.
• Fusion systems¹ that correct and stabilize abnormal spine curves.
• Artificial cervical discs² to replace damaged or degenerated discs in the neck. Our latest disc is made of surgical-grade stainless steel and allows motion so patients can go back to doing everyday activities they love.
• Infuse^® Bone Graft,³ a biologic that stimulates the body to regrow bone and is used to treat certain spinal, tibial, and maxillofacial conditions. Infuse Bone Graft eliminates the need to harvest bone from another area of the patient's body, thus eliminating an additional, often painful, surgery.

For more information, visit Medtronic Spinal and Biologics and for consumer education information visit their patient education site. 

In this study, patients diagnosed with cervical radiculopathy or myelopathy that required surgical intervention were randomly selected. Patients either had cervical artificial disc (Bryan artificial disc) or anterior cervical discectomy and fusion. The study then followed the patients for two-years to determine their functional outcome and radiographic results. 

In summary, this study concluded that the Bryan artificial disc replacement was a comparable surgical alternative to an anterior cervical discectomy and fusion for patients suffering with 1-level cervical disc disease. (1-level is where only one of the spinal discs is affected). Following surgery, both groups showed improvement in their functional outcomes. In respect to the patient’s range of motion, at two-years – those patients that underwent the Bryan artificial disc replacement had a greater range of motion than those that underwent the anterior cervical discectomy and fusion. This study did demonstrate that the artificial disc replacement is a comparable procedure to the spinal fusion. Further studies are underway, to determine longer term results of this investigational device.

Recently, I had the honor of being the co-chairman of an annual spine meeting hosted by the American Academy of Orthopaedic Surgeons.  The focus of this meeting was “Contemporary Techniques in Spinal Surgery 2008”.

At this meeting I gave presentations on spinal decompression and reconstruction techniques, including; ACDF, corpectomies and struts.  I also presented information that compared the cervical artificial replacement procedure with the spinal fusion.  Additionally, I was a lab instructor – which provided hands-on training to orthopaedic surgeons. A few procedures reviewed included X-Stop – a procedure which utilizes a device in spine surgery for lumbar spinal stenosis; XLIF – this is a minimally invasive spine surgery procedure used to treat back pain that is caused by degenerative disc disease. 

In the recent issue of Spine, an article that I co-wrote was published. This article is entitled, Comparison of BRYAN Cervical Disc Arthoplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

This article summarizes the results of a two-year clinical research study, following spine surgical patients that either had a spinal fusion or a cervical artificial disc implanted.  In conclusion, the study showed that cervical disc arthoplasty is a viable spine surgical alternative for patients suffering from single-level cervical disc disease.  

For more information, here is the abstract to the study.

A recent question that was received from a reader, was in respect to spine reserach.  They asked about stem cells in the treatment of degenerative disc disease.  Here is the link to the blog comment  entitled Stem Cells Can Aid Spinal Disc Repair that was referenced.  This appeared on The Washington Times' web site. 

At this time stem cell technology for degenerative disc disease is in the very early research stage. There are no current available spine treatment options for this technique. There are some researchers that are even very concerned about the future of this technology for this problem for many different reasons.

Physicians with Indiana Spine Group are actively involved in research.  The goals of the research that they participate in are to develop minimally invasive surgical techniques, and to identify and develop minimally invasive procedures that allow the patients to return to normal activities as quickly as possible.

A few research projects that Indiana Spine Group has participated in include:

Lumbar Disc Implant – Drs. Rick Sasso (a spine surgeon with Indiana Spine Group) and Kenneth Renkens (a neurosurgical spine surgeon with Indiana Spine Group) participated in the FlexiCore lumbar disc study.  Used to treat degenerative disc disease, the lumbar disc implant replaces the damaged disc. This procedure is an alternative to a spinal fusion.

Percutaneous Reference Frame (PRF) – Dr. Rick Sasso developed this devise that improves the capability for spine surgeons to perform minimally invasive spine surgery.  By the use of an infrared camera and the PRF - this allows spine surgeons exact placement of spine surgical instruments – with less of an incision. This technology has been referred to as “global positioning of instrumentation” – and it works similar to the GPS technology used in cars.

Cervical Artificial Disc – Drs. Rick Sasso and Kenneth Renkens also participated in the study for the Bryan Cervical Disc, and performed the first cervical artificial disc implant in North America in 2002.  This cervical artificial disc has received preliminary approval from the FDA last summer. 

Electrothermal Disc Decompression (EDD) and Intradiscal Elctrothermal Therapy (IDET) Studies – Dr. Kevin Macadaeg, a minimally invasive spine specialist with Indiana Spine Group, participated in this study that evaluated the effectiveness of EDD and IDET to treat lower back pain and sciatica.  These treatments use a heat coil, which is inserted via a catheter in the disc of the spine.

In previous blogs, I have referenced the exciting research that was summarized in a recent article on cervical artificial discs.  Again, this is an alternative spine surgery procedure to spinal fusion as a treatment for degenerative disc disease.  This information was also presented at the Back Talk physician symposium sponsored by Indiana Spine Group.

Spinal fusion, which is considered the “gold standard” spine surgical treatment for degenerative disc disease has a few disadvantages.  One key disadvantage is the degenerative of the adjacent cervical discs over time.  The other is the complications that are associated with the site of the bone graft used in the spinal fusion; the iliac crest bone (hip bone). 

It is projected, that as a result of motion preservation with the cervical artificial discs that this will prevent or delay adjacent disc degeneration.  These initial results are exciting, and as studies are completed and results reported, I will continue to provide updates on my blog. 

The advancements and preliminary research results for cervical artificial disc replacements as an alternative spine surgical treatment for degenerative disc disease are promising.  When spine surgery is required for degenerative disc disease, the traditional procedure has been a spinal fusion.  This has been considered the “gold standard” of treatment.  I predict that in the future, the “gold standard” of surgical treatment of certain types of cervical radiculopathy caused by a herniated disc will be a cervical artificial disc rather than a spinal fusion. 

A recent article that I co-wrote, provides an overview and summary of the different cervical artificial discs that are currently being used in FDA-trials.  The Prestige Disc was approved last summer (2007).  Also last summer, the BRYAN cervical artificial disc received preliminary FDA-approval and the Prodisc-C was approved earlier this year.

In continuing my blog entries on the lumbar spine and degenerative disc disease, I will answer some frequently asked questions by my patients.

What is lumbar degenerative disc disease?
Generally speaking, degenerative disc disease is the result of the normal aging process.  This is where the disc becomes more brittle and less flexible.  When the discs of the lower back are affected, this is referred to lumbar degenerative disc disease.  Often this results in lower back pain. 

 Technically called invertebral discs, spinal discs are discs found between each vertebrae that act as a cushion..  The spinal discs are what helps maintain the position of your spine, as well as allows motion between each vertebrae.  Sometimes they are called the “shock absorbers” of the spine - in that they compress with weight, and spring back when weight is removed. 

Anatomically, the discs are flat and round – and less than an inch thick.  The outer shell is a tough tissue and this is called the annulus fibrosis.  This tissue is filled with a jelly like consistency fluid that is called the nucleus pulposus.  Cartilage then connects the spinal discs to the vertebrae. 

Even though degenerative disc disease is a part of the aging process, everyone ages differently and no - everyone does not get degenerative disc disease. 

In addition to aging, wear and tear can also cause degenerative disc disease.  There are many lifestyle factors that can affect the health of the spinal discs.  For example, for individuals who are over weight; this would increase the stress on the spine.  Additionally, someone who has a job that requires heavy lifting – this can increase their risk for degenerative disc disease.  In some instances, trauma can lead to degenerative disc disease – lumbar or cervical. 

This blog entry is in response to a reader comment where they wanted more information on the Prestige Cervical Artificial Disc that was approved by the FDA last summer.  Here is a link to an article that I wrote for Spine Universe.  This article discusses cervical artifical discs that are used as a spine surgical treatment for degenerative disc disease.  Additionally, here is a link that provides more specific information about the Prestige Cervical Artifical Disc by the manufacture. 

This blog entry is in response to a recent comment where I was asked if there was a clinical study for a lumbar artificial disc.  The answer to that question is yes.  Currently I am participating in a FDA-approved clinical trial for the Flexicore artificial lumbar disc.  This lumbar artificial disc is a metal on metal disc used as a spine surgery treatment option for lumbar degenerative disc disease.  Here is a link to an abstract of a recent article published an article in Spine. I co-authored this study entitled, Prospective, Randomized Trial of Metal-on-Metal Artificial Lumbar Disc Replacement: Initial Results for Treatment of Discogenic Pain.

To find out more about this study and participant criteria, my research nurse can answer your questions.  Please call our office at 317.228.7000 and ask to speak to Dr. Sasso's research nurse. 

This blog entry will highlight more frequently asked questions about degenerative disc disease.

Q: How do you treat degenerative disc disease?

A:  The most common treatment for degenerative disc disease is non-operative treatment.  Usually, it gets better with rest - in a few days to a week. If necessary, people will get steroid injections to help eliminate the back pain.

Unfortunately, in some cases it does not resolve itself with non-operative treatments - especially if it's associated with weakness or tingling. Approximately, 200,000 people in the United States each year will undergo spine surgery for degenerative disc disease.  The goal of this spine surgery is to take the pressure off of a nerve in the neck.

Q: What does that operation consist of?

A: The standard spine surgery procedure for degenerative disc disease is a spinal fusion.  This is where we take the pressure off the nerve and then fuse that segment. The main disadvantage of the spinal fusion is that when we fuse a disc, there may be a quicker wearing out of those discs next to the fused disc.  Once a patient has a fusion, there is about a 30 percent chance, that in the next 10 years the patient will need a spinal fusion at a different disc level.

A:  Is there an alternative procedure to a spinal fusion for the treatment of degenerative disc disease?

Q:    Over the decades, medical researchers have been trying to develop artificial discs that would allow continued normal motion across that segment – a mobile disc.  Needless to say, it is s a lot harder than the development of an artificial hip or knee.

Fortunately, there has been great success in this development.  Just last summer, the Food and Drug Administration approved a surgical cervical disc replacement and recommended approval for another cervical disc.  (To see FDA announcement, click here.)  Additionally, there are many more similar devices under development.  
 

Last year, I was interviewed for an article in The Indianapolis Star.  This interview was by health reporter Shari Rudavsky.  This interview was about degenerative disc disease. 

The following are a few of the common questions about degenerative disc disease, which were asked during this interview.

Q:  How common is degenerative disc disease?

A:  Degenerative disc disease is quite common, especially in people in their 30’s and 40’s.  It is one of the main reason’s that people see their family doctor.

Q:  What causes degenerative disc disease? 

A:  Usually this occurs from normal degenerative changes as a result of aging. The discs in the spine are specialized joints.  Just like a knee or hip that can get arthritic, the disc can also get arthritis.  A common analogy used for the spinal discs is a jelly doughnut.  The inside is soft and it is surrounded by a shell.  When this outer shell tears, the degenerated pieces can extrude through this shell (outer covering) and then sit on the nerves on the spinal cord.

Q: What are the symptoms of degenerative disc disease?

A: The most common symptoms are neck and arm pain that radiates down the arm, below the elbow, down to the hand, associated with weakness and tingling.

Spinal disorders such as spinal stenosis, excessive kyphosis, vertebral fractures, degenerative disc disease or other spinal disorders – can sometimes affect more than one vertebrae level of the spine.  In instances where surgery is necessary, this can provide a challenge to spine surgeons.