In July, I presented at the 15^th annual International Meeting of Advanced Spinal Techniques.  I was honored to present two scientific papers at this medical education program.  One was about the US FDA IDE trial for the Bryan cervical disc replacement.  My second presentation was also about the Bryan cervical artificial disc replacement, and was a detailed motion analysis of the Bryan cervical disc. 

Here are links to the abstracts presented –“Radiographic Results from the BRYAN® Cervical Disc IDE Study,”and “Comparison of BRYAN Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized Controlled Clinical Trial.” 

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. 

In some of my blog entries, I have discussed surgical procedures for a herniated cervical disc.  These surgical procedures include spinal fusion and artificial cervical disc replacement.  The good news is that very few individuals with a herniated cervical disc require surgery.  It is projected that only about 5-10% of patients with a herniated cervical disc need surgery.

Many times medical management is an effective treatment for herniated cervical discs.  To learn more about the non-operative spine treatment options for a herniated cervical disc, click here.  This is an article that I wrote for Spine Universe, which outlines the non-surgical treatments for herniated cervical discs. 

In some of my blog entries, I have discussed surgical procedures for herniated cervical disc.  These surgical procedures include spinal fusion and artificial cervical disc replacement.  The good news is that very few individuals with a herniated cervical disc require surgery.  It is projected that only about 5-10% of patients with herniated cervical disc need surgery.

Many times medical management is an effective treatment for herniated cervical discs.  To learn more about the non-spine surgical treatment options for herniated cervical disc, click here.  This is an article that I wrote for Spine Universe, which outlines the non-surgical treatments for herniated cervical discs. 

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.  
 

On Friday the continuing medical education session will also be on spine surgery.  Dr. Rick Sasso, a spine surgeon with Indiana Spine Group, will discuss the indications and surgical options for the cervical patient.

Dr. Sasso’s discussion will:

§          Review traumatic and degenerative cervical pathologies.

§          Review the indications and considerations for cervical disc fusion and artificial cervical disc replacement.

§          Provide a brief overview of the surgical procedures and expected outcomes for cervical disc fusions and artificial cervical discs.

This continuing medical education program will also provide in-depth information on spine surgery – areas focused on will be lumbar surgery and cervical spine surgery. 

This session will be presented by neurosurgical spine surgeon Kenneth Renkens, MD, and will provide an overview of spine surgery procedures for the lower back and indications. 

Topics discussed will include:

 §     Identify and discuss the indications for common lumbar surgical  procedures, including decompression, lumbar spinal fusion and disc replacement.

For patient’s suffering from degenerative disc disease in the lumbar spine – surgical treatment options are either a lumbar spinal fusion or an artifical lumbar disc replacement.  The artifical lumbar disc has recently been approved by the FDA.

One spine surgical procedure that is an option to traditional spinal fusion is an artificial cervical disc replacement.  Today, there is one artificial cervical disc that has received FDA- approval and that is the Prestige Disc.  Additionally, there is the BRYAN cervical disc which has received preliminary FDA-approval. 

I have been involved in the clinical study of the BRYAN cervical disc – and have blogged about my involvement in this research.  Recently, I co-authored an article which summarized a 24-month follow-up study of patient’s that have received this BRYAN Cervical Disc. 

In this study, the outcomes of cervical arthoplasty (artificial BRYAN cervical disc) were compared to traditional spinal fusion surgery for the treatment of cervical radiculopathy and myelopathy. In a spinal fusion surgery, technically called ACDF (anterior cervical discectomy and fusion), the damaged cervical disc is removed and then bone is fused to the treated area to maintain stability.  With the artificial BRYAN cervical disc, the damaged disc is removed and the artificial cervical disc is inserted/implanted. 

This study concluded that cervical disc arthoplasty had similar results to the ACDF as defined by the standard outcome scores.  More long-term studies are needed, but preliminary results indicate that the BRYAN disc created less strain on adjacent discs than fusion and it is projected that cervical disc arthroplasty will result in minimizing adjacent disc degeneration. 

Approximately five years ago (May 2002), I performed the first artificial cervical disc replacement in the U.S.  (Read the press release about this procedure.)  As a physician who is involved in the research and development of minimally invasive spine surgery techniques – I was excited to be involved in this research study.  It is my opinion that the cervical artificial disc will be the new gold standard to the traditional fusion procedure. 

Here is more information about the cervical artificial disc.  When a patient suffers with a herniated cervical disc – also called a ruptured disc or slipped disc – traditionally the standard surgical treatment is a spinal fusion surgery.  With a fusion – the damaged cervical disc is removed and then a bone is grafted into place to stabilize the spinal area affected.  The bone used is synthetic or grafted from a second surgical site.  The patient then undergoes a long recovery period – a cervical collar is worn to immobilize the neck for a period of time, and the patient may have two surgical sites undergoing recovery (depending on the source of the bone graft).  Then following the recovery period – the patient may have some stiffness (decreased) mobility in the neck region. 

Now with a cervical artificial disc, the damaged cervical disc is removed – and the cervical artificial disc is inserted into this area.  The cervical artificial disc is designed to mimic the action of the original disc. Following this procedure, the patient returns to normal activities in a few weeks.  The advantages of this procedure are:  shorter recovery time, no cervical collar, one surgical site which reduces the chance for post-op infections/complication, and a shorter hospital.  Additionally, the patient’s mobility is not decreased – and neck movement is normal and not limited.  Needless to say, patients that are active and want to remain active love this alternative! 

To learn more about his procedure visit our web site or  call Indiana Spine Group at 317.228.7000.

Prior to talking more about cervical artificial discs – here is an overview of cervical herniated discs sometimes called bulging discs.  The cervical artificial disc is a surgical treatment option.  The cervical artificial spine surgery procedure provides a minimally invasive spine surgery treatment for herniated discs. 

Here is the definition - a herniated disc is where the soft center of the spinal disc “bulges” or breaks through the weakened part of the disc. This usually occurs in the lower part (lumbar area) of the spine, but can occur anywhere; i.e. in the cervical (neck) or thoracic (chest) areas of the spine.   This is also called a slipped, prolapsed or ruptured disc. 

Last summer, I was asked to testify at the FDA  hearing for the Bryan® Cervical Disc.  For the last five years, I had participated in the clinical trial for this cervical artificial disc.  This cervical artificial disc provides a surgical alternative to a traditional fusion in spine surgery.

Also testifying at this hearing, was one of my patients.  This patient was accepted into the trial and had the cervical artificial disc implanted in 2002.  Suffering from a herniated cervical disc – this procedure brought him much needed relief.  As an avid golfer – he was excited to be accepted into the trial.  Now, he can easily be found on area golf courses or sometimes water-skiing in area lakes. 

This cervical artificial disc did receive preliminary FDA approval at the hearing (July 2007).  Final FDA approval is expected sometime late in 2008.

Additionally, in July 2007 – the Prestige Cervical Disc did receive FDA approval.  Here is the link to the media release.

The Back Talk agenda is in the process of being finalized. 

Conference topics will include information about the diagnosis of spinal pain including spinal imaging.  There will also be presentations about medical and minimally invasive spinal therapeutics including the non-operative management of spinal problems and minimally invasive treatments. 


The section on spine surgery will address the appropriate timing for patient referrals for spine surgery and when surgery is an option.  Additionally, the surgery section will discuss surgical options for lumbar surgery and surgical options for cervical degenerative disc disease – including updates on cervical artificial discs. 

This past summer, the Prestige Cervical Artificial disc received FDA approval. 

Now patients who suffer from degenerative disc disease, that need surgical treatment, have a second option.  Patients no longer have to be accepted to a research study to receive a cervical artificial disc.