In July, I presented at the 15th 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. 


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.  
 

In Indianapolis, Indiana Spine Group did the first artificial cervical disc in the United States over five years ago, and we've been involved in these trials.  Studies have concluded that the functional outcomes for these patients are better, and that they are able to return to their normal activities quicker. 

One newer treatment option for lower back pain is Intradiscal Electrothermal Therapy (IDET).  This minimally invasive treatment uses heat energy delivered to the affected disc.  During the procedure, a heat coil is inserted into the disc of the spine by the use of a catheter that is guided by X-ray.  The coil is heated to a temperature slightly below that of boiling water.  This heat energy destroys the nerve endings that have been found to grow inside of painful, torn discs, therefore eliminating the cause of the back pack.

 

This minimally invasive IDET procedure is used for the treatment of lower back pain that is a result of spinal disc damage (tears or small herniations in the lumbar disc).  Prior to the procedure, testing is performed to clearly identify the affected disc and to confirm the diagnosis. 


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.

 

To review a study that I co-authored, Propsective, randomized trial of metal-on-metal artifical lumbar disc replacement:  Initial results for treatment of discogenic pain, which reviewed the spine surgery outcomes between lumbar artifical disc and spinal fusion – click here.

The overall purpose of this study was to compare the surgical outcomes of a FlexiCore lumbar disc replacement compared to a standard spinal fusion.  Patients treated had single level degenerative disc disease and had undergone six months of conservative medical management but still had lower back pain which was incapacitating. 

 

Conservative minimially invasive treatment options for degenerative disc disease can include epidural injections, physical therapy, acupuncture and spinal manipulation (chiropractic care).  The goal of these treatments is to minimize and/or eliminate the lower back pain that is caused by degenerative disc disease.

 

This study concluded that lumbar artifical disc replacement, with the FlexiCore metal-on-metal intervertebral disc prosthesis, compared favorably with the spinal fusion - which is the current standard back surgery treatment option for degenerative disc disease.


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. 

 

Here is the link to the article that I co-wrote. This article provides more information about cervical herniated discs.  

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.


Mark Your Calendar - Indiana Spine Group 

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. 


People with back problems – may have more than just back pain.  Sometimes, if you suffer from leg pain – this can be related to your spine.  If a person has ongoing leg pain that is persistent and increases as you lift your knee to your chest or bend over – it could be related to your back.  One back problem – that causes a shooting pain down your leg referred to as “sciatica” is lumbar radiculopathy. 

 

Lumbar radiculopathy is most often the result of nerve compression due to a lumbar disc herniation.  The pain is caused by the compression of the roots of the spinal nerves. This damage or herniated disc is often the result of wear and tear – or degeneration (degenerative disc disease).  To learn more about the diagnosis of lumbar radiculopathy and diagnosing back pain – click here.

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.

 

Here is a link to an article that I wrote for Spine Universe – about the Prestige Cervical Disc and Cervical Artificial Disc replacement