Bryan Artificial Disc Study

Friday, May 14, 2010 by Rick Sasso, MD

One spine surgery research study that I participated in - compared the post-operative results of cervical arthroplasty and arthrodesis on approximately 500 patients. The objective of this study was to compare any side effects of patients undergoing a cervical arthroplasty with the implantation of a Bryan Cervical Artificial Disc to those patients that underwent a spinal fusion.

In this study, of which there were 31 institutions where patients underwent spine surgery, there were 242 patients who received the Bryan Cervical Artificial Disc and 221 patients that underwent cervical discectomy and spinal fusion. Patients that participated in this study were over 21 years of age, had single level cervical degenerative disc disease causing radiculopathy or myelopathy as well as a few other clinical indicators. Once identified, these patients were evaluated before spine surgery and post-operatively at regular intervals beginning one and one half months following spine surgery up to 2 years. 

This study concluded that both procedures are safe, and that there is not a significant difference in adverse effects with the newer arthroplasty procedure utilizing the Bryan Cervical Artificial Disc when compared to the traditional surgical option of spinal fusion.

 To read the complete study,link here.

More About Back Talk Educational Tracks

Wednesday, April 21, 2010 by Indiana Spine Group

At Indiana Spine Group’s Back Talk continuing medical education symposium, as highlighted in a previous blog entry , there are two educational tracks that will be available for conference attendees on day one.  In addition to the general track discussed in the prior blog, there is a more in-depth track entitled, More Specifics | Spinal Diagnostics and Treatment. 

 

In this education track there will be a few sessions focusing on the diagnosis of spinal disorders and abnormalities.  One session titled Spinal Imaging | Technology and Diagnosis, will be presented by Stephen Pomeranz, MD. Dr. Pomerance is a radiologist. In this session, Dr. Pomeranz will provide an in-depth look at spinal imaging technologies and highlight the latest developments in spinal imaging technology and their applications in spinal diagnostics.  Additionally, using case studies, he will review radiological finds and diagnostic indicators. 

The second session of this educational track will focus on
The Electrodiagnostic Evaluation, and will be presented by physical medicine and rehabilitation specialist Dr. Shashank Dave.  During his presentation, Dr.Dave will discuss the role and application of electromyography in the diagnosis of spinal disorders and diseases.  Additionally, he will review case studies which utilize electromyography and identify specific diagnoses. 

 

Another session presented for the in-depth track will focus on Diagnostic and Therapeutic Injections of the Spine.  This will be presented by minimally invasive spine specialist John Arbuckle, MD.  During this session Dr. Arbuckle will review and differentiate between the different type of therapeutic injections and will review the treatment efficacy of injections, the clinical protocols, indications and expected outcomes. 

 

The last session of this continuing education track will highlight spine surgery, and is entitled Surgical Perspectives | Fusion vs Arthroplasty, presented by spine surgeon Rick Sasso, MD.  During this session, Dr. Sasso will provide a detailed analysis of spinal fusion and arthroplasty and he will discuss motion preservation modalities for the treatment of generative disc disease.  He will highlight lumbar and cervical artificial discs as well as review research studies and discuss patient selection, indications and expected outcomes. 

 


Spine Wellness Tips

Monday, February 22, 2010 by Indiana Spine Group

The next series of blog entries will focus on a few spine wellness tips.  Simple solutions that provide health benefits to your spine. 

 

One popular New Year’s resolution is to go on a diet and lose weight.  Losing weight provides many health and wellness benefits, including spine wellness.  Did you know that obesity is one contributing factor to back pain? 

 

Being overweight can significantly contribute to symptoms associated with osteoporosis, osteoarthritis (OA), rheumatoid arthritis (RA), degenerative disc disease (DDD), spinal stenosis, and spondylolisthesis.  Talk to your physician to get help with starting your weight loss journey.  Successful weight loss takes a combination of eating right, exercise and family/ social support. For additional information about protecting your spine while dieting, link here to this spine wellness fact sheet.

Spine Wellness Tip #1: Drop Some Pounds 

Cervical Artificial Disc

Monday, January 11, 2010 by Indiana Spine Group

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:


Blogger Questions

Friday, July 24, 2009 by Rick Sasso, MD

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. 


Keeping The Motion – Bryan Cervical Disc

Tuesday, July 7, 2009 by Rick Sasso, MD

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. 

 

This study indicated that the patients that underwent the cervical arthroplasty procedure retained significantly more motion than those that received the spinal fusion. At 24-months the average range of motion for the patients in the cervical arthroplasty group was 7.95 degrees, as compared to 0.87 degrees for the patients in the spinal fusion group. Link here to read an abstract of this study, which was published in the Journal of Spinal Disorders and Techniques

Back to Work

Thursday, July 2, 2009 by Rick Sasso, MD

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.  


Bryan Cervical Disc - Artificial Disc Story

Thursday, July 2, 2009 by Indiana Spine Group
Recently, Dr. Rick Sasso was interviewed by the Indianapolis Star.  This story was about the Bryan Cervical Disc (cervical artificial disc), that was recently approved by the FDA.  Additionally, the first patient to receive the Bryan Cervical Disc in the United States was interviewed. 

The Bryan Cervical Disc is used in cervical spine surgery as one of the cervical artificial disc options during arthroplasty.  Arthroplasty is a new spine surgical treatment option for degenerative disc disease. To learn more about the Bryan Cervical Disc, click here

Here is a link to the story on INDYSTAR.com - interviewing Dr. Rick Sasso. 

Bryan Cervical Disc - Receives FDA Approval

Thursday, May 28, 2009 by Rick Sasso, MD
The Bryan Cervical Disc has received FDA approval.  This approval, received in mid-May, was just announced on the FDA web site.  For a link to this approval, click here.

I am excited to have been involved with the clinical trials for the Bryan Cervical Disc.  I implanted the first Bryan Cervical Disc in the United States in 2002.  Since that time, I have been involved in these clinical trials.  I recently co-authored a study - which following spine surgery patients that received the Bryan Cervical Disc for a two-year period. 

The Bryan Cervical Disc is a cervical artificial disc that is used in cervical arthroplasty.  Cervical arthroplasty, is a newer spine surgery that is an alternative to traditional spinal fusion surgery.  For patients that suffer from cervical degenerative disc disease, when medical management is ineffective, cervical arthroplasty may be indicated.

With cervical arthroplasty the damaged cervical disc is removed, and the cervical artificial disc is implanted.  The advantage of this procedure over the standard spinal fusion is that patients are able to maintain their normal neck motion.   

Rapp Medical Systems Inc. | Medtronic Spinal & Biologics

Friday, April 17, 2009 by Indiana Spine Group



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. 


Part Two : More About the Study and Results Overview

Monday, March 30, 2009 by Rick Sasso, MD

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.

 

Presentation - Cervical Degenerative Disease

Thursday, March 19, 2009 by Rick Sasso, MD
I recently gave a presentation at the annual American Association of Orthopaedic Surgeons meeting.  This meeting was held in February in Las Vegas. I was a co-presenter of an instructional course entitled, "The Degenerative Cervical Spine:  What You Need to Know".  During this lecture we reviewed the different treatment options for cervical degenerative disease - their indications and effectiveness.  This discussion included a  review of the spine surgery options and indications including the cervical artificial disc. 

American Association of Orthopaedic Surgeons Meeting

Wednesday, February 25, 2009 by Rick Sasso, MD

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. 

Definitions

Friday, February 6, 2009 by Rick Sasso, MD

In an earlier blog, I talked about the AO Spine International meeting that I presented at in December. With this blog entry, I wanted to define a few of the terms that were used. These were spine surgery topics that I presented on.

 

One term is cervical myelopathy. In defining cervical myelopathy – first I will define myelopathy. When the word myelopathy is used it refers to any condition that affects the spinal cord. Therefore cervical myelopathy is a condition of the cervical (neck) area of the spinal cord. In respect to cervical myelopathy it means that there is compression on the spinal cord that is either a result of disc herniation or spinal stenosis. Cervical myelopathy is a degenerative spine disease that is more common in the elderly. 

 

Another term used in the blog entry was cervical radiculopathy. The term radiculopathy refers to a disease of the spine nerve roots and spinal nerves.  Cervical radiculopathy is when a spinal nerve root in the neck (cervical) is compressed and/or irritated. This can be caused by disc herniation, spinal stenosis or other degenerative spine disorders. 

Cervical Artificial Disc

Thursday, January 29, 2009 by Rick Sasso, MD

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.

Reader Question

Friday, January 9, 2009 by Indiana Spine Group

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.

Indiana Spine Group and Research

Monday, October 27, 2008 by Indiana Spine Group

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 ImplantDrs. 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) StudiesDr. 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.

More About Cervical Artificial Discs

Friday, September 26, 2008 by Rick Sasso, MD

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. 

Cervical Artificial Disc

Friday, September 26, 2008 by Rick Sasso, MD

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.

The Lumbar Degenerative Disc Disease Defined

Tuesday, July 29, 2008 by Rick Sasso, MD

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. 

  

What exactly are spinal discs?

 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. 

 

So, do all old people have degenerative disc disease?

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.