Artificial Disc Replacement

A recent blog entry highlighted articles about the cervical artificial disc, written by Dr. Rick Sasso  - a spine surgeon with Indiana Spine Group.

In this spine wellness educational video, Dr. Sasso discusses cervical artificial disc; the indications, overview of surgical procedure and the advantages of this procedure. 

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 
  

In October, I was a faculty member at the 8^th Annual Symposium on “Innovative Techniques in Spine Surgery.” This continuing education meeting, hosted in Phoenix, addressed the innovative and emerging technologies of spinal surgery including; arthroplasty, minimally invasive procedures, motion sparring technologies and biologics.  At this meeting I gave a talk on Lumbar Artificial Disc Replacement, and presented the results of the FDA studies for the Cervical Artificial Disc.

This education program was sponsored by the Organization of Spinal Teaching and Research.  The purpose of this group is to facilitate education and discussion among spine care providers and industry and this organization includes leaders in the field of spine surgery and technology that utilize the most advanced and effective technology available for the treatment of spinal disorders.

A lot of patients ask me about the differences with arthroplasty (cervical artificial disc) and spinal fusion; as well as how does the cervical artificial disc work. A few years ago, I was interviewed by Barbara Lewis on Sound Medicine. This segment titled, “New Artificial Cervical Discs”, can be heard by visiting this link. 

A few topics discussed during this interview included:

• Comparison of a spinal fusion to cervical artificial disc,
• More detailed information about the cervical artificial disc,
• Comparison of cervical artificial disc to artificial hip and knee,
•  The future of cervical artificial disc.

In my prior blog entry, I talked about the Bryan Cervical Artificial Disc study that has recently concluded.  To evaluate patient outcomes and functionality for this spine study, one measurement used was the neck disability index (NDI).  With this assessment, patients provide a self-evaluation and answer a series of questions of how their neck pain affects their ability to manage everyday life. 

Previously, I blogged about the research results of a spine patient study – which evaluated the clinical outcomes of patients who received a Bryan Cervical Disc compared to those that had a standard spinal fusion at 24-months post-operatively. I recently completed a new study, which evaluated these patients 48-months post-operatively. This study will soon be published.

In this study – the functional outcomes of patients at 48-months (4 years) following their spine surgery was evaluated. This study had two groups of patients – one group received a spinal fusion (Anterior Cervical Discectomy and Fusion - ACDF) and the other group received the Bryan cervical artificial disc prosthesis. This spine surgery was for the treatment of radiculopathy and myelopathy, after minimally invasive spine procedures were determined ineffective.

There were 47 patients enrolled in this spine study. Of this group, 21 were enrolled in the Bryan cervical disc arm of the study and their mean age was 40.  In the group that received a spinal fusion (control group), there were 26 participants and their mean age was 43.

This study concluded that patients that received the Bryan Artificial Cervical Disc at 48-months, when compared to the control group:

•     Had less neck and arm pain,
•     Greater mobility,
•     Less adjacent segment degeneration, and
•     Lower secondary operation rate.

At the 16^th International Meeting on Advance Spine Techniques physician continuing medical education conference in July, in addition to participating in various continuing education lectures (discussed in prior blog entry) I also presented an abstract that I co-authored. This abstract summarized a spine research study recently completed and is entitled, Blood Metal Ion Levels Following Implantation of an All-Metal Lumbar Intervertebral Disc Replacement.

The purpose of this study was to measure the level of metal ions in an individuals blood stream following the implantation of a metal device; the all-metal lumbar intervertebral disc. This study concluded, that after six months and one year following surgery, that most patients that participated in the study did not have measurable levels of metal ions (cobalt and molybdenum ions) in their blood streams following total disc arthroplasty with the lumbar intervertebral disc replacement.

One unique session for “Back Talk”, the continuing medical education symposium sponsored by Indiana Spine Group, will feature a hands-on component. During this session, entitled Hands-On | Surgical Case Studies, attendees will have the opportunity to get a first-hand look at spinal instrumentation, cervical artificial disc implants and other surgical devices used during spine surgery. Spine surgeons Kenneth Renkens, MD, and Thomas Reilly, MD, will lead this discussion. As they review the technology, they will discuss spine surgery case studies including diagnoses, recommended surgical interventions and expected outcomes.

For more information about Back Talk, and a complete continuing medical education conference agenda, click here.

An article in Science Daily entitled “Artificial Disc Replacement As Good or Better Than Spinal Fusion, Study Suggests”, highlights a published study that I co-wrote. 
 

In this article in Science Daily, co-author K. Daniel Riew, MD – a cervical spine surgeon at Washington University Orthopaedics and Barnes-Jewish Hospital, stated that one of the most important findings of the study was that people who received the Bryan Cervical Disc were able to preserve all of their motion.

 

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.  

In a recent blog entry, Indiana Spine Group announced the FDA approval of the Bryan™ Cervical Disc. This cervical artificial disc, provides spine surgeons an alternative device for implantation when performing cervical arthroplasty.  In 2007, the Prestige Disc received FDA approval. In a recent press release, Dr. Rick Sasso stated that “The Bryan Cervical Disc more closely mimics natural spine disc movement with shock absorbing characteristics than a previously approved device.”

Indiana Spine Group is excited to announce that we are one of the providers of this latest technology. At this time, physicians with Indiana Spine Group are the only ones using the Bryan Cervical Disc in cervical arthroplasty in Indiana. 
 

Dr. Rick Sasso, a spine surgeon with Indiana Spine Group, was a principal investigator in the clinical trials for the Bryan Cervical Disc.  Additionally, Dr. Kenneth Renkens was an investigator in this trial. Dr. Renkens is a neurosurgical spine surgeon with Indiana Spine Group. 

To learn more about the Bryan Cervical Disc, click here.  
 

For more information or to schedule an appointment, call 317.228.7000 or
toll-free 866.947.7463.    

In September, Indiana Spine Group is sponsoring a continuing medical education symposium entitled “BACK TALK: Comprehensive Concepts in the Diagnosis and Treatment of Spinal Disorders”. At this conference I will be providing a few talks – one is on spine surgery; specific to the cervical spine surgery patient. The other talk is on the future of spine care. 

During the cervical spine surgery talk, I will be discussing the cervical pathology and diagnoses indicative for spine surgery – both degenerative and traumatic. Additionally, I will discuss common cervical spine surgical procedures, their indications and expected outcomes.

In the talk about the future of spine care – I will review the latest FDA-approved technologies and treatments. Additionally, I will discuss interventional and surgical innovations that are either in development or clinical trials. Additionally, this presentation will provide highlights about the cervical artificial discs; i.e. the Prestige™ artificial disc and the Bryan™ artificial disc. 

In March, I attended and presented at the annual continuing medical education meeting of the American Association of Neurological Surgeons in Phoenix. This meeting was entitled,  The Backbone of Spinal Surgery: Evidence, Appraisal and Advocacy. At this meeting, I co-presented a special course entitled – New Developments in Arthroplasty. 

The overall objective of this course was to review the indications for cervical and lumbar arthroplasty. (Arthroplasty is the procedure that utilizes a cervical artificial disc or lumbar artificial disc – and this artificial disc is used as an alternative to spinal fusion). 

The overall course objectives were as follows:

·         Have an understanding of the indications and contraindications for arthroplasty.

·         Discuss the associated complications and management strategies for them.

·         Gain a better understanding of the biology and biomechanics of the devices.
 

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.

Another study that I participated in has recently been completed, and the results published. This study compared the results of Bryan artificial disc replacement to anterior cervical fusion, two years following spine surgery. This study is entitled, Artificial Disc versus Fusion | A Prospective Randomized Study with 2-Year Follow-up on 99 Patients.  

This study evaluated 99 patients for a two-year period. Patients were from three spine surgical centers that were involved in the US FDA Investigational Trial for the Bryan artificial cervical disc. One of the centers involved in this investigational trial was Indiana Spine Group. I was honored to implant the first Bryan cervical artificial disc in the US, in May 2002.