Indiana Disc Replacement

Congratulations to Rick Sasso, MD, a spine surgeon with Indiana Spine Group, on his recent patent assignment. This patent, filed in 2007 was approved in September 2011. US Patent number 8.016,831 is for” instruments and techniques for guiding instruments to a spinal column.”

This patent is related to spine surgery instrumentation and  techniques for anterior cervical discectomy and spinal fusion, as well as safely and accurately placing cervical artificial discs replacements into the intradiscal space. For more detail about this patent, visit this link.

Congratulations to Rick Sasso, M.D., Indiana Spine Group spine surgeon, for his recent publication of a chapter in Rothman Simeone The Spine – 6^th edition. Dr. Sasso co-authored a book chapter on “Cervical Disc Replacement”.

The Spine provides spine surgeons a continuing medical education resource to help them achieve optimal outcomes in the clinical practice of spine surgery for adults and pediatric patients. This resource includes chapters contributed by international experts on spine surgery, and highlights state-of the-art treatments and surgical techniques.

For more information about this resource, visit .

While at the American Association of Neurological Surgeon’s continuing medical education meeting in Phoenix, in addition to being a faculty member for a course on cervical myelopathy (previously blogged about), I was also a co-author for other research presentations.

These podium presentations included:

• Factors Associated with the Occurrence of Perioperative Complications in the Treatment of Cervical Spondylotic Myelopathy Based on 302 Patients from the AOSpine North America Cervical Spondylotic Myelopathy Study

• Cervical Disc Replacement: Interim Five-year Follow-up Results from the United States Prospective Randomized Bryan Clinical Trial

• Functional and Quality of Life Outcomes in Geriatric Patients with Type II Odontoid Fracture: One-Year Results from the AOSpine North America Multi-Center GOF Prospective Study

 For more information about this meeting, visit this link.

I co-authored a book chapter on “Cervical Disc Replacement”, that has been recently published in Rothman Simeone The Spine – 6^th Edition.

The Spine is a continuing medical educational resource for spine surgeons and highlights state-of-the-art spine treatments and spine surgery techniques. In addition to the text, there is also a video resource for physicians highlighting different surgical techniques and procedures.

Some sections of this book include: Basic Science, Spinal Diagnosis, Surgical Anatomy and Approaches, Thoracic and Lumbar Disc Disease, Minimally Invasive Surgery, Spinal Stenosis, Spinal Fusion and Instrumentation and more. For more information about The Spine and a table of contents, visit this link.

A recent blogger submitted a few questions about degenerative disc disease, and asked about treatment options for the lumbar spine. 

The blogger asked the following:

What about dynamic stabilization devices as an alternative to lumbar fusion? I have been doing some online research, hoping to get plugged into a 522 study, or otherwise explore whether insurance might cover something like this in my situation. (2 degenerating discs.)

Paul Kraemer, MD, a spine surgeon with Indiana Spine Group responded to these questions.

First, there is no perfect treatment for degenerative discs. The technology of motion stabilization is still very much in its early infancy, and at this point that is probably not the best solution.

There are two categories of implants that exist, disc replacement and motion stabilization, but trials have had problems and neither is currently being implanted.  One motion stabilization implant, sought to minimize motion of the disc to prevent pain and decrease revision surgery, but no definitive proof for either of those claims exists, and they have run into recent trouble with the FDA for their longer term data. Another motion stabilization concept, facet replacement devices are motion preservation devices aimed at facet joints, and at least one recent trial was ended early by the FDA.

Disc replacement in the lumbar spine has been done for over 20 years and works well in appropriately selected patients.  This procedure is FDA approved, but insurance companies frequently refuse to acknowledge convincing data. The results for this surgery seem very reproducible, but it’s only approved for single level disease with healthy facet joints.

All of this skips over the point that back surgery is usually not the first or best answer for back pain, and many people with degenerative discs have little or no pain. It's always recommended to talk to a spine surgeon to see what your specific treatment options are.

In respect to web sites that provide spine specific information – a few very popular sites are Spine Universe and Spine Health.  

In addition to the talks previously highlighted in prior blogs, I also gave a few talks on the cervical spine at the annual American Academy of Orthopaedic Surgeons continuing medical education meeting. One Instructional Course lecture, where I served as faculty, focused on the degenerative cervical spine and was entitled, “The Degenerative Cervical Spine: What You Need to Know”.  This talk focused on the evaluation and treatment options for the degenerative spine and it addressed anterior and posterior spine surgery options, as well as non-operative treatment options.

The other talk was a Podium Presentation of the research results for the five-year study of the Bryan Cervical Artificial Disc. This continuing medical education presentation was entitled, “Cervical Disc Replacement: Five Year Follow-up from the U.S. Prospective Randomized Bryan Trial”.  This link provides an overview of the initial results of this study – which followed spine surgery patients post-operatively for five years. Patients evaluated either underwent spinal fusion or arthroplasty (cervical artificial disc).

Blog Entry: Annual AAOS Meeting

In February, Drs. Rick Sasso, and Paul Kraemer presented at the annual continuing medical education meeting of the American Academy of Orthopaedic Surgeons in San Diego.

Drs. Kraemer and Sasso co-presented a talked entitled, “Differentiating Cervical Spine and Shoulder Pathology: Common Disorders and Key Points of Evaluation and Treatment.” Additionally, Dr. Sasso co-presented other talks, of which a couple were: "The Degenerative Cervical Spine: What You Need to Know," and "Cervical Disc Replacement: Five Year Follow-up from the U.S. Prospective Randomized Bryan Trial." For a complete, continuing medical education program, visit this link.  

A prior study published, evaluated patients two years following spine surgery and their participation in the Bryan Cervical Disc Trial. In addition to this study, a more recent study I participated in evaluated Bryan Cervical Disc study patients five years following their spine surgery.

This study concluded that patients still continued to have excellent spine surgical outcomes five years postoperatively in both study groups – arthroplasty (artificial cervical disc) and ACDF (spinal fusion). Additionally, those patients that had arthroplasty and received the Bryan cervical disc show significant improvement and less neck pain than those in the control group (spinal fusion). In respect to complications and a second spine surgery – both groups had low adverse effects. 

To read the abstract of this cervical disc replacement study, visit this link.

I recently co-authored a few chapters in a continuing medical education book published by the American Academy of Orthopaedic Surgeons. This continuing education, instructional course lecture spine book focused on the Bryan disc and motion.

A few chapters of this book included:

• Emergency evaluation, imaging and classification of thoracolumbar injuries
• Nonsurgical treatment of thoracolumbar spinal fractures
• Surgical treatment of thoracolumbar fractures
• Update on cervical artificial disc replacement
   

In mid-October, I was a faculty member at a continuing education meeting held at the Orthopaedic Learning Center outside of Chicago. This meeting was sponsored by The American Academy of Orthopaedic Surgeons and theLumbar Spine Research Society. The focus of this continuing medical education meeting was “Contemporary Techniques in Spinal Surgery”.  I was a lecturer and lab instructor at this spine surgery education meeting. 

One topic that I lectured on was related to the surgical technique for a spinal fusion (C1 lateral mass screw, C2 laminar screw technique for posterior C1-C2 spinal fusion). Additionally, I participated in a debate about cervical disc replacement (arthroplasty) versus fusion. In this debate, I was pro cervical disc replacement. A few of the continuing medical education spine surgery labs that I instructed included: anterior cervical discectomy, laminoplasty, high cervical and upper thoracic dissection and laminoplasty.

While at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, in addition to presiding as President of the Federation of Spine Societies spine specialty day, I also gave a few talks on cervical radiculopathy.

The first session that I moderated was on the current concepts in cervical radiculopathy.  The objective of this continuing medical education session was to provide the most up-to-date information on the pathophysiology, diagnosis and treatment of cervical disc disorders, including the role of selective nerve root sleeve injections and artificial disc replacement.

Another session that I served as a faculty member for was the spine instructional course lecture entitled, “The Degenerative Cervical Spine: What You Need to Know.”  This presentation provided an overview of cervical degenerative diseases and addressed the patient evaluation and treatment options, including anterior, posterior and non-operative options.

The American Academy of Orthopaedic Surgeons (AAOS) held their annual continuing medical education meeting in New Orleans, in early March.  In addition to attending the annual continuing medical education meeting, I also had the honor of coordinating and hosting the spine specialty day. The spine specialty day presented a common forum by the Federation Societies, of which I am the president.  The Federation Societies is comprised of four spine-focused organizations, and includes the Cervical Spine Research Society, North American Spine Society, Scoliosis Research Society and the American Spinal Injury Association.  

A few of the educational objectives for the day included discussing the current concepts in the diagnosis and management of spinal disorders, and to review and update the clinical results and complications of the new technologies and concepts.  The information was presented in the form of instructional presentations, discussions, papers and debates. 

Highlighted topics were presented by each society within the Federation.  During the day in the North American Spine Societies section, I presented a talk on cervical disc replacement, and for the American Spinal Injury Association I discussed spinal cord injury and the appropriate time for decompression. 

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.

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.

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.

 

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.

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.

Recently an article that I co-wrote was published in the January issue of Spine.  This article is entitled, “Comparison of Short-term SF-36 Results between Total Joint Arthroplasty and Cervical Spine Decompression and Fusion or Arthroplasty.” 

The purpose of this research was to evaluate patient outcomes – comparing cervical spine surgery with hip and knee surgery.  The measurement tool was a functional outcome score that measures a patient’s ability to perform activities of daily living.  This is a patient derived score, based on results obtained from a questionnaire that the patient completes. 

The surgical procedures were hip and knee arthroplasty compared to cervical spine surgical procedures. The spine surgical procedures evaluated were cervical arthroplasty, (cervical disc replacement), and cervical discectomy with cervical fusion. 

In summary, all groups showed significant improvement in their scores post-surgery.  Although, patients that underwent cervical spine surgery showed greater or equal improvement.