Indiana Disc Replacement

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. 

Early in December, I had the opportunity to present at a spine surgery meeting sponsored by AO Spine International.  This meeting was held in Davos, Switzerland.

At this meeting I gave ten invited talks.  The main focus of these talks was about the spine surgical treatment of cervical myelopathy and radiculopathy, cervical disc replacement, and the treatment of cervical trauma. 

AO Spine International is an organization that is dedicated to furthering the education of spine surgeons.  The vision of AO Spine International is to provide knowledge and expertise to spine surgeons with the goal of improving patient outcomes and ensuring cost effective spine surgery.  For more information about AO Spine International, click here.

Physicians with Indiana Spine Group presented at the fall conference of the Indiana State Chiropractic Association this past weekend, on November 1 and 2. 

On Saturday Dr. Kevin Macadaeg, a minimally invasive spine specialist, spoke on minimally invasive techniques used to help manage spinal pain.  Additionally, he addressed diagnostic and therapeutic spinal injections.  Spine surgeons - Dr. Thomas Reilly, Dr. Kenneth Renkens and Dr. Rick Sasso also spoke on Saturday.  Dr. Reilly discussed when spine surgery is a potential treatment option.  Dr. Renkens’ talk entitled “Understanding Lumbar Surgery”, focused on the lower back and reviewed spine surgery options and indications for the lumbar spine.  Additionally, he discussed the different types of lumbar fusions and their applications.  Dr. Rick Sasso focused on cervical surgery, and his talk was entitled “The ABC’s of Cervical Surgery”.  In this talk, he discussed common cervical surgical procedures; including spinal fusion and cervical artificial disc replacement. 

On Sunday, minimally invasive spine specialists Dr. Jonathan Gentile and Dr. John Arbuckle reviewed case studies of minimally invasive diagnostic and therapeutic techniques.  Spine surgeons Dr. Thomas Reilly and Dr. Paul Kraemer also reviewed case studies of surgery patients.

For more information about this conference, click here. 

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 Implant – Drs. 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) Studies – Dr. 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.

In mid-October, I attended the North American Spine Society’s (NASS) 23rd Annual Meeting in Toronto, Canada. 

While attending this meeting, I was a co-presenter and here are a few of the presentations that I gave:

• Total Disc Replacement for Treating Lumbar Discogenic Back Pain: A Prospective, Randomized, Multicenter Study of Flexicore® vs. 360 Spinal Fusion
• Motion Characteristics and Related Outcomes for a L-TDR Device with a Fixed Center of Rotation
• Predictors of Outcome Following Anterior Surgery for Cervical Spondylotic Myelopathy: Results from a Multicenter Prospective Clinical Study with
  Independent Outcomes Assessments Surgical Treatment for Cervical Spondylotic Myelopathy: One Year Outcomes of a Prospective, Multicenter Study of 316 Patients
• A Comparison of the Dynamic Compliance Characteristics of Prosthetic Cervical Disc Materials
• Radiographic Results from the Bryan® Cervical Disc IDE Study

I also was a co-chair of a technique workshop on Interbody Fusion Technologies.

NASS is a medical organization dedicated to fostering the highest quality, evidence-based, and ethical spine care by promoting education, research and advocacy.  To learn more about the North American Spine Society, click here.

Physicians with Indiana Spine Group attended the 23^rd annual meeting of the North American Spine Society(NASS) in Toronto, Canada.  At this international meeting, all aspects of caring for the patient with spine problems were discussed.  This includes medical management, minimally invasive spine treatments and spine surgery. 

Additionally, Dr. Rick Sasso a spine surgeon with Indiana Spine Group gave numerous presentations.  A few of his presentations included:  A Comparison of the Dynamic Compliance Characteristics of Prosthetic Cervical Disc Materials and Total Disc Replacement for Treating Lumbar Discogenic Back Pain: A Prospective, Randomized, Multicenter Study of Flexicore® vs. 360 Spinal Fusion.  Additionally, he chaired a technique workshop on Interbody Fusion Technologies. 

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.

In August, Indiana Spine Group sponsored a medical education conference/symposium for physicians and other health care practitioners.  At this conference, one of the topics I spoke on was What is on the Horizon?  In this talk, I discussed some of the latest spine surgery developments currently available, in FDA-trials or under development. 

One of the things I discussed was the results of a research project on spinal kinematics related to lumbar and cervical artificial disc replacement.  Generally speaking kinematics – is the study of motion. 

The purpose of this study was to study the kinematics of the cervical spine and lumbar spine – then how it relates to the motion of the artificial discs that are being used in spine surgery for cervical artificial disc replacements or lumbar artificial disc replacements.   With this information, it provides spine surgeons more information as they work with their spine surgical patients that require cervical artificial discs or lumbar artificial discs to help them select the type of disc that best meets the patient’s needs. 

Here is a link to the article I co-wrote, Cervical Kinematics After Fusion and Bryan Disc Arthoplasty. 

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 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.