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.  

A few weeks ago,  Anne Marie Tiernon - news anchor with WTHR, interviewed me about the recent FDA-approval of the Bryan™ Cervical Disc.  This story aired on June 9, and here is the link to this story. 

As mentioned in previous blogs, I have been involved in the clinical trials for this device, and implanted the first Bryan Cervical Disc in the United States.  This procedure was done at St.Vincent Hospital, and was performed with Kenneth Renkens, MD.  Dr. Renkens is a neurosurgical spine surgeon, also with Indiana Spine Group.  

Additionally, cervical arthroplasty patient Kevin Wacasey was interviewed in this story.  Kevin received the first Cervical Disc in the United States in 2002.  Today, he is doing great!  He enjoys spending time with his teenage son, golfing, fishing and other hobbies. 

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.    

On Monday, Anne Marie Tiernon - news anchor with WTHR, interviewed Dr. Rick Sasso about the recent FDA-approval of the Bryan™ Cervical Disc. This story aired on June 9, and here is the link to this story. 

Dr. Rick Sasso, a principal investigator in the Bryan Cervical Disc clinical trial, implanted the first Bryan Cervical Disc in the United States. This procedure was done at St.Vincent Hospital, and was performed with Kenneth Renkens, MD. Dr. Renkens, also involved with this clinical trial, is a neurosurgical spine surgeon with Indiana Spine Group.

Additionally, cervical arthroplasty patient Kevin Wacasey was interviewed in this story. Kevin received the first Bryan Cervical Disc in the United States in 2002. Today, he is doing great! He enjoys spending time with his teenage son, golfing, fishing and other hobbies. 

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. 

Recently we have updated the educational resources on our Indiana Spine Group web site.  With this update, we included a few educational videos.  These videos include myself and other physicians with Indiana Spine Group discussing different topics; i.e. artificial cervical disc, spinal pain, spinal stenosis, etc.

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 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.
 

Prior blogs have discussed the cervical artificial. Also as I had mentioned in an earlier blog entry, we have recently updated the education component of the Indiana Spine Group web site. When we did these updates, we also included a few patients’ stories. 

Visit the patient story page, of our web site, to see a few stories from patients that were part of the cervical artificial cervical disc study (Bryan Cervical Disc).

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. 

This past year, we have been enhancing the spine education information provided on Indiana Spine Group’s web site.  Recently, we have added a spine education video that was made on cervical artificial discs.  In this video I provide an overview of this spine surgical procedure - Cervical Artificial Disc.  To view this video on cervical artificial disc – click here.

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.

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.