Expanding Indications for Cervical Artificial Disc Replacement

The indications for cervical artificial disc replacement are expanding.  Based on a number of recent clinical research trials, the benefits of cervical disc replacement are becoming more apparent, not only for treating patients with single level disc herniation, but also for patients suffering pinched nerves from herniated discs at two levels, and patients with spinal cord dysfunction due to herniated discs. Until recently, patients with these conditions were managed with spinal fusion which may have detrimental effects on the remaining discs over time.

Jeff McConnell, MD, was honored by the invitation to present information on cervical artificial disc replacement at the November, 2017 Cervical Spine Research Society meeting in Hollywood, Florida.  During this prestigious scientific forum, Dr. McConnell presented 2 studies based on the results of the landmark two-level Prestige-LP cervical artificial disc IDE clinical trial:

  1. Long-term Outcomes of Arthroplasty for Cervical Myelopathy versus Radiculopathy, And Arthroplasty versus Arthrodesis for Cervical Myelopathy”
    • The results of this study challenge the traditional recommendation of spinal fusion to treat patients with cervical myelopathy (spinal cord dysfunction) due to herniated discs.
    • Patients with myelopathy treated with disc replacement at two levels did just as well as those treated with fusion.
    • Patients with myelopathy demonstrated similar rates of clinical success as patients with radiculopathy when treated with two-level disc replacement.
  2. Comparison of the Long Term Results of One-Level vs Two-level Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion”
    • Although patients with herniated discs at two-levels in the cervical spine have twice the problem, and require more surgery to correct, they do equally as well as patients treated with artificial disc replacement at one level.
    • Patients who received cervical fusion had higher reoperation rates at the operated levels and adjacent disc levels.

The information presented by Dr McConnell and his coauthors adds to the growing body of clinical evidence that cervical artificial disc replacement, at one and two levels, is safe and effective for treating a number of conditions due to cervical disc disease.

Learn more about cervical artificial disc replacement.

Two Level Artificial Disc Replacement Effective in Treating Cervical Myelopathy

congress of neurological surgeons

At the October, 2017 Congress of Neurological Surgeons meeting in Boston, Jeff McConnell, MD, gave a presentation entitled:  “Long-term Outcomes of Arthroplasty for Cervical Myelopathy versus Radiculopathy, And Arthroplasty versus Arthrodesis for Cervical Myelopathy”

The study results were significant because the conclusion challenges the traditional treatment of patients with cervical myelopathy (spinal cord dysfunction) due to herniated discs in the neck.  The standard recommended treatment for this condition has been decompression and fusion. However, fusion has been shown to have detrimental effects on the function of the cervical spine leading to adjacent segment problems. Cervical artificial disc replacement has been shown to be superior to fusion in treating patients with one or two level herniated discs and radiculopathy (nerve root pain). Additionally, the role of decompression and cervical disc replacement in treating patients with myelopathy has been controversial.

The information presented in the study was based upon the FDA IDE clinical trial data for the two-level Prestige LP artificial cervical disc, in which 2 comparisons were made:

  • The first found that clinical outcomes between artificial disc replacement in patients with myelopathy versus patients with radiculopathy (nerve root pain) alone were equally safe and effective.
  • The second comparison examined the difference between patients with myelopathy treated with artificial disc replacement and those treated with fusion. Compared to fusion, patients treated with disc replacement demonstrated similar levels of clinical improvement and had less implant related complications.

The results of this study challenge the traditional thinking that fusion is the only option for treating patients with two-level cervical disc herniation and myelopathy – it demonstrated that artificial disc replacement is a safe and effective alternative for managing this condition. Learn more about cervical artificial disc replacement.

X-ray showing two level artificial disc replacement using the Prestige-LP performed by Dr. McConnell

Dr. Jeff McConnell First in the U.S. to Implant New, Larger Sized Cervical Artificial Disc.

The size of your Cervical Artificial Disc Replacement makes a difference.

Mobi-C cervical artificial disc replacement

Dr. McConnell implanting larger sized Mobi-C implant at C6-7 level

Cervical artificial disc replacement is an excellent alternative to the traditional treatment of fusion for one or two herniated discs in the neck.  Artificial disc replacement in the cervical spine preserves normal motion between vertebrae allowing the neck to move in a more natural way.  Several recent long-term follow-up studies have demonstrated that patients treated with cervical disc replacement have higher rates of overall clinical success when compared to patients treated with fusion.

Mobi-C cervical artificial disc

Mobi-C cervical artificial disc replacement

One of the goals of cervical artificial disc replacement is to match, as closely as possible, the dimensions (or ‘footprint”) of the disc being replaced.  The cervical discs you’re born with vary in shape and size from person to person, men and women, and by their level in the neck. Filling as much of the disc space and covering as much of the vertebral body end plate as possible helps prevent subsidence (settling) of the artificial disc and the likelihood of bone growing around the replacement disc, which restricts its movement.  That’s why it’s important that a surgeon choose an artificial disc that most closely matches the size of the patient’s natural cervical disc.  There are 6 different cervical artificial disc replacements available commercially and the decision of which disc to use for a particular patient is often determined by the range of sizes offered by the manufacturer.

Zimmer-Biomet, maker of the Mobi-C cervical disc replacement, recently increased the number of sizes available for the Mobi-C. Specifically, the company is now offering a 17 x 17 mm and a 17 x 19 mm footprints which will allow a better fit for mostly male patients requiring disc replacement surgery at C5-6 and/or C6-7.

x-ray of implanted Mobi-C cervical artificial disc

Lateral x-ray of the cervical spine showing new, larger sized 17 x 17 mm Mobi-C implant at C6-7 (lower level)

Dr. McConnell was the first surgeon in the United States to successfully implant the 17 x 17 mm Mobi-C cervical artificial disc.  His patient was a 45 year old male suffering with two pinched nerves in his neck due to herniated discs at C5-6 and C6-7.  Dr. McConnell was pleased at how well he could match the size of the patient’s disc space with the new larger sized Mob-C: “Having the right size implant for my patients is important to the long-term outcome of their cervical disc replacement surgery.”

As the use of cervical artificial disc replacement grows, Dr. McConnell predicts custom designed, digitally printed, implants that fit each patient’s unique anatomy are the next evolution in artificial disc replacement.

Learn more about cervical artificial disc replacement.

total disc replacement

Cervical Artificial Disc Replacement: 10 Years and Going Strong

This video tells the story of Stephen Miller, one of the first patients Dr. McConnell treated with the Prestige-LP Cervical Total Disc Replacement.

When Stephen was 24, he dove into a swimming pool and was temporarily paralyzed. Fortunately, his girlfriend was present and she saved his life by dragging him off the bottom of the pool.

Stephen had persistent symptoms – enormous pain and stiffness in his arms and legs – and showed signs of cervical myelopathy associated with herniated discs at C5-6 and C6-7. He was an excellent candidate for a clinical trial starting at the time for the Prestige-LP Cervical Total Disc Replacement. Stephen was one of the first patients treated by Dr. McConnell with this groundbreaking cervical artificial disc replacement.

Stephen checked in this week with Dr. McConnell for his 10-year follow-up and we’re happy to say that Stephen is doing extraordinarily well. In the video he describes his symptoms prior to receiving the procedure, and how the Prestige-LP Cervical Total Disc Replacement procedure changed his life.

The Prestige LP Cervical Disc System is an option for patients suffering from degenerative disc disease at one or two contiguous levels in the cervical spine from C3 to C7.

Symptoms of Cervical Myelopathy

Cervical myelopathy produces two types of symptoms: the ones you may feel in the neck, and the ones appearing elsewhere in the body at or below the compressed area of the spinal cord.

Neck symptoms may include:

  • Neck pain
  • Stiffness
  • Reduced range of motion

As the disease progresses, one may experience shooting pain that originates in the neck and travels down the spine. Other cervical myelopathy symptoms may include:

  • Weakness in the arms and hands
  • Numbness or tingling in the arms and hands
  • Clumsiness and poor coordination of the hands
  • Difficulty handling small objects, like pens or coins
  • Balance issues
Johns Hopkins Medicine

One and Two Level Artificial Disc Replacement are Effective in Treating Disc Problems in the Neck

Monday, April 24, 2017 | Los Angeles, California

During the recent American Association of Neurological Surgeons meeting in Los Angeles,  Dr Jeffrey McConnell  presented a paper which explored the results of one of the longest follow-up studies on cervical total disc replacement to date.

Comparison of the Long Term Results of One-Level vs Two-level Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion”, compared patients who received fusion surgery vs patients who received artificial disc replacement surgery at one or two discs in the neck.

The highlights:

  • After 7 years, patients who received the Prestige-LP two level artificial disc replacement had superior overall clinical results when compared to the fusion patients.
  • One and 2-level artificial disc replacement appear to be equally safe and effective in the treatment of cervical disc disease at 7 years
  • Patients receiving two artificial disc replacements did equally as well as patients receiving one level disc replacement.
  • Patients who received cervical fusion had higher reoperation rates at the index and adjacent disc levels.

These long-term clinical results demonstrate the effectiveness of total disc replacement at 2 contiguous levels in the cervical spine and the importance of maintaining motion in the cervical spine.

Cervical artificial disc replacement is a type of joint replacement procedure. An artificial disc, such as the Prestige LPTM cervical disc made by Medtronic, is placed between two adjacent cervical vertebrae to replace a diseased cervical disc. It is designed to maintain the distance between two adjacent cervical vertebrae.

The Prestige-LP two level artificial disc replacement.

Cervical total disc replacement has been demonstrated to be a very effective alternative to the traditional surgery of fusion for painful herniated discs in the neck.  Total disc replacement in the neck is more successful because it maintains normal motion in the neck while fusion eliminates motion.  This preservation of motion is key to minimizing the degeneration of adjacent cervical discs.

Learn more about cervical disc replacement.

Published: Two Level Cervical Disc Replacement Better Than Fusion After 7 years

Dr. Jeff McConnell was co-author of the recently published article in the Journal of Neurosurgery Spine, Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. ( 2017 Apr 7:1-13. doi: 10.3171/2016.11.SPINE16746. [Epub ahead of print])

This landmark study was the culmination of an FDA Investigational Device Exemption clinical trial comparing artificial disc replacement at two consecutive levels in the neck versus the traditional surgical treatment of fusion.

Fusion for painful herniated discs in the neck is effective, however this type of surgery permanently stops movement of the vertebra that are fused together. It is now well established that fusing vertebrae in the neck can cause detrimental effects on the remaining normal discs in the neck. It has been shown that patients who have had fusion in their neck can develop accelerated degeneration of the discs above and below the fused levels. These degenerative changes can then cause additional problems and may require additional surgery for treatment.

In the article published in the Journal of Neurosurgery, patients requiring surgery for two herniated discs in the neck were randomized to undergo either total disc replacement using the Prestige-LP device or the traditional fusion surgery. After 7-years, overall success and Neck Disability Index scores were superior for total disc replacement when compared to fusion. The authors concluded that total disc replacement with the Prestige-LP device at two contiguous levels is safe and effective and is a very good alternative to the traditional fusion surgery treatment. This is a longer term follow-up study on the same group of patients that Dr McConnell and his co-authors published previously.

Prestige-LP artificial cervical disc.

X-ray showing two level artificial disc replacement using the Prestige-LP performed by Dr. McConnell.

X-ray of traditional 2-level anterior fusion with spinal plate and screws.

Cervical Artificial Discs Minimize Future Surgery Risk

Wednesday, April 12, 2017 | Boca Raton, Florida

International Society for the Advancement of Spinal Surgery, ISASS

Dr McConnell recently reported the long term beneficial effects of total disc replacement in the neck at the International Society for the Advancement of Spinal Surgery (ISASS) in Boca Raton, Florida.

The presentation, Motion Preservation and the Incidence of Subsequent Surgical Intervention after Treatment with the Selectively Constrained SECURE®-C Cervical Artificial Disc, concluded that artificial total disc replacement surgery for painful herniated discs in the neck is a sound alternative to the traditional treatment of discectomy and fusion.

While fusion surgery is generally successful for treating herniated discs in the neck, it comes at the expense of lost motion between two vertebra.  Lack of movement at one disc will increase stress and strain at the adjacent discs.  As a result, the disc adjacent to a fusion can degenerate faster and may become painful and require additional surgical intervention.

SECURE®-C Cervical Artificial Disc

SECURE®-C Cervical Artificial Disc

The study followed 380 patients for 7 years. Each patient suffered with herniated discs and were treated with either total disc replacement (Secure-C artificial disc) or fusion surgery. The study attempted to determine the effects on the discs adjacent to the site of each surgery.

Of the patients who received fusion in their neck, 17.4% eventually required additional surgery at an adjacent disc, while only 4.2% of patients treated with Secure-C required adjacent disc surgery. After 7 years, patients treated with fusion surgery in the neck for a herniated disc were 4 times more likely to require surgery at any adjacent disc level than patients treated with an artificial disc.

These study results were significant and highlight the benefits of total disc replacement in helping to prevent accelerated degeneration of adjacent discs, as well as the importance of maintaining normal motion in the neck.

Read more about cervical total disc replacement.

Published: Artificial Disc Replacement at Two Levels in the Neck is Superior to Fusion

Dr Jeff McConnell was co-author of the recently published article in the Journal of Neurosurgery Spine (2017 March 17:1-15) titled: Cervical Disc Arthroplasty with the Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion, at 2 Levels: Results of a Prospective, Multicenter Randomized Controlled Clinical Trial at 24 Months.

This landmark study was the culmination of an FDA Investigational Device Exemption clinical trial comparing artificial disc replacement at two consecutive levels in the neck versus the traditional surgical treatment of fusion. Fusion for painful herniated discs in the neck is effective, however this type of surgery permanently stops movement of the vertebra that are fused together. It is now well established that fusing vertebrae in the neck can cause detrimental effects on the remaining normal discs in the neck. It has been shown that patients who have had fusion in their neck can develop accelerated degeneration of the discs above and below the fused levels. These degenerative changes can then cause additional problems and may require additional surgery for treatment.

In the article published in the Journal of Neurosurgery, patients requiring surgery for two herniated discs in the neck were randomized to undergo either total disc replacement using the Prestige-LP device or the traditional fusion surgery. Overall success and Neck Disability Index scores were superior for total disc replacement when compared to fusion. The authors concluded that total disc replacement with the Prestige-LP device at two contiguous levels is safe and effective and is a very good alternative to the traditional fusion surgery treatment.

Prestige-LP artificial cervical disc.

X-ray showing two level artificial disc replacement using the Prestige-LP performed by Dr. McConnell.

X-ray of traditional 2-level anterior fusion with spinal plate and screws.

cervical replacement surgery

Two Level Cervical Artificial Disc Replacement Superior To Fusion

 

eurospine conference

During the recent Eurospine meeting in Berlin, Germany,  a paper co-authored by Dr Jeffrey McConnell was presented, which explored the results of one of the longest follow-up studies on cervical total disc replacement to date.

Long Term Clinical and Radiographic Results of Two-level Cervical Total Disc Replacement from a Level 1 Prospective, Randomized, Clinical Trial”, compared patients who received fusion surgery vs patients who received artificial disc replacement surgery. The highlights:

  • After 7 years, patients who received the Prestige-LP two level artificial disc replacement had superior overall clinical results when compared to the fusion patients.
  • Subsequent surgeries were required 3 times less often in patients who received the two-level artificial disc replacement.
  • Patients who had cervical fusion required surgery at adjacent disc levels twice as often as the patients who had disc replacement.

These long term clinical results demonstrate the effectiveness of total disc replacement at 2 contiguous levels in the cervical spine and the importance of maintaining motion in the cervical spine.

 

The Prestige-LP two level artificial disc replacement.

Cervical artificial disc replacement is a type of joint replacement procedure. An artificial disc, such as the Prestige LPTM cervical disc made by Medtronic, is placed between two adjacent cervical vertebrae to replace a diseased cervical disc. It is designed to maintain the distance between two adjacent cervical vertebrae.

Cervical total disc replacement has been demonstrated to be a very effective alternative to the traditional surgery of fusion for painful herniated discs in the neck.  Total disc replacement in the neck is more successful because it maintains normal motion in the neck while fusion eliminates motion.  This preservation of motion is key to minimizing the degeneration of adjacent cervical discs.

Learn more about cervical disc replacement.

cervical total disc replacement

Can Artificial Total Disc Replacement in the Neck Prevent Problems at Adjacent Discs?

Thursday, October 27, 2016 | Boston, MA, USA

Artificial total disc replacement surgery for painful herniated discs in the neck is an alternative to the traditional treatment of discectomy and fusion.  img_6372

While fusion surgery is generally successful for treating herniated discs in the neck it comes at the expense of lost motion between two vertebra.  Lack of movement  at one disc will increase stress and strain at the adjacent discs.  The disc adjacent to a fusion can degenerate faster and may become painful and require additional surgical intervention.

Dr McConnell recently reported the long term beneficial effects of total disc replacement in the neck at the North American Spine Society Meeting in Boston.  The presentation was entitled:  Motion Preservation at the Operative Level and the Incidence of Symptomatic Adjacent Segment Disease after Treatment with Secure-C or ACDF.  This study followed 380 patients with herniated discs treated with either total disc replacement (Secure-C artificial disc) or fusion to see what happened to the adjacent discs after 7-years.  Of the patients  who had fusion in their neck 17.4% had additional surgery at an adjacent disc while only 4.2% of the patients treated with Secure-C had adjacent disc surgery.  After 7 years, patients treated with fusion surgery in the neck for a herniated disc were 4 times more likely to require surgery at any adjacent disc level then patients treated with an artificial disc.   These results were significant and highlight the benefits of total disc replacement in helping to prevent accelerated degeneration of adjacent discs and the importance of maintaining normal motion in the neck.

 

Read more about cervical total disc replacement.

 

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