Expanding Indications for Cervical Artificial Disc Replacement

Cervical Disc Replacement, Herniated Disc, News, Uncategorized

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

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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.

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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.

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

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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

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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

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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

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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.

Operation Straight Spine 2017: Another Successful Mission Delivers Spine Care to Those in Need

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Spinal surgery at the Ramakrishna Mission Hospital

Spinal surgery at the Ramakrishna Mission Hospital during OSS 2017.

For ten consecutive years Operation Straight Spine (OSS) has been performing complex spinal surgeries for Indian patients who cannot afford or do not have access to treatment of their spinal deformities or diseases. In 2017, Dr Jeffrey McConnell and a team of specialists from the United States, England and India returned to the Ramakrishna Mission Hospital in Kolkata, India to treat patients of all ages suffering from a variety of spinal conditions.

Operation Straight Spine 2017 team members from the USA, India and England.

Supported by generous donations from companies such as Globus Medical Inc., Implanet, and Nuvasive Spine Foundation the OSS team was able to provide state-of-the-art implants and equipment for their surgeries.  Emirates Airlines Foundation was kind enough to donate the airline tickets for all team members which provided a huge boost to the project’s operating budget.

The youngest patient treated during this year’s trip was just 18 months-old and suffered from a congenital scoliosis.  The oldest patient was a 63 year-old woman with a painful and severe case of spinal stenosis with a slipped vertebra in the lumbar spine.  Other cases treated during the two week mission trip included adolescent scoliosis, early onset scoliosis and tuberculosis of the spine.  The work was challenging and all surgeries were successful in their outcomes and proved to be a truly life-changing experience for the patients.

Dr. McConnell with three of the patients treated as part of Operation Straight Spine 2017.

Case Study: Congenital Scoliosis in an 18 Month-old Boy

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baby scoliosis surgery

18-month old Arannya Adhakary with congenital scoliosis waiting for his surgery

Operation Straight Spine (OSS) is an annual mission trip to Kolkata, India, where doctors, nurses and spinal monitoring technicians from the US, England and India treat patients with spinal disorders. During the 2017 trip, Dr. Jeffrey McConnell and the OSS team treated an 18-month old boy with congenital scoliosis.

Arannya Adhakary, 18 months old, was the youngest patient treated during OSS 2017.  He was diagnosed with congenital scoliosis when he was just 3 months of age.

 Congenital scoliosis can be caused by a number of different defects in the development of the spine during the first trimester of fetal growth. Abnormalities occur when part of a vertebra fails to form or several vertebra fail to separate during the very earliest stages of fetal development when the spine and other major organs are starting to form. Patients can have a single abnormality or multiple defects throughout the spine. 

Arannya’s congenital spine defect was known as a hemivertebra, which occurs when the vertebra is triangular in shape instead of the normal rectangular shape.   This type of congenital defect has a very high propensity to cause a severe and progressive deformity of the spine, usually a kyphosis or scoliosis,  as the child grows.

Arannya’s hemivertebra was located at the 11th thoracic vertebra, approximately in the middle of his spine. Hemivertebra are best treated at an early age by removing the abnormal vertebra, correcting the deformity and fusing the growth plates above and below the hemivertebra so the deformity does not recur. Arannya’s surgery consisted of removal of the T11 hemivertebra, correction of the local kyphosis and scoliosis, and limited fusion from T10 to T12.  To stabilize the spine and help fuse where the hemivertebra was removed, two small screws and a single 3.5mm diameter rod was placed from T10 to T12 on the right side.

Arannya did amazingly well after surgery, a testament to his young age, and by the 4th postoperative day was going on walks in the courtyard, smiling, carried in his mother’s arms.

scoliosis deformity xray

Pre-operative MRI of the thoracic spine showing the T11 hemivertebra and acutely angled scoliosis deformity.

scoliosis postop xray

Post-operative X-ray after removal of the T11 hemivertebra and placement of spinal screws and rod.

india scoliosis

Four days after surgery on walk with his mother.

Case Study: Severe Scoliosis in an 11-Year Old Girl with Rare Syndrome

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Shruti Sharma during her pre-operative evaluation with the OSS 2017 team.

Kolkata, India,  January 25, 2017

During their annual mission trip to Kolkata, India, Dr McConnell and the other members of the Operation Straight Spine (OSS) team were faced with a very challenging case of severe scoliosis in an 11 year-old girl.

Shruti Sharma was diagnosed with Prader-Willi syndrome (PWS) at a young age.  PWS is a complex genetic disorder affecting approximately one in 15,000-30,000 individuals. The disorder results in short stature, disorders of metabolism, cognitive disabilities and behavioral problems. One of the hallmarks of the disorder is insatiable appetite and obesity which often leads to childhood diabetes mellitus (Type 2 diabetes).  Due to low muscle tone, patients will often develop spinal deformities such as scoliosis. Shruti was certainly the most challenging case the OSS team faced this year, not only from a medical management standpoint, but also by the severity of her spinal deformity.

Shruti originally presented to the OSS team in 2016 for consideration of corrective surgery for her thoracic scoliosis, however her diabetes was newly diagnosed and poorly controlled. The team thought it best to delay her surgery until their return trip in 2017 so that her diabetes could be brought under better control. By 2017 her left thoracic scoliosis curvature had progressed to 92 degrees.

Pre-operative X-ray showing severe, 92 degree thoracic scoliosis

Shruti’s scoliosis surgery

After Shruti was placed under anaesthesia, blood started collecting in her right lung for unknown reasons. This delayed her surgery for several hours. The bleeding eventually stopped and she was stable enough to complete the procedure, which lasted about 6 hours. It consisted of a posterior correction of the scoliosis and the placement of spinal rods and fusion from the 2nd thoracic vertebra to the 3rd lumbar vertebra. Due to her relatively small size, small 4.5mm rods and implants were used. Then, special bands resembling zip ties, known as  “Jazz Bands”, were attached to several vertebra. By slowly tightening the Jazz Bands the severe curvature of Shruti’s spine was gradually straightened and anchored to the spinal rods.

Shruti’s postop and recovery

Shruti’s postoperative course was somewhat stormy.  She remained intubated in the ICU for the first 24 hours. as her blood pressure was unstable and she ran a high temperature. On post-op day #1 the breathing tube was removed, but her right lung had filled with fluid and she required aggressive manual pulmonary therapy to help clear the lung. Ultimately, Shruti did very well and by the 4th post-op day she was smiling, walking, and coloring pictures.

About 3-4 weeks after her scoliosis surgery, Shruti had a slight setback when part of her spinal incision came open and developed an infection.  Luckily, Dr Ujjwal Debnath, based in India, was able to re-operate on Shruti’s back, wash out the wound and clear the infection. She required additional hospitalization and antibiotic therapy but ultimately recovered.

Post-operative X-ray showing excellent correction of the scoliosis deformity.

Shruti walking on 4th post-op day with OSS team member Bethan Salmon, RN

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