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Cervical Spine | Lumbar Spine


Lumbar Spine (Lower Back) Surgery

Individuals with degenerated discs in the lower (lumbar) spine sometimes suffer from disabling, chronic low back pain. Most patients with symptomatic degenerative conditions in the spine are treated non-surgically with anti-inflammatory medications, physical therapy and injections. Most of these individuals will favorably respond to non-surgical methods of treatment, but a subset of individuals will continue to experience pain. The chronic nature of back pain often interferes with the ability to work and participate in regular daily activities. As a result, surgical treatment may become necessary.

There are multiple conservative and minimally invasive treatment options available to manage symptomatic degenerative disc disease. However, if surgery is indicated the surgical treatment of choice has traditionally consisted of a lumbar spinal fusion. Unfortunately, there are a number of drawbacks to undergoing a spinal fusion. First, the ability of the bone to heal or “fuse” varies. The average success rate of a lumbar spinal fusion is approximately 75%-80%. Failure of the fusion to heal may be associated with continued symptoms. Second, a spinal fusion at one or more levels will cause stiffness and decreased motion of the spine. Third, having a spinal fusion at one or more levels will cause more stress to be transferred to adjacent levels. The problem with the transferred stress is that it may cause new problems to develop at the other levels, which may also lead to additional back surgery.

For these reasons, neurosurgeons and orthopedic surgeons have engaged in research to offer an alternative to lumbar spinal fusion surgery. One promising area of research includes the development of an artificial spinal disc. In order to better appreciate the advantages and disadvantages of artificial spinal disc replacement, it is important to have a basic understanding of normal spinal anatomy, including the function of the spinal discs.

The spine is a column that is made of up bones and discs. The blocks of bone (or vertebrae) provide the anterior support and structure of the spine. Posteriorly, the two facet joints at each level provide stability and movement of the motion segment. The spinal discs are in between the bones and act like a cushion or “shock absorber” between the vertebrae. The discs also contribute to the flexibility and motion of the spinal column. The discs are made up of two parts: 1) the inner portion of the disc is called the nucleus pulposus and is a jelly-like material 2) the outer part of the disc is a stronger, more fibrous, material called the annulus fibrosus. The annulus fibrosus surrounds and supports the inner jelly material. The annulus is also in contact with nerve fibers or pain receptors, called nociceptors. Disc material is primarily composed of water and other proteins. As a normal part of aging, the water content gradually diminishes which can cause the disc to flatten out and even develop tears or cracks throughout the annulus fibrosus. These discs are often referred to as “degenerative”discs and may or may not cause pain.

herniated
lumbar

 

In the case of a degenerative disc, the inner jelly material can bulge out and press up against the annulus fibrosus. This can stimulate the pain receptors causing back pain to occur. The cracks or tears that develop within the annulus fibrosus can also become a source of pain. Back pain that is caused by the spinal disc is often referred to as discogenic low back pain.

Sir John Charley revolutionized orthopedics in the 1960’s with the advent of the total hip replacement. At that time, early research in the development of artificial disc replacement began as well. Despite the early interest, lumbar spinal fusion remained the gold standard treatment for back pain. Because of the complications associated with lumbar spinal fusion, a renewed interest in artificial disc replacement resurfaced in the 1990’s. The purpose and advantage of artificial disc replacement is to replace the worn out disc, while preserving the motion at the operated spinal level. This could potentially not only treat the underlying back pain, but also protect patients from developing problems at an adjacent level of the spine.

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charite
Figure 1.
CHARITÉ™ Artificial Disc (DePuy Spine, Inc.)
Photograph Courtesy of DePuy Spine, Inc.
vertebral sagittal midline
Figure 2.

prodisc

Figure 3.

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The Food and Drug Administration (FDA) has approved the CHARITÉ™ Artificial Disc (DePuy Spine, Inc. of Raynham, MA) for use in treating pain associated with degenerative disc disease. The device was approved for use at one level in the lumbar spine (from L4-S1) for patients who have had no relief from low back pain after at least six months of non-surgical treatment.

Currently, artificial disc replacement is undergoing rigorous evaluation and only a few are approved by the Food and Drug Administration (FDA). Most of the research that has been conducted on artificial discs has been carried out in Europe. Different models have been developed, but the most widely used and known artificial disc is the LINK SB Charite III prosthesis made by Waldemar Link GmbH & Company, Hamburg, Germany. The model consists of two metal metallic plates that have teeth to anchor the implant between the bones or vertebral bodies. Between the two plates is a rubber core made up of polyethylene that allows for motion (See Figure 1). A metal ring surrounds the outside of the rubber core so that it can be located on x-ray (See Figure 2).

“Another approved Lumbar Disc Replacement is the Synthes ProDisc-L. (Please click here to visit website) This is a prosthesis more commonly used in Australasia, and I have experience in this device during my Canadian Fellowship. The ProDisc-L total disc replacement has been determined to be safe and effective in the treatment of degenerative disc disease (DDD) at one level from L3-S1.  During the total disc replacement procedure, the diseased intervertebral disc is removed and replaced with a motion preserving ProDisc-L implant.  The ProDisc-L total disc replacement surgery is intended to:

    • Remove the diseased disc
    • Restore disc normal height
    • Reduce discogenic pain
    • Provide the potential to preserve motion in the affected vertebral segment

Please refer to Figure 3

One of the more advanced and stringently tested Lumbar Artificial Discs to be introduced is the Spinal Kinetics M6-L.
(Please click here to visit the website)

The M6-L artificial lumbar disc offers an innovative option compared to other artificial lumbar disc replacement because of its unique design, which is based on the qualities of the natural disc.

The M6-L is the only artificial disc that incorporates an artificial nucleus (made from polycarbonate urethane) and a woven fiber annulus (made from polyethylene). The M6-L artificial nucleus and annulus are designed to provide the same physiologic motion characteristics of a natural disc. Extensive biomechanical testing with the M6-L artificial lumbar disc has demonstrated equivalent Quality of Motion compared to the healthy disc.

Together, the M6-L’s artificial nucleus and annulus provide compressive capabilities and a controlled range of natural motion in all 6 degrees of freedom. This “natural” motion is designed to provide the freedom to move your back naturally while minimizing the stress to adjacent discs and other important spinal joints, and possibly preventing or delaying additional adjacent level degeneration.

The M6-L has two titanium outer plates with keels for anchoring the disc into the bone of the vertebral body. These outer plates are coated with a titanium plasma spray that promotes bone growth into the metal plates, providing long-term fixation and stability of the disc in the bone.

Description: M6-L Disc Cutout


Description: M6-LArtificial Disc Components


Description: Artificial Nucleus

Artificial Nucleus

  • Viscoelastic polymer designed to simulate native nucleus
  • Allows physiologic axial compression
  • Retained between endplates by fiber annulus matrix
  • Designed to facilitate physiologic Center of Rotation (COR)

Description: Artificial Annulus

Artificial Annulus

  • Ultra High Molecular Weight Polyethylene (UHMWPE) fiber material
  • Intended to simulate native annulus and its performance characteristics
  • Designed to provide controlled motion in all planes & axes of rotation
  • Robust fiber matrix with multiple fiber layers similar to native annulus

Description: Sheath

Sheath

  • Viscoelastic polymer designed to minimize tissue in-growth and debris migration
  • Flexible design allows for full range of motion

Description: Fixation

Fixation

  • Titanium endplates with low-profi¬le keel design provides for optimal acute and long-term ¬fixation
  • Titanium Plasma Spray (TPS) coated endplates provide for osseointegration

With over 16000 implantations worldwide since 2006, and a successful IDE study with subsequent supportive studies, the M6-L is a proven device.

In order to avoid complications that may arise from artificial disc replacement surgery, careful selection of patients by the surgeon is critical. At present, it is thought that the best candidates for spinal disc replacement are adults with a one level symptomatic degenerative disc. Patients whose bone may not be as strong due to aging, or some other bone disorder, may develop problems if the implant settles into the “soft” bone. Therefore, these individuals are not considered optimal candidates for this type of procedure. Since there can be movement of the implant, patients with a slippage of one vertebra on another (termed “spondylolisthesis”) are also not considered candidates for artificial disc replacement. Based on the current research, the clinical diagnoses that seem the most fitting for artificial disc replacement include symptomatic degenerative disc disease and post-discectomy syndrome. Post-discectomy syndrome is persistent back pain following previous surgery to remove a herniated disc.

In addition to the potential complications associated with undergoing surgery and general anesthesia, the complications associated with artificial disc replacement may include breakage of the metal plate, dislocation of the implant, and infection. To help minimize complications associated with the implant itself, proper selection of patients and size of implant is very important. Patients may also not improve following the procedure and may require additional surgery. Finally, like joint replacement surgery, artificial implants may fail over time due to wear of the materials and loosening of the implants. Therefore, long term studies that track the life span of the implants are needed.


The conclusions for Lumbar Disc Replacement are still not clear. The Royal Australasian College of Surgeons have an advisory committee which have conducted a review of the current evidence. The latest conclusions are found here.

Please click here to access Dr Pope’s review article on Disc Replacement Surgery in Volume 11, Edition 2 of the GP News 2011

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