Approximately 80% of Americans experience significant back pain at least once in their lifetime, and for many people, spinal disorders are a lifelong problem. The personal and monetary costs associated with this widespread problem are staggering. One of the main causes of back pain and spinal disorders is the degeneration of spinal discs. Disc degeneration is painful and often difficult to treat. One of the most promising surgical advancements that has been developed and FDA-approved since 2005 is lumbar artificial disc replacement.

What is a Spinal Disc?

The spaces between each vertebra in your spine (spinal discs) serve as areas of motion for your spine. As we age, these discs can deteriorate. When this happens, they lose their functional motion abilities and cause pain and wear and tear on the vertebra. To treat this condition, alternatives to disc replacement include fusion, nonoperative care or no treatment. Typically, surgery is not considered for disc-related pain unless the pain has been severe for a prolonged period (typically over six months) and the patient has gone through nonoperative treatments (such as active physical therapy, medication, injections, activity modification and/or spinal manipulation).

With the introduction of total disc replacement (TDR) surgery, surgeons can offer their patients an alternative to spinal fusion surgery for the treatment of degenerative disc disease (DDD) in the lumbar spine, or the treatment of symptomatic cervical disc disease (SCDD) in the cervical spine. The TDR procedure is intended to relieve pain and preserve motion in the spine. During both TDR surgery and spinal fusion surgery, the pain-generating disc is removed and the disc height is restored. During a fusion surgery, the spinal segment is stabilized with an implant and plate and/or rods and screws. Bone graft may be used to promote osseous fusion of the vertebrae. Conversely, during a TDR surgery, an implant that allows the potential for motion is inserted into the disc space. There are two FDA approved Lumbar Disc Replacement devices available, these include the PRODISC®-L and CHARITÉ ®.

PRODISC®-L What is it?

The PRODISC®-L Total Disc Replacement is an artificial intervertebral disc made from metal and plastic that is used to treat pain associated with degenerative disc disease (DDD). DDD is defined as discogenic back pain (pain resulting from a degenerated intervertebral disc) with degeneration of the disc confirmed by patient history and radiographic studies. The PRODISC®-L Total Disc Replacement is implanted to replace a diseased or damaged intervertebral disc during a surgical procedure called spinal arthroplasty.

How does it work?

The PRODISC®-L Total Disc Replacement consists of three parts:

  • Two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the spinal bones (vertebrae)
  • A plastic (ultra-high molecular weight polyethylene, or UHMWPE) inlay that fits between the two endplates
  • The plastic inlay and endplates help restore the natural distance between the two vertebrae (disc height). The top (superior) endplate can slide over the domed part of the inlay, which can allow movement at the level where it is implanted.

When is it used?

The PRODISC®-L Total Disc Replacement is indicated for spinal arthroplasty in patients who:

  • are skeletally mature
  • have degenerative disc disease (DDD) at one level in the lumbar spine (from L3-S1)
  • have no more than Grade 1 spondylolisthesis at the involved level
  • have had no relief from pain after at least six months of non-surgical treatment

What will it accomplish?

The PRODISC®-L Total Disc Replacement is used to replace a damaged intervertebral disc. The device may restore disc height, may reduce pain, and may allow movement at the level where it is implanted.

When should it not be used?

The PRODISC®-L Total Disc Replacement should not be used in patients who have any of the following:

  • Active systemic infection or infection localized to the site of implantation
  • Osteopenia or osteoporosis defined as DEXA bone density measured T-score < -1.0
  • Bony lumbar spinal stenosis
  • Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium)
  • Isolated radicular compression syndromes, especially due to disc herniation
  • Pars defect
  • Involved vertebral endplate dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions
  • Clinically compromised vertebral bodies at affected level due to current or past trauma
  • Lytic spondylolisthesis or degenerative spondylolisthesis of Grade > 1

CHARITÉ® What is the CHARITÉ® Artificial Disc?

The CHARITÉ® Artificial Disc is a three-piece articulating medical device consisting of a sliding core sandwiched between two metal endplates. The sliding core is made from a medical grade plastic and the endplates are made from medical grade cobalt chromium alloy. These materials usually do not harm the human body and are used in many other medical implants such as total knee replacement implants.

The endplates support the core and have small teeth which secure them to the vertebrae above and below the disc space. The sliding core fits in between.

Laboratory testing shows that the CHARITÉ® Artificial Disc design allows your spine to move. In the clinical study, patients were observed to have motion between 0 and 21 degrees while bending forward and backward.

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