Health Problem: It is estimated that 60% to 80% of the adult population in the United States will experience clinically significant low back pain (LBP) at some point in time. The vast majority of LBP is mechanical in nature, i.e., arising from anatomic structures of the spine. Nonspecific chronic LBP may be attributed to normal degenerative changes in the intervertebral discs that are evident by the second or third decade of life. The prevalence of lumbar disc degeneration (DDD) in asymptomatic individuals is 37% in 20-year-olds and increases to 96% in 80-year-olds. The goals of treating patients with symptomatic lumbar DDD are to decrease pain and improve function; the vast majority of patients with this condition are successfully managed with conservative treatment. Lumbar spinal fusion therapy is the standard treatment for patients who fail conservative therapy. In spinal fusion surgery, the diseased or damaged disc is removed by discectomy and the 2 adjacent vertebrae are fused to each other using bone grafts from the hip or pelvis.
Technology Description: The artificial disc for lumbar total disc replacement (LTDR) was developed to preserve the motion of the natural spine that can be lost due to spinal fusion. Artificial discs differ in terms of biomechanics, biomaterials, and fixation (spike or keel). Currently, there are 2 artificial lumbar discs approved by the Food and Drug Administration for use in the United States: the ActivL Artificial Lumbar Disc (Aesculap AG) and the ProDisc-L Total Disc Replacement (Centinel Spine LLC, formerly DePuy Synthes Inc., a Johnson & Johnson Company). The Charité disc was developed in the mid-1980s in Germany. Currently approved lumbar artificial discs are designed to be placed in the disc space through a midline mini-laparotomy with the patient under general anesthesia.
Controversy: There is a notable lack of studies comparing LTDR with continued treatment with more conservative nonsurgical treatments or to surgical treatments other than fusion. Given that a prerequisite for LTDR is having failed more conservative treatments, it could be argued that a comparison with conservative treatment is inappropriate. A principal aim of LTDR is also to prevent adjacent segment degeneration, but whether LTDR prevents this from occurring in patients who have this surgery has yet to be demonstrated conclusively due to a lack of studies specifically evaluating this outcome.
- Does LTDR improve outcomes in patients with symptomatic DDD, and how does it compare with lumbar fusion?
- Are there clinically relevant differences in outcomes between the different lumbar artificial discs?
- Is LTDR safe?
- Is there sufficient evidence to define patient selection criteria for LTDR?
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