- Monday, April 9, 2018

Good prospective data on clinical outcomes in patients who have undergone cervical (neck) fusion spine surgery has historically been limited.

In a Cochrane Review of cervical spine fusion surgery, the authors concluded that “the available small randomised trials do not provide reliable evidence on the effects of surgery for cervical spondylotic radiculopathy or myelopathy.”1 This reinforces the need for prospective randomized controlled studies in this area. (Fouyas et al, 2010).

Concerted effort has recently been made in orthopedic and neurosurgery to rectify this deficiency. One example is the Neuropoint Alliance (www.neuropoint.org), which was established in 2008 by the American Association of Neurological Surgeons to “collect, analyze and report on nationwide clinical data from neurosurgical practices using online technologies.”2 With this and other prospective efforts, we have the potential to appreciate the benefits and limitations on surgical treatment of spinal disorders.

This same paucity of prospective data exists in lumbar or low back surgery.

In a Cochrane Review of lumbar spine surgery, the authors noted that, “There have also been significant increases in the rate of complex fusion and the use of spinal spacer implants compared to that of traditional decompression surgery, even though the former is known to incur costs up to three times higher. Moreover, the superiority of these new surgical procedures over traditional decompression surgery is still unclear.”3 The authors further conclude that, “The addition of fusion to decompression is not only more costly, but also leads to more intraoperative blood loss and longer operation time, and fails to result in superior clinical outcomes when compared with decompression alone. Operation using interspinous spacer devices is quicker, and results in less blood loss and shorter hospital length of stay than fusion. These devices, however, do not provide better outcomes than conventional decompression, and are associated with higher reoperation rates.” (Machado et al, 2016)

There are excellent reasons for spinal fusion surgery, such as spinal instability from degenerative changes, congenital defects or trauma, amongst others. However, in the absence of compelling reasons for fusing, it may be preferable to achieve decompression without fusion.

SonoSpine’s SonoSculpt fusion avoidance surgery was developed to achieve this goal of better decompression without fusion.

In an initial retrospective review (Ellegala, et al, submitted for presentation, North American Spine Society, 2018), the authors report an 88 percent patient-reported outcome of “excellent” and 12 percent “good” at four weeks post-surgery.

Moreover, 56 percent of patients reported a 0/10 pain score at their four-week follow up, and complication rates were 1.54 percent. Procedures were outpatient surgery.

To further the advancement of fusion-avoidance decompression surgery in the spine, an ultrasonic spine study group with leading surgeons in this field is being formed to prospectively study outcomes. Data-driven clinical outcomes may provide the possibility of changing the standard of care with fusion avoidance surgery in appropriate cases.

1 Nikolaidis I, Fouyas IP, Sandercock PAG, Statham PF. Surgery for cervical radiculopathy or myelopathy. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD001466. DOI: 10.1002/14651858.CD001466.pub3

2 http://www.neuropoint.org. Retrieved March 23, 2018.

3 Machado GC, Ferreira PH, Yoo RIJ, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher C, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD012421. DOI: 10.1002/14651858.CD012421

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