BackgroundLumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD) using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis.MethodsThis study evaluated the 5-year clinical outcomes for IPD (Superion®) from a randomized controlled US Food and Drug Administration (FDA) noninferiority trial. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf), and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI).ResultsAt 5 years, 84% of patients (74 of 88) demonstrated clinical success on at least two of three ZCQ domains. Individual ZCQ domain success rates were 75% (66 of 88), 81% (71 of 88), and 90% (79 of 88) for ZCQss, ZCQpf, and ZCQps, respectively. Leg and back pain success rates were 80% (68 of 85) and 65% (55 of 85), respectively, and the success rate for ODI was 65% (57 of 88). Percentage improvements over baseline were 42%, 39%, 75%, 66%, and 58% for ZCQss, ZCQpf, leg and back pain VAS, and ODI, respectively (all P<0.001). Within-group effect sizes were classified as very large for four of five clinical outcomes (ie, >1.0; all P<0.0001). Seventy-five percent of IPD patients were free from reoperation, revision, or supplemental fixation at their index level at 5 years.ConclusionAfter 5 years of follow-up, IPD with a stand-alone spacer provides sustained clinical benefit.
In thoracolumbar burst fracture the "reverse cortical sign" is a known entity that corresponds to a fragment of the posterior wall that has been flipped 180 degrees with the cancellous surface of the fragment facing posteriorly in the canal and the cortical surface (posterior wall) facing anteriorly. The identification of such reverse cortical fragment is crucial as ligamentotaxis is classically contraindicated as the posterior longitudinal ligament is ruptured. Recognition of such a flipped cortical fragment has relied so far on the axial CT. The advent of CT scans with sagittal reconstruction has allowed us to better describe such entities that have received little attention in the literature. The goal of this report was therefore to describe the appearance of the reverse cortical sign and its likes as they can appear on axial CT scans, sagittal reconstructions and MRI. During 1-year practice at our institution we had to treat three patients with thoracolumbar burst fracture associated with what looked like a reverse cortical sign on the axial CT scans. Further analysis of the sagittal reconstruction CT could differentiate the true reverse cortical sign from a new entity that we coined "the pseudoreverse cortical sign" as observed in two out of the three cases. In the pseudo reverse cortical sign what appears to be a flipped piece of posterior vertebral body is actually part of the superior or inferior endplate that is depressed into the comminuted vertebral body. In such cases the posterior longitudinal ligament appears to be in continuity and therefore such fracture can theoretically be treated with posterior ligamentotaxis as evidenced in one of our case. Careful analysis of the CT scan and specifically the sagittal reconstruction and MRI can differentiate two separate entities that may correspond to a different severity injury.
Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center. We computed the within-group effect sizes from the Superion IDE trial and compared them to results extrapolated from two randomized trials of decompressive laminectomy. For the ODI, effect sizes were all very large (>1.0) for Superion and laminectomy at 2, 3, and 4 years. For ZCQ, the 2-year Superion symptom severity (1.26) and physical function (1.29) domains were very large; laminectomy effect sizes were very large (1.07) for symptom severity and large for physical function (0.80). Current projections indicate a marked increase in the number of patients with spinal stenosis. Consequently, there remains a keen interest in minimally invasive treatment options that delay or obviate the need for invasive surgical procedures, such as decompressive laminectomy or fusion. Stand-alone interspinous spacers may fill a currently unmet treatment gap in the continuum of care and help to reduce the burden of this chronic degenerative condition on the health care system.
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