The spine journal : official journal of the North American Spine Society
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Clinical Trial
Ten-year survival and clinical outcome of the AcroFlex lumbar disc replacement for the treatment of symptomatic disc degeneration.
We have previously reported on the osseointegration, stability, and preserved motion of the AcroFlex lumbar disc replacement (LDR) in a nonhuman primate model. Detailed biomechanical testing of the device predicted implant survival for at least 10 years of in vivo use. Significant improvements in the clinical outcome were reported at 2 years. However, mechanical failure of the polyolefin rubber was detected by fine-cut computed tomography (CT) in a number of subjects within 2 years. As a result, no further devices were implanted. ⋯ The cumulative survival was 60.7% at 10 years when the first revision surgery was taken as the end point. The etiology of the implant failure prompting the revision included failure of osseointegration, midsubstance elastomeric tears, and osteolysis. Further use of this implant is not justified. The incidence of adjacent-level disc degeneration for the AcroFlex was comparable with that observed adjacent to the spinal fusion. Salvage procedures involving conversion to spinal fusion are technically demanding, but appear to improve outcomes modestly.
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Besides their clinical impact, the economic impact of health care-related adverse events (AEs) is significant. Although a number of studies have attempted to estimate the economic impact of AEs, few have directly linked costs to clinician-reported event severity. ⋯ In this surgical spine cohort, AEs accounted for 16% of the total cost of in-hospital care. Higher severity AEs were progressively more costly on a per-case basis; however, the more frequent lower severity events (ie, Grade I and II) also had a substantial aggregate cost (43%). These results suggest that a strong business case exists for patient safety strategies focused not only on severe AEs but also on the reduction of lower severity events that may be more amenable to prevention efforts.
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The rates of pseudoarthrosis after a single-level spinal fusion have been reported up to 35%, and the agents that increase the rate of fusion have an important role in decreasing pseudoarthrosis after spinal fusion. Previous studies have analyzed the effects of local insulin application to an autograft in a rat segmental defect model. Defects treated with a time-released insulin implant had significantly more new bone formation and greater quality of bone compared with controls based on histology and histomorphometry. A time-released insulin implant may have similar effects when applied in a lumbar spinal fusion model. ⋯ This study demonstrates the potential role of a time-released insulin implant as a bone graft enhancer using a rat posterolateral intertransverse lumbar fusion model. The insulin-treatment group had significantly higher fusion rates based on the radiographs and manual palpation and had significantly higher levels of IGF-I and significantly more bone volume on micro-CT.