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Intervertebral body fusion devices (IBFDs) are commonly used in the treatment of various spinal pathologies. Intra-operative fractures of polyether-ether-ketone (PEEK) implants have been reported in the literature and to the FDA as device-related adverse events. The device and/or implant inserter failures typically occur during device impaction into the disc space and require implant removal and replacement. These additional steps may cause further complications along with increased surgical time and cost. Currently, there are no standardized test methods that evaluate clinically relevant impaction loading conditions on IBFDs. This study aims to develop an in vitro test method that would evaluate implant resistance to failure during intra-operative impaction. To achieve this, (1) surgical implantations of IBFDs were simulated in nine lumbar cadaver specimens by three different orthopedic spine surgeons (n = 3/surgeon). Impact force and mallet speed data were acquired for each surgeon. (2) Based on the acquired surgeon data, a benchtop mechanical test setup was developed to differentiate between two TLIF IBFD designs and two inserter designs (for a total of four IBFD-inserter combinations) under impaction loading. During implant insertion, impact force measurements indicated that lumbar IBFDs are subjected to high energy forces that may exceed their mechanical strength. Our test method successfully replicated clinically-relevant loading conditions and was effective at differentiating failure parameters between different implant and inserter instrument designs. The mechanical test method developed shows promise in its ability to assess impaction resistance of IBFD/inserter designs and evaluate potential risks of device failure during intraoperative loading., (Published by Elsevier Ltd.)

Objective: Postoperative subsidence of transforaminal lumbar interbody fusion (TLIF) cages can result in loss of lordosis and foraminal height, and potential recurrence of nerve root impingement. The objectives of this study were to determine factors associated with TLIF cage subsidence. Specifically, the authors sought to determine if preoperative disc height compared to cage height could be used to predict TLIF interbody cage subsidence, and if decreased postoperative vertebral Hounsfield units (HUs) predisposed to cage subsidence., Methods: The authors retrospectively reviewed all patients undergoing instrumented TLIF from two institutions between July 2004 and June 2014. The preoperative disc height was measured for the operative and adjacent-level disc on MRI. The difference between cage and disc heights was measured and compared between the subsidence and nonsubsidence groups. The average HUs of the L1 vertebral body were measured on CT scans., Results: Eighty-nine patients were identified with complete imaging and follow-up information. Forty-five patients (50.6%) had evidence of interbody cage subsidence on follow-up CT. The average cage subsidence was 5.5 mm (range 2.2-10.8 mm). The average implant height was significantly higher in the subsidence group compared to the nonsubsidence group (12.6 vs 11.2 mm). Additionally, the difference between cage height and preoperative adjacent-level disc height was also significantly larger in the subsidence group (3.8 vs 1.2 mm). First lumbar vertebral body (L1) HUs were significantly higher in the nonsubsidence versus the subsidence group (167.8 vs 137.71 HUs, p = 0.002). Multivariate logistic regression analysis identified suprajacent disc height and L1 HUs to be independent predictors of interbody cage subsidence. Receiver operating characteristic curves identified a suprajacent to cage height difference > 1.3 mm to have a 93.3% sensitivity for cage subsidence., Conclusions: This study is the first of its kind to demonstrate the association between vertebral body HUs and suprajacent disc height with the development of interbody cage subsidence after TLIF. The authors found that patients with lower HUs in the L1 vertebral body were more likely to experience subsidence, regardless of surgical level. Additionally, the study demonstrated that interbody cage height > 1.3 mm above the height of the suprajacent level is an independent risk factor for cage subsidence, with 93.3% sensitivity. These findings suggest that these factors may be utilized to create a template preoperatively for intraoperative cage selection.

Background Context: The evidence surrounding the topic of adjacent segment degeneration and disease has increased dramatically with an abundant amount of literature discussing the incidence of and techniques to avoid it. However, this evidence is often confusing to discern because of various definitions of both adjacent segment degeneration and disease., Purpose: To organize and review the recent evidence for adjacent segment degeneration and disease., Results: Although multifactorial, three distinct causes of adjacent segment disease in both the lumbar and cervical spine have been discussed: the natural history of the adjacent disc; biomechanical stress on the adjacent level caused by the fusion; and disruption of the anatomy at the adjacent level with the initial surgery. The incidence of adjacent segment degeneration in the lumbar spine has been widely reported in the literature from 0% to 100%; conversely, the reported incidence in the cervical spine is less variable. Similarly, strategies at avoiding adjacent segment disease in the lumbar spine include arthroplasty, dynamic fixation, and percutaneous fixation, whereas in the cervical spine the focus has remained on arthroplasty., Conclusions: Adjacent segment disease and degeneration remain a multifactorial problem with several techniques being developed recently to minimize them. In the future, it is likely that the popularity of these techniques will be dependent on the long-term results, which are currently unavailable., (Published by Elsevier Inc.)