Autologous bone graft remains the gold standard by which bone graft substitutes are compared in spine fusion surgery. The utilization of bone graft substitutes, either as (1) an extender for spinal fusion constructs or (2) an alternative to minimize morbidity while maximizing outcomes, is changing. Moreover, current procedural technology (CPT) code 20939 became effective in 2018 defining bone marrow aspirate for bone grafting, spine surgery only. Changes in the complex landscape of grafting materials have prompted ISASS to provide category guidance for bone graft substitutes by comparing and contrasting US regulatory pathways, mechanisms of action, and supportive clinical evidence for these bone grafting materials. Testing & Regulatory Affairs

Background: To alleviate the symptoms of lumbar spinal stenosis, widely accepted methods of surgical treatment include decompression alone and decompression with fusion. As an alternative to these methods, interlaminar stabilization (ILS) devices with decompression were introduced. There is a large amount of research dedicated to examining the efficacy of ILS devices in single-level procedures, but fewer studies focus on their efficacy in 2-level procedures. The purpose of this study was to compare decompression with instrumented posterolateral fusion to decompression with interlaminar stabilization in patients who require surgical treatment at 2 levels for lumbar spinal stenosis at 5 years postoperation. Methods: Of the 322 patients enrolled in the Investigational Device Exemption clinical trial, 116 required surgical treatment at 2 levels. The ILS group consisted of 77 patients, and the fusion group consisted of 39 patients. Efficacy was measured using composite clinical success (CCS). Patients achieve CCS if they achieve all 4 of the following outcomes: 15-point improvement from baseline Oswestry Disability Index (ODI); no reoperation or epidural injections; no persistent, new, or increasing neurological deficits; and no major device-related complications. Results: There was a 91% rate of follow-up within the participant population in the 5-year data. There was a difference trending toward significance between groups for the absence of reoperation or epidural injection, with 68.8% of ILS patients and only 51.3% of fusion patients meeting this criteria (P ¼ .065); 13.0% of ILS patients and 25.7% of fusion patients required secondary surgery. The percentage of patients achieving overall CCS was much greater in the ILS group than the fusion group, with 55.1% (38/69) of ILS patients and only 36.4% (12/33) of fusion patients achieving CCS at month 60 (P ¼ .077). With regard to the ODI, the visual analog scale back and worse leg pain, the Short Form-12, and the Zurich Claudication Questionnaire, both groups had significantly better results at every followup time point when compared to their respective baseline scores. Conclusions: The 2-level ILS patient group performed as well as, if not better than, the 2-level fusion group across almost all outcome measures, demonstrating both clinical outcome success and favorably low reoperation rates in patients who received ILS surgery. Clinical Relevance: This is the first 5-year analysis of the 2-level ILS experience, which supplements previous studies that describe the advantages of ILS by extending such advantages to 2-level cases. New Technology

Background: Three-dimensional (3D) computer-assisted navigation (CAN) has emerged as a potential alternative to 2-dimensional (2D) fluoroscopy in the surgical placement of spinal instrumentation. Recently, 3D-CAN systems have improved significantly in their ability to provide real-time anatomical referencing while shortening the registration and set-up time. A novel system in navigation, Machine-Vision Image-Guided Surgery (MvIGS; 7D Surgical, Toronto, Canada) was cleared by the US Food and Drug Administration, but its potential benefits in reducing intra-operative radiation exposure to patients and enhancing surgical accuracy of pedicle screw placement are not fully known. Purpose: We sought to conduct a prospective, randomized, clinical study comparing the 3D-MvIGS spinal navigation system and 2D-fluoroscopy for pedicle screw insertion up to 3 levels (T10-S1) and for various measures of surgical efficacy. Methods: Sixty-two eligible patients were randomized to receive spine surgery using either the 3D-MvIGS group or the conventional 2D-fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis and degenerative spondylolisthesis. Intra-operative parameters and procedure-related unintended protocol violations were recorded. Results: Operative time and estimated blood loss were not significantly different between groups. Radiation time and exposure to patients were significantly reduced in the 3D-MvIGS group. There was no difference between groups in pedicle screw placement accuracy (2D-fluoroscopy group, 96.6%; 3D-MvIGS group, 94.2%). There were no major complications or cases that required revision surgery. Conclusion: The 3D-MvIGS navigation system performed comparably with 2D-fluoroscopy in terms of pedicle screw placement accuracy and operative time. The 3D-MvIGS showed a significant reduction in radiation exposure to patients. In more complex cases or larger cohorts, the true value of greater anatomical visualization can be elucidated.

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