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

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Objectives: To compare the strength of fixation of percutaneous screw versus plate/screw fixation in a paired cadaver model of OTA 41-B3 (Schatzker type II) split-depression fractures of the lateral tibial plateau. Methods: Six matched pairs of cadaveric knees were acquired. An OTA 41-B3 (Schatzker type II) split-depression fracture was created in all specimens using a standardized method. One specimen from each matched pair of knees was fixed with percutaneous screws, and the other was fixed with a plate/screw construct. All specimens underwent augmentation of the central metaphyseal defect with calcium phosphate. Mean residual displacement (depression) was measured on thin-slice high-resolution computed tomography using a standardized methodology following 3 experimental conditions: (1) after they were fixed, before loading; (2) unloaded cycling (simulating postoperative range of motion exercises); and (3) loaded cycling (simulating postoperative weight-bearing). Load to failure was also compared. Results: After adjustment for baseline measurements, there was no significant difference in mean residual depression of the lateral tibial plateau between treatments groups after unloaded or loaded cyclic testing. Mean residual depression was less than 1 mm in both the treatment groups. Load to failure was statistically equivalent between treatment groups. Conclusions: In our cadaveric study, in combination with calcium phosphate augmentation for both methods, percutaneous screw fixation conferred comparable strength of fixation compared with plate/screw constructs for treatment of OTA 41-B3 (Schatzker type II) tibial plateau fractures.