ABSTRACT
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 procedures 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.
Footnotes
Disclosures and COI: Olivier Clerk-Lamalice reports no disclosures. Douglas Beall reports the following disclosures unrelated to the preparation of this manuscript: compensation, grants, and personal fees from Medtronic related to consultancy, research and teaching; grants from Benvenue, Alphatech Spine, Medical Metrics, Liventa, Vexim, and Mesoblast; consultancy fees from DEFINE and Osseon; other from Lilly, Smith & Nephew, Biomet, Vertiflex, Synthes, and Integral Spine Solutions. Kevin Ong reports the following disclosures unrelated to the preparation of this manuscript: employee and shareholder of Exponent, a scientific and engineering consulting firm. Exponent has been paid fees by entities in the biomedical arena for consulting services, including Zimmer Biomet, Stryker Orthopaedics, Joerns Healthcare, Ossur, DJO, Ethicon, Ferring Pharmaceuticals, Pacira Pharmaceuticals, Paradigm Spine, and Medtronic. Morgan Lorio reports the following disclosures unrelated to the preparation of this manuscript: royalties from Choice Spine Thunderbolt, stock ownership in OrthogenRx, stock options with OrthoKinematics, intellectual property with Transformer Spine.
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