ISASS Policy 2018—Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity

Olivier Clerk-Lamalice; Douglas P. Beall; Kevin Ong; Morgan P. Lorio

doi:10.14444/5096

ABSTRACT

The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of “the seeming disconnect between the conclusions of … two [Level I] PRCT's and previous experience and data” regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 is based on a thorough literature search for relevant studies, including systematic reviews and meta-analyses, that are subjected to thorough quality appraisal for the purpose of informing public opinion and decision making. Given the abundance of high-quality information, ISASS can confidently advocate that there is strong support for vertebral augmentation in the treatment of symptomatic vertebral compression fractures.

Footnotes

Disclosures and COI: OCL reports no disclosures. DB 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. KO 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. ML 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.