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There are many excellent manuscripts on which to base a literature evaluation and a few meta-analyses that capture the essence of the information on vertebral augmentation, but this article uses almost none of this recent information.1 The manuscript is an attempt to more objectively report some of the highly controversial and suboptimally constructed sham versus vertebroplasty articles.
The title of the paper contains the descriptor vertebral augmentation (VA) which includes vertebroplasty (VP), balloon kyphoplasty (BKP) and implant kyphoplasty (IK), but 14 out of the 15 articles in table 1 are about only VP. The single mention of kyphoplasty (KP) is a 10-year-old BKP paper that is scarcely even discussed; there is not a single mention of IK which is the only technology shown to be superior to the predicate device in a pivotal trial.2 The authors do mention that more than 4000 articles have been published on VP alone but then proceed to discuss only four of the 4000 and only four of the 14 articles listed in their table.
In addition to the 4000 articles on VP alone there are 2000 articles on KP with 250 manuscripts per year dedicated to VA, and the last two large meta-analyses analyzed a total of 2524 papers that included 52 level I and …
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests Consulting: Medtronic, Spineology, Merit Medical, Lilly, Johnson & Johnson, SpinTech, Imaging3, IZI, Medlantis, Techlamed, Consultant, Peterson Enterprises, Medical Metrics, Radius Pharmaceuticals, Avanos, Vertiflex, Sollis Pharmaceuticals, Simplify Medical, Stryker, Lenoss Medical, Spine BioPharma. Research Funding: Medtronic, SpinTech, Medical Metrics, Avanos, Relievant, Vertiflex, Stryker, Sollis Pharmaceuticals, Simplify Medical, Lenoss Medical, Spine BioPharma. Advisory Board: Medtronic, Imaging3. Board Member: SpinTech, Nocimed. Stock Holder: Artio, Sophiris, Eleven Biotherapeutics, Radius Pharmaceuticals, Flow Forward, Lenoss Medical, Spine BioPharma. Editorial Support: Thieme, Springer, Humana. Speakers Bureau: Eli Lilly, Radius Pharmaceuticals, Stryker, Medtronic, Vivex, Vertiflex, Merit, Medlantis, Avanos.
Patient consent for publication Not required.
Provenance and peer review Commissioned; externally peer reviewed.
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