Background and Purpose Recently, the SpineJack has gained FDA clearance for marketing in the United States. These systems are quick and easy to deploy and have the advantage of being installed percutaneously under local anesthesia. As such, they are currently transforming the treatment landscape for patients with osteoporotic and malignant vertebral compression fractures (VCFs). Given the recency of this clearance, there is a dearth of information in the literature pertaining to experience with implementing the SpineJack in the United States. This study seeks to provide one of the first detailed analyses of outcomes following the use of the SpineJack for treating osteoporotic and maliganant VCFs in the United States. This study will focus on determining the extent to which the SpineJack is able to achieve adequate vertebral height restoration, pain reduction, and functional restoration, while minimizing the incidence of adjacent level fractures and volume of cement required to be injected into the vertebrae.
Methods Retrospective data will be collected from cases at our institution in which the SpineJack was applied to treat patients presenting with osteoporotic or maliganant VCFs. We expect to acquire data from approximately 25 cases of SpineJack procedures used to treat VCF, representing our instituition’s collective early experiences with this novel system. A detailed dataset will be generated from each case, including patient demographics, fracture etiology and characteristics, medical comorbidities, procedure characteristics, procedure-related complications, resource utilization outcomes, pain and disability outcomes, as well as quantitative measures of radiographic endpoints obtained from follow up spine CT studies. Restoration of vertebral height, as determined by the vertebral body height ratio, is the primary endpoint. Secondary enpoints include pain reduction measured by VAS score, functional improvement measured by the Owestry Disability Index, and the rate of adjacent level fractures. Complete datasets will be collected from cases pre-operatively, as well as 1, 3, and 6 months post-operatively.
Expected Outcomes We anticipate observing that the SpineJack achieves adequate restoration of vertebral height with shorter procedure times and smaller volumes of cement relative to previously reported values for other vertebral augmentation described in the literature. We also expect to observe significant and sustained improvement in both pain and function scores at pre-determined time points up to at least 6 months post-operation compared to baseline scores measured pre-operatively.
Discussion With a strong mechanistic rationale based on the promising findings from a previous prospective study carried out in Europe, this study will provide among the first comprehensive characterizations of early experiences with the SpineJack in the United States. As with any early experiences with a novel technology, key insights that improve future use of the technology may be gleaned from rigorous analysis of thoroughly collected data.
Disclosures M. Martini: None. K. Yaeger: None. D. Nistal: None. A. Doshi: None. R. De Leacy: None.
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