177. Vertebral height restoration following painful vertebral compression fracture: an international multicenter experience using spine jack

Abstract

BACKGROUND CONTEXT Currently, there is no standard of care regarding the management of osteoporotic, malignant or traumatic vertebral compression fractures (VCFs). It is unclear which clinical parameters constitute sufficient indication for proceeding beyond conservative treatment. The criteria for surgical intervention are also not well defined. Recently, the SpineJack (Stryker, Kalamazoo, MI, USA) implantable device for the reduction of VCFs has gained FDA clearance for marketing in the United States. To date, there have not been any large reports describing early use cases, outcomes, or adverse events with SpineJack in the United States. Of immediate relevance is the use of the device in cases of osteoporotic compression fractures (for which it is FDA approved) and malignant compression fractures (for which it is not). The present study is a retrospective analysis of the largest international multicenter registry for vertebral augmentation using SpineJack. PURPOSE To review the efficacy of vertebral height restoration for painful VCFs using the SpineJack implantable device in a large international sample of real-world cases. STUDY DESIGN/SETTING Retrospective analysis is conducted utilizing a multicenter retrospective registry comprised of 180 patients who underwent vertebral augmentation using SpineJack in the United States and Europe. PATIENT SAMPLE The inclusion criteria of this study encompass any patient who underwent vertebral augmentation in whom the SpineJack device was used for the treatment of painful osteoporotic, malignant, or traumatic VCFs. OUTCOME MEASURES Primary outcomes measures include: (1) vertebral height restoration (mm), (2) change in NRS pain score, (3) rate of adjacent level fractures, and (3) rate of serious adverse events (SAEs). Secondary outcome measures include: (1) change in kyphotic angle, and (2) change in opioid utilization. METHODS Case enrollment began in August 2019. Pre- and postprocedural pain was recorded using the Numeric Rating Scale (NRS). Functional recovery is measured using the Oswestry Disability Index, and change in opioid utilization postprocedurally is measured in morphine equivalent units. Vertebral height is measured at the anterior vertebral body on pre- and postprocedural imaging. Loss of vertebral height due to VCF is calculated using prefracture imaging when available, or the average of vertebral height at the adjacent levels above and below the VCF. In a preliminary analysis of 27 cases, local kyphotic angle is measured as the angle of intersection between planes drawn along the superior and inferior endplates of the affected vertebrae. Final analysis will include segmental kyphotic angle, measured by the method of cobb utilizing the superior endplate of the level above the fracture and the inferior endplate of the level below. Follow-up for all outcome measures in conducted in the immediate postoperative period, 1 month, 3 months and 6 months after the procedure. RESULTS Case enrollment is schedule to close in August 2020. In a preliminary analysis of 27 patients who underwent vertebral augmentation with SpineJack at 34 separate levels, patients experienced an average vertebral height recovery of 74% (loss of 30±19% to 13±25% post procedurally). Local kyphotic angle was reduced by an average of 50% (7.5±7.5° to 4.0±5.3° post procedurally). 33% of patients (n=9) achieved complete restoration of prefracture vertebral height. 49% of patients achieved pain reduction (NRS decrease >50%) within the first 24 hours post-operatively. There were no SAEs or adjacent level fractures in this prelimary cohort, and the rate of opioid utilization remained unchaged in the immediate postoperative period. CONCLUSIONS The present study presents real-world evidence for the safety and efficacy of SpineJack as used in six centers in the United States and Europe. Preliminary results suggest excellent vertebral height restoration and reduction in local kyphotic angle. There were no SAEs or adjacent level fractures. FDA DEVICE/DRUG STATUS SpineJack (Not approved for this indication)