Procedural Complications and Implant Cutout of the SpineJack®-System in Thoracolumbar Vertebral Fractures: A Retrospective Analysis of 204 Implants from a Level-1 Trauma Center
Abstract
Study Design Retrospective cohort study. Objectives Implant-related complications of SpineJack® stent-kyphoplasty, particularly endplate cutout, remain poorly characterized. This study determined the incidence of procedural complications, with a focus on cutout, and identified associated factors. Methods All patients treated with stand-alone SpineJack® stent-kyphoplasty at a level-1 trauma center (November 2014–December 2022) were retrospectively reviewed, excluding malignant fractures. In total, 204 implants were analyzed (129 OVFs, 75 VCFs). Intraoperative complications and postoperative endplate cutout, assessed on imaging after mobilization, were analyzed by fracture type, AO/OF classification, region and vertebral level. Results Mean age was 64.9 years (SD 17.5); OVF patients were significantly older than VCF patients (74.3 vs 48.8 years, p<0.001). Vascular cement leakage occurred in 2 cases (1.0%); no technical failures or conversions were recorded. Cement leakage occurred in 18 implants (8.8%) and cutout in 16 (7.8%), neither differing by fracture type. Cutout incidence differed significantly across OF grades (p=0.018), though not after excluding the small OF1 subgroup (p=0.211) or in multivariable analysis (OR 1.03, p=0.918), suggesting limited power; cutout was not correlated with cement leakage or vertebral level. Conclusions Stand-alone SpineJack® stent-kyphoplasty is associated with infrequent vascular and cement-related complications. Endplate cutout (7.8%) was numerically more frequent in severely collapsed osteoporotic (OF4) fractures, but this association was not robust to sensitivity or multivariable analysis, consistent with limited power rather than a true absence of effect; no cutout event in this cohort had a demonstrated clinical consequence. Prospective, adequately powered study is needed to confirm this association.