Vertebroplasty and SpineJack® percutaneous implantable vertebral augmentation device for osteoporotic vertebral compression fractures treatment: a comparative and prospective study

Introduction Osteoporotic vertebral compression fractures (OVCFs) can compromise spinal stability, leading not only to functional impairments but also to significant impacts across multiple health domains. This study compares the clinical outcomes and prognostic significance of percutaneous vertebroplasty (PVP) and the SpineJack® (SJ) technique in the stabilization of OVCFs. Objective To determine whether PVP or the SJ technique provides superiority in pain relief in patients with OVCFs. Because an implant designed to restore vertebral height will, on mechanical grounds, correct kyphosis more than a stabilization-only technique, the clinically relevant question addressed here is whether the additional anatomical correction achieved with SJ translates into superior clinical outcomes compared with PVP. Secondary outcomes include improvement in functional outcomes and kyphosis restoration at a six-month follow-up. Materials and methods Prospective, comparative study including thirty-one patients with painful OVCFs (VAS > 5) eligible for both percutaneous vertebral stabilization techniques. Procedures were performed by the Interventional Radiology service at Hospital del Mar. Clinical outcomes were assessed preprocedure and at four hours, one month and six months using the Visual Analog Scale (VAS) for pain, the Oswestry Disability Index (ODI) and local kyphotic angle changes as variables. PVP and SJ outcomes were compared with longitudinal and bivariate analyses. The predefined primary endpoint was the change in VAS score from baseline to six months; all remaining outcomes were secondary. Because treatment allocation was physician-driven and non-randomized, the between-group comparison was predefined as exploratory and hypothesis-generating. Results Both groups showed significant pain (VAS) and disability (ODI) improvement. SJ achieved greater pain relief at one month and significantly higher correction of local kyphotic angle. Complication rates were low and similar between groups. Conclusions SJ provides greater correction of local kyphosis compared with PVP, though both techniques offer significant pain and disability improvement. Six-month pain outcome may depend more on fracture stabilization than on deformity correction. Further multicenter, prospective, randomized trials are needed to confirm potential advantages of SJ in OVCFs.