Sphereplasty with 3D porous titanium microspheres for thoracolumbar vertebral compression fractures: analysis of clinical efficacy and safety profile of a novel technique

Abstract

PURPOSE: Porous Titanium Microspheres (PTM)-based Sphereplasty has been recently proposed as a novel vertebral augmentation technique for thoracolumbar Vertebral Compression Fractures (VCFs), potentially promoting bony fusion and reducing long-term complications. This study aims to evaluate the clinical efficacy and safety of PTM-based Sphereplasty for the treatment of post-traumatic thoracolumbar VCFs and compared the results with data from the literature on standard PMMA-based kyphoplasty. METHODS: Fifty-two patients (32 females), treated with PTMs Sphereplasty for 57 post-traumatic AO Spine A1 and A3 thoracolumbar VCFs, were prospectively enrolled. Data on demographics, fracture types, surgical details, pain scores (NRS) and disability (ODI) were analyzed. Imaging included x-ray, MRI and CT. Vertebral Body Height (VBH), Wedge Angle (WA) and Kyphosis Angle (KA) were measured. RESULTS: Median age was 62.7 years and median follow-up was 334.0 days. Median NRS scores decreased from 8.0 to 4.0 (p < 0.001) and ODI improved from 66.35% to 28.45% (p < 0.001). Radiological evaluation demonstrated median KA values of 6.9° preoperatively, 5.5° postoperatively and 7.71° at final follow-up (p = 0.026). WA decreased from 8.4° to 5.0° and 5.1°, respectively (p < 0.001). Anterior and middle VBH improved significantly, from 19.52 to 21.65 mm (p = 0.003) and from 17.49 to 21.20 mm (p < 0.001), whereas there was no clinically relevant change in cranial and caudal VBHs. CONCLUSION: Sphereplasty is a safe and effective treatment for post-traumatic thoracolumbar VCFs, providing primary stability, pain relief and functional improvement. PTMs may represent a promising alternative to PMMA kyphoplasty, promoting bony fusion and reducing long-term complications.