Vertebral augmentation with nitinol endoprosthesis: clinical experience with one year follow up in 40 patients

Aim: To assess safety, effectiveness and vertebral height restoration of prosthesis-assisted vertebroplasty during 1-year follow-up. Methods: 40 patients (36 females, mean age 73.6 years) were treated with percutaneous vertebral augmentation (PVA) performed by placement of nitinol implants. Fracture edema at MRI was required. All PVA were performed in local anesthesia with fluoroscopic-CT guidance. Implants were inserted through a bipedicular access. CT scan was performed to measure vertebral height (6 point) at baseline after the expanded implant was cemented and at 1-year follow up (f/u). Visual Analogue Scale (VAS) and Oswestry disability Index (ODI) were calculated before, after procedure. and at 1-year f/u (Mean:15 months). Results: No major complications occurred. 2 patients were lost at f/u. VAS and ODI were improved in 39 patients (97.5%) (p<0.0001 Wilcoxon test). Higher restoration values were in center measurement both in mid-coronal (3.9 mm, 3.0 SD) and in mid-sagittal reconstruction (4.7 mm, 3.6 SD). No significant height loss occurred over time. During follow-up no device change or migration was observed. 4 patients (10%) had a spontaneous new vertebral fracture. Conclusions: Vertebral augmentation performed with nitinol endoprosthesis is a safe and effective procedure. PVA provides a long-lasting pain relief and vertebral height gain.