Abstract No. 15: Nitinol Endovertebral Prosthesis Assisted Vertebroplasty: Clinical Experience on 40 Patients

To assess feasibility, safety, effectiveness, vertebral height restoration and leakage rate reduction of a novel device From December 2009, 40 consecutive patients (36 female, mean age 76±6 years) were treated on 42 painful osteoporotic vertebral collapses by nitinol endovertebral prosthesis (Spinealign) assisted vertebroplasty. All procedures were performed in local anesthesia with bilateral approach under hybrid fluoro-CT guidance (Philips Allura Xper CT). After the working cannulas were inserted, two Nitinol endoprosthesis were expanded within the vertebral body; bone cement (PMMA) was then injected under fluoroscopic control. Rotational acquisition with 2-dimensional reconstruction was performed before and after the procedure to measure vertebral height, in latero-lateral (LL) (posterior, center, anterior) and postero-anterior (PA) view (left, center, right) and to detect any PMMA leakages. Preprocedural MRI was carried-out in all patients to confirm bone marrow edema within the vertebral fracture. Visual Analog scale (VAS) and Oswestry disability questionnaire (ODQ) was evaluated before the procedure and after 6 months follow-up. The procedure was completed in all patients without complications and same procedural day discharge from the Hospital. VAS and ODQ significantly improved (p<0.0005 paired t-test) from average of 8.0±1.6 to 0.7±1.4 and 69.7±16.0% to 5.5±8.7% respectively. Vertebral height significantly increased (p<0001 paired t-test): average height restoration (millimeters) in LL was 1.9±2.1 (posterior), 4.6±3.6 (center), 2.2±2.2 (anterior) and in PA 2.3±2.4 (left), 3.8±3.0 (center), 1/5±1.9 (right). In 3/42 vertebrae (7.1%) a discal PMMA leakage was detected whereas in 2 (4.8%) a minimal asymptomatic venous leakage occurred. 3/40 patients (7.5%) had a new vertebral fracture during follow-up. Nitinol endovertebral prosthesis assisted vertebroplasty is feasible and effective to obtain pain regression; some height restoration and PMMA leakages reduction can be also achieved.