Modified unilateral extrapedicular vertebroplasty for thoracolumbar osteoporotic vertebral compression fractures in a prospective Phase II study

Abstract Background A unilateral extrapedicular trajectory may facilitate vertebral-midline access, but its feasibility and approach-specific risks require prospective evaluation. This Phase II study assessed a modified extrapedicular technique for thoracolumbar osteoporotic vertebral compression fractures. Methods This prospective, single-center, single-arm study enrolled 20 patients aged over 60 years with acute magnetic-resonance-imaging-confirmed fractures at T10-L3 and a pain score greater than 4 on a 0–10 visual analogue scale. The needle was slid along the superior-lateral pedicle surface to the posterosuperior vertebral body. Outcomes included procedure completion, midline access, cement distribution, operative variables, complications, pain, and disability through 1 month. Analyses were descriptive, with exact 95% confidence intervals for participant-level technical success and serious adverse events. Results The cohort included 16 women and 4 men with a mean age of 75.2 years (range 60–96); 22 vertebrae were treated. All patients completed the procedure without conversion (20/20; 100%; exact 95% confidence interval 83.2–100%). Midline access and bilateral cement distribution were achieved in all 22 vertebrae. Mean cement volume was 3.9 ± 0.7 mL and operative time was 23.7 ± 6.5 min per vertebra. Mean visual analogue scale scores decreased from 7.8 ± 1.0 before surgery to 2.1 ± 0.7 on day 1 and 1.9 ± 0.6 at 1 month. Mean Roland-Morris Disability Questionnaire scores decreased from 21.5 ± 2.4 to 10.6 ± 1.5 and 9.8 ± 1.6. Three vertebrae (13.6%) had asymptomatic cement leakage. No serious procedure-related adverse event was observed (0/20; exact 95% confidence interval 0-16.8%). Conclusions The modified approach was technically feasible in this small T10-L3 cohort and consistently achieved midline access and bilateral cement distribution. The absence of a comparator, limited sample, and short follow-up preclude conclusions about comparative efficacy or uncommon harms. Trial registration Chinese Clinical Trial Registry, ChiCTR2000033687; prospectively registered on 9 June 2020.