Safety and Efficacy of Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures: A Multicenter Retrospective Study in Japan.

Purpose: Bone cement enhancement by percutaneous vertebroplasty (PVP) for the treatment of osteoporotic vertebral compression fractures remains unapproved, as it has not been fully evaluated in Japan. The current multicenter study was conducted in Japan to verify the safety and efficacy of PVP in patients with painful osteoporotic vertebral fractures. Material and Methods: In this retrospective study, we referred to previous studies to evaluate the non-inferiority of PVP to balloon kyphoplasty (BKP). We reviewed consecutive patient data from April 2017 to March 2018 from four institutions based on the medical records of the intervention. We statistically investigated the adverse events due to cement leakage or other factors associated with PVP, and new vertebral compression fractures after PVP were evaluated for safety, pain relief, and gait improvement. Results: This study included 485 patients; most of whom were in the middle- to oldest- age groups (mean age, 81.4 years). No serious adverse events were reported in patients available for safety evaluation (n = 485). Cement leakage and new vertebral compression fractures occurred in 35.7% and 18.6% (26.2%-38.4% and 8.9%-20.7%) of the patients undergoing PVP, respectively, both of which were also judged to be equivalent to those of BKP. The pain score improved in those undergoing PVP, and this improvement was maintained during a one-year follow-up. Of the 206 patients who had difficulty walking at baseline, 156 had restored walking at discharge. Conclusions: PVP was shown to be a safe and effective treatment, even in elderly patients with painful osteoporotic vertebral fractures.

Laser-guided computed tomography puncture system: simulation experiments using artificial phantom lesions and preliminary clinical experience.

PURPOSE: To conduct computed tomography (CT)-guided puncture exactly and safely, we newly developed a laser guiding puncture system that can be used in a commercially available CT scanner. MATERIALS AND METHODS: The laser-guided CT puncture system is built on the CT table with an aluminum frame. Preliminary simulation tests were conducted using two models representing the body and nodular lesions, and puncture procedures were carried out for 15 patients using this system. RESULTS: The mean distance and standard deviation from the center in simulation experiments conducted using this puncture system were 2.95 +/- 1.20 mm for operator A and 3.52 +/- 1.12 mm for operator B. There was no statistically significant difference between the operators (P = 0.40) or the angles (P = 0.32). For five lung biopsy patients, the distance from the target point planned before biopsy to the actual last puncture point was 0-8 mm. For 10 percutaneous vertebroplasty (PVP) patients (two performed in Th11, one in Th12, five in L1, two in L2), the plan before the puncture procedure was to pass the needle through the vertebral pedicle in all cases. The distance between the planned target point and the actual last puncture point was 0-5 mm. CONCLUSION: This system has the potential to accomplish the CT-guided puncture procedure safely and accurately.

Percutaneous vertebroplasty immediately relieves pain of osteoporotic vertebral compression fractures and prevents prolonged immobilization of patients.

To assess the immediate efficacy of percutaneous vertebroplasty (PVP) in relief of pain and improving mobility of patients with vertebral compression fractures (VCF) secondary to osteoporosis, 205 cases (175 patients) underwent 250 percutaneous injections of polymethylmethacrylate (PMMA; unilateral, 247 levels; bilateral, 3 levels) into vertebrae under CT and fluoroscopic guidance for 34 months. Patients were prospectively asked to quantify their pain on a visual analog scale (VAS) before and a day after PVP. The interval to mobilization was recorded in those who were immobilized because of pain and/or bed-rest therapy (115 cases). PVP was technically successful in all patients, with three cases of minimal complications. The mean VAS score available for 196 cases was improved from 7.22+/-1.89 (range, 3-10) to 2.07+/-1.19 (range, 0-10) by PVP. Ninety-four of 115 immobilized cases (81.7%) were mobile by 24 h after PVP, and the mean value was 1.9+/-2.8 days. The incidence of recurrent and new fractures was 15.6% in 4-25 months (mean, 15.3 months). PVP is a safe and effective treatment for relieving the pain associated with osteoporotic VCF and strengthening the vertebrae, avoiding refractures. This therapy leads to early mobilization and avoidance of the dangers of conservative therapy of bed-rest.