Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

Abstract

Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time. In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment. Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5days and 1, 3, 6, and 12months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12months. Spine X-rays were taken 48h prior to procedure and 5days and 6 and 12months after. SpineJack® led to a significantly shorter intervention period (23 vs 32min; p < 0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82% at 12months) and in functional disability (94 vs 90% at 12months), a greater and sustainable mean correction of anterior (12 ± 13 vs 0 ± 7% for BKP, p = 0.003) and central height (12 ± 10 vs 2 ± 6% for BKP, p = 0.001) at 12months, and a larger restoration of the vertebral body angle still evident 12months after implantation (-4.4° ± 5.8° vs 0.2° ± 3.0° for BKP; p = 0.012). This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.