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

UNLABELLED: Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack(R) and Kyphx Xpander(R) 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. INTRODUCTION: In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack(R) (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. METHODS: 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 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after. RESULTS: SpineJack(R) led to a significantly shorter intervention period (23 vs 32 min; p < 0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82 % at 12 months) and in functional disability (94 vs 90 % at 12 months), 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 12 months, and a larger restoration of the vertebral body angle still evident 12 months after implantation (-4.4 degrees +/- 5.8 degrees vs 0.2 degrees +/- 3.0 degrees for BKP; p = 0.012). CONCLUSIONS: This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack(R) procedure has a higher potential for vertebral body height restoration and maintenance over time

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