Safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study
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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 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.
SpineJack® 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° ± 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.
KeywordsBack pain Balloon kyphoplasty Osteoporosis SpineJack Vertebral augmentation Vertebral compression fracture
Compliance with ethical standards
Conflicts of interest
David César Noriega has received a speaker honorarium from Vexim and Medtronic. Rubén Hernández Ramajo: none. Israel Sánchez Lite: none. Borja Toribio: none. Raul Corredera: none. Francisco Ardura has received a speaker honorarium from Vexim. Antonio Krüger has received a speaker honorarium from Medtronic, Soteira, Biomed, DFine and Vexim.
- 6.Baxter D, Yeh J (2012). The use of polymethyl methacrylate (PMMA) in neurosurgery. In: Luigi Ambrosio, Elizabeth Tanner (ed) Biomaterials for Spinal Surgery, Woodhead Publishing in Materials, Woodhead Publishing Limited, p 380Google Scholar
- 18.Yeom JS, Kim WJ, Choy WS, Lee CK, Chang BS, Kang JW (2003) Leakage of cement in percutaneous transpedicular vertebroplasty for painful osteoporotic compression fractures. J Bone Joint Surg Brit :83–9Google Scholar
- 22.Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR (2015) KAST Study: the Kiva® System as a vertebral augmentation treatment—a safety and effectiveness trial: a randomized, non-inferiority trial comparing the Kiva® system to balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976) 40:865–875CrossRefGoogle Scholar