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Introduction: The SpineJackⓇ (SJ) system received FDA clearance in 2018, therefore this device is currently available to perform kyphoplasty in osteoporotic vertebral fractures. This study aims to assess the outcome of the SJ system in the management of vertebral fragility fractures (VFFs). Evidence Acquisition and Synthesis: OVID-MEDLINEⓇ, EMBASE, Cochrane Library, SCOPUS, Springer Link, Web of Science, Google Scholar and PubMed were searched from January 2015 to November 2021 to identify relevant studies. The methodological qualities of the studies were evaluated, and relevant data were extracted. Seven clinical trials, recruiting 644 patients with 690 VFFs were included. Although PVP, balloon kyphoplast (BKP) and SJ showed comparable effectiveness in back pain relief in patients with VFFs, SJ showed a faster and higher pain relief and a better quality of life, compared with the other two augmentation techniques. Moreover, patients treated with SJ, compared with PVP and BKP, showed a better vertebral body height (VBH) restoration and kyphotic correction; these findings were confirmed also at long-term follow-up. Asymptomatic cement leakage and adjacent level fractures (ALFs) were observed in patients treated with SJ, but with a lower incidence compared with PVP and BKP. Conclusions: This systematic review shows that SJ has an excellent risk/benefit profile and is more effective than the other augmentation techniques in VBH restoration and kyphotic correction. These findings correlate with a better postoperative quality of life. [ABSTRACT FROM AUTHOR]

Summary: This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction.Introduction: Patient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months.Methods: Thirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after.Results: Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5Dindex score was significantly in favor of the SJ group (0.93 ± 0.11 vs 0.81 ± 0.09; p = 0.007). Vertebral height restoration/kyphotic correction was still evident at 36 months with a greater mean correction of anterior (10 ± 13% vs 2 ± 8% for BKP, p = 0.007) and central height (10 ± 11% vs 3 ± 7% for BKP, p = 0.034) and a larger correction of the vertebral body angle (− 5.0° ± 5.1° vs 0.4° ± 3.4°; p = 0.003) for SJ group.Conclusions: In this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure. [ABSTRACT FROM AUTHOR]

Summary: 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. Introduction: 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. 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® 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). Conclusions: 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. [ABSTRACT FROM AUTHOR]