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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-5D index 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.

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3°; p < 0.001), remained at 12 months (−4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

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