Hospital Clinico Universitario de Valladolid, Calle Ramon y Cajal, 47008, Valladolid, Spain.
Osteoporos Int. 2019 Mar;30(3):637-645. doi: 10.1007/s00198-018-4773-5. Epub 2018 Nov 28.
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.
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.
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.
Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5D 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.
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.
本研究在 30 例伴有疼痛性骨质疏松性椎体压缩性骨折的患者中进行了单中心研究，比较了两种椎体增强术。在术后 3 年的随访中，球囊扩张椎体后凸成形术和 SpineJack ® 技术均显著改善了疼痛/残疾/生活质量，但后者可更好地恢复椎体高度和矫正后凸畸形。
在比较治疗疼痛性骨质疏松性椎体压缩性骨折（VCF）的椎体增强术的临床试验中，患者随访时间很少超过 2 年。这项由研究者发起的前瞻性研究旨在比较 SpineJack ®（SJ）和球囊扩张椎体后凸成形术（BKP）的长期结果。初步结果显示，SJ 可更好地恢复椎体高度和角度，在 12 个月内保持稳定。
30 例患者被随机分为 SJ 组（n=15）或 BKP 组（n=15）。临床终点为镇痛药消耗量、腰背疼痛强度（视觉模拟评分（VAS））、Oswestry 残疾指数（ODI）和生活质量（EQ-VAS 评分）。这些指标在术前、术后 5 天（EQ-VAS 除外）、1、3、6、12 和 36 个月时进行记录。在手术前 48 小时和术后 5 天、6、12 和 36 个月拍摄脊柱 X 线片。
两组患者在 3 年期间均观察到临床改善，且无显著组间差异，但最终平均 EQ-5D 评分明显更有利于 SJ 组（0.93±0.11 比 0.81±0.09；p=0.007）。SJ 组的前位（10±13%比 BKP 的 2±8%，p=0.007）和中央高度（10±11%比 BKP 的 3±7%，p=0.034）以及椎体角度的矫正更大（-5.0°±5.1°比 BKP 的 0.4°±3.4°；p=0.003），表明椎体高度恢复/后凸畸形矫正在 36 个月时仍明显。
在这项研究中，两种技术在骨质疏松性 VCF 患者中均表现出非常好的长期临床疗效和安全性。在 3 年的随访中，SpineJack ® 术式的椎体高度恢复/后凸畸形矫正效果更好。
