PDF(Pubmed)
Abstract：
UNASSIGNED: Segmental spinal deformity results from vertebral compression fracture (VCF) and progressive collapse of the fractured vertebral body (VB). The VB stenting (VBS) systemⓇ comprises a balloon-assisted, expandable, intrasomatic, metal stent that helps maintain the restored VB during balloon removal and cement injection, which minimizes cement leakage. We performed a prospective, multicenter, clinical trial of the VBS system in Japanese patients with acute VCF owing to primary osteoporosis.
UNASSIGNED: Herein, 88 patients, 25 men and 63 women aged 77.4±8.3 years, with low back pain, numerical rating scale (NRS) score of ≥4, and mean VB compression percentage (VBCP) of <60% were enrolled. The primary endpoints were the VBCP restoration rate and reduction in low back pain 1 month and 7 days after VBS surgery, respectively. Secondary endpoints included changes in VBCP, NRS pain score, Beck index, kyphosis angle, and quality of life according to the short form 36 (v2) score. Safety was assessed as adverse events, device malfunctions, and new vertebral fractures.
UNASSIGNED: Overall, 70 patients completed the study. VBS surgery increased the restoration rates of anterior and midline VBCP by 31.7%±26.5% (lower 95% confidence intervals (CI): 26.8) and 31.8%±24.6% (lower 95% CI: 27.2), respectively, and the reduction in NRS pain score was -4.5±2.4 (upper 95% CI: -4.0). As these changes were greater than the predetermined primary endpoint values (20% for VBCP and -2 for NRS score), they were judged clinically significant; these changes were maintained throughout the 12-month follow-up (p<0.001). Likewise, significant improvement was observed in the Beck index, kyphosis angle, and quality of life score, which were maintained throughout the follow-up. There were three serious adverse events. New fractures occurred in 12 patients-all in the adjacent VB.
UNASSIGNED: VBS surgery effectively restored the collapsed VB, relieved low back pain, and was tolerable in patients with acute osteoporotic VB fracture.
UNASSIGNED: Herein, 88 patients, 25 men and 63 women aged 77.4±8.3 years, with low back pain, numerical rating scale (NRS) score of ≥4, and mean VB compression percentage (VBCP) of <60% were enrolled. The primary endpoints were the VBCP restoration rate and reduction in low back pain 1 month and 7 days after VBS surgery, respectively. Secondary endpoints included changes in VBCP, NRS pain score, Beck index, kyphosis angle, and quality of life according to the short form 36 (v2) score. Safety was assessed as adverse events, device malfunctions, and new vertebral fractures.
UNASSIGNED: Overall, 70 patients completed the study. VBS surgery increased the restoration rates of anterior and midline VBCP by 31.7%±26.5% (lower 95% confidence intervals (CI): 26.8) and 31.8%±24.6% (lower 95% CI: 27.2), respectively, and the reduction in NRS pain score was -4.5±2.4 (upper 95% CI: -4.0). As these changes were greater than the predetermined primary endpoint values (20% for VBCP and -2 for NRS score), they were judged clinically significant; these changes were maintained throughout the 12-month follow-up (p<0.001). Likewise, significant improvement was observed in the Beck index, kyphosis angle, and quality of life score, which were maintained throughout the follow-up. There were three serious adverse events. New fractures occurred in 12 patients-all in the adjacent VB.
UNASSIGNED: VBS surgery effectively restored the collapsed VB, relieved low back pain, and was tolerable in patients with acute osteoporotic VB fracture.
摘要：
■节段性脊柱畸形是由椎体压缩性骨折（VCF）和椎体骨折（VB）的进行性塌陷引起的。VB支架（VBS）系统由球囊辅助，可扩展,Intrasomatic,金属支架，有助于在球囊移除和水泥注射期间保持恢复的VB，最大限度地减少水泥渗漏。我们做了一个潜在的，多中心，VBS系统在日本原发性骨质疏松症急性VCF患者中的临床试验。
■这里，88名患者,25名男性和63名女性，年龄为77.4±8.3岁，腰痛，纳入的数字评定量表(NRS)评分≥4分,平均VB压缩百分比(VBCP)<60%.主要终点是VBCP恢复率和VBS手术后1个月和7天下腰痛的减少，分别。次要终点包括VBCP的变化，NRS疼痛评分,贝克指数,后凸角度,和生活质量根据短表36（v2）评分。安全性评估为不良事件，设备故障，和新的椎骨骨折。
■总的来说，70名患者完成了研究。VBS手术使VBCP的恢复率增加了31.7％±26.5％（较低的95％置信区间（CI）：26.8）和31.8％±24.6％（较低的95％CI：27.2），分别,NRS疼痛评分降低为-4.5±2.4(95%CI:-4.0)。由于这些变化大于预定的主要终点值（VBCP为20%，NRS评分为-2），他们被认为具有临床意义;这些变化在整个12个月的随访中保持不变(p<0.001).同样，贝克指数显著改善，后凸角度,和生活质量评分，在整个后续行动中保持不变。有3起严重不良事件。新骨折发生在12例患者中，均发生在相邻的VB中。
■VBS手术有效恢复了塌陷的VB，缓解腰痛，急性骨质疏松性VB骨折患者可耐受。
■这里，88名患者,25名男性和63名女性，年龄为77.4±8.3岁，腰痛，纳入的数字评定量表(NRS)评分≥4分,平均VB压缩百分比(VBCP)<60%.主要终点是VBCP恢复率和VBS手术后1个月和7天下腰痛的减少，分别。次要终点包括VBCP的变化，NRS疼痛评分,贝克指数,后凸角度,和生活质量根据短表36（v2）评分。安全性评估为不良事件，设备故障，和新的椎骨骨折。
■总的来说，70名患者完成了研究。VBS手术使VBCP的恢复率增加了31.7％±26.5％（较低的95％置信区间（CI）：26.8）和31.8％±24.6％（较低的95％CI：27.2），分别,NRS疼痛评分降低为-4.5±2.4(95%CI:-4.0)。由于这些变化大于预定的主要终点值（VBCP为20%，NRS评分为-2），他们被认为具有临床意义;这些变化在整个12个月的随访中保持不变(p<0.001).同样，贝克指数显著改善，后凸角度,和生活质量评分，在整个后续行动中保持不变。有3起严重不良事件。新骨折发生在12例患者中，均发生在相邻的VB中。
■VBS手术有效恢复了塌陷的VB，缓解腰痛，急性骨质疏松性VB骨折患者可耐受。
