New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial.
New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial.
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DOI：
10.1007/s11657-015-0229-0
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发表时间：
2015
影响因子：
3
通讯作者：
Buchbinder R
中科院分区：
文献类型：
--
作者：
Staples MP;Howe BM;Ringler MD;Mitchell P;Wriedt CH;Wark JD;Ebeling PR;Osborne RH;Kallmes DF;Buchbinder R
评估椎体成形术（VP）对术后两年内放射学上明显的椎体骨折风险的影响。我们在急性骨质疏松性椎体骨折患者中进行了一项随机安慰剂对照试验。符合条件的参与者被随机分配到VP组（n=38）或安慰剂组（n=40）。记录VP组的水泥体积和渗漏情况。分别在基线、12月和24月拍摄胸腰椎平片。两名独立的放射科医生对同一相邻和非相邻节段的新发骨折和进展性骨折进行了评估。在12个月和24个月时，分别有45名（58%）和47名（60%）参与者可获得x线片。新发骨折或进展性骨折组间无差异：12个月和24个月后，VP组为32例和40例，安慰剂组为21例和33例（风险比（HR） 1.80, 95%可信区间（CI） 0.82至3.94）。当只考虑相邻(HR （95% CI): 2.30(0.57至9.29)）和非相邻(HR (95% CI): 1.45（0.55至3.81）水平时，可以看到类似的结果。在所有的比较中，VP组发生任何类型骨折的风险都有升高的趋势。在VP组中，骨折风险与总水泥体积(HR (95% CI): 0.91（0.71至1.17）或相对水泥体积(HR （95% CI): 1.31(0.15至11.48)）或水泥泄漏(HR （95% CI): 1.20(0.63至2.31)）无关。我们的研究并没有显示，与未接受VP手术的椎体骨折患者相比，接受VP手术的患者随后发生骨折的风险明显增加。然而，由于观察到的数值增加不显著，因此需要足够的研究来得出关于骨折风险的明确结论。
To assess the effect of vertebroplasty (VP) on the risk of further radiologically apparent vertebral fracture within two years of the procedure. We conducted a randomised placebo-controlled trial of VP in people with acute osteoporotic vertebral fracture. Eligible participants were randomly assigned to VP (n=38) or placebo (n=40). Cement volume and leakage were recorded for the VP group. Plain thoracolumbar radiographs were taken at baseline, 12 and 24 months. Two independent radiologists assessed these for new and progressed fractures at the same, adjacent and non-adjacent levels. At 12 and 24 months, radiographs were available for 45 (58%) and 47 (60%) participants respectively. There were no between-group differences for new or progressed fractures: 32 and 40 in the VP group after 12 and 24 months compared with 21 and 33 in the placebo group (hazard ratio (HR) 1.80, 95% confidence interval (CI) 0.82 to 3.94). Similar results were seen when considering only adjacent (HR (95% CI): 2.30 (0.57 to 9.29)), and non-adjacent (HR (95% CI): 1.45 (0.55 to 3.81) levels. In all comparisons there was a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Within the VP group, fracture risk was unrelated to total (HR (95% CI): 0.91 (0.71 to 1.17)) or relative (HR (95% CI): 1.31 (0.15 to 11.48)) cement volume, or cement leakage (HR (95% CI): 1.20 (0.63 to 2.31)). For patients undergoing VP our study did not demonstrate significant increases in subsequent fracture risk beyond that experienced by those with vertebral fractures who did not undergo the procedure. However, because of the non-significant numerical increases observed, studies with adequate power are needed to draw definite conclusions about fracture risk.