Andresen Reimer, Radmer Sebastian, Andresen Julian Ramin, Schober Hans-Christof
Institute of Diagnostic and Interventional Radiology/Neuroradiology, Westkuestenklinikum Heide, Academic Teaching Hospital of the Universities of Kiel, Luebeck and Hamburg, Esmarchstraße 50, 25746, Heide, Germany.
Centre for Orthopaedics, Berlin, Germany.
Eur Spine J. 2017 Dec;26(12):3235-3240. doi: 10.1007/s00586-016-4935-0. Epub 2017 Jan 9.
The objective of this prospective, randomised study was to examine the feasibility and clinical outcome of balloon sacroplasty and radiofrequency sacroplasty.
In 40 patients with a total of 57 sacral fractures, CT-guided cement augmentation was performed by means of BSP or RFS. For BSP, the balloon catheter was inflated and deflated in the fracture zone, and the hollow space, thus, created was then filled with PMMA cement. For RFS, the spongious space in the fracture zone was initially extended using a flexible osteotome, and the highly viscous PMMA cement, activated by radiofrequency, was then inserted into the prepared fracture zone. Pain intensity was determined on a VAS before the intervention, on the second day, and 6, 12 and 18 months after the intervention. The results were tested for significance by means of paired Wilcoxon rank-sum tests and Mann-Whitney U tests.
BSP and RFS were technically fully feasible in all patients. An average of 6.3 ml cement per fracture was inserted in the BSP group and an average of 6.1 ml per fracture in the RFS group. Leakage could be ruled out for both procedures. The mean pain score on the VAS before the intervention was 8.6 ± 0.55 in the BSP group and 8.8 ± 0.58 in the RFS group. On the second postoperative day, a significant pain reduction was seen (p < 0.001), with an average value of 2.5 (BSP ± 0.28, RFS ± 0.38) for both groups. After 6 (12; 18) months, these values were stable for the BSP group at 2.3 ± 0.27 (2.3 ± 0.24; 2.0 ± 0.34) and for the RFS group at 2.4 ± 0.34 (2.2 ± 0.26; 2.0 ± 0.31). With regard to pain, exceedance probability values of p = 0.86 (6 months), p = 0.94 (12 months) and p = 1 (18 months) were seen, so that neither treatment method leads to differences in results.
BSP and RFS are interventional, minimally invasive procedures that enable reliable cement augmentation and achieve equally good clinical outcomes in the medium term.
本前瞻性随机研究的目的是检验球囊骶骨成形术和射频骶骨成形术的可行性及临床疗效。
对40例共57处骶骨骨折患者，采用球囊骶骨成形术（BSP）或射频骶骨成形术（RFS）在CT引导下进行骨水泥强化。对于BSP，将球囊导管在骨折区域充气和放气，然后用聚甲基丙烯酸甲酯（PMMA）骨水泥填充形成的空腔。对于RFS，先用柔性骨刀初步扩大骨折区域的海绵状间隙，然后将经射频激活的高粘性PMMA骨水泥插入准备好的骨折区域。在干预前、第二天以及干预后6、12和18个月，通过视觉模拟评分法（VAS）测定疼痛强度。采用配对Wilcoxon秩和检验和Mann-Whitney U检验对结果进行显著性检验。
BSP和RFS在所有患者中技术上完全可行。BSP组每处骨折平均注入骨水泥6.3 ml，RFS组每处骨折平均注入6.1 ml。两种手术均未发现渗漏。干预前BSP组VAS平均疼痛评分为8.6±0.55，RFS组为8.8±0.58。术后第二天，疼痛显著减轻（p<0.001），两组平均值均为2.5（BSP±0.28，RFS±0.38）。6（12；18）个月后，BSP组这些值稳定在2.3±0.27（2.3±0.24；2.0±0.34），RFS组稳定在2.4±0.34（2.2±0.26；2.0±0.31）。在疼痛方面，6个月时p = 0.86、12个月时p = 0.94、18个月时p = 1的超概率值表明，两种治疗方法在结果上均无差异。
BSP和RFS是介入性微创手术，能可靠地进行骨水泥强化，中期临床疗效相当。
