Feng Lei, Shen Jin-Ming, Feng Chun, Chen Jie, Wu Yu
Department of Orthopedics, The First Affiliated Hospital of Zhejiang Chinese Medicine University The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Medicine (Baltimore). 2017 Jun;96(25):e7150. doi: 10.1097/MD.0000000000007150.
Balloon kyphoplasty (BKP) is a widely adopted minimally invasive treatment for vertebral compression fractures (VCFs), but leakage of cement is a main complication of BKP. A novel vertebral augmentation technique radiofrequency kyphoplasty (RFK) with high viscosity cement was developed in 2009. Here, we aim to evaluate whether RFK can relieve symptoms efficiently and reduce cement leakage.
A literature search was performed using Pubmed, Embase, and Cochrane CENTRAL until September 30, 2016. Both randomized controlled trial (RCT) and non-RCT studies comparing RFK and BKP were included. The main outcomes included pain relief (VAS), functionality improvement (ODI), operation time, reduction of deformity (vertebral height and kyphosis angle), and incidence of cement leakage. The origin of heterogeneity was further explored by subgroup stratification.
A total of 6 studies involving 833 patients with VCFs were included. The reduction of VAS score in the RFK group was 3.96 points more than that in the BKP group (P = .0007) postoperatively, and the improvement persisted until 12 months after the surgery (P < .00001). The operation time was shorter in RFK group than that in BKP group (P = .01). The increase of anterior vertebral height shortly after the operation was 0.53 mm greater in RFK group (P = .01). The decrease of kyphotic angle after RFK was 0.63° and 0.92° greater than that after BKP, both immediately and 6 months after operation (P = .002 and P < .00001, respectively). There was no significant difference between the incidence of cement leakage after RFK and BKP (P = .06). Further subgroup analysis stratified by study design indicated that the incidence of leakage decreased 15% in RFK than BPK (P < .00001) in non-RCT subgroup, but RFK and BKP treatments were equivalent in the RCT studies (P = .86).
RFK appears to be more effective and safer than BKP in the present meta-analysis. The incidence of cement leakage diverges in RCT and non-RCT studies, so large-sample multicentered RCT studies are required to validate this new surgery system.
球囊后凸成形术(BKP)是一种广泛应用于治疗椎体压缩骨折(VCF)的微创治疗方法,但骨水泥渗漏是BKP的主要并发症。2009年开发了一种采用高粘度骨水泥的新型椎体强化技术——射频后凸成形术(RFK)。在此,我们旨在评估RFK是否能有效缓解症状并减少骨水泥渗漏。
使用Pubmed、Embase和Cochrane CENTRAL进行文献检索,直至2016年9月30日。纳入比较RFK和BKP的随机对照试验(RCT)和非RCT研究。主要结局包括疼痛缓解(视觉模拟评分法[VAS])、功能改善(Oswestry功能障碍指数[ODI])、手术时间、畸形矫正(椎体高度和后凸角)以及骨水泥渗漏发生率。通过亚组分层进一步探讨异质性来源。
共纳入6项研究,涉及833例VCF患者。术后RFK组VAS评分降低幅度比BKP组多3.96分(P = 0.0007),且这种改善持续至术后12个月(P < 0.00001)。RFK组手术时间比BKP组短(P = 0.01)。术后不久RFK组椎体前缘高度增加比BKP组多0.53毫米(P = 0.01)。RFK术后后凸角的减小在术后即刻和术后6个月分别比BKP术后大0.63°和0.92°(分别为P = 0.002和P < 0.00001)。RFK和BKP术后骨水泥渗漏发生率无显著差异(P = 0.06)。按研究设计进行的进一步亚组分析表明,在非RCT亚组中,RFK的渗漏发生率比BPK降低15%(P < 0.00001),但在RCT研究中RFK和BKP治疗效果相当(P = 0.86)。
在本荟萃分析中,RFK似乎比BKP更有效、更安全。RCT和非RCT研究中骨水泥渗漏发生率存在差异,因此需要大样本多中心RCT研究来验证这种新的手术系统。