背景:骨质疏松性椎体压缩性骨折(OVCFs)可以通过经皮椎体后凸成形术(PKP)治疗。与传统的PKP相比,新型可偏转经皮椎体后凸成形术(DPKP),是一种单侧经椎弓根入路手术,允许类似的双侧穿刺效果,这归因于可偏转的弯曲骨扩张器产生跨中心线腔,以实现水泥的均匀分布和生物力学平衡,同时减少手术时间和辐射暴露。
目的:本研究的目的是前瞻性地比较和评估一种创新的外科手术,DPKP,与常规双侧经皮椎体后凸成形术(BPKP)相比。
方法:这是一项前瞻性随机对照试验(RCT)。
方法:在2019年5月至2020年10月期间,所有患有OVCF的参与者(n=90)通过SAS9.3进行随机分组,以生成区组随机序列。它被用来以1:1的比例随机分组,分配到DPKP组(n=45)和BPKP组(n=45)进行相应的程序。
方法:主要结果是总手术时间。次要结果包括:视觉模拟量表(VAS)评分的比较评估,Oswestry残疾指数(ODI),后凸角度(KA),受伤椎骨的前缘高度(AH),术中X射线透视的频率,注射量,骨水泥的分布规律和渗漏率。
方法:所有受试者都接受了至少一位资深骨科医生和放射科医生的VAS评分评估,ODI,KA,受伤的椎骨,总手术时间,注射量,分布模式,术前和24小时骨水泥渗漏率,6个月,术后1年。这项前瞻性研究的纳入标准如下:(1)60岁<80岁;(2)术前脊柱X线,CT,MRI证实为单节段,新鲜胸腰椎OVCF(T5-L5,15%<塌陷<80%);MRI在T1-WI上显示低信号,在T2-WI上显示高信号,特别是具有以椎体水肿为特征的STIR高信号;(3)难以治疗的疼痛性OVCFs,2周<症状持续时间<3个月;(4)具有明显的局部压痛体征;(5)骨密度(BMD)T评分<-2.5。
结果:DPKP组的总手术时间显着减少(43.3±19.58分钟,95%CI:37.23-49.37)与BPKP组(55.16±11.56分钟,95%CI:51.78-58.54)(p<0.001)。与BPKP组相比(术中X线透视频率:43.42±8.64,95%CI:40.90-45.95;骨水泥注入量:5.56±0.85ml,95%CI:5.31-5.81),术中X线透视频率(30.05±17.41,95%CI:24.66-35.45)和骨水泥注射量(5.08±0.97ml,95%CI:4.78-5.38)与DPKP组相比显著降低(p<0.001)。此外,与术前相比,两组患者术后VAS评分均有显著改善,ODI,KA,和AH(p<0.001),但DPKP组和BPKP组之间在任何时间点都没有统计学差异(p>0.05)。有趣的是,虽然没有统计学差异,在DPKP组中观察到较低的骨水泥渗漏率趋势。
结论:我们的研究结果表明,创新的DPKP在缓解疼痛方面与BPKP一样安全有效,提高患者的生活质量,重建椎体高度。特别是,与BPKP相比,DPKP确实减少了手术时间和辐射暴露,这与单边和双边暴露程序相关。此外,在DPKP中,最终的水泥分布是不可预测的,需要进一步的研究来阐明DPKP与常规单侧经皮椎体后凸成形术(UPKP)和BPKP的优势。
BACKGROUND: Osteoporotic vertebral compression fractures (OVCFs) can be treated with percutaneous kyphoplasty (PKP). In contrast to conventional PKP, the novel deflectable percutaneous kyphoplasty (DPKP), is a
unilateral transpedicular approach procedure allowing a similar bilateral puncture effect, which owes to the deflectable curved bone expander creating a transcentral line cavity to achieve uniform distribution of cement and biomechanical balance while reducing operative time and radiation exposure.
OBJECTIVE: The purpose of this study was to prospectively compare and evaluate an innovative surgical procedure, DPKP, versus conventional bilateral percutaneous kyphoplasty (BPKP).
METHODS: This is a prospective randomized controlled trial (RCT).
METHODS: The totality of the participants (n=90) suffering from OVCFs between May 2019 and October 2020, were randomized by SAS 9.3 to generate a block randomization sequence, which was utilized to randomize the groups in a 1:1 ratio, assigned to the DPKP group (n=45) and the BPKP group (n=45) to undergo accordingly procedures.
METHODS: The primary outcome was the total operative time. The secondary outcomes included: comparative assessment of visual analog scale (VAS) scores, Oswestry disability index (ODI), kyphosis angle (KA), anterior border height (AH) of the injured vertebra, frequency of intraoperative X-ray fluoroscopy, the injection volume, distribution pattern and leakage rate of bone cement.
METHODS: All subjects underwent assessment by at least one senior orthopedist and radiologist for the VAS scores, ODI, KA, AH of the injured vertebra, total operative time, the injection volume, distribution pattern, leakage rate of bone cement at preoperative and 24 hours, 6 months, and 1 year postoperatively. Inclusion criteria for subjects in this prospective study were as follows: (1) 60 < age < 80 years old; (2) preoperative spinal X-ray, CT, and MRI confirmed as single-segment, fresh thoracolumbar OVCFs (T5-L5, 15% < collapse < 80%); MRI shows low signal on T1-WI and high signal on T2-WI, especially with STIR high signal characterized by vertebral edema; (3) painful OVCFs refractory to medical treatment, 2 weeks < Symptom duration < 3 months;(4) With significant physical signs of local tenderness; (5) T score of bone mineral density (BMD) < -2.5.
RESULTS: The total operative time was significantly reduced in the DPKP group (43.3±19.58 minutes, 95% CI: 37.23-49.37) compared to the BPKP group (55.16±11.56 minutes, 95% CI: 51.78-58.54) (p<.001). Compared to the BPKP group (frequency of intraoperative X-ray fluoroscopy: 43.42±8.64, 95% CI: 40.90-45.95; the volume of bone cement injected: 5.56±0.85 mL, 95% CI: 5.31-5.81), the frequency of intraoperative X-ray fluoroscopy (30.05±17.41, 95% CI: 24.66-35.45) and volume of bone cement injected (5.08±0.97 mL, 95% CI: 4.78-5.38) significantly reduced in the DPKP group compared to the (p<.001). In addition, compared to the preoperative period, both groups showed significant improvements in the postoperative VAS scores, ODI, KA, and AH (p<.001), but there was no statistical difference between the DPKP and BPKP groups (p>.05) at any time-point. Interestingly, although without statistical differences, a tendency towards a lower rate of bone cement leakage was observed in the DPKP group.
CONCLUSIONS: Our study results indicate that the innovative DPKP is as safe and effective as BPKP in relieving pain, improving the patient\'s quality of life, and reconstructing vertebral body height. Particularly, DPKP did reduce operative time and radiation exposure compared to BPKP, which correlated with
unilateral and bilateral exposure procedures. Moreover, the final cement distribution was less predictable in DPKP, and further studies are warranted to clarify the advantages of DPKP versus conventional
unilateral percutaneous kyphoplasty (UPKP) and BPKP.