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单节段腰椎间盘切除术后通过椎体终板穿孔维持椎间盘高度的随机对照试验

Vertebral End-Plate Perforation for Intervertebral Disc Height Preservation After Single-level Lumbar Discectomy: A Randomized-controlled Trial.

作者信息

Vodičar Miha, Košak Robert, Gorenšek Matevž, Korez Robert, Vrtovec Tomaž, Koder Jadran, Antolič Vane, Vengust Rok

机构信息

*Department of Orthopaedic Surgery, University Medical Centre Ljubljana †Laboratory of Imaging Technologies, Faculty of Electrical Engineering, University of Ljubljana ‡Institute of Radiology, University Medical Centre Ljubljana, Ljubljana, Slovenia.

出版信息

Clin Spine Surg. 2017 Jul;30(6):E707-E712. doi: 10.1097/BSD.0000000000000305.

DOI:10.1097/BSD.0000000000000305
PMID:28632557
Abstract

STUDY DESIGN

Pilot single-centre, stratified, prospective, randomized, double-blinded, parallel-group, controlled study.

OBJECTIVE

To determine whether vertebral end-plate perforation after lumbar discectomy causes annulus reparation and intervertebral disc volume restoration. To determine that after 6 months there would be no clinical differences between the control and study group.

SUMMARY OF BACKGROUND DATA

Low back pain is the most common long-term complication after lumbar discectomy. It is mainly caused by intervertebral disc space loss, which promotes progressive degeneration. This is the first study to test the efficiency of a previously described method (vertebral end-plate perforation) that should advocate for annulus fibrosus reparation and disc space restoration.

METHODS

We selected 30 eligible patients according to inclusion and exclusion criteria and randomly assigned them to the control (no end-plate perforation) or study (end-plate perforation) group. Each patient was evaluated in 5 different periods, where data were collected [preoperative and 6-mo follow-up magnetic resonance imaging and functional outcome data: visual analogue scale (VAS) back, VAS legs, Oswestry disability index (ODI)]. Intervertebral space volume (ISV) and height (ISH) were measured form the magnetic resonance images. Statistical analysis was performed using paired t test and linear regression. P<0.05 was considered statistically significant.

RESULTS

We found no statistically significant difference between the control group and the study group concerning ISV (P=0.6808) and ISH (P=0.8981) 6 months after surgery. No statistically significant differences were found between ODI, VAS back, and VAS legs after 6 months between the 2 groups, however, there were statistically significant differences between these parameters in different time periods. Correlation between the volume of disc tissue removed and preoperative versus postoperative difference in ISV was statistically significant (P=0.0020).

CONCLUSIONS

The present study showed positive correlation between the volume of removed disc tissue and decrease in postoperative ISV and ISH. There were no statistically significant differences in ISV and ISH between the group with end-plate perforation and the control group 6 months after lumbar discectomy. Clinical outcome and disability were significantly improved in both groups 3 and 6 months after surgery.

摘要

研究设计

单中心、分层、前瞻性、随机、双盲、平行组对照试验。

目的

确定腰椎间盘切除术后椎体终板穿孔是否会导致纤维环修复和椎间盘体积恢复。确定6个月后对照组和研究组之间无临床差异。

背景数据总结

腰痛是腰椎间盘切除术后最常见的长期并发症。主要由椎间盘间隙丢失引起,这会促进椎间盘进行性退变。这是第一项测试先前描述的一种方法(椎体终板穿孔)有效性的研究,该方法应有助于纤维环修复和椎间盘间隙恢复。

方法

根据纳入和排除标准选择30例符合条件的患者,并将他们随机分配到对照组(无终板穿孔)或研究组(终板穿孔)。在5个不同时期对每位患者进行评估,收集数据[术前和6个月随访时的磁共振成像及功能结局数据:视觉模拟量表(VAS)背部评分、VAS腿部评分、Oswestry功能障碍指数(ODI)]。从磁共振图像中测量椎间盘间隙体积(ISV)和高度(ISH)。采用配对t检验和线性回归进行统计分析。P<0.05被认为具有统计学意义。

结果

术后6个月,对照组和研究组在ISV(P=0.6808)和ISH(P=0.8981)方面无统计学显著差异。两组在术后6个月时,ODI、VAS背部评分和VAS腿部评分之间无统计学显著差异,然而,这些参数在不同时间段存在统计学显著差异。切除的椎间盘组织体积与术前和术后ISV差异之间的相关性具有统计学意义(P=0.0020)。

结论

本研究表明,切除的椎间盘组织体积与术后ISV和ISH的减少呈正相关。腰椎间盘切除术后6个月,终板穿孔组和对照组在ISV和ISH方面无统计学显著差异。两组在术后3个月和6个月时临床结局和功能障碍均有显著改善。

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