Prospective, Multicenter, Randomized, Controlled Study of Anular Repair in Lumbar Discectomy Two-Year Follow-up
Prospective, Multicenter, Randomized, Controlled Study of Anular Repair in Lumbar Discectomy Two-Year Follow-up
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DOI：
10.1097/brs.0b013e31828b2e2f
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发表时间：
2013-06-15
期刊：
影响因子：
3
通讯作者：
Huffmon, George V.
中科院分区：
文献类型：
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作者：
Bailey, Alexander;Araghi, Ali;Huffmon, George V.
研究设计.前瞻性、多中心、单盲、随机、对照临床研究。探讨腰椎间盘切除术后修复纤维环治疗髓核突出症的疗效。在接受椎间盘切除术的患者中，再突出的发生率为10%至15%。腰椎间盘切除术后纤维环缺损的修复可能会降低这些患者的复发率。共750例患者接受了腰椎间盘突出症治疗，并以2：1的比例随机分配至使用Xclose组织修复系统（Anulex Technologies，明内通卡，MN）进行椎间盘切除术的环状修复（n = 500）或不进行环状修复的椎间盘切除术（n = 250）。患者自我报告的测量包括腿部和背部疼痛的视觉模拟量表、奥斯韦斯特里残疾指数和简明健康调查表-12。记录不良事件和随后的再疝手术。将术前结果指标与术后2周、6个月、1年和2年的随访结果进行比较。两个研究组中，术后患者症状改善的方式相同。在总体研究分析中，Xclose患者在所有随访时间点的再疝手术率均较低，但这些差异无统计学意义。在以腿部疼痛为主的患者中，接受Xclose的患者术后3个月和6个月的再疝风险显著降低。2年内保持正降低，临床相关风险降低45%，但无统计学显著性。安全性得到证实，患者结局改善相似，报告的不良事件无差异。在椎间盘切除术后没有一种安全有效的方法来闭合纤维环，目前的做法是使纤维环处于受损状态。这项多中心随机研究表明，虽然没有统计学显著性，但纤维环修复减少了后续再疝手术的需要，同时保留了椎间盘切除术的受益，没有增加患者的风险。
Study Design. Prospective, multicenter, single-blind, randomized, controlled clinical study.Objective. To investigate outcomes associated with repairing the anulus fibrosus after lumbar discectomy for the surgical management of herniated nucleus pulposus.Summary of Background Data. In patients undergoing discectomy, the incidence of reherniation ranges from 10% to 15%. Repair of the anulus fibrosus defect after lumbar discectomy may decrease the incidence of recurrent herniation for these patients.Methods. A total of 750 patients were treated for herniated lumbar discs and randomly assigned in a 2: 1 ratio to discectomy with the Xclose Tissue Repair System (Anulex Technologies, Minnetonka, MN) for anular repair (n = 500) or discectomy without anular repair (n = 250). Patient self-reported measures included visual analogue scales for leg and back pain, Oswestry Disability Index, and Short Form-12 Health Survey. Adverse events and subsequent reherniation surgical procedures were documented. Preoperative outcome measures were compared with follow-up visits at 2 weeks, 6 months, 1 year, and 2 years.Results. Patient symptoms were improved after surgery in an equivalent manner in both study groups. In the overall study analysis, the rate of reherniation surgery was lower for Xclose patients at all follow-up time points, but these differences were not statistically significant. In patients with predominant leg pain, there was a significant reduction in reherniation risk at 3 and 6 months postoperation for patients receiving Xclose. A positive reduction was maintained through 2 years, with a clinically relevant risk reduction of 45%, although not statistically significant. Safety was demonstrated with similar improvements in patient outcomes and no difference in reported adverse events.Conclusion. Without a safe and effective method for closing the anulus fibrosus after discectomy, current practice has been to leave the anulus in a compromised state. This multicenter randomized study demonstrated that, while not statistically significant, anular repair reduced the need for subsequent reherniation surgery while retaining the benefits of discectomy with no increased risk for patients.