Klassen Peter Douglas, Bernstein Derek Thomas, Köhler Hans-Peter, Arts Mark P, Weiner Bradley, Miller Larry E, Thomé Claudius
Department of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany.
Department of Orthopaedic Surgery, Methodist Hospital, Houston, TX, USA.
J Pain Res. 2017 Aug 26;10:2047-2055. doi: 10.2147/JPR.S144500. eCollection 2017.
The purpose of this study was to evaluate perioperative complications of lumbar discectomy with or without bone-anchored annular closure device (ACD) implant in patients at high risk of recurrent disc herniation.
This was a post hoc analysis of a randomized controlled trial that compared outcomes of lumbar discectomy with or without additional placement of an ACD. Patients presented with imaging evidence of lumbar disc herniation and radicular pain that was unresponsive to conservative care. Randomization occurred intraoperatively following discectomy completion and confirmation of annular defect width ≥6 mm. Main outcomes included serious adverse events (SAEs) from any cause, device- or procedure-related SAEs, and reoperations at the index level. The perioperative period included all outcomes occurring between the day of surgery and 90 days following hospital discharge.
Analyses were performed on a modified intention-to-treat population consisting of 272 patients treated with ACD and 278 patients treated with lumbar discectomy only (controls). Mean patient age was 44 years, 59% were men, and mean body mass index was 26 kg/m. Baseline patient characteristics and operative outcomes were comparable between groups. The risks of all-cause SAE (9.7% vs 16.3%, =0.056), device- or procedure-related SAE (4.5% vs 10.2%, =0.02), and index-level reoperation (1.9% vs 5.4%, =0.03) were lower with ACD vs controls. In multivariable logistic regression, control group assignment and female gender were independently associated with higher risk of device- or procedure-related SAE and index-level reoperation, respectively.
In patients undergoing lumbar discectomy to treat symptomatic intervertebral disc herniation, adjunctive placement of an ACD reduces the risk for perioperative complications occurring through 90 days following hospital discharge.
本研究旨在评估在复发性椎间盘突出症高危患者中，使用或不使用骨锚定环形闭合装置（ACD）植入物进行腰椎间盘切除术的围手术期并发症。
这是一项对随机对照试验的事后分析，该试验比较了腰椎间盘切除术联合或不联合额外放置ACD的疗效。患者有腰椎间盘突出症的影像学证据且神经根性疼痛对保守治疗无效。在椎间盘切除完成且确认环形缺损宽度≥6mm后，术中进行随机分组。主要结局包括任何原因导致的严重不良事件（SAE）、与器械或手术相关的SAE以及在索引节段的再次手术。围手术期包括手术当天至出院后90天内发生的所有结局。
对由272例接受ACD治疗的患者和278例仅接受腰椎间盘切除术的患者（对照组）组成的改良意向性治疗人群进行了分析。患者平均年龄为44岁，59%为男性，平均体重指数为26kg/m²。两组患者的基线特征和手术结局具有可比性。与对照组相比，ACD组全因SAE（9.7%对16.3%，P = 0.056）、与器械或手术相关的SAE（4.5%对10.2%，P = 0.02）以及索引节段再次手术（1.9%对5.4%，P = 0.03）的风险更低。在多变量逻辑回归分析中，对照组分配和女性性别分别独立与器械或手术相关的SAE以及索引节段再次手术的较高风险相关。
在接受腰椎间盘切除术治疗有症状的椎间盘突出症患者中，辅助放置ACD可降低出院后90天内发生围手术期并发症的风险。
