Davis Reginald J, Errico Thomas J, Bae Hyun, Auerbach Joshua D
Greater Baltimore Neurosurgical Associates, Baltimore, MD, USA.
Spine (Phila Pa 1976). 2013 Aug 15;38(18):1529-39. doi: 10.1097/BRS.0b013e31829a6d0a.
Prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial.
To evaluate the safety and efficacy of Coflex interlaminar stabilization compared with posterior spinal fusion in the treatment of 1- and 2-level spinal stenosis and degenerative spondylolisthesis.
Long-term untoward sequelae of lumbar fusion for stenosis and degenerative spondylolisthesis have led to the search for motion-preserving, less-invasive alternatives.
Three hundred twenty-two patients (215 Coflex and 107 fusions) from 21 sites in the United States were enrolled between 2006 and 2010. Subjects were randomized to receive laminectomy and Coflex interlaminar stabilization or laminectomy and posterolateral spinal fusion with spinal instrumentation in a 2:1 ratio. Overall device success required a 15-point reduction in Oswestry Disability Index, no reoperations, no major device-related complications, and no postoperative epidural injections.
Patient follow-up at minimum 2 years was 95.3% and 97.2% in the Coflex and fusion control groups, respectively. Patients taking Coflex experienced significantly shorter operative times (P < 0.0001), blood loss (P < 0.0001), and length of stay (P < 0.0001). There was a trend toward greater improvement in mean Oswestry Disability Index scores in the Coflex cohort (P = 0.075). Both groups demonstrated significant improvement from baseline in all visual analogue scale back and leg parameters. Patients taking Coflex experienced greater improvement in Short-Form 12 physical health outcomes (P = 0.050) and equivalent mental health outcomes. Coflex subjects experienced significant improvement in all Zurich Claudication Questionnaire outcomes measures compared with fusion (symptom severity [P = 0.023]; physical function [P = 0.008]; satisfaction [P = 0.006]). Based on the Food and Drug Administration composite for overall success, 66.2% of Coflex and 57.7% of fusions succeeded (P = 0.999), thus demonstrating noninferiority. The overall adverse event rate was similar between the groups, but Coflex had a higher reoperation rate (10.7% vs. 7.5%, P = 0.426). At 2 years, fusions exhibited increased angulation (P = 0.002) and a trend toward increased translation (P = 0.083) at the superior adjacent level, whereas Coflex maintained normal operative and adjacent level motion.
Coflex interlaminar stabilization is a safe and efficacious alternative, with certain advantages compared with lumbar spinal fusion in the treatment of spinal stenosis and low-grade spondylolisthesis.
前瞻性、随机、多中心、美国食品药品监督管理局医疗器械研究豁免试验。
评估与后路脊柱融合术相比，Coflex椎间稳定系统治疗单节段和双节段腰椎管狭窄症及退变性腰椎滑脱症的安全性和有效性。
腰椎融合术治疗腰椎管狭窄症及退变性腰椎滑脱症的长期不良后遗症促使人们寻找保留运动功能、侵入性较小的替代方法。
2006年至2010年间，来自美国21个地点的322例患者（215例使用Coflex系统，107例行融合术）入组。受试者按2:1的比例随机接受椎板切除术加Coflex椎间稳定系统或椎板切除术加后路脊柱融合内固定术。总体器械成功率要求Oswestry功能障碍指数降低15分，无再次手术，无重大器械相关并发症，且术后无硬膜外注射。
Coflex组和融合对照组患者至少随访2年的比例分别为95.3%和97.2%。使用Coflex系统的患者手术时间（P<0.0001）、失血量（P<0.0001）和住院时间（P<0.0001）明显更短。Coflex队列的平均Oswestry功能障碍指数评分有更大改善的趋势（P = 0.075）。两组在所有视觉模拟量表背部和腿部参数方面均较基线有显著改善。使用Coflex系统的患者在简短健康调查问卷的身体健康结果方面有更大改善（P = 0.050），心理健康结果相当。与融合术相比，使用Coflex系统的患者在所有苏黎世跛行问卷结果指标方面均有显著改善（症状严重程度[P = 0.023]；身体功能[P = 0.008]；满意度[P = 0.006]）。根据美国食品药品监督管理局的总体成功综合标准，Coflex组的成功率为66.2%，融合术组为57.7%（P = 0.999），因此显示出非劣效性。两组的总体不良事件发生率相似，但Coflex组的再次手术率更高（10.7%对7.5%，P = 0.426）。在2年时，融合术在上位相邻节段出现成角增加（P = 0.002）和移位增加的趋势（P = 0.083），而Coflex系统保持正常的手术节段和相邻节段活动。
Coflex椎间稳定系统是一种安全有效的替代方法，在治疗腰椎管狭窄症和低度腰椎滑脱症方面与腰椎融合术相比具有一定优势。
1级
