>Study Design Retrospective case series. >Objective StaXx XD (Spine Wave, Inc., Shelton, CT, United States) is an expandable polyaryl-ether-ether-ketone (PEEK) wafer implant utilized in the treatment of lumbar degenerative disease. PEEK implants have been successfully used as interbody devices. Few studies have focused on expandable PEEK devices. The aim of the current study is to determine the radiographic and clinical outcome of expandable PEEK cages utilized for transforaminal lumbar interbody fusion in patients with lumbar degenerative diseases. >Methods Forty-nine patients who underwent lumbar interbody fusion with implantation of expandable PEEK cages and posterior instrumentation were included. The clinical outcome was evaluated using the visual analog scale (VAS) and the Oswestry Disability Index (ODI). Radiographic parameters including disk height, foraminal height, listhesis, local disk angle of the index level/levels, regional lumbar lordosis, and graft subsidence were measured preoperatively, postoperatively, and at latest follow-up. >Results At an average follow-up of 19.3 months, the minimum clinically important difference for the ODI and VAS back, buttock, and leg were achieved in 64, 52, 58, and 52% of the patients, respectively. There was statistically significant improvement in VAS back (6.42 versus 3.11, p < 0.001), VAS buttock (4.66 versus 1.97, p = 0.002), VAS leg (4.55 versus 1.96, p < 0.001), and ODI (21.7 versus 12.1, p < 0.001) scores. There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005). The subsidence of 0.66 mm (7.4%) observed at the latest follow-up was not significant (p = 0.35). >Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence.
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机译:>研究设计 strong>回顾性案例系列。 >物镜 strong> StaXx XD(Spine Wave,Inc.,美国康涅狄格州谢尔顿)是一种可膨胀的聚芳基醚醚酮(PEEK)晶片植入物,用于治疗腰椎退行性疾病。 PEEK植入物已成功用作体内装置。很少有研究关注可扩展的PEEK设备。本研究的目的是确定用于腰椎退行性疾病患者经椎间孔腰椎椎体间融合的可扩展PEEK笼的放射学和临床结果。 >方法 strong>包括49例行腰椎椎间融合术并植入可扩展PEEK笼和后路器械的患者。使用视觉模拟量表(VAS)和Oswestry残疾指数(ODI)评估临床结局。术前,术后以及最晚随访时,测量包括椎间盘高度,椎间孔高度,李氏硬度,指数水平/水平的局部椎间盘角度,局部腰椎前凸和移植物沉降的影像学参数。 >结果 strong>在平均随访19.3个月时,分别有64%,52、58和52%的患者实现了ODI和VAS背部,臀部和腿部的最小临床重要差异,分别。 VAS后背(6.42 vs.3.11,p <0.001),VAS臀部(4.66 vs 1.97,p = 0.002),VAS腿(4.55 vs 1.96,p <0.001)和ODI(21.7 vs 12.1,p <0.001)分。平均椎间盘高度(6.49 vs.8.18 mm,p = 0.037)和椎间孔高度(15.6 vs. 18.53 mm,p = 0.0001)显着增加,李斯特菌显着减少(5.13 vs 3.15 mm,p = 0.005)。 )。最近一次随访观察到的0.66mm的下沉(7.4%)不显着(p = 0.35)。 >结论 strong>中期结果表明,可扩展的PEEK垫片可以有效,持久地恢复椎间盘和椎间孔的高度,并改善预后而无明显下沉。
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