Rickert M, Fleege C, Tarhan T, Schreiner S, Makowski M R, Rauschmann M, Arabmotlagh M
Orthopaedic University Hospital Friedrichsheim gGmbH, Marienburgstraße 2, 60528 Frankfurt am Main, Germany.
Department of Radiology and Neuroradiology, Charité-University, Charitéplatz 1, 10117 Berlin, Germany.
Bone Joint J. 2017 Oct;99-B(10):1366-1372. doi: 10.1302/0301-620X.99B10.BJJ-2016-1292.R2.
We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF).
We conducted a randomised clinical pilot trial of 40 patients who were scheduled to undergo a TLIF procedure at one or two levels between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D, and back and leg pain were determined pre-operatively, and at three, six, and 12 months post-operatively. Fusion rates were assessed by thin slice CT at three months and by functional radiography at 12 months.
At final follow-up, one patient in each group had been lost to follow-up. Two patients in each of the PEEK and TiPEEK groups were revised for pseudarthrosis (p = 1.00). The rate of complete or partial fusion at three months was 91.7% in both groups. Overall, there were no significant differences in ODI or in radiological outcomes between the groups.
Favourable results with identical clinical outcomes and a high rate of fusion was seen in both groups. The titanium coating appears to have no negative effects on outcome or safety in the short term. A future study to determine the effect of titanium coating is warranted. Cite this article: 2017;99-B:1366-72.
我们比较了使用带钛涂层的聚醚醚酮椎间融合器(TiPEEK)和不带钛涂层的聚醚醚酮椎间融合器(PEEK)进行经椎间孔腰椎椎体间融合术(TLIF)的临床和影像学结果。
我们对40例计划在L2至L5之间的一个或两个节段进行TLIF手术的患者进行了一项随机临床试验。术前、术后3个月、6个月和12个月测定Oswestry功能障碍指数(ODI)、欧洲五维健康量表(EuroQoL-5D)以及腰背痛和腿痛情况。3个月时通过薄层CT评估融合率,12个月时通过功能X线摄影评估融合率。
在末次随访时,每组各有1例患者失访。PEEK组和TiPEEK组各有2例患者因假关节形成接受翻修手术(p = 1.00)。两组在3个月时的完全或部分融合率均为91.7%。总体而言,两组在ODI或影像学结果方面无显著差异。
两组均取得了良好的结果,临床结局相同且融合率高。钛涂层在短期内似乎对结局或安全性没有负面影响。有必要进行进一步研究以确定钛涂层的作用。引用本文:2017;99-B:1366 - 72。