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使用带或不带钛涂层的聚醚醚酮斜向椎间融合器的经椎间孔腰椎椎间融合术:一项随机临床试点研究。

Transforaminal lumbar interbody fusion using polyetheretherketone oblique cages with and without a titanium coating: a randomised clinical pilot study.

作者信息

Rickert M, Fleege C, Tarhan T, Schreiner S, Makowski M R, Rauschmann M, Arabmotlagh M

机构信息

Orthopaedic University Hospital Friedrichsheim gGmbH, Marienburgstraße 2, 60528 Frankfurt am Main, Germany.

Department of Radiology and Neuroradiology, Charité-University, Charitéplatz 1, 10117 Berlin, Germany.

出版信息

Bone Joint J. 2017 Oct;99-B(10):1366-1372. doi: 10.1302/0301-620X.99B10.BJJ-2016-1292.R2.

Abstract

AIMS

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).

MATERIALS AND METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

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。

材料与方法

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。

结果

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。

结论

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。

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