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非窗口型3D打印多孔钛笼用于腰椎后路椎间融合术的可行性:一项随机对照多中心试验

Feasibility of the Non-Window-Type 3D-Printed Porous Titanium Cage in Posterior Lumbar Interbody Fusion: A Randomized Controlled Multicenter Trial.

作者信息

Ham Dae-Woong, Park Sang-Min, Kim Youngbae B, Chang Dong-Gune, Yang Jae Jun, Kwon Byung-Taek, Song Kwang-Sup

机构信息

Department of Orthopedic Surgery, Chung-Ang University Hospital, College of Medicine, Chung-Ang University, Seoul, Republic of Korea.

Spine Center and Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnamsi, Republic of Korea.

出版信息

J Bone Joint Surg Am. 2024 Nov 20;106(22):2102-2110. doi: 10.2106/JBJS.23.01245. Epub 2024 Sep 11.

Abstract

BACKGROUND

Three-dimensionally printed titanium (3D-Ti) cages can be divided into 2 types: window-type cages, which have a void for bone graft, and non-window-type cages without a void. Few studies have investigated the necessity of a void for bone graft in fusion surgery. Therefore, the present study assessed the clinical and radiographic outcomes of window and non-window-type 3D-Ti cages in single-level posterior lumbar interbody fusion.

METHODS

A total of 70 patients were randomly assigned to receive either a window or non-window cage; 61 patients (87%) completed final follow-up (32 from the window cage group, 29 from the non-window cage group). Radiographic outcomes, including fusion rates, subsidence, and intra-cage osseointegration patterns, were assessed. Intra-cage osseointegration was measured using the intra-cage bridging bone score for the window cage group and the surface osseointegration ratio score for the non-window cage group. Additionally, we looked for the presence of the trabecular bone remodeling (TBR) sign on computed tomography (CT) images.

RESULTS

Of the 61 patients, 58 achieved interbody fusion, resulting in a 95.1% fusion rate. The fusion rate in the non-window cage group was comparable to, and not significantly different from, that in the window cage group (96.6% and 93.8%, p > 0.99). The subsidence rate showed no significant difference between the window and non-window cage groups (15.6% and 3.4%, respectively; p = 0.262). The intra-cage osseointegration scores showed a significant difference between the groups (p = 0.007), with the non-window cage group having a higher proportion of cases with a score of 4 compared with the window cage group. The TBR sign was observed in 87.9% of patients who achieved interbody fusion, with a higher rate in the non-window cage group across the entire cohort although the difference was not significant (89.7% versus 78.1%, p = 0.385).

CONCLUSIONS

Non-window-type 3D-Ti cages showed equivalent clinical outcomes compared with window-type cages and comparable interbody fusion rates. These results suggest that the potential advantages of 3D-Ti cages could be optimized in the absence of a void for bone graft by providing a larger contact surface for osseointegration.

LEVEL OF EVIDENCE

Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

三维打印钛(3D-Ti)椎间融合器可分为两种类型:有用于植骨空隙的开窗型融合器和无空隙的非开窗型融合器。很少有研究探讨融合手术中植骨空隙的必要性。因此,本研究评估了开窗型和非开窗型3D-Ti椎间融合器在单节段腰椎后路椎间融合术中的临床和影像学结果。

方法

总共70例患者被随机分配接受开窗型或非开窗型融合器;61例患者(87%)完成了最终随访(开窗型融合器组32例,非开窗型融合器组29例)。评估了包括融合率、下沉情况和融合器内骨整合模式在内的影像学结果。对于开窗型融合器组,使用融合器内桥接骨评分来测量融合器内骨整合情况;对于非开窗型融合器组,使用表面骨整合比率评分来进行测量。此外,我们在计算机断层扫描(CT)图像上寻找小梁骨重塑(TBR)征的存在情况。

结果

61例患者中,58例实现了椎间融合,融合率为95.1%。非开窗型融合器组的融合率与开窗型融合器组相当,且差异无统计学意义(分别为96.6%和93.8%,p>0.99)。开窗型和非开窗型融合器组的下沉率差异无统计学意义(分别为15.6%和3.4%;p=0.262)。融合器内骨整合评分在两组间存在显著差异(p=0.007),与开窗型融合器组相比,非开窗型融合器组评分4分的病例比例更高。在实现椎间融合的患者中,87.9%观察到了TBR征,尽管差异无统计学意义(89.7%对78.1%,p=0.385),但在整个队列中,非开窗型融合器组的发生率更高。

结论

与开窗型融合器相比,非开窗型3D-Ti椎间融合器显示出相当的临床结果和可比的椎间融合率。这些结果表明,在没有植骨空隙的情况下,通过提供更大的骨整合接触表面,3D-Ti椎间融合器的潜在优势可能会得到优化。

证据水平

治疗性二级。有关证据水平的完整描述,请参阅作者指南。

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