非窗口型三维打印多孔钛笼在后腰椎椎间融合术中的可行性:随机对照多中心试验。

Dae-Woong Ham,Sang-Min Park,Youngbae B Kim,Dong-Gune Chang,Jae Jun Yang,Byung-Taek Kwon,Kwang-Sup Song
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引用次数: 0

摘要

背景三维打印钛(3D-Ti)保持架可分为两种类型:有空隙的窗口型保持架和无空隙的非窗口型保持架。很少有研究探讨在融合手术中是否有必要为植骨留出空隙。因此,本研究评估了开窗型和非开窗型 3D-Ti椎间融合器在单层腰椎后路椎体间融合术中的临床和放射学结果。方法共有 70 名患者被随机分配接受开窗型或非开窗型椎间融合器,其中 61 名患者(87%)完成了最终随访(开窗型椎间融合器组 32 人,非开窗型椎间融合器组 29 人)。评估了包括融合率、下沉和笼内骨结合模式在内的放射学结果。对于开窗骨架组,我们使用骨架内桥骨评分来测量骨架内骨整合情况;对于非开窗骨架组,我们使用表面骨整合率评分来测量骨架内骨整合情况。此外,我们还观察了计算机断层扫描(CT)图像上是否出现骨小梁重塑(TBR)征象。结果 61例患者中,58例实现了椎间融合,融合率为95.1%。非开窗椎体笼组的融合率与开窗椎体笼组相当,无显著差异(96.6% 和 93.8%,P > 0.99)。开窗笼组和非开窗笼组的下沉率无明显差异(分别为 15.6% 和 3.4%;P = 0.262)。笼内骨结合评分在两组之间有显著差异(p = 0.007),与开窗笼组相比,非开窗笼组的 4 分病例比例更高。结论非开窗型 3D-Ti椎间融合器与开窗型椎间融合器相比,临床效果相当,椎间融合率也相当。这些结果表明,通过提供更大的骨结合接触面,3D-Ti 骨架的潜在优势可以在没有骨移植空隙的情况下得到优化。有关证据等级的完整描述,请参阅 "作者须知"。
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Feasibility of the Non-Window-Type 3D-Printed Porous Titanium Cage in Posterior Lumbar Interbody Fusion: A Randomized Controlled Multicenter Trial.
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.
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