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强化骨-种植体界面 第2部分:3D打印和TPS涂层三角形种植体的体内评估

Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants.

作者信息

MacBarb Regina F, Lindsey Derek P, Woods Shane A, Lalor Peggy A, Gundanna Mukund I, Yerby Scott A

机构信息

SI-BONE, Inc., San Jose, CA, USA.

MPI Research, Mattawan, MI, USA.

出版信息

Int J Spine Surg. 2017 Jun 1;11(3):16. doi: 10.14444/4016. eCollection 2017.

Abstract

BACKGROUND

Minimally invasive surgical fusion of the sacroiliac (SI) joint using machined solid triangular titanium plasma spray (TPS) coated implants has demonstrated positive clinical outcomes in SI joint pain patients. Additive manufactured (AM), 3D-printed, fenestrated triangular titanium implants with porous surfaces and bioactive agents, such as nanocrystalline hydroxyapatite (HA) or autograft, may further optimize bony fixation and subsequent biomechanical stability.

METHODS

A bilateral ovine distal femoral defect model was used to evaluate the cancellous bone-implant interfaces of TPS-coated and AM implants. Four implant groups (n=6/group/time-point) were included: 1)TPS-coated, 2)AM, 3)AM+HA, and 4)AM+Autograft. The bone-implant interfaces of 6- and 12-week specimens were investigated via radiographic, biomechanical, and histomorphometric methods.

RESULTS

Imaging showed peri-implant bone formation around all implants. Push-out testing demonstrated forces greater than 2500 N, with no significant differences among groups. While TPS implants failed primarily at the bone-implant interface, AM groups failed within bone ~2-3mm away from implant surfaces. All implants exhibited bone ongrowth, with no significant differences among groups. AM implants had significantly more bone ingrowth into their porous surfaces than TPS-coated implants (<0.0001). Of the three AM groups, AM+Auto implants had the greatest bone ingrowth into the porous surface and through their core (<0.002).

CONCLUSIONS

Both TPS and AM implants exhibited substantial bone ongrowth and ingrowth, with additional bone through growth into the AM implants' core. Overall, AM implants experienced significantly more bone infiltration compared to TPS implants. While HA-coating did not further enhance results, the addition of autograft fostered greater osteointegration for AM implants.

CLINICAL RELEVANCE

Additive manufactured implants with a porous surface provide a highly interconnected porous surface that has comparatively greater surface area for bony integration. Results suggest this may prove advantageous toward promoting enhanced biomechanical stability compared to TPS-coated implants for SI joint fusion procedures.

摘要

背景

使用机加工的实心三角形钛等离子喷涂(TPS)涂层植入物对骶髂关节(SI)进行微创外科融合,已在SI关节疼痛患者中显示出积极的临床效果。增材制造(AM)的、3D打印的、带有多孔表面和生物活性剂(如纳米晶羟基磷灰石(HA)或自体骨)的开窗三角形钛植入物,可能会进一步优化骨固定及随后的生物力学稳定性。

方法

采用双侧绵羊股骨远端缺损模型来评估TPS涂层植入物和AM植入物的松质骨-植入物界面。包括四个植入物组(每组n = 6/每个时间点):1)TPS涂层组,2)AM组,3)AM + HA组,4)AM + 自体骨组。通过影像学、生物力学和组织形态计量学方法对6周和12周标本的骨-植入物界面进行研究。

结果

影像学显示所有植入物周围均有植入物周围骨形成。推出试验显示力大于2500 N,各组之间无显著差异。虽然TPS植入物主要在骨-植入物界面处失效,但AM组在距植入物表面约2 - 3mm的骨内失效。所有植入物均表现出骨长入,各组之间无显著差异。AM植入物多孔表面的骨长入明显多于TPS涂层植入物(<0.0001)。在三个AM组中,AM + 自体骨植入物多孔表面和贯穿其核心的骨长入最多(<0.002)。

结论

TPS和AM植入物均表现出大量的骨长入和向内生长,并且有额外的骨通过生长进入AM植入物的核心。总体而言,与TPS植入物相比,AM植入物的骨浸润明显更多。虽然HA涂层并未进一步改善结果,但自体骨的添加促进了AM植入物更好的骨整合。

临床意义

具有多孔表面的增材制造植入物提供了高度相互连接的多孔表面,其具有相对更大的骨整合表面积。结果表明,与用于SI关节融合手术的TPS涂层植入物相比,这可能有利于促进增强的生物力学稳定性。

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