A Mechanistic and Preclinical Assessment of BioRestore Bioactive Glass as a Synthetic Bone Graft Extender and Substitute for Osteoinduction and Spine Fusion.

IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Clinical Spine Surgery Pub Date : 2024-08-01 Epub Date: 2024-03-22 DOI:10.1097/BSD.0000000000001597
Elianna J Fred, Silvia Minardi, Alyssa M Goodwin, Tejas S Nandurkar, Mark A Plantz, Joseph G Lyons, Jonathan T Paul, James P Foley, Allison J Wintring, Andrew A Furman, Soyeon Jeong, Chawon Yun, Stuart R Stock, Wellington K Hsu, Erin L Hsu
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Abstract

Study design: Preclinical animal study.

Objective: Evaluate the osteoinductivity and bone regenerative capacity of BioRestore bioactive glass.

Summary of background data: BioRestore is a Food and Drug Administration (FDA)-approved bone void filler that has not yet been evaluated as a bone graft extender or substitute for spine fusion.

Methods: In vitro and in vivo methods were used to compare BioRestore with other biomaterials for the capacity to promote osteodifferentiation and spinal fusion. The materials evaluated (1) absorbable collagen sponge (ACS), (2) allograft, (3) BioRestore, (4) Human Demineralized Bone Matrix (DBM), and (5) MasterGraft. For in vitro studies, rat bone marrow-derived stem cells (BMSC) were cultured on the materials in either standard or osteogenic media (SM, OM), followed by quantification of osteogenic marker genes ( Runx2, Osx, Alpl, Bglap, Spp1 ) and alkaline phosphatase (ALP) activity. Sixty female Fischer rats underwent L4-5 posterolateral fusion (PLF) with placement of 1 of 5 implants: (1) ICBG from syngeneic rats; (2) ICBG+BioRestore; (3) BioRestore alone; (4) ICBG+Allograft; or (5) ICBG+MasterGraft. Spines were harvested 8 weeks postoperatively and evaluated for bone formation and fusion via radiography, blinded manual palpation, microCT, and histology.

Results: After culture for 1 week, BioRestore promoted similar expression levels of Runx2 and Osx to cells grown on DBM. At the 2-week timepoint, the relative ALP activity for BioRestore-OM was significantly higher ( P <0.001) than that of ACS-OM and DBM-OM ( P <0.01) and statistically equivalent to cells grown on allograft-OM. In vivo, radiographic and microCT evaluation showed some degree of bridging bone formation in all groups tested, with the exception of BioRestore alone, which did not produce successful fusions.

Conclusions: This study demonstrates the capacity of BioRestore to promote osteoinductivity in vitro. In vivo, BioRestore performed similarly to commercially available bone graft extender materials but was incapable of producing fusion as a bone graft substitute.

Level of evidence: Level V.

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BioRestore 生物活性玻璃作为骨诱导和脊柱融合的合成骨移植扩展剂和替代物的机制和临床前评估。
研究设计目的:评估 BioRestore 生物活性玻璃的骨诱导性和骨再生能力:评估 BioRestore 生物活性玻璃的骨诱导性和骨再生能力:BioRestore 是一种经美国食品和药物管理局 (FDA) 批准的骨空隙填充物,尚未作为脊柱融合术的骨移植扩展剂或替代物进行过评估:方法:采用体外和体内方法比较 BioRestore 与其他生物材料促进骨分化和脊柱融合的能力。评估的材料包括:(1) 可吸收胶原海绵 (ACS);(2) 同种异体移植;(3) BioRestore;(4) 人类脱矿物质骨基质 (DBM);(5) MasterGraft。在体外研究中,用标准或成骨培养基(SM、OM)在材料上培养大鼠骨髓干细胞(BMSC),然后对成骨标记基因(Runx2、Osx、Alpl、Bglap、Spp1)和碱性磷酸酶(ALP)活性进行定量分析。60 只雌性 Fischer 大鼠接受了 L4-5 后外侧融合术 (PLF),植入了 5 种植入物中的一种:(1) 来自同种异体大鼠的 ICBG;(2) ICBG+BioRestore;(3) BioRestore;(4) ICBG+Allograft;或 (5) ICBG+MasterGraft。术后 8 周取回脊柱,并通过射线照相、盲法人工触诊、显微 CT 和组织学评估骨形成和融合情况:培养 1 周后,BioRestore 促进的 Runx2 和 Osx 表达水平与在 DBM 上培养的细胞相似。在培养 2 周时,BioRestore-OM 的相对 ALP 活性明显更高(PConclusions:这项研究证明了 BioRestore 在体外促进骨诱导的能力。在体内,BioRestore 的表现与市售骨移植扩展材料相似,但无法作为骨移植替代物产生融合:证据等级:V 级。
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来源期刊
Clinical Spine Surgery
Clinical Spine Surgery Medicine-Surgery
CiteScore
3.00
自引率
5.30%
发文量
236
期刊介绍: Clinical Spine Surgery is the ideal journal for the busy practicing spine surgeon or trainee, as it is the only journal necessary to keep up to date with new clinical research and surgical techniques. Readers get to watch leaders in the field debate controversial topics in a new controversies section, and gain access to evidence-based reviews of important pathologies in the systematic reviews section. The journal features a surgical technique complete with a video, and a tips and tricks section that allows surgeons to review the important steps prior to a complex procedure. Clinical Spine Surgery provides readers with primary research studies, specifically level 1, 2 and 3 studies, ensuring that articles that may actually change a surgeon’s practice will be read and published. Each issue includes a brief article that will help a surgeon better understand the business of healthcare, as well as an article that will help a surgeon understand how to interpret increasingly complex research methodology. Clinical Spine Surgery is your single source for up-to-date, evidence-based recommendations for spine care.
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