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首页> 外文期刊>JOR spine. >Evaluation of lumbar spinal fusion utilizing recombinant human platelet derived growth factor-B chain homodimer (rhPDGF-BB) combined with a bovine collagen/β-tricalcium phosphate (β-TCP) matrix in an ovine model
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Evaluation of lumbar spinal fusion utilizing recombinant human platelet derived growth factor-B chain homodimer (rhPDGF-BB) combined with a bovine collagen/β-tricalcium phosphate (β-TCP) matrix in an ovine model

机译：利用重组人血小板衍生生长因子-B链偶联（RHPDGF-BB）与绵羊模型中的牛胶原/β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-β-TCP）基质进行评价

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Background context While the clinical effectiveness of recombinant human Platelet Derived Growth Factor-B chain homodimer combined with collagen and β-tricalcium phosphate (rhPDGF-BB?+?collagen/β-TCP) treatment for indications involving hindfoot and ankle is well-established, it is not approved for use in spinal interbody fusion, and the use of autograft remains the gold standard. Purpose The purpose of this study was to compare the effects of rhPDGF-BB?+?collagen/β-TCP treatment on lumbar spine interbody fusion in an ovine model to those of autograft bone and collagen/β-TCP treatments using biomechanical, radiographic, and histological assessment techniques. Study design Thirty-two skeletally mature Columbian Rambouillet sheep were used to evaluate the safety and effectiveness of rhPDGF-BB?+?collagen/β-TCP matrix in a lumbar spinal fusion model. Interbody polyetheretherketone (PEEK) cages contained either autograft, rhPDGF-BB?+?collagen/β-TCP, collagen/β-TCP matrix, or left empty. Methods Animals were sacrificed 8- or 16-weeks post-surgery. Spinal fusion was evaluated via post-sacrifice biomechanical, micro-computed tomography (μCT), and histological analysis. Outcomes were statistically compared using a two-way analysis of variance (ANOVA) with an alpha value of 0.05 and a Tukey post-hoc test. Results There were no statistically significant differences between groups within treatment timepoints for flexion-extension, lateral bending, or axial rotation range of motion, neutral zone, neutral zone stiffness, or elastic zone stiffness. μCT bone volume fraction was significantly greater between treatment groups independent of timepoint where Autograft and rhPDGF-BB?+?collagen/β-TCP treatments demonstrated significantly greater bone volume fraction as compared to collagen/β-TCP ( P =?.026 and P =?.038, respectively) and Empty cage treatments ( P =?.002 and P =?.003, respectively). μCT mean bone density fraction was most improved in rhPDGF-BB?+?collagen/β-TCP specimens at the 8?week and 16-week timepoints as compared to all other treatment groups. There were no statistically significant differences in histomorphometric measurements of bone, soft tissue, or empty space between rhPDGF-BB?+?collagen/β-TCP and autograft treatments. Conclusions The results of this study indicate that the use of rhPDGF-BB combined with collagen/β-TCP promotes spinal fusion comparable to that of autograft bone. Clinical significance The data indicate that rhPDGF-BB combined with collagen/β-TCP promotes spinal fusion comparably to autograft bone treatment and may offer a viable alternative in large animal spinal fusion. Future prospective clinical studies are necessary to fully understand the role of rhPDGF-BB combined with collagen/β-TCP in human spinal fusion healing.
机译：背景技术，而重组人血小板衍生生长因子-B链同源过二聚体与胶原蛋白和β-β-β-+？β-β-TCP）治疗涉及后脚和踝关节和踝关节的临床疗效，而临床效果（rhPDGF-BB？+？β-TCP）。它未被批准用于脊柱椎体融合，自动移植物的使用仍然是黄金标准。目的本研究的目的是比较rhPDGF-BB？+？胶原蛋白/β-TCP处理对绵延模型中的腰椎椎体和胶原蛋白/β-TCP治疗的影响，使用生物力学，射线照相，和组织学评估技术。研究设计三十二个骨骼成熟的哥伦比亚羊皮叶绵羊用于评估rhPDGF-BB的安全性和有效性在腰椎融合模型中的rhPDGF-BB？+？胶原/β-TCP矩阵。椎体间聚醚醚酮（PEEK）笼含有自体移植物，rhPDGF-BB？+？胶原蛋白/β-TCP，胶原/β-TCP矩阵或留空。方法治疗动物后术后8-或16周。通过牺牲后生物力学，微计算断层扫描（μCT）和组织学分析评估脊柱融合。使用具有0.05的α值（ANOVA）的双向分析和HOC测试的双向分析和HOC测试进行了统计学比较。结果治疗时间点内没有统计学上显着的差异，用于屈曲 - 延伸，横向弯曲或运动，中性区域，中性区刚度或弹性区刚度的轴向旋转范围。与胶原蛋白/β-TCP相比，治疗组之间的治疗组无关，μCT骨体积分数明显更大。与胶原/β-TCP相比=？分别为038）和空笼式处理（P =→002和P = 003）。 μCT平均骨密度级分在rhPDGF-BBα+？胰蛋白/β-TCP样本中最有改善，与所有其他治疗组相比，8？周和16周的时间点。骨骼，软组织或rhPDGF-BB + +β-β-TCP和自体移植治疗之间的骨骼，软组织或空间隙中没有统计学显着的差异。结论该研究的结果表明，使用rhPDGF-BB与胶原/β-TCP的使用促进与自体移植骨的脊髓融合相当。临床意义数据表明，rhPDGF-BB与胶原蛋白/β-TCP相结合，促进了与自体移植骨骼治疗相当的脊髓融合，并可在大型动物脊柱融合中提供可行的替代品。未来的前瞻性临床研究是充分了解rhPDGF-BB与胶原蛋白/β-TCP在人脊柱融合愈合中的作用。

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