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.
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.
复制标题
在绵羊模型中使用重组人血小板衍生生长因子-B链同型二聚体（rhPDGF-BB）与牛胶原/β-磷酸三钙（β-TCP）基质联合进行腰椎融合的评价。
DOI：
10.1002/jsp2.1166
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发表时间：
2021-09
期刊：
影响因子：
3.7
通讯作者：
Easley JT
中科院分区：
文献类型：
--
作者：
Gadomski BC;Labus KM;Puttlitz CM;McGilvray KC;Regan DP;Nelson B;Seim HB 3rd;Easley JT
虽然重组人血小板衍生生长因子-B链同型二聚体联合胶原蛋白和β-磷酸三钙（rhPDGF-BB + 胶原蛋白/β-TCP）治疗涉及后足和踝关节的临床疗效已得到证实，但尚未批准用于脊柱椎间融合，并且使用自体移植物仍然是金标准。本研究的目的是使用生物力学、放射学和组织学评估技术，比较 rhPDGF-BB + 胶原蛋白/β-TCP 治疗对绵羊模型中腰椎椎间融合的效果与自体移植骨和胶原蛋白/β-TCP 治疗的效果。使用 32 只骨骼成熟的哥伦比亚朗布依埃羊来评估 rhPDGF-BB + 胶原蛋白/β-TCP 基质在腰椎融合模型中的安全性和有效性。椎间聚醚醚酮 (PEEK) 笼包含自体移植物、rhPDGF-BB + 胶原/β-TCP、胶原/β-TCP 基质，或留空。手术后8周或16周处死动物。通过牺牲后生物力学、微型计算机断层扫描 (μCT) 和组织学分析来评估脊柱融合。使用 alpha 值为 0.05 的双向方差分析 (ANOVA) 和 Tukey 事后检验对结果进行统计比较。在治疗时间点内，各组之间的屈伸、侧向弯曲或轴向旋转运动范围、中性区、中性区刚度或弹性区刚度没有统计学上的显着差异。与胶原/β-TCP（分别为 P = .026 和 P = .038）和空笼治疗（分别为 P = .002 和 P = .003）相比，自体移植和 rhPDGF-BB + 胶原/β-TCP 治疗显示出显着更大的骨体积分数，治疗组之间的 μCT 骨体积分数显着更高，与时间点无关。与所有其他治疗组相比，rhPDGF-BB + 胶原蛋白/β-TCP 标本的 μCT 平均骨密度分数在第 8 周和 16 周时间点得到最大改善。 rhPDGF-BB + 胶原蛋白/β-TCP和自体移植治疗之间的骨、软组织或空腔的组织形态测量没有统计学上的显着差异。这项研究的结果表明，使用 rhPDGF-BB 与胶原蛋白/β-TCP 相结合可促进脊柱融合，与自体移植骨相当。数据表明，rhPDGF-BB 与胶原蛋白/β-TCP 相结合可促进脊柱融合，与自体移植骨治疗相比，可能为大型动物脊柱融合提供可行的替代方案。未来的前瞻性临床研究有必要充分了解rhPDGF-BB联合胶原蛋白/β-TCP在人体脊柱融合愈合中的作用。研究了重组人血小板衍生生长因子（rhPDGF-BB）与牛胶原β磷酸三钙联合用于大型动物腰椎融合。这项研究的结果表明，这种治疗与金标准自体移植治疗之间的愈合效果相当。
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. 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. 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. 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. 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. 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. 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. The use of recombinant human platelet‐derived growth factor (rhPDGF‐BB) combined with bovine collagen beta tricalcium phosphate was investigated for large animal lumbar spine fusion. Results of this study demonstrate comparable healing results between this treatment and gold‐standard autograft treatment.
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