RESEARCH FOR HA/ POLY-L-LACTIDE COMPOSITE AS BIORESORBABLE HIGH-STRENGTH OSTEOSYNTHETIC IMPLANTS

HA/聚左旋丙交酯复合材料作为可生物吸收的高强度骨合成植入物的研究

• 批准号: 09671487
• 负责人: MATSUSE Yoshitaka
• 金额: $ 2.05万
• 依托单位: KYOTO UNIVERSITY
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 1997
• 资助国家: 日本
• 起止时间: 1997 至 1998
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-09671487/
• 关键词: RESORBABLE; HYDROXY APATITE; POLY-L-LACTIDE; COMPOSITE; FRACTURE REPAIR; BIOACTIVE; HIGH STRENGTH; bloactive; ceramic; hydroxyapatite; fixation; high strengtn

The biodegradation behavior of the ultra-high-strength hydroxyapatite/poly(1-lactide) (HA/PLLA) composite rods for fracture repair was investigated both in subcutis and medullary cavity in rabbits. The bending strength of the composites implanted in the subcutis was maintained at more than 200 MPa at 25 weeks and at 150 MPa at 52 weeks. The molecular weight dropped to 45% of the initial values at S weeks and to approximately 10% at 52 weeks. SEM demonstrated that HA particles disappeared increasingly from the rod surfaces over time and that the spaces left by these HA particles formed many pores in the composite surfaces at 52 weeks. Histologically, a fibrous tissue layer was formed around the composite rod from 4 weeks in the subcutis and in the diaphyseal area of the medullary canal. In the medullary cavity, the affinity indices of all composite rods were significantly higher than those of unfilled PLLA rods during follow-up, (p < 0.01 ; two-way ANOVA). The maximum affinity index (4 1%) was attained at 4 weeks in c-HA40 rods. The only significant difference in affinity indices among the composites was that calcined HA40 had a higher affinity index than unsintered HA40 (p < 0.05 at 4 weeks). During the experimental period, there were no inflammatory cells such as mono- or multi-nuclear phagocytes. Although further long-term studies for degradation are needed, the composites have promising mechanical strength and no adverse tissue reaction for use as fracture-fixation devices during the experimental periods.

研究了超高强度羟基磷灰石/聚乳酸（HA/PLLA）复合棒在兔皮下和髓腔内的生物降解行为。植入皮下的复合材料的抗弯强度在25周时维持在200 MPa以上，在52周时维持在150 MPa以上。在S周时，分子量下降到初始值的45%，在52周时下降到约10%。扫描电镜显示，随着时间的推移，HA颗粒越来越多地从杆表面消失，在52周时，这些HA颗粒留下的空间在复合材料表面形成了许多孔隙。组织学上，从4周开始，在髓管的皮下和干骺端，复合棒周围形成纤维组织层。在髓腔内，随访期间，所有复合棒的亲和力指数均显著高于未填充的PLLA棒，（p < 0.01；双向方差分析）。在c-HA40细胞中，4周时亲和指数达到最大值（4.1%）。复合材料间亲和指数有显著差异的是，煅烧HA40的亲和指数高于未烧结HA40（第4周p < 0.05）。实验期间未见单核、多核吞噬细胞等炎性细胞。虽然需要进一步的长期降解研究，但在实验期间，复合材料具有良好的机械强度，并且没有不良的组织反应，可用于骨折固定装置。

项目成果

Y.Matsusue: "Tissue reaction of bioabsorbable ultra high strength poly(1-lactide)rod : A long term study in rabbits." Clin.Orthop.317. 246-253 (1995)

Y.Matsusue：“生物可吸收超高强度聚（1-丙交酯）棒的组织反应：兔子的长期研究。”

Y.Matsusue: "A long-term clinical study on drawn poly-L-lactide implants in orthopaedic surgery" J.Long-term Eff.Med.Impl.7. 119-137 (1997)

Y.Matsusue：“骨科手术中拉制聚左旋丙交酯植入物的长期临床研究”J.Long-term Eff.Med.Impl.7。

Y,Matsusue: "A long - term clinical study on drawn poly -L-lactide implants in orthopaedic surgery" J. Long-term Eff. Med. Impl.7. 119-137 (1997)

Y，Matsusue：“骨科手术中拉伸聚左旋丙交酯植入物的长期临床研究”J.长期效果。

Yoshitaka Matsusue, Takashi Nakamura, Hirokazu Iida, et al: "A long-term clinical study on drawn poly-L-lactide implants in orthopaedic surgery." J.Long-tem Eff.Med.Impl.7 (2). 119-137 (1997)

Yoshitaka Matsusue、Takashi Nakamura、Hirokazu Iida 等人：“骨科手术中拉制聚左旋丙交酯植入物的长期临床研究。”

T.Furukawa, Y.Matsusue, T,Yasunaga, et al: "Ultra-high-strength hydroxyapatite/poly (L-lactide) composite rods for internal fixation of bone fractures : In vivo study." Ceramics in Medicine (New York) November. 5-8 (1998)

T.Furukawa、Y.Matsusue、T、Yasunaga 等人：“用于骨折内固定的超高强度羟基磷灰石/聚（L-丙交酯）复合棒：体内研究。”