Development and evaluation of durable hybrid-type artificial ligament composed of high molecular synthetic fibers and human collagen fiber bundles

1 .植入后的拉伸试验表明，聚酯纤维的强度是合成纤维中最大的，具有良好的组织相容性和临床应用价值。在人体胶原纤维束中，半腱肌腱的抗拉强度最大（124.3 MPa）。在合成纤维与人体胶原纤维束的串联连接方法中，平针涤纶纤维与环状屈肌腱的α型连接方法最强。使用混合型合成韧带重建前交叉韧带的股骨-移植物-胫骨复合体的抗拉强度约为900N，其中扁平编织聚酯纤维与人类胶原纤维束通过α型连接方法串联。在现有方法重建的复合材料中，它是最大的，并能抵抗次极大循环荷载。术后6周，更多的人工韧带在骨隧道内被厚结缔组织固定。固定强度不受移植物和骨隧道直径不一致的影响。在植入后3周、6周、9周、12周和24周，混合型合成韧带胶原纤维束部分的抗拉强度分别为59、50、51和56%。各时期的恶化率均低于自体髌腱移植。应力剥夺和应力增强使移植的胶原纤维束部分的抗拉强度下降。然而，其恶化率低于自体髌骨肌腱移植。基于上述基础数据，我们研制了一种临床可用的由合成聚酯纤维和人胶原纤维束组成的混合型合成韧带，并在110例ACL重建中进行了临床评价。结果表明，91%的膝关节恢复了正常的稳定性。该结果优于以往文献报道。少

l.Tensile tests after implantation demonstrated that the strength of the polyester fiber is the greatest in synthetic fibers which have favorable histocompatibility and clinical utility.2.The tensile strength of the semitendinosus tendon is the greatest (124.3 MPa) in the collagen fiber bundles harvested from human body.3.The alpha-type connection method between flatly knit polyester fibers and looped flexor tendons is the strongest in serial connection methods between synthetic fibers and human collagen fiber bundles.4.The tensile strength of the femur-graft-tibia complex that has undergone ACL reconstruction using the hybrid-type synthetic ligament, where flatly knit polyester fibers are connected in series with human collagen fiber bundles using the alpha -type connection method, is approximately 900N.It is the greatest in the complexes reconstructed with currently available procedures, and is resistant to submaximal cyclic loading.5.The collagen bundle portion in the hybrid-type sy … More nthetic ligament is fixed by thick connective tissues in bone tunnels at 6 weeks postoperatively. The fixation strength is not affected by disagreement of the diameter between a graft and a bone tunnel.6.The tensile strength of the collagen fiber bundle portion of the hybrid-type synthetic ligament changes into 59,50,5l, and 56% at 3,6,9,12, and 24 weeks, respectively, after implantation. The deterioration rate is less than that of the patellar tendon autograft at each period.7.The tensile strength of the grafted collagen fiber bundle portion is deteriorated by both stress deprivation and stress enhancement. The deterioration rate, however, is less than that of the patellar tendon autograft.8.Based on the above-described basic data, a clinically available hybrid-type synthetic ligament composed of synthetic polyester fibers and human collagen fiber bundles has been developed, and evaluated clinically in 110 cases of ACL reconstruction. The result demonstrated that normal stability is restored in 91% of the knees. This result is superior to that reported in previous literature. Less