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A Load-Sharing Tissue Engineered Meniscus Scaffold: One Year Outcome

机译:分担组织工程设计的半月板支架:一年成果

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Objectives: Arthroscopic partial meniscectomy is one of the most commonly performed orthopaedic procedures. Although the procedure provides good symptom relief, long term follow up suggests the procedure results in an early onset of degenerative knee arthritis in a significant percentage of patients. Currently, treatment options for lost meniscal tissue are extremely limited and those available do not provide a long term solution. Therefore, there exists a need for a functional meniscus replacement in order to prevent joint deterioration. The objective of this project was to test a cross-linked collagen-hyaluronan sponge reinforced with synthetic, resorbable poly(DTD DD) fibers for meniscal implantation in an ovine model. Methods: Meniscus scaffolds were fabricated from poly(DTD DD) fibers woven into a semi-lunar wedge shape with extended tails for rigid tibial fixation. A dispersion of hyaluronic acid and type I bovine collagen was injected into the woven fiber scaffold. The scaffold was then lyophilized, crosslinked, and irradiated. The time-zero mechanical properties of the scaffold were evaluated with ultimate tensile testing and compression creep testing, and for load sharing function with a novel hoop stress evaluation and joint pressure distribution using Tekscan monitoring. The scaffolds were evaluated in an in vivo ovine model. A total medial meniscectomy was performed in the right hind leg of 30 sheep. Twenty-four of these sheep received a tissue engineered scaffold. The scaffold was anchored to the tibial plateau at the anterior and posterior root locations with titanium interference screws and sutured to the medial capsule. The remaining 6 sheep did not receive an implant and served as controls. Eight experimental and two control sheep were sacrificed at 16, 32 and 52 weeks. Scaffolds and adjacent articular cartilage underwent comprehensive mechanical and histological evaluation. Results: Pre-implantation characterization: Ultimate tensile strength of the implant was 660 N. The compressive modulus was 0.15 MPa. Hoop stress evaluation demonstrated a linear correlation between joint axial load and tensile stress in the implant. Tekscan evaluation demonstrated the implant increased joint contact area and decreased peak contact stress. In vivo evaluation demonstrated, at all time points, all 24 implants were fully intact and well healed to the surrounding capsule and maintained the meniscus-like shape (Figure 1). Gross and histological evaluation of the articular cartilage adjacent to the implant demonstrated minimal degenerative change in experimental knees. Control knees demonstrated advanced cartilage degradation adjacent to the meniscal resection. Robust tissue ingrowth into the implants was histologically demonstrated with tissue deposition occurring in a pattern consistent with tensile stresses in the implant. The tensile strength of the scaffold explant was 255 N at 16 weeks and 237 N at 32 weeks and 210 N at 52 weeks. The compressive modulus was 0.29 MPa at 16 weeks, 0.34 MPa at 32 weeks, and 0.49 MPa at 52 weeks. Conclusion: The results of this study support the feasibility of a tissue engineered load sharing scaffold for treatment of significant meniscal damage. The scaffold has the potential to prevent degenerative changes that occur after meniscectomy. Longer term studies will be necessary to confirm the true chondroprotective capabilities of this scaffold.
机译:目的:关节镜下半月板切除术是最常用的骨科手术之一。尽管该程序可提供良好的症状缓解,但长期随访表明,该程序可导致相当一部分患者早期发生退行性膝关节炎。当前,用于半月板组织丢失的治疗选择非常有限,并且可用的治疗方法不能提供长期的解决方案。因此,为了防止关节恶化,需要进行功能性的弯月面置换。该项目的目的是测试用合成的,可吸收的聚(DTD DD)纤维增强的交联胶原-透明质酸海绵,以在羊模型中进行半月板植入。方法:半月板支架由聚(DTD DD)纤维制成,编织成半月形楔形,尾巴延长,用于胫骨固定。将透明质酸和I型牛胶原的分散液注入编织的纤维支架中。然后将支架冻干,交联并照射。通过极限拉伸测试和压缩蠕变测试评估了脚手架的零时机械性能,并通过新颖的环向应力评估和使用Tekscan监测的联合压力分布评估了负载共享功能。在体内绵羊模型中评估支架。在30只绵羊的右后腿进行全内半月板切除术。这些绵羊中有二十四只接受了组织工程支架。用钛干扰螺钉将支架固定在胫骨平台的前根和后根位置,并缝合至内侧囊。其余6只绵羊没有接受植入物并作为对照。在16、32和52周处死8只实验羊和2只对照羊。脚手架和邻近的关节软骨进行了全面的力学和组织学评估。结果:植入前表征:植入物的极限拉伸强度为660N。压缩模量为0.15 MPa。箍应力评估表明植入物的关节轴向载荷与拉伸应力之间存在线性关系。 Tekscan评估表明,植入物可增加关节接触面积,并降低峰值接触应力。体内评估表明,在所有时间点,所有24个植入物均完好无损,并已愈合至周围的囊膜,并保持了半月板状形状(图1)。植入物附近的关节软骨的肉眼和组织学评估显示,实验性膝关节的退行性变化最小。对照膝关节在半月板切除术附近显示出晚期软骨退化。组织学证实,健壮的组织向内生长到植入物中,组织沉积以与植入物中的拉应力一致的方式发生。支架外植体的抗张强度在16周时为255 N,在32周时为237 N,在52周时为210N。 16周时的压缩模量为0.29MPa,32周时的压缩模量为0.34MPa,52周时的0.49MPa。结论:这项研究的结果支持组织工程负载分担支架治疗重大半月板损伤的可行性。该支架有可能防止在半月板切除术后发生退行性改变。为了确定该支架的真正软骨保护能力,将需要进行长期研究。

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