Div. Supplement: Performance Evaluation of a non-Degradable Synthetic Device for Chondral and Osteochondral Defects of the Knee

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• 批准号: 10089242
• 负责人: TONY CHEN
• 金额: $ 10.48万
• 依托单位: HYDRO-GEN, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10089242
• 关键词: 3-Dimensional; 3D Print; Animals; Appearance; Biology; Caliber; Cartilage; Clinical; Complex; Defect; Degenerative polyarthritis; Development Plans; Devices; Ensure; Environment; Ethers; Evaluation; Geometry; Goals; Height; Hydrogels; Hydrogen; Image; Implant; Joints; Ketones; Knee; Knee Injuries; Lead; Measurement; Mechanics; Metals; Morphologic artifacts; Pain; Performance; Polymers; Printing; Process; Recording of previous events; Running; Shear Strength; Solid; Surface; Testing; Tissues; Titanium; Traumatic injury; Validation; Work; antimicrobial; articular cartilage; base; bone; design; early onset; in vivo; interfacial; joint function; manufacturability; manufacturing process; mechanical properties; next generation; osteochondral tissue; porous hydrogel; repaired; theories

Traumatic injury to the joint can cause the formation of defects in the articular cartilage and underlying bone leading to reduced joint function caused by pain and locking of the joint. Hydro-Gen has been developing a non-degradable osteochondral implant that consists of a porous hydrogel edge, a solid hydrogel core, and a porous titanium (pTi) base that fills the defect and restores joint mechanics. Pilot animal trials with this design have shown robust host cartilage and bone integration into the implant. While the results from the current implant have proven to be favorable, Hydro-Gen has begun to explore a next generation design in which the pTi would be replaced with a polymer. The polymer base would allow for easier imaging (avoiding metal artifact), easier revision, and in theory, allow for use of larger implants to treat larger defects. To this end, Hydro-Gen has recently been in contact with Oxford Performance Materials (OPM) who have developed a 3D printable poly(ether ketone ketone), PEKK, that has mechanical properties similar to bone and can be printed in a similar geometry as the current pTi design. While the material is promising, the performance of this material in the complex environment of the knee has not been characterized. Therefore, the objective of this supplement is to optimize and characterize implants made with PEKK and compare mechanical properties and in vivo performance to the current pTi design. To complete this goal, Hydro-Gen will work with OPM to optimize the 3D printing process to be within the design tolerances for the base. Additionally, Hydro-Gen will work with our third party manufacturing company, RK Manufacturing, to adapt and optimize the current implant manufacturing process for the inclusion of the PEKK bases – the manufacturability of the PEKK based implants will be determined through shear testing of the hydrogel-polymer interface as well as hydrogel overflow onto the base and measurements of the as manufactured implants.

关节的创伤性损伤可导致关节软骨和底层软骨缺损的形成。 导致关节疼痛和锁定引起的关节功能降低的骨。Hydro-Gen已经 开发一种不可降解的骨软骨植入物，其由多孔水凝胶边缘、固体 水凝胶芯和多孔钛（pTi）基底填充缺损并恢复关节力学。试点 采用这种设计的动物试验已经显示出牢固的宿主软骨和骨整合到植入物中。而 目前植入的结果已被证明是有利的，Hydro-Gen已开始探索下一个 第二代设计，其中pTi将被聚合物取代。聚合物基将允许 更容易成像（避免金属伪影），更容易翻修，理论上允许使用更大的植入物， 处理较大的缺陷。为此，Hydro-Gen公司最近与牛津高性能材料公司进行了接触 (OPM)他们开发了一种3D打印的聚（醚酮酮），PEKK，具有机械性能， 特性与骨相似，并且可以以与当前pTi设计相似的几何结构打印。而 材料是有前途的，这种材料在膝关节的复杂环境中的性能还没有得到 表征了因此，本补充的目的是优化和表征植入物， 与PEKK进行比较，并将机械性能和体内性能与当前pTi设计进行比较。到 为了实现这一目标，Hydro-Gen将与OPM合作，优化3D打印过程， 底座的设计公差。此外，Hydro-Gen将与我们的第三方制造商合作 公司，RK制造，以适应和优化目前的植入物制造工艺， 包含PEKK基-将确定PEKK基植入物的可制造性 通过水凝胶-聚合物界面的剪切测试以及水凝胶溢出到基底上， 制造的植入物的测量。