I-Corps: Treating Bone Trauma Using a Biodegradable Bone Fixation Device

I-Corps：使用可生物降解的骨固定装置治疗骨创伤

• 批准号: 2024076
• 负责人: Hamdy Ibrahim
• 金额: $ 5万
• 依托单位: University of Tennessee Chattanooga
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2024076&HistoricalAwards=false
• 关键词: Corps; Treating; Bone; Trauma; Using

The broader impact/commercial potential of this I-Corps project is the improvement of bone trauma treatment outcomes through patient-specific biodegradable bone fixation devices. Current modalities of treating patients with bone trauma rely on the use of permanent and stiff bone fixation devices that carry substantial risks and increase the suffering of patients and the total operation cost. The new biodegradable (nonpermanent) devices have superior design and properties that, if adopted, may address these problems and result in a significant clinical breakthrough. No other technology with advantages similar to these has been identified in the US or the global market. The global targeted craniomaxillofacial fixation market is estimated to reach a value of USD $1,500 million by the end of 2020. In addition, the market size of biodegradable bone graft materials in North America only is expected to exceed $690 million by 2020. This I-Corps project is focused on the development of nonpermanent bone fixation devices made of a patent-pending biodegradable magnesium-based alloy with properties achieved using novel post-fabrication processes. Based on preliminary in-vitro studies, these devices are expected to be both strong enough to bear loads then lose strength and fully resorb following bone healing. It is hypothesized that the team's fixation devices will transfer enough compressive stresses to the healing bone to facilitate continuous bone remodeling. A preliminary proof-of-concept through a series of in vitro studies was successfully achieved. In addition, the biocompatibility of the alloy before and after the post-fabrication processes was assured. The success in developing nonpermanent fixation devices is expected to result in reduced post-surgery complications, reduced overall hospital stays and costs, and elimination of the need for a second surgery for implant removal.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该I-Corps项目更广泛的影响/商业潜力是通过患者特定的可生物降解骨固定器械改善骨创伤治疗结局。目前治疗骨创伤患者的方式依赖于使用永久性和刚性骨固定装置，其具有相当大的风险并增加患者的痛苦和总手术成本。新型可生物降解（非永久性）装置具有卓越的上级设计和性能，如果采用，可能会解决这些问题并带来重大的临床突破。在美国或全球市场上还没有发现具有类似优势的其他技术。到2020年底，全球定向颅颌面固定市场的价值估计将达到15亿美元。此外，到2020年，北美可生物降解骨移植材料的市场规模预计将超过6.9亿美元。该I-Corps项目的重点是开发非永久性骨固定器械，该器械由正在申请专利的可生物降解镁基合金制成，其性能采用新型后制造工艺实现。根据初步体外研究，预期这些器械的强度足以承受载荷，然后失去强度，并在骨愈合后完全吸收。据推测，该团队的固定装置将足够的压缩应力转移到愈合的骨，以促进连续的骨重建。通过一系列体外研究成功实现了初步概念验证。此外，还确保了合金在后制造过程前后的生物相容性。开发非永久性固定装置的成功预计将减少术后并发症，减少总体住院时间和成本，并消除第二次手术取出植入物的需要。该奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。