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装置改善骨创伤治疗结果。目前治疗骨外伤患者的方式依赖于使用永久且坚硬的骨固定装置，这会带来很大的风险并增加患者的痛苦和总手术成本。新的可生物降解（非永久性）装置具有卓越的设计和特性，如果采用，可以解决这些问题并带来重大的临床突破。美国或全球市场尚未发现具有类似优势的其他技术。预计到2020年底，全球颅颌面固定目标市场价值将达到15亿美元。此外，仅北美地区的生物可降解骨移植材料市场规模预计到2020年将超过6.9亿美元。该项目的重点是开发由正在申请专利的可生物降解镁基合金制成的非永久性骨固定装置，其性能通过新型后加工实现流程。根据初步的体外研究，这些装置预计强度足以承受负载，然后在骨愈合后失去强度并完全吸收。据推测，该团队的固定装置将向正在愈合的骨骼传递足够的压应力，以促进持续的骨骼重塑。通过一系列体外研究成功实现了初步概念验证。此外，还保证了合金在后加工过程之前和之后的生物相容性。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费用，并消除第二次植入物移除手术的需要。该奖项反映了 NSF 的法定使命，并被认为是值得的通过使用基金会的智力优势和更广泛的影响审查标准进行评估来提供支持。