Degradable orthopedic hardware

可降解矫形硬件

• 批准号: 9438859
• 负责人: DAVID L. KAPLAN
• 金额: $ 44.48万
• 依托单位: TUFTS UNIVERSITY MEDFORD
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9438859
• 关键词: Address; Alloys; Animal Model; Animals; Biocompatible Materials; Biological Assay; Biomechanics; Biomedical Engineering; Bone Regeneration; Bone remodeling; Child; Clinical; Data; Deposition; Device Removal; Devices; Diagnostic radiologic examination; Evaluation; Excision; Formulation; Fracture Fixation; Goals; Gold; Histologic; Histology; Image Analysis; In Vitro; Infection; Inflammatory; Kinetics; Mechanics; Metals; Modeling; Modification; Molecular Weight; Morphology; Operative Surgical Procedures; Orthopedics; Osteolysis; Outcome; Patient-Focused Outcomes; Polyglycolic Acid; Porosity; Property; Proteins; Rattus; Reaction; Recording of previous events; Research; Research Personnel; Role; Running; Silk; Stress; Structure; Surgeon; System; Testing; Time; TimeLine; Tissues; Titanium; Variant; X-Ray Computed Tomography; base; biodegradable polymer; bone; design; healing; implantation; improved; in vivo; insight; interest; lead candidate; mechanical properties; meetings; nano; osteogenic; poly(lactic acid); poly-L-lactic acid; public health relevance; repaired; response; retinal rods; screening; single photon emission computed tomography

 DESCRIPTION: Degradable orthopedic repair devices would provide significant clinical benefits to overcome current limitations in bone remodeling, degradation kinetics and bone integration. Current options are limited primarily to nondegradable metals which have become the gold standard for orthopedic repairs due to robust mechanical properties and ease of implantation, while limitations of stress shielding, infections, bone remodeling and second surgical removals have shifted significant interest toward degradable devices. Orthopedic screws and plates composed of polylactic and polyglycolic acids have become lead candidates for degradable hardware with a reduced need for removal and improved bone remodeling. However, polylactic and polyglycolic acid screws and plates are associated with inflammatory reactions due to degradation products, osteolysis and incomplete bone remodeling. Thus, orthopedic hardware that has appropriate mechanical properties, tunable and full degradation and is pro-osteogenic would have a major impact on orthopedic repairs in promoting accelerated healing, reducing second surgeries and improving long-term patient outcomes. Our long term goal is to develop fully degradable screws, plates and rods using silk protein functionalized by bioactive molecules to promote healthy bone remodeling and integration. The objective of the proposed research is to determine the ability of the proposed silk format to meet the structural needs of degradable orthopedic systems and successfully direct pro-osteogenic remodeling. We hypothesize that functionalized silk orthopedic hardware can be tuned to fully degrade over a 6-12 month time while promoting osteointegration to optimize utility in orthopedic repairs and meeting mechanical requirements. Our extensive preliminary in vitro and in vivo data support this hypothesis. The rationale for this research is to gain fundamental insight into the role of functionalized and degradable orthopedic screws and plates in accelerating healing and directing successful bone remodeling. The anticipated outcomes are expected to have a substantial positive impact on orthopedic repairs by presenting hardware designs capable of meeting mechanical needs of fracture fixation and addressing current limitations and complications. An interdisciplinary team of investigators who have a history of collaborative efforts will conduct the studies [David Kaplan - silk biomaterials, bioengineering, Ara Nazarian - biomechanics/biomiaging and animal studies, Sam Lin and Brian Snyder - orthopedic surgeons].

 产品说明：可降解骨科修复器械将提供显著的临床受益，以克服当前骨重建、降解动力学和骨整合方面的局限性。目前的选择主要限于不可降解的金属，由于其强大的机械性能和易于植入，已成为骨科修复的黄金标准，而应力屏蔽、感染、骨重建和二次手术切除的限制已使人们对可降解器械的兴趣显著转移。由聚乳酸和聚乙醇酸组成的骨科螺钉和接骨板已成为可降解硬件的主要候选产品，可减少取出需求并改善骨重建。然而，聚乳酸和聚乙醇酸螺钉和接骨板由于降解产物、骨质溶解和不完全骨重建而与炎症反应相关。因此，具有适当机械性能、可调和完全降解以及促成骨的骨科硬件将对骨科修复产生重大影响，促进加速愈合，减少二次手术并改善长期患者结局。我们的长期目标是利用生物活性分子功能化的丝蛋白开发完全可降解的螺钉、板和棒，以促进健康的骨重建和整合。拟议研究的目的是确定拟议的丝形式满足可降解骨科系统的结构需求并成功引导促成骨重塑的能力。我们假设，功能化的丝骨科硬件可以被调整为在6-12个月的时间内完全降解，同时促进骨整合，以优化骨科修复的效用并满足机械要求。我们广泛的初步体外和体内数据支持这一假设。本研究的基本原理是从根本上了解功能化和可降解骨科螺钉和接骨板在加速愈合和指导成功骨重建中的作用。预期结果预计将对骨科修复产生实质性的积极影响，因为硬件设计能够满足骨折固定的机械需求，并解决当前的局限性和并发症。一支由拥有悠久历史的跨学科调查人员组成的团队 合作的努力将进行研究[大卫卡普兰-丝绸生物材料，生物工程，阿拉纳扎里安-生物力学/生物成像和动物研究，山姆林和布赖恩斯奈德-整形外科医生]。