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].

 描述：可降解骨科修复装置将提供显着的临床益处，以克服目前在骨重塑、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，这些金属已成为骨科修复的黄金标准，而应力屏蔽、感染、骨重塑和二次手术切除的限制已将人们的极大兴趣转向可降解的装置。由聚乳酸和聚乙醇酸组成的骨科螺钉和板已成为可降解硬件的主要候选者，减少了移除的需要并改善了骨重塑。然而，聚乳酸和聚乙醇酸螺钉和板与由于降解产物、骨溶解和不完全骨重塑引起的炎症反应有关。因此，具有适当机械性能、可调节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、减少二次手术和改善长期患者预后。我们的长期目标是使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，以促进健康的骨骼重塑和整合。本研究的目的是确定所提出的丝格式是否能够满足可降解骨科系统的结构需求并成功直接进行促骨重塑。我们假设功能化丝绸矫形硬件可以在 6-12 个月的时间内完全降解，同时促进骨整合，以优化矫形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。这项研究的基本原理是从根本上了解功能化和可降解的骨科螺钉和板在加速愈合和指导成功的骨重塑方面的作用。通过提出能够满足骨折固定机械需求并解决当前限制和并发症的硬件设计，预期结果预计将对骨科修复产生重大积极影响。具有合作历史的跨学科研究小组将进行研究[David Kaplan - 丝绸生物材料、生物工程，Ara Nazarian - 生物力学/生物医学和动物研究，Sam Lin 和 Brian Snyder - 整形外科医生]。