Feasibility of Non-surgical Implant Adjustment

非手术种植体调整的可行性

• 批准号: 8780885
• 负责人: Stephen Daniel Fening
• 金额: $ 22.29万
• 依托单位: APTO ORTHOPAEDICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8780885
• 关键词: 6 year old; Address; Affect; Age; American; Animals; Biomechanics; Bone Lengthening; Braces-Orthopedic appliances; Caring; Chest; Child; Child health care; Childhood; Clinical; Data; Deformity; Development; Devices; Diagnosis; Economics; Evaluation; Excision; Future; Goals; Growth; Health; Health Care Costs; Healthcare Systems; Idiopathic scoliosis; Implant; Lateral; Lead; Learning; Left; Length; Life; Marketing; Mission; Operative Surgical Procedures; Orthopedics; Outcome; Parents; Patient Care; Patients; Personal Satisfaction; Phase; Physicians' Offices; Population; Preparation; Procedures; Public Health; Recovery; Regimen; Repeat Surgery; Reporting; Research; Resistance; Small Business Technology Transfer Research; Solutions; Spinal; Spinal Curvatures; Spinal Fusion; Surgical incisions; Technology; Time; Treatment Protocols; United States; Ursidae Family; Vertebral column; Visit; Work; biomaterial compatibility; commercialization; cost; early onset; experience; high risk; implantable device; implantation; improved; in vivo; lung development; minimally invasive; new technology; next generation; public health relevance; retinal rods; scoliosis; skeletal

DESCRIPTION (provided by applicant): While minimally invasive surgery has transformed the practice of surgery, access to implants for removal or alteration still requires surgery which generates risk and high cost. A next-generation approach is non-invasive, where implants are adjusted without an incision. There are clear applications in all fields of surgery, but particulary in orthopaedics where implants require frequent adjustment. One condition, early onset scoliosis, is disproportionally responsible for high cost and poor patient outcomes. Scoliosis, a pathological lateral curvature of the spine greater than 10, affects 2-4% of the population, or an estimated 6 million people in the United States. If left untreated, early onset scoliosis can cause damaging spinal deformity early in life; thus affecting other aspects of the child's health. There s no known cure for early onset idiopathic scoliosis. The most common surgical treatment of early onset scoliosis utilizes growing rods. In this procedure, rods are lengthened at 6 month intervals to maintain correction and control of the spinal deformity and to accommodate and facilitate spinal / thoracic growth without fusion. Studies have reported the mean age of the child at surgery to be 4.5 years with a mean number of procedures per patient was 9.3. The proposed novel technology performs essentially the same function as existing technology (growing rods). However, whereas the existing treatment requires invasive surgery every 6 months to access and tighten the set screw by a screwdriver, the Apto device adjusts the set screws non-invasively using a rotating magnet. The result of this non-invasive adjustment is transformational - the ability to lengthen the construct without surgery. This has the clear potential to both significantly improve patient outcomes and to significantly decrease healthcare costs. To the 6-year old (and his/her parents) recently diagnosed with early onset scoliosis, the prospect of facing surgery every six months for his/her entire childhood is daunting. The proposed solution promises to give these pediatric patients a childhood filled with learning, activity, and fun - not constant recovery or preparation for spinal surgery. Our long-term goal is to commercialize non-invasively adjustable implants, which have the potential to provide superior outcomes while reducing the cost of care. The objective of this proposal is to demonstrate the feasibility of non-invasively adjusting the length of growing rods for the application of early onset scoliosis. We plan to achieve our proposal's overall goals by addressing the following three specific aims: 1) Demonstrate the biocompatibility of the device; 2) Demonstrate the feasibility of implantation of the device in a living animal; and 3) Demonstrate the feasibility of non-invasive lengthening of growing rods at 2 time points. Completion of this proposal would demonstrate the feasibility of non-invasive adjustment of an orthopaedic implant.

描述（由申请人提供）：虽然微创手术已经改变了手术实践，但植入物的移除或改变仍然需要手术，这会产生风险和高成本。下一代方法是非侵入性的，无需切口即可调整植入物。在所有外科领域都有明显的应用，特别是在植入物需要频繁调整的骨科领域。其中一种情况是早发性脊柱侧凸，它是造成高成本和不良预后的不成比例的原因。脊柱侧凸是一种脊柱侧弯大于 10 的病理性病症，影响着 2-4% 的人口，即美国估计有 600 万人。如果不及时治疗，早发性脊柱侧弯会导致 生命早期造成脊柱畸形；从而影响孩子其他方面的健康。对于早发性特发性脊柱侧凸，尚无已知的治疗方法。早发性脊柱侧弯最常见的手术治疗方法是使用生长棒。在此手术中，杆每隔 6 个月延长一次，以维持脊柱畸形的矫正和控制，并适应和促进脊柱/胸部生长而不融合。研究报告称，接受手术的孩子的平均年龄为 4.5 岁，每位患者的平均手术次数为 9.3 次。所提出的新技术执行与现有技术（生长棒）基本相同的功能。然而，现有的治疗方法需要每 6 个月进行一次侵入性手术，用螺丝刀接触并拧紧固定螺钉，而 Apto 设备则使用旋转磁铁非侵入性地调整固定螺钉。这种非侵入性调整的结果是变革性的——无需手术即可延长结构的能力。这显然有可能显着改善患者的治疗效果并显着降低医疗成本。对于最近被诊断出患有早发性脊柱侧弯的 6 岁儿童（及其父母）来说，他/她整个童年每六个月就要接受一次手术，前景令人望而生畏。拟议的解决方案有望为这些儿科患者提供一个充满学习、活动和乐趣的童年，而不是 持续康复或为脊柱手术做准备。我们的长期目标是将非侵入性可调节植入物商业化，这种植入物有可能提供卓越的结果，同时降低护理成本。该提案的目的是证明非侵入性调整生长棒长度在早发性脊柱侧凸应用中的可行性。我们计划通过解决以下三个具体目标来实现提案的总体目标：1）展示设备的生物相容性； 2）证明该装置植入活体动物体内的可行性； 3) 论证在2个时间点无创延长生长棒的可行性。该提案的完成将证明骨科植入物无创调整的可行性。