R-FIX (Rib-FIXation System) for Severe Progressive Spinal Deformity

R-FIX（肋骨固定系统）用于治疗严重进行性脊柱畸形

• 批准号: 10482559
• 负责人: Richard H. Gross
• 金额: $ 29.99万
• 依托单位: APEX ORTHOPAEDIC TECHNOLOGIES LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482559
• 关键词: 10 year old; 3-Dimensional; Anatomy; Animal Model; Anterior; Applications Grants; Basic Science; Biomechanics; Biomedical Engineering; Case Study; Chest; Child; Childhood; Clinical; Clinical Data; Clinical Trials; Complex; Complication; Data; Deformity; Development; Devices; Distal; Early treatment; Epiphysial cartilage; Equipment; Etiology; Failure; Family suidae; Fracture; Geometry; Grant; Growth; Histologic; Human; Hybrids; Hyperkyphosis; Implant; Institution; Kyphosis deformity of spine; Label; Lateral; Legal patent; Lung; Mechanics; Methods; Nervous System Trauma; Operative Surgical Procedures; Orthopedics; Osteoporosis; Osteoporotic; Patients; Performance; Phase; Prosthesis; Protocols documentation; Publishing; Research; Rib Fractures; Risk; Rod; Safety; Secondary to; Series; Site; Small Business Innovation Research Grant; Spinal; Spinal Curvatures; Spinal Fusion; Structure; Study models; Surgeon; System; Techniques; Technology; Testing; Titanium; Torque; Torsion; United States National Institutes of Health; Universities; Vertebral column; biomechanical test; cortical bone; design; early childhood; early onset; efficacy evaluation; high risk; implant design; implantation; innovation; instrument; instrumentation; novel; off-label use; rib bone structure; risk minimization; safety assessment; sample fixation; scoliosis; spine bone structure; standard of care; user-friendly

Project Summary Early-onset spinal deformity (EOSD) is deformity that begins before 10 years of age. Curvature can be in the lateral direction (scoliosis), anterior direction (hyperkyphosis) or both (kyphoscoliosis). The most common surgical treatment for EOSD is expandable growing rods fixed to the spine with pedicle screws. There are many challenging problems with this technique. Auto-fusion of the vertebrae is common, resulting in stunted spinal growth and sub-optimal pulmonary development. Complication rates are high including proximal fixation failure (pedicle screw pull-out), rod fracture, proximal junctional kyphosis (PJK), and neurological injury. Proximal fixation failure is especially problematic in osteoporotic patients with hyperkyphotic or kyphoscoliotic deformity, and can sometimes make successful treatment of these patients impossible. The VEPTR (Vertical Expandable Prosthetic Titanium Rib) is an alternative device, but it cannot be contoured in the sagittal plane and is contraindicated for hyperkyphosis and kyphoscoliosis. This application proposes a new technique called the rib construct for correcting EOSD. Instead of anchoring rods to the spine with pedicle screws, the rib construct moves proximal fixation to the ribs using a series of hooks. This approach is a conceptual shift in approaching spinal deformity, in that the thorax is manipulated to secondarily reposition the spine. The rib construct allows the surgeon to manipulate the thorax in any combination of both sagittal, coronal, and axial planes, allowing for safer, more effective, and versatile deformity correction. Rib fixation with the rib construct can be achieved with either: 1) off-label laminar hooks, which are already commercially available for spinal fixation to the lamina but can also be used on the ribs, or 2) rib hooks as part of our novel patented R-FIX (Rib-FIXation System). While laminar hooks have performed favorably compared to pedicle screws in our preliminary clinical use, these have been used entirely off-label and there is no commercially available surgical system designed for this technique. There have been issues with loss of fixation under torsional forces, implant prominence, and occasional cases of rib fracture with laminar hooks. The R-FIX System, which originated from a bioengineering lab (one of the applicants' lab) at Clemson University and has been further developed by Apex Orthopaedic Technologies, is designed to resolve these issues. The objective of this proposal is twofold: 1) to prove the overall concept of rib fixation with the rib construct by obtaining basic science data to support the clinical data we have already obtained and 2) to demonstrate the superior performance of R-FIX rib hooks compared to laminar hooks. This research will be conducted over 12 months and the data obtained from this grant proposal will be used in a 510(k) application for FDA clearance and the NIH SBIR Phase II application. Major milestones to be achieved with this grant include 1) ex vivo biomechanical evaluation of R-FIX rib hooks compared to pedicle screws and laminar hooks, and 2) assessment of the safety and efficacy of R-FIX rib hooks compared to pedicle screws and laminar hooks in a pediatric hyperkyphosis porcine animal model.

项目摘要 早发性脊柱畸形（EOSD）是在10岁之前开始的畸形。曲率可以在 侧向（脊柱侧凸）、前向（过度脊柱后凸）或两者（脊柱后凸）。最常见的 EOSD的外科治疗是用椎弓根螺钉将可膨胀的生长棒固定到脊柱上。有很多 挑战性的问题。椎骨的自动融合是常见的，导致发育不良的脊柱 生长和次优的肺部发育。并发症发生率较高，包括近端固定失败 （椎弓根螺钉拔出）、棒断裂、近端交界性脊柱后凸（PJK）和神经损伤。近侧 固定失败在具有过度后凸或脊柱后凸畸形的脊柱侧凸患者中尤其成问题， 有时会使这些患者无法获得成功治疗。VEPTR（垂直可扩展） 假体钛肋）是一种替代器械，但它不能在矢状面中塑形， 禁忌用于过度脊柱后凸和脊柱后凸。这个应用程序提出了一个新的技术称为肋骨 用于纠正EOSD的结构。代替用椎弓根螺钉将杆锚定到脊柱， 使用一系列钩将近端固定移动到肋骨。这种方法是一种概念上的转变， 脊柱畸形，因为胸部被操纵以二次重新定位脊柱。肋骨结构允许 外科医生可以在矢状面、冠状面和轴向面的任意组合中操纵胸腔， 更安全、更有效、更灵活的畸形矫正。肋骨结构的肋骨固定可通过以下方法实现： 或者：1）标签外椎板钩，其已经市售用于椎板脊柱固定，但 也可用于肋骨，或2）肋骨钩作为我们的新型专利R-FIX（肋骨固定系统）的一部分。而 在我们的初步临床应用中，椎板钩的性能优于椎弓根螺钉， 完全标签外使用，目前尚无针对该技术设计的市售手术系统。 存在扭转力下固定丢失、植入物突出和偶发病例的问题 用椎板钩固定肋骨骨折R-FIX系统起源于一个生物工程实验室（ 申请人的实验室）在克莱姆森大学，并已进一步开发的顶点骨科技术，是 旨在解决这些问题。本提案的目的是双重的：1）证明肋的整体概念 通过获得基础科学数据来支持我们已经获得的临床数据， 2）证明R-FIX肋骨钩的上级性能优于椎板钩。这 研究将在12个月内进行，从这项拨款申请中获得的数据将用于 FDA批准的510（k）申请和NIH SBIR II期申请。有待实现的主要里程碑 该授权包括1）R-FIX肋骨钩与椎弓根螺钉相比的体外生物力学评价， 椎板钩，2）与椎弓根螺钉相比，评估R-FIX肋骨钩的安全性和有效性， 椎板钩在小儿过度脊柱后凸猪动物模型。