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.

项目概要 早发性脊柱畸形 (EOSD) 是 10 岁之前开始的畸形。曲率可以在 横向（脊柱侧凸）、向前（脊柱后凸）或两者（脊柱后凸）。最常见的 EOSD 的手术治疗是用椎弓根螺钉将可扩张的生长棒固定在脊柱上。有许多 这项技术具有挑战性的问题。椎骨自融合很常见，导致脊柱发育不良 生长和肺部发育欠佳。并发症发生率很高，包括近端固定失败 （椎弓根螺钉拔出）、杆断裂、近端交界后凸 (PJK) 和神经损伤。近端 固定失败对于患有后凸或脊柱后凸畸形的骨质疏松患者来说尤其成问题， 有时会使这些患者的成功治疗变得不可能。 VEPTR（垂直可扩展 假体钛肋骨）是一种替代装置，但它不能在矢状面上绘制轮廓，并且 禁忌用于后凸畸形和脊柱后凸。该申请提出了一种称为肋骨的新技术 用于校正EOSD的构造。肋骨结构不是用椎弓根螺钉将杆锚定到脊柱上 使用一系列钩子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，即通过操作胸部来重新定位脊柱。肋结构允许 外科医生可以在矢状面、冠状面和轴向面的任意组合上操作胸部，从而实现 更安全、更有效、多功能的畸形矫正。肋骨固定与肋骨结构可以通过以下方式实现 要么： 1) 标签外的椎板钩，这些钩子已经在商业上可用于将脊柱固定到椎板上，但是 也可用于肋骨，或 2) 肋骨钩，作为我们新型专利 R-FIX（肋骨固定系统）的一部分。尽管 在我们的初步临床使用中，与椎弓根螺钉相比，层板钩表现良好，这些具有 完全在标签外使用，并且没有专为该技术设计的市售手术系统。 在扭转力、种植体突出和偶尔的情况下会出现固定丢失的问题 肋骨骨折的层状钩。 R-FIX 系统起源于生物工程实验室（生物工程实验室之一） 申请人的实验室）位于克莱姆森大学，并由 Apex Orthopedic Technologies 进一步开发， 旨在解决这些问题。该提案的目的有两个：1）证明 rib 的整体概念 通过获取基础科学数据来支持我们已经掌握的临床数据来固定肋骨结构 2) 证明 R-FIX 肋骨钩与层流钩相比具有优越的性能。这 研究将进行 12 个月，从本拨款提案中获得的数据将用于 FDA 批准的 510(k) 申请和 NIH SBIR II 期申请。需要实现的主要里程碑 这笔资助包括 1) R-FIX 肋骨钩与椎弓根螺钉相比的离体生物力学评估 2) 与椎弓根螺钉和 R-FIX 肋骨钩相比，评估 R-FIX 肋骨钩的安全性和有效性 小儿后凸畸形猪动物模型中的层状钩。