Continuously Load-Sharing Elastically Deformable Spinal Fusion Implant

 描述(由申请人提供)：Revivo Medical，LLC已经开发出下一代脊柱融合植入物，以帮助外科医生和医院实现《平价医疗法案》的目标。Revivo的脊柱植入物是第一个利用骨形成的基础科学来减少融合时间，同时还减少了并发症发生率，减少了手术室时间，并降低了总成本。Revivo Medical改善脊柱融合的解决方案是一套连续分担载荷的弹性可变形脊柱植入物。根据设计，Revivo植入物的硬度允许在生理载荷下的微小变形。这促进了持续的负荷分担，我们预计这将导致更快的骨融合。这项第一阶段计划的目标是展示我们的弹性可变形、持续分担载荷的脊柱植入物的有效性，以促进相对于现有钢板更快、更高质量的脊柱融合。在拟议的第一阶段工作中，我们将建立通过受控微运动的持续负荷分担将提高体内椎间融合的速度和质量。在临床相关的活体大型动物模型中，我们将把植入物设计与临床相关指标--下沉、螺钉回撤、融合率和融合率和质量--联系起来。我们假设，与现有的静态和动态钢板相比，弹性可变形、持续分担载荷的植入物将减少下沉、减少螺丝钉回撤，并提高骨融合的速度和质量。我们将对18只山羊进行颈椎前路髓核摘除和融合术，动物分组接受前路(A)静态钢板、(B)动态钢板或(C)Revivo Medical弹性变形钢板。在14周的时间里，将通过普通X光和6周和12周的CT扫描每两周监测融合的进展。尸检后，将对切除的脊柱进行CT扫描和组织学分析，以确定融合的质量。将对系列X光进行分析，以寻找下沉、螺丝钉回退、植入物移位和融合程度的证据。数据将在不同的治疗组和不同的时间点进行比较，以评估差异。

 DESCRIPTION (provided by applicant): ReVivo Medical, LLC has developed the next generation of spinal fusion implants to help surgeons and hospitals achieve the goals of the Affordable Care Act. ReVivo's spinal implants are the first to leverage the basic science of bone formation to reduce time to fusion, while also diminishing complication rates, decreasing operating room time, and lowering overall cost. ReVivo Medical's solution to improving spine fusion is a suite of continuously load-sharing elastically deformable spinal implants. By design, the stiffness of ReVivo's implants allows for micro-deformation under physiologic loading. This promotes continuous load-sharing which we expect will lead to more rapid bony fusion. The objective of this Phase I proposal is to demonstrate the efficacy of our elastically deformable, continuously load-sharing spinal implants to promote a faster and higher quality spinal fusion relative to existing plates. In the proposed Phase I work, we will establish that continuous load-sharing through controlled micro-motion will improve the rate and quality of interbody fusion in vivo. In a clinically relevant in vivo large animal model, we will correlate implant design to the clinically relevant metrics of subsidence, screw backout, and rate and quality of fusion. We hypothesize that an elastically deformable, continuously load-sharing implant will reduce subsidence, reduce screw backout, and enhance the rate and quality of bony fusion relative to existing static and dynamic plates. We will perform an anterior cervical discectomy and fusion on 18 goats with animals grouped to receive either anterior (a) static plates, (b) dynamic plates, or (c) ReVivo Medical's elastically deformable plates. Over a 14 week period, the progression of fusion will be monitored biweekly by plain x-rays and by CT scans at 6 and 12 weeks. Post mortem, excised spines will be CT scanned and analyzed histologically to determine quality of fusion. Serial x-rays will be analyzed for evidence of subsidence, screw backout, implant migration, and extent of fusion. Data will be compared across treatment groups and across time points to assess differences.