The X-VISUAL (X-ray Visualized Indicator for Screw-strain Under Applied Load)
X-VISUAL(施加负载下螺钉应变的 X 射线可视化指示器)
基本信息
- 批准号:10822470
- 负责人:
- 金额:$ 30万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-25 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAnatomyBody WeightBone callusCadaverCannulationsCaringClinicalCollaborationsCommunicationComputer ModelsDay SurgeryDevice or Instrument DevelopmentDevicesExcisionFailureFatigueFeedbackFemurFinite Element AnalysisFractureFracture FixationGeometryGrowthHealth care facilityHip FracturesHip region structureHospital MortalityHumanImageImage AnalysisImplantIndustryInterobserver VariabilityIntertrochanteric FracturesInterventionIntramedullary NailingLeadLegal patentLengthLife ExpectancyLocationMeasurementMeasuresMechanicsMedical Device DesignsMethodologyMethodsModelingMorbidity - disease rateMorphologyMotionNail plateOperative Surgical ProceduresOpticsOrthopedic SurgeryOrthopedicsOsteoporosisOutcomePathologyPatient ReadmissionPatientsPelvisPeriodicityPhasePhysiciansPositioning AttributePostoperative PeriodProceduresPublic HealthQuality of lifeRadiology SpecialtyRecording of previous eventsResearchResearch Project GrantsRiskRoentgen RaysSalesSecond Look SurgerySheepSlideSmall Business Innovation Research GrantSpecimenSurveysSystemTechniquesTestingTimeTractionTrochantersVisualWeightWeight-Bearing stateWorkX ray visualizationX-Ray Medical Imagingarmbiomechanical testbonebone fracture repairbone healingclinical predictorsclinical translationclinically relevantcomorbiditycostdesignfracture riskhealinghuman old age (65+)human tissueimaging modalityimprovedindividual patientindividualized medicineinnovationmanufacturemechanical devicemortalitynoveloperationpatient mobilitypatient populationphysical therapistpreventprototyperadiological imagingresponsesample fixationsensorsimulationstandard of caretime use
项目摘要
ABSTRACT
We are developing and sensor, the X-VISUAL (X-ray Visualized Indicator for Screw bending Under Applied
Load), to track fracture healing in canulated screws used to treat hip fractures. Hip fractures are a major public
health concern with high in-hospital mortality rate. Approximately 330,000 hip fixation procedures are
performed annually in the US. The average hip fixation hardware failure rate is around 5%, but increases to
over 20% in patients with comorbidities such as osteoporosis, unstable fractures and poor initial fracture
reduction. When healing is delayed, the screw, other hardware, and bone can fatigue and fail, requiring costly
revision surgery with significant risk of morbidity and mortality for these frail patients. For example, the 1-year
all-cause mortality rate for patients readmitted within 30 days of surgery is 56%, compared to 19% for those
not readmitted. Screws only bend and cutout when they are loaded, and this risk disappears as a fracture
callus heals and carries the load. Thus, measuring screw bending under standing load is an ideal way to
assess fracture healing and risk failure. This improves communications with the patient and care team,
enabling normally healing patients and physical therapists to feel more comfortable with activity, while
detecting and avoiding pathologies for slowly healing patients. Innovatively, the X-VISUAL is the first sensor
that can detect screw bending (and associated load on the screw), a measurement that is hard to perform in
other ways because of the confined geometry. The patent protected device is designed to load into a screw
after guidewire removal, and is read using plain radiography which is ubiquitously available in healthcare
facilities but is usually insensitive to mechanical strain and usually detects pathologies when they have
progressed so far that non-surgical interventions often don’t work. Using previous designs we demonstrated
proof of concept for measuring screw bending with X-rays in Sawbones specimens, FEA models, cadaveric
specimens, and tracked healing in a sheep. However, the old designs were cumbersome to insert and read,
thus this Phase I proposal designs an elegant addon with a gain mechanism and readout on indicator along
the pin. We will develop and test the design in FEA computational models, sawbones, and cadaveric
specimens. The clinical, industry, and academic partners assembled for this work have a strong history of
collaboration in orthopaedic device development and testing. They bring together expertise in measurement
systems, mechanical testing, medical device design and orthopaedic surgery. The research is relevant to
public health because, it provides a non-invasive means of assessing biomechanical reduction and postop
fracture healing to avoid costly and risky revisions.
摘要
我们正在开发和传感器,X-VISUAL(X射线可视化指示器,用于螺钉弯曲下的应用
载荷),以跟踪用于治疗髋部骨折的空心螺钉中的骨折愈合。髋部骨折是一个主要的公众
住院死亡率高健康问题。大约有330,000例髋关节固定手术
每年在美国举行。平均髋关节固定硬件故障率约为5%,但增加到
超过20%的合并症患者,如骨质疏松症、不稳定性骨折和初始骨折不良
还原当愈合延迟时,螺钉、其他硬件和骨可能疲劳和失效,需要昂贵的治疗。
翻修手术对这些虚弱的患者具有显著的发病率和死亡率风险。例如,1年
在手术后30天内再次入院的患者的全因死亡率为56%,而在手术后30天内再次入院的患者的全因死亡率为19%。
没有再入院。螺钉仅在加载时发生弯曲和切断,这种风险会随着断裂而消失
愈伤组织愈合并承载负荷。因此,在固定载荷下测量螺钉弯曲是一种理想的方法,
评估骨折愈合和失败风险。这改善了与患者和护理团队的沟通,
使正常愈合的患者和物理治疗师在活动时感到更舒适,
检测和避免缓慢愈合患者的病理。创新性地,X-VISUAL是第一个传感器
可以检测螺钉弯曲(以及螺钉上的相关载荷),这是一种难以在
其他方式,因为受限的几何形状。受专利保护的装置被设计成装载到螺钉中
取出导丝后,使用在医疗保健中普遍可用的平片X线摄影读取
设备,但通常对机械应变不敏感,并且通常在它们具有
进展到非手术干预往往不起作用。使用以前的设计,我们证明了
在人工骨样本、FEA模型、尸体中使用X射线测量螺钉弯曲的概念验证
标本,并跟踪愈合的羊。然而,旧的设计很难插入和阅读,
因此,这个第一阶段的建议设计了一个优雅的附加装置,带有增益机制和沿着的指示器读数
别针。我们将在FEA计算模型、人工骨和尸体中开发和测试设计
标本为这项工作聚集的临床,工业和学术合作伙伴具有强大的历史,
在骨科器械开发和测试方面的合作。他们汇集了测量方面的专业知识
系统、机械测试、医疗器械设计和骨科手术。这项研究与以下方面有关:
因为它提供了一种评估生物力学复位和术后的非侵入性方法,
骨折愈合,以避免昂贵和危险的修订。
项目成果
期刊论文数量(0)
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John David DesJardins其他文献
John David DesJardins的其他文献
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{{ truncateString('John David DesJardins', 18)}}的其他基金
X-ray Visualized Interbody Spacer Indicating Biomechanical Load (X-VISIBL) Fusion Device
X 射线可视化椎间垫片指示生物力学负荷 (X-VISIBL) 融合装置
- 批准号:
10157213 - 财政年份:2021
- 资助金额:
$ 30万 - 项目类别:
Undergraduate Education and Device Innovation through Clinical and Translational
通过临床和转化的本科教育和设备创新
- 批准号:
8661486 - 财政年份:2014
- 资助金额:
$ 30万 - 项目类别:
Undergraduate Education and Device Innovation through Clinical and Translational
通过临床和转化的本科教育和设备创新
- 批准号:
8847711 - 财政年份:2014
- 资助金额:
$ 30万 - 项目类别:
Undergraduate Education and Device Innovation through Clinical and Translational
通过临床和转化的本科教育和设备创新
- 批准号:
9272391 - 财政年份:2014
- 资助金额:
$ 30万 - 项目类别:
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