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临床试验/NCT02534259
NCT02534259已完成不适用

Mobile Monitoring of Fracture Healing

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
Forces measured in the external fixator during ambulation during clinical visits

研究概览

简要总结

The objective of this study is to develop methods for using forces measured on circular external fixators to predict the state of individual patient's healing of severe tibial fractures and defects.

详细描述

Patients receiving external fixators for tibial fractures and defects will be recruited. Normal struts on the device will be substituted with similar but instrumented struts which enable force measurement. During clinical visits, forces in the fixator, plus foot forces, will be measured during ambulation. Changes in force measurements across treatment and bone healing will be analyzed.

Severe fractures in the lower limb are associated with high energy trauma in both civilian and military patients,and are sometimes treated with external fixation devices to stabilize the bone until healing has occurred. The devices are kept on the patient for up to a year or more at significant cost, intrusiveness, and risk of infection. The clinician must decide when to remove the device such that adequate healing has occurred and the bone will not re-fracture, but healing rates are variable and x-rays can be misleading. The clinician must also identify when a patient is starting to progress poorly and an early revision surgery is needed to prevent further complications.

The investigators' goal is to develop novel approaches for instrumenting and collecting mechanical data from orthopaedic braces and devices, and identifying new methodologies for interpreting this large volume of functional data for optimizing personalized treatment. The present study is focused on external fixators. Strain gauges will be adhered to the fixators so that fixator forces can be measured during clinical visits. In this pilot study the investigators will develop methods to predict healing based on these measured forces.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 80 years of age
  • Patients scheduled to undergo or currently undergoing treatment at Hershey Medical Center for tibia fracture and/or defect using a circular external fixator including Ilizarov and Taylor Spatial Frame types.
  • Ability to perform study procedures including ambulation (with assistance device if needed)

排除标准

  • External fixator design that cannot be suitably instrumented for force measurements due to space constraints or other issues
  • Axially stable fracture
  • Inability to understand English
  • Inability to provide informed consent
  • Difficulty maintaining follow-up

结局指标

主要结局

Forces measured in the external fixator during ambulation during clinical visits

时间窗: Approximately 5 times across treatment, with treatment lasting months to a year or more

次要结局

  • Forces measured in instrumented insoles during ambulation during clinical visits(Approximately 5 times across treatment, with treatment lasting months to a year or more)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory S. Lewis

Assistant Professor

Milton S. Hershey Medical Center

研究点 (1)

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