A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Loading patterns
研究概览
简要总结
In this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.
详细描述
Ten patients treated with a large external fixator after tibial fracture will be enrolled for this prospective case series.
Patients will be equipped with the AO Fracture Monitor (a data logger device) attached post-operatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to normal weight bearing for up to 12 months by means of a strain gauge. The strain signal is processed on-board and several parameters related to the loading characteristics of the fracture are stored.
Simultaneously, patients will be equipped with a fully integrated sensor insole (OpenGo Insole, Moticon GmbH, München). This product offers long-term weight bearing data (recording and storage) and allows non-invasive documentation of real life loading in patients without affecting the daily life activity of the patient. Recording of weight-bearing data will be obtained for a maximum of 4 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Diagnosis of tibial fracture (AO 41-43)
- •External fracture fixation with large external fixator
- •Capable of at least partial weight-bearing
- •Bone segment transport (if applicable) must be completed
- •Informed consent obtained, i.e.:
- •Ability to understand the content of the patient information/ Informed Consent Form (ICF)
- •Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- •Signed and dated Ethics Committee (EC)
排除标准
- •External fixation as temporary stabilization
- •Bone fragment compression
- •Joint-bridging external fixation
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the study period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Loading patterns
时间窗: Up to 4 months
Average peak force per step
次要结局
- Activity(Up to 4 months)
- Healing(Up to 4 months)
- Pain level(Up to 4 months)