Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
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
- Changes in Parameters derived from the AO Fracture Monitor during bone healing
研究概览
简要总结
20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 6 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval.
详细描述
Maturation of fracture callus leads to unloading of the fracture fixation hardware due to an increased load-share of the repair tissue. A novel data logger device (AO Fracture Monitor) continuously measures the decline in fixation hardware deflection under physiological loading as indirect indicator for the healing progress. Parameters obtained from the data logger device carry potential to significantly improve the assessment of fracture healing in the future. Meaningful interpretation of measurements requires a set of clinical reference data.
20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 4 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval. Data is collected from the AO Fracture Monitor at follow-up visits of the patient by wireless data transfer. Together with additional variables such as treatment details, fracture healing and pain reported by the patient, the collected data is used to build up a database. Data from the AO Fracture Monitor will be correlated with patient data to investigate the relevance and reliability of the data derived from the AO Fracture Monitor.
In this phase, the study does not imply changes on the operational treatment, nor does it allow for therapeutic consequences based on the derived data.
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 Femoral or tibial fracture (AO 41-43)
- •External fracture fixation with AO large external fixator
- •Capable of at least partial weight-bearing
- •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 Focused Registry according to the Registry Plan (RP)
- •Signed and dated Ethics Committee (EC) approved written informed consent
排除标准
- •Preoperative exclusion criteria:
- •External fixation as temporary stabilization
- •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 nursing mother
- •Emergency patient
- •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
Changes in Parameters derived from the AO Fracture Monitor during bone healing
时间窗: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
AO Fracture Monitor: * Mean deformation amplitude per 6 hours * Mean deformation rate * Number of load-cycles * Histogram of patient activity (load intensity distribution)
次要结局
- Repeated reference deformation at a load of 20 / 30 kg(Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery))
- Change in weight-bearing during bone healing(Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery))
- Treatment information(Discharge)
- Development of the radiological healing assessment: RUST system(Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery))
- Change in Pain during bone healing(Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery))
- Patient information(Up to 4 weeks before surgery)