Prospective First in Human Clinical Investigation to Evaluate the Safety of the Fracture Monitor T1 in Patients with Femur Fractures Treated with a Locking Compression Plate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Incidence of ADEs
研究概览
简要总结
Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients' smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care.
The primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability.
All adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device.
All patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months.
The results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 or older
- •Closed growth plates at time of injury
- •Femoral fracture requiring osteosynthesis and treated with one of the following plates:
- •DePuy Synthes LCP® 4.5/5, Broad
- •DePuy Synthes LCP® 4.5/5, Broad Curved
- •DePuy Synthes LCP® Condylar Plate 4.5/5.0
- •DePuy Synthes VA-LCP® Condylar Plate 4.5/5.0
- •DePuy Synthes LCP® Distal Femur
- •DePuy Synthes LCP® Proximal Femoral Plate 4.5/5.0
- •DePuy Synthes LCP® Proximal Femur Hook Plate
- •41medical AG, Biphasic Plate DF
- •ASA score 1-3
- •Full weight-bearing capacity prior to the injury
- •The patient is foreseen to be capable of postoperative weight bearing of at least 15 kg
- •Willingness to undergo an additional surgery to remove the Fracture Monitor T1 if its removal is not done together with the fixation plate within two years according to standard of care
- •Ability to provide written informed consent
- •Preoperative
排除标准
- •Concomitant fractures in the contralateral leg
- •Electromagnetic hypersensitivity
- •Implanted electromagnetic bone stimulators
- •Pregnancy (determined by pregnancy test)
- •Known history of substance abuse (eg, recreational drugs and alcohol) that would preclude reliable assessments
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present clinical investigation
- •Intraoperative exclusion criteria:
- •Use of compression lag screw across fracture fragment
- •Compression osteosynthesis
- •Precontouring of implant at the area of the attachment of Fracture Monitor T1
- •Double-plating technique
- •Soft-tissue coverage > 6 cm above the data logger
- •Concurrent use of intramedullary nail
- •Patients foreseen to require magnetic resonance imaging scanning at any part of the body or shockwave therapy at the proximity of the Fracture Monitor T1
- •Fracture Monitor T1 not functional according to the instruction for use (IFU, section 24, A) and no functional replacement implant available
结局指标
主要结局
Incidence of ADEs
时间窗: 6 months postsurgery
To evaluate the safety, (ie the incidence of adverse device effects (ADEs), of the investigational device Fracture Monitor T1 in femoral fracture patients)
次要结局
- Clinical performance: Relationship - implant load/weight bearing(6 months)
- Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST)(6 months)
- Other safety parameters: DD(6 months)
- Other safety parameters: AEs(6 months)
- Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT)(6 months)
- Clinical performance: Relationship - implant load/Patient reported outcomes(6 months)
- Clinical performance: Curve drop(6 months)
- Clinical performance: Relationship - implant load/bone healing(6 months)
- Clinical performance: Difference curve drop/soc x-ray(6 months)
- Technical performance in a clinical setup(6 months)