Fracture Monitor - Femur

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Femoral Fracture

Intervention / Treatment
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* Device: Fracture Monitor (implantable device class III)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 exclusion Criteria: Concomitant fractures in the contralateral leg Electromagnetic hypersensitivity Implanted electromagnetic bone stimulators Pregnancy (determined by pregnancy test) Prisoner 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter prospective interventional clinical investigation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fracture Monitor T1 (implantable device class III)<br> | Device: Fracture Monitor (implantable device class III)<br>* Femoral fracture fixation (bridge plating aiming at secondary bone healing) using a locking plate with an attached investigational Fracture Monitor T1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ADEs | To evaluate the safety, (ie the incidence of adverse device effects (ADEs), of the investigational device Fracture Monitor T1 in femoral fracture patients) | 6 months postsurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance: Relationship - implant load/bone healing | Relationship between relative implant load and bone healing status | 6 months | 
| Clinical performance: Relationship - implant load/weight bearing | Relationship between relative implant load and prescribed weight bearing | 6 months | 
| Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT) | Relationship between relative implant load and Function Index for Trauma (FIX-IT) score FIX-IT: max 12 points - 0 worse/12 best | 6 months | 
| Clinical performance: Relationship - implant load/Patient reported outcomes | Relationship between relative implant load and Patient reported outcomes: pain, EuroQol 5- dimension (EQ-5D) EQ-5D health states can be summarised using a 5-digit code or represented by a single summary number (index value) which reflects how good or bad a health state is according to the preferences of the general population of a country/region. | 6 months | 
| Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST) | Relationship between relative implant load and mRUST score. mRUST: The mRUST score ranges from 4-16 as the four cortices assessed in two orthogonal planes have a score range from 1 to 4 (1: absent callus - 4 callus remodeled) | 6 months | 
| Clinical performance: Curve drop | Analyses of the loading curve drop based on: -Time to curve drop | 6 months | 
| Clinical performance: Difference curve drop/soc x-ray | Analyses of the loading curve drop based on: Difference in the timing between drop in the loading curve (50%) and standard-of-care x-ray | 6 months | 
| Other safety parameters: AEs | - Incidence of adverse events (AEs) | 6 months | 
| Other safety parameters: DD | - Incidence of device deficiencies within 6 months | 6 months | 
| Technical performance in a clinical setup | • Average minimum sensor strain per loading event | 6 months | 
| Technical performance in a clinical setup | • Daily active time of implant (patient activity triggers recording of implant) | 6 months | 
| Technical performance in a clinical setup | • Number of daily activations (implant switches from idle to recording) | 6 months | 
| Technical performance in a clinical setup | • User calibration range (patient-specific calibration on stiffness of fixation construct) | 6 months | 
| Technical performance in a clinical setup | • Data down and upload frequency | 6 months | 
| Technical performance in a clinical setup | • Number of Bluetooth adverts | 6 months | 
| Technical performance in a clinical setup | • Bluetooth signal strength (dBm) | 6 months | 
| Technical performance in a clinical setup | • Bluetooth connection time (s) | 6 months | 
| Technical performance in a clinical setup | • Battery voltage after each month | 6 months | 
| Technical performance in a clinical setup | • Power consumption (device lifetime) | 6 months | 
| Technical performance in a clinical setup | • Internal device temperature | 6 months | 
| Technical performance in a clinical setup | • Initialization and daily system test results | 6 months | 
| Technical performance in a clinical setup | • Internal clock accuracy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture fixation, internal, Femur, Fracture healing