Femoral Fracture
Conditions
Keywords
Fracture fixation, internal, Femur, Fracture healing
Brief summary
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.
Interventions
DEVICEFracture Monitor (implantable device class III)
Femoral fracture fixation (bridge plating aiming at secondary bone healing) using a locking plate with an attached investigational Fracture Monitor T1.
Sponsors
AO Innovation Translation Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter prospective interventional clinical investigation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ADEs | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance: Relationship - implant load/weight bearing | 6 months | Relationship between relative implant load and prescribed weight bearing |
| Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT) | 6 months | Relationship between relative implant load and Function Index for Trauma (FIX-IT) score FIX-IT: max 12 points - 0 worse/12 best |
| Clinical performance: Relationship - implant load/Patient reported outcomes | 6 months | 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. |
| Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST) | 6 months | 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) |
| Clinical performance: Relationship - implant load/bone healing | 6 months | Relationship between relative implant load and bone healing status |
| Clinical performance: Difference curve drop/soc x-ray | 6 months | 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 |
| Other safety parameters: AEs | 6 months | \- Incidence of adverse events (AEs) |
| Other safety parameters: DD | 6 months | \- Incidence of device deficiencies within 6 months |
| Technical performance in a clinical setup | 6 months | • Average minimum sensor strain per loading event |
| Clinical performance: Curve drop | 6 months | Analyses of the loading curve drop based on: -Time to curve drop |
Countries
Germany
Contacts
Primary ContactViola Grünenfelder
Backup ContactAleksandra Vidakovic
Outcome results
None listed