Fracture Monitor - Femur

AO Innovation Translation Center37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Universitätsklinikum des Saarlandes

Homburg, Germany

RECRUITING

Universitätsklinikum Münster

Münster, Germany

RECRUITING

Berufsgenossenschaftliche Unfallklinik Tübingen

Tübingen, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, Germany

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 6 months postsurgery

Secondary Outcomes

Clinical performance: Relationship - implant load/bone healing

Relationship between relative implant load and bone healing status

Time frame: 6 months

Clinical performance: Relationship - implant load/weight bearing

Relationship between relative implant load and prescribed weight bearing

Time frame: 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

Time frame: 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.

Time frame: 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)

Time frame: 6 months

Clinical performance: Curve drop

Analyses of the loading curve drop based on: -Time to curve drop

Time frame: 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

Time frame: 6 months

Other safety parameters: AEs

\- Incidence of adverse events (AEs)

Time frame: 6 months

Other safety parameters: DD

\- Incidence of device deficiencies within 6 months

Time frame: 6 months