Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05410587

Fracture Monitor - Femur

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Femoral Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum des Saarlandes, Homburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fracture Monitor (implantable device class III)

Device

Femoral fracture fixation (bridge plating aiming at secondary bone healing) using a locking plate with an attached investigational Fracture Monitor T1.

Primary outcomes

  1. Incidence of ADEs

    Time frame: 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 outcomes

  1. Clinical performance: Relationship - implant load/bone healing

    Time frame: 6 months

    Relationship between relative implant load and bone healing status

  2. Clinical performance: Relationship - implant load/weight bearing

    Time frame: 6 months

    Relationship between relative implant load and prescribed weight bearing

  3. Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT)

    Time frame: 6 months

    Relationship between relative implant load and Function Index for Trauma (FIX-IT) score FIX-IT: max 12 points - 0 worse/12 best

  4. Clinical performance: Relationship - implant load/Patient reported outcomes

    Time frame: 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.

  5. Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST)

    Time frame: 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)

  6. Clinical performance: Curve drop

    Time frame: 6 months

    Analyses of the loading curve drop based on:

    -Time to curve drop

  7. Clinical performance: Difference curve drop/soc x-ray

    Time frame: 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

  8. Other safety parameters: AEs

    Time frame: 6 months

    • Incidence of adverse events (AEs)

  9. Other safety parameters: DD

    Time frame: 6 months

    • Incidence of device deficiencies within 6 months

  10. Technical performance in a clinical setup

    Time frame: 6 months

    • Average minimum sensor strain per loading event

  11. Technical performance in a clinical setup

    Time frame: 6 months

    • Daily active time of implant (patient activity triggers recording of implant)

  12. Technical performance in a clinical setup

    Time frame: 6 months

    • Number of daily activations (implant switches from idle to recording)

  13. Technical performance in a clinical setup

    Time frame: 6 months

    • User calibration range (patient-specific calibration on stiffness of fixation construct)

  14. Technical performance in a clinical setup

    Time frame: 6 months

    • Data down and upload frequency

  15. Technical performance in a clinical setup

    Time frame: 6 months

    • Number of Bluetooth adverts

  16. Technical performance in a clinical setup

    Time frame: 6 months

    • Bluetooth signal strength (dBm)

  17. Technical performance in a clinical setup

    Time frame: 6 months

    • Bluetooth connection time (s)

  18. Technical performance in a clinical setup

    Time frame: 6 months

    • Battery voltage after each month

  19. Technical performance in a clinical setup

    Time frame: 6 months

    • Power consumption (device lifetime)

  20. Technical performance in a clinical setup

    Time frame: 6 months

    • Internal device temperature

  21. Technical performance in a clinical setup

    Time frame: 6 months

    • Initialization and daily system test results

  22. Technical performance in a clinical setup

    Time frame: 6 months

    • Internal clock accuracy

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandra Vidakovic

CONTACT

[email protected]

Viola Grünenfelder

CONTACT

[email protected]

+41 79 696 33 97

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2022
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.