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Fracture Monitor - Femur

Primary Purpose

Femoral Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fracture Monitor (implantable device class III)
Sponsored by
AO Innovation Translation Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fracture focused on measuring Fracture fixation, internal, Femur, Fracture healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Münster
  • Berufsgenossenschaftliche Unfallklinik Tübingen
  • Universitätsklinikum Ulm

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fracture Monitor T1 (implantable device class III)

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Clinical performance: Relationship - implant load/bone healing
Relationship between relative implant load and bone healing status
Clinical performance: Relationship - implant load/weight bearing
Relationship between relative implant load and prescribed weight bearing
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
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.
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)
Clinical performance: Curve drop
Analyses of the loading curve drop based on: -Time to curve drop
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
Other safety parameters: AEs
- Incidence of adverse events (AEs)
Other safety parameters: DD
- Incidence of device deficiencies within 6 months
Technical performance in a clinical setup
• Average minimum sensor strain per loading event
Technical performance in a clinical setup
• Daily active time of implant (patient activity triggers recording of implant)
Technical performance in a clinical setup
• Number of daily activations (implant switches from idle to recording)
Technical performance in a clinical setup
• User calibration range (patient-specific calibration on stiffness of fixation construct)
Technical performance in a clinical setup
• Data down and upload frequency
Technical performance in a clinical setup
• Number of Bluetooth adverts
Technical performance in a clinical setup
• Bluetooth signal strength (dBm)
Technical performance in a clinical setup
• Bluetooth connection time (s)
Technical performance in a clinical setup
• Battery voltage after each month
Technical performance in a clinical setup
• Power consumption (device lifetime)
Technical performance in a clinical setup
• Internal device temperature
Technical performance in a clinical setup
• Initialization and daily system test results
Technical performance in a clinical setup
• Internal clock accuracy

Full Information

First Posted
April 28, 2022
Last Updated
January 30, 2023
Sponsor
AO Innovation Translation Center
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1. Study Identification

Unique Protocol Identification Number
NCT05410587
Brief Title
Fracture Monitor - Femur
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Innovation Translation Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fracture
Keywords
Fracture fixation, internal, Femur, Fracture healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter prospective interventional clinical investigation
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fracture Monitor T1 (implantable device class III)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Fracture Monitor (implantable device class III)
Intervention Description
Femoral fracture fixation (bridge plating aiming at secondary bone healing) using a locking plate with an attached investigational Fracture Monitor T1.
Primary Outcome Measure Information:
Title
Incidence of ADEs
Description
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 Outcome Measure Information:
Title
Clinical performance: Relationship - implant load/bone healing
Description
Relationship between relative implant load and bone healing status
Time Frame
6 months
Title
Clinical performance: Relationship - implant load/weight bearing
Description
Relationship between relative implant load and prescribed weight bearing
Time Frame
6 months
Title
Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT)
Description
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
Title
Clinical performance: Relationship - implant load/Patient reported outcomes
Description
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
Title
Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST)
Description
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
Title
Clinical performance: Curve drop
Description
Analyses of the loading curve drop based on: -Time to curve drop
Time Frame
6 months
Title
Clinical performance: Difference curve drop/soc x-ray
Description
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
Title
Other safety parameters: AEs
Description
- Incidence of adverse events (AEs)
Time Frame
6 months
Title
Other safety parameters: DD
Description
- Incidence of device deficiencies within 6 months
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Average minimum sensor strain per loading event
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Daily active time of implant (patient activity triggers recording of implant)
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Number of daily activations (implant switches from idle to recording)
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• User calibration range (patient-specific calibration on stiffness of fixation construct)
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Data down and upload frequency
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Number of Bluetooth adverts
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Bluetooth signal strength (dBm)
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Bluetooth connection time (s)
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Battery voltage after each month
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Power consumption (device lifetime)
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Internal device temperature
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Initialization and daily system test results
Time Frame
6 months
Title
Technical performance in a clinical setup
Description
• Internal clock accuracy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viola Grüenfelder
Phone
+41 79 696 33 97
Email
viola.gruenfelder@aofoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Vidakovic
Email
aleksandra.vidakovic@aofoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedikt Braun
Organizational Affiliation
University Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Pohlemann
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Raschke
Facility Name
Berufsgenossenschaftliche Unfallklinik Tübingen
City
Tübingen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedikt Braun
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Schütze

12. IPD Sharing Statement

Plan to Share IPD
No

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Fracture Monitor - Femur

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