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Femoral FractureNCT05410587

Fracture Monitor - Femur

A study testing Fracture Monitor (implantable device class III) in people with Femoral Fracture, run by AO Innovation Translation Center at 4 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Femoral Fracture
What is being tested?
Fracture Monitor (implantable device class III)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
4 sitesGermany
Study dates
3 Oct 2023to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 33Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Viola Grünenfelder contact

+41 79 696 33 97

viola.gruenenfelder@aofoundation.org

Aleksandra Vidakovic contact

aleksandra.vidakovic@aofoundation.org

Germany4 sites, 4 recruiting

  • Universitätsklinikum des Saarlandes

    Homburg

    Tim Pohlemann

    Recruiting

  • Universitätsklinikum Münster

    Münster

    Michael Raschke

    Recruiting

  • Berufsgenossenschaftliche Unfallklinik Tübingen

    Tübingen

    Benedikt Braun

    Recruiting

  • Universitätsklinikum Ulm

    Ulm

    Konrad Schütze

    Recruiting

Other trials in Germany

About this study

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

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.

Read more

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.

Being tested
Fracture Monitor (implantable device class III)
Keywords
Fracture fixation, internal, Femur, Fracture healing
Medical subject headings
Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05410587
Study groupRoleWhat they receive
Fracture Monitor T1 (implantable device class III)OtherNot described
Receives: Device: Fracture Monitor (implantable device class III)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months postsurgery

Secondary outcomes (22)

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

    Relationship between relative implant load and bone healing status

    Measured: 6 months

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

    Relationship between relative implant load and prescribed weight bearing

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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)

    Measured: 6 months

  6. Clinical performance: Curve drop

    Analyses of the loading curve drop based on:

    -Time to curve drop

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. Other safety parameters: AEs

    • Incidence of adverse events (AEs)

    Measured: 6 months

  9. Other safety parameters: DD

    • Incidence of device deficiencies within 6 months

    Measured: 6 months

  10. Technical performance in a clinical setup

    • Average minimum sensor strain per loading event

    Measured: 6 months

  11. Technical performance in a clinical setup

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

    Measured: 6 months

  12. Technical performance in a clinical setup

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

    Measured: 6 months

  13. Technical performance in a clinical setup

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

    Measured: 6 months

  14. Technical performance in a clinical setup

    • Data down and upload frequency

    Measured: 6 months

  15. Technical performance in a clinical setup

    • Number of Bluetooth adverts

    Measured: 6 months

  16. Technical performance in a clinical setup

    • Bluetooth signal strength (dBm)

    Measured: 6 months

  17. Technical performance in a clinical setup

    • Bluetooth connection time (s)

    Measured: 6 months

  18. Technical performance in a clinical setup

    • Battery voltage after each month

    Measured: 6 months

  19. Technical performance in a clinical setup

    • Power consumption (device lifetime)

    Measured: 6 months

  20. Technical performance in a clinical setup

    • Internal device temperature

    Measured: 6 months

  21. Technical performance in a clinical setup

    • Initialization and daily system test results

    Measured: 6 months

  22. Technical performance in a clinical setup

    • Internal clock accuracy

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start3 Oct 2023
  3. Primary completionOct 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter prospective interventional clinical investigation
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410587
Sponsor's protocol ID
FM_AO_001
Status last verified
Jan 2025
First submitted
28 Apr 2022
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Braun BJ, Raschke MJ, Schutze K, Pohlemann T, Joeris A, Ernst M. 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: a study protocol. BMJ Open. 2025 Jul 30;15(7):e102749. doi: 10.1136/bmjopen-2025-102749.

    PubMed 40744509

Questions about this trial

What is this clinical trial studying?

A study testing Fracture Monitor (implantable device class III) in people with Femoral Fracture, run by AO Innovation Translation Center at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Viola Grünenfelder (+41 79 696 33 97, viola.gruenenfelder@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ADEs (time frame: 6 months postsurgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05410587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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