RecruitingNAINTERVENTIONAL

Fracture Monitor - Femur

This study aims to evaluate a new implantable device called the Fracture Monitor T1 for patients who have broken their thigh bone (femur) and are having it fixed with a special plate. The monitor, attached during surgery, collects information about the bone's healing process. This data is sent wirelessly to a phone app and then securely to a cloud server. The main goal is to check the device's safety and how well it works. While you won't see the data during your recovery, it helps doctors understand how such devices could assist in future patient care. Everyone in the study receives the standard care for their fracture.

At a glance

Status

Recruiting

Phase

Sponsor

AO Innovation Translation Center

Enrolment target

Start

03 Oct 2023

Estimated completion

01 Jul 2026

Femoral Fracture

What is this study about?

Imagine you've broken your thigh bone, or 'femur'. This study is looking at a new small device, called the Fracture Monitor T1, designed to help understand how this type of broken bone heals. It's not about changing how your bone is fixed today; you'll get the standard treatment for your fracture, just like any other patient. This study is simply adding a small, special monitor designed to sit next to the metal plate used to fix your bone.

This tiny monitor collects information about your healing bone. This data is then sent through a smartphone app (either on your own phone or a provided one) to a secure online server. Don't worry, you won't be able to see this information on your phone app, and neither will your doctor, during your recovery. This is important because the study wants to make sure that decisions about your treatment are based solely on standard medical practice, not on the data from this new device.

The main purpose of this study is to see if the Fracture Monitor T1 is safe and how well it works. By gathering this information, researchers hope to learn if such a device could help doctors detect problems earlier or understand bone healing better in the future, ultimately improving care for people with similar fractures.

Key takeaways

This study is for people with a broken thigh bone (femur) being fixed with a plate.
A small monitor will be implanted during surgery to collect information on bone healing.
The main aim is to check the device's safety and how well it performs.
You won't see the data during your healing, and it won't change your usual medical care.
Your progress will be followed for at least 6 months.
Your participation helps to improve future patient care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a broken thigh bone that requires surgery using a specific type of metal plate. You should have been able to put your full weight on your leg before your injury and be expected to be able to put at least 15 kg of weight on it after surgery.

There are also some reasons why you might not be able to join. For example, if you have other fractures in your healthy leg, are pregnant, or have certain types of medical implants that interact with electronic devices. Also, if you've recently been in another medical study or have conditions like electromagnetic sensitivity, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a broken thigh bone that needs surgery with a plate?
Were you able to walk without major issues before your injury?
Are you able and willing to attend follow-up appointments?
Are you comfortable with the possibility of a second minor surgery to remove the device if it's not taken out with your plate?

Answer every question to see your result.

What does participation involve?

If you join this study, after your thigh bone surgery, the Fracture Monitor T1 will be attached to the plate fixing your bone. Before you leave the hospital, the device will be connected to a smartphone app, and you'll either use your own smartphone or one provided. The device will continuously collect data, which will automatically be sent to a secure online server via your phone's Bluetooth. You won't see this data on your phone, and it won't affect your treatment decisions.

Your doctors will follow up on your progress for at least 6 months after surgery, just as they normally would. If the monitor isn't removed within these 6 months, an additional safety check will happen when it is eventually taken out. This study doesn't involve any extra visits beyond your usual recovery appointments for your broken leg.

Potential risks and benefits

The main benefit of taking part is contributing to medical knowledge that could help future patients. This device is designed to collect information and does not directly treat your fracture, so there are no direct medical benefits to you. Potential risks include those associated with any implantable device, such as discomfort or a slight risk of infection, though these are rare. If the device needs to be removed after 6 months and it's not taken out with your existing plate, you might need an additional minor surgery. Remember, you can withdraw from the study at any time without it affecting your medical care.

Locations (4)

Universitätsklinikum des Saarlandes
Verified postcode
Homburg, Germany· Recruiting
Universitätsklinikum Münster
Verified postcode
Münster, Germany· Recruiting
Berufsgenossenschaftliche Unfallklinik Tübingen
Verified postcode
Tübingen, Germany· Recruiting
Universitätsklinikum Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is a 'femoral fracture'?

A femoral fracture is simply a break in your thigh bone, which is called the femur.

Will this device change how my bone heals?

No, this device is for gathering information only. You will receive the standard medical care for your broken bone, and the device will not influence your treatment.

Will I see the data from the monitor?

No, during your recovery, you and your doctors will not be able to see the data collected by the device. It's for research purposes only at this stage.

Is the device safe?

The main goal of this study is to collect information on the safety of the device and how well it works. All potential risks will be carefully monitored.

Do I have to keep the smartphone?

If you don't use your own smartphone, one will be provided, and that's how the device's data will be securely sent to the research team.

How to find out more

Viola Grünenfelder

viola.gruenenfelder@aofoundation.org +41 79 696 33 97 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.