RecruitingOBSERVATIONAL

An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Doctors are setting up a worldwide study to learn more about a serious problem called bone loss, which happens when a piece of a long bone in an arm or leg goes missing after an injury. This can be tricky to treat, and there isn't much clear guidance yet on the best way to help patients. The study aims to collect information from many people across different hospitals. By looking at how these patients are treated, what complications they experience, and how well they recover, doctors hope to get a clearer picture. This will help them understand how common bone loss is, what treatments are used, and ultimately, how to give better care to patients in the future.

At a glance

Status

Recruiting

Sponsor

AO Innovation Translation Center

Enrolment target

600

Start

03 Jul 2024

Estimated completion

30 Mar 2029

Limb Fracture Bone Loss

What is this study about?

Imagine you've had a bad injury, and a significant part of a long bone in your arm or leg is missing. This is called a 'long bone defect.' It's a complicated problem that can happen after accidents, but also because of conditions like tumours or infections. Doctors find these defects challenging to treat, and currently, there isn't a lot of clear guidance on the very best approaches.

That's where this important study comes in. It's not testing a new medicine or treatment, but rather observing how doctors currently treat these bone defects in many different hospitals around the world. The goal is to create a large collection of information, like a big database, about patients who have these injuries. They want to understand how often this happens, what kinds of treatments are being used, what problems might crop up, and how well people recover.

By gathering all this information, doctors hope to spot patterns and learn what works best. This will help them develop better advice and guidelines for treating long bone defects in the future, ultimately leading to improved care for patients like you.

Key takeaways

The study aims to understand serious bone loss after injury.
It collects information on current treatments and patient outcomes globally.
Participation involves sharing medical data, not receiving new treatments.
The goal is to improve future care for patients with bone defects.
You must be 18+ and have an injury-related bone defect of over 2cm.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and your bones must have finished growing. A key requirement is that you have a bone defect in a long bone (like an arm or leg bone) that is bigger than two centimetres. This defect must have happened because of an injury, either right after the injury or after a surgery to clean up the wound.

Before joining, you'll need to understand what the study involves and confirm you're willing to take part. This will include signing a consent form. There are some reasons why you wouldn't be able to join, such as having certain other serious health problems, being pregnant, or if you're already in another similar study that could affect the results of this one.

Quick self-check

Are you at least 18 years old?
Have your bones finished growing?
Do you have a bone defect from an injury in a long bone (arm/leg)?
Is this defect larger than 2 centimetres?
Are you able and willing to understand and sign a consent form?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, doctors will mainly collect information about your bone defect and the treatment you receive. This involves recording details of any surgery you have for the bone defect, as well as general information about your health and how you are recovering. The study aims to follow many patients over about three years.

This isn't a trial where you'll be given new experimental treatments. Instead, doctors will record the standard care you're already receiving. You won't have to take specific medications for the study or attend extra visits beyond your usual medical appointments. The overall duration of your participation will depend on how long your treatment and recovery take, as they'll be tracking your progress.

Potential risks and benefits

Taking part in this study won't change the medical care you receive, as it's designed to observe existing treatments. The main benefit is that the information gathered from many patients like you will help doctors worldwide understand bone defects better and improve future treatments for others. There are no direct medical risks from participating, as you'll be receiving your usual care. The main commitment is providing consent for your medical information to be collected and shared with the study team. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (21)

Cedar Sinai
Los Angeles, United States· Recruiting
Sinai Hospital of Baltimore
Baltimore, United States· Recruiting
John Hunter Hospital
Newcastle, Australia· Recruiting
Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
Rio de Janeiro, Brazil· Recruiting
Hospital Base Valdivia
Valdivia, Chile· Recruiting
Hospital Universitario de la Samaritana
Bogotá, Colombia· Suspended
Hospital Pablo Tobon Uribe
Medellín, Colombia· Recruiting
University Hospital Frankfurt
Frankfurt, Germany· Recruiting
Universitätsspital Gießen
Giessen, Germany· Recruiting
Universitätsklinikum Heidelberg (Unfallchirurgie)
Heidelberg, Germany· Terminated
Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
Münster, Germany· Recruiting
Krankenhaus Johanneum
Wildeshausen, Germany· Not yet recruiting

+9 more sites — see the official record for the full list.

Common questions

What kind of bone defect is this study interested in?

They're looking at significant bone loss in long bones (like arms or legs) that's happened because of an injury, measuring more than 2 centimetres.

Will I get a new treatment in this study?

No, this isn't a study testing new treatments. It's observing and recording the treatments you would normally receive for your bone defect.

How long will I be in the study?

Your information will be collected as part of a three-year effort to gather data from many patients. Your personal involvement will be as long as your treatment and follow-up care take.

Is my information kept private?

Yes, all personal medical information collected for the study will be handled with strict confidentiality and privacy rules.

Who is running this study?

This is an international study involving many different hospitals and experts working together to improve understanding of bone defects.

How to find out more

Marco Minoia

marco.minoia@aofoundation.org +41 79 612 09 67 Official trial record

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