Active not recruitingOBSERVATIONAL

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

This study is about understanding how people recover from a specific type of broken lower leg bone, called a tibia shaft fracture. Around 1000 patients who are having surgery for this type of break will be included. Doctors will collect information about their injury, treatment, and how they feel after surgery over one year, and sometimes longer. This helps doctors learn more about the best ways to treat these fractures and what patients can expect during their recovery. The aim is to improve care for people with these common leg breaks.

At a glance

Status

Active not recruiting

Sponsor

AO Clinical Investigation and Publishing Documentation

Enrolment target

1,000

Start

04 Apr 2019

Estimated completion

31 Dec 2025

Tibial Fracture Fracture of the Tibia Type AO/OTA 42

What is this study about?

This study focuses on a common type of broken lower leg bone, specifically a tibia shaft fracture. The tibia is the larger of the two bones in your lower leg, and a shaft fracture means the break is in the long middle part of this bone. When you have this type of break, doctors often recommend surgery to help the bone heal properly.

This study, called a registry, aims to gather information from about 1000 patients who have surgery for a tibia shaft fracture. The main goal is to understand how people recover after this surgery. By collecting details about their injury, the treatment they receive, and how they feel and function afterward, doctors hope to learn more about the recovery process. This information is really important because it helps medical teams improve the way they treat these fractures in the future and gives a clearer picture of what patients can expect during their healing journey.

Over time, the study will build a bigger picture of what works well and where improvements can be made. This can lead to better care, fewer complications, and a smoother recovery for people who break their tibia shaft in the future. It’s all about making sure patients get the best possible outcome after such an injury.

Key takeaways

A study for people having surgery for a specific lower leg break (tibia shaft fracture).
It collects information from your routine follow-up appointments.
Aims to understand recovery and improve future patient care.
Does not involve new treatments or extra visits.
You must be 18 or older with a primary tibia shaft fracture.
You can stop participating at any time without affecting your care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old when your injury happened. You must also have been diagnosed with a primary break in the main part of your lower leg bone (a tibia shaft fracture) that your doctor plans to treat with surgery as part of your usual care.

You would not be able to join if your broken bone was caused by a serious illness like cancer, rather than by an accident. Also, if you've recently taken part in another medical study involving a new device or medicine in the past month, and that study's results might affect this one, you wouldn't be able to participate. This helps make sure the information collected in this study is clear and accurate.

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 lower leg bone (tibia shaft fracture)?
Is your doctor planning surgery for this broken leg?
Was your bone broken by an accident, not by a serious illness?
Have you not participated in another device or drug study in the last month?

Answer every question to see your result.

What does participation involve?

If you join this study, your regular medical care for your broken leg will continue as normal. You won't be trying out any new, experimental treatments. Instead, doctors will collect information from your standard check-up appointments. These typically happen at 6 weeks, 6 months, and 1 year after your surgery. They might continue to follow your progress for up to 3 years if your doctor feels it's needed for your care.

During these visits, the medical team will record details about your injury, the surgery you had, and how you are healing. They will also ask you questions about how you are feeling, how well you can move and use your leg, and if you've had any problems or complications related to the surgery or implant. There are no extra visits or medications required specifically for the study beyond your usual follow-up care.

Potential risks and benefits

Taking part in this study primarily involves allowing doctors to collect anonymous information from your usual medical appointments. There are no additional medical procedures or changes to your treatment plan, so there are no direct extra medical risks from participating. A potential benefit is that the information gathered from many patients will help improve future treatment for tibia fractures. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NYU Langone and affiliated Hospitals
Verified postcode
New York, United States
NYU Langone Jamaica Hospital Medical Center
Verified postcode
New York, United States
Vanderbilt University Medical Center
Verified postcode
Nashville, United States
Department of Trauma Surgery, UZ Leuven
Verified postcode
Leuven, Belgium
University Medical Center Mainz
Verified postcode
Mainz, Germany
Medical Faculty LMU Munich
Verified postcode
Munich, Germany
University Hospital Münster
Verified postcode
Münster, Germany
Queen Mary Hospital
Verified postcode
Hong Kong, Hong Kong
Sengkang General Hospital
Verified postcode
Singapore, Singapore
Tygerberg Hospital
Verified postcode
Cape Town, South Africa
Korea University Guro Hospital
Verified postcode
Seoul, South Korea
University Hospital Basel
Verified postcode
Basel, Switzerland

Common questions

What kind of broken leg injury is this study about?

It's about a specific type of break in the main bone of your lower leg, called a tibia shaft fracture.

Will I get a different type of surgery if I join this study?

No, you will receive the usual standard surgery that your doctor recommends for your fracture. The study just collects information about your recovery.

How long will I be followed in the study?

You'll be followed for at least one year. Sometimes, if needed, this can extend up to three years during your routine check-ups.

Do I need to come for extra hospital visits?

No, the study gathers information during your normal follow-up appointments that are part of your standard care.

What kind of information will doctors collect?

They will collect details about your injury, your surgery, how you are recovering, your pain levels, and any problems you might experience.