RecruitingNAINTERVENTIONAL

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

This research is looking at different surgical options for fixing a broken collarbone. Many people who have surgery for a collarbone fracture need a second operation later to take out the plate because it causes irritation. This study compares two methods: using two smaller plates, or one specially shaped plate. Previous studies suggest two smaller plates might lead to fewer follow-up surgeries for plate removal. This trial aims to be the first major study to directly compare these two techniques to see which is better in terms of avoiding further operations, how well the bone heals, and whether there are any other problems. The goal is to find a way to fix broken collarbones that works well and is less likely to cause irritation.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

04 Apr 2022

Estimated completion

01 Jan 2028

Clavicle Fracture

What is this study about?

If you've broken your collarbone, you might have heard that surgery could be an option. For many years, doctors often treated these types of breaks with just a sling or bandage. However, more recent research has shown that for certain breaks, surgery can help the bone heal better, get you back to your normal activities sooner, and leave you feeling more satisfied with the outcome. This is especially true for breaks where the bone pieces are significantly moved apart.

Once surgery is chosen, there are different ways to fix the break. Often, a metal plate is used to hold the bone pieces in place so they can heal properly. While surgery generally helps, a common problem is that the plate itself can sometimes cause discomfort or irritation under the skin. This can lead to a second operation just to remove the plate, which can be inconvenient and means more recovery time. In some cases, as many as one in four people who have a plate put in for their collarbone eventually need to have it taken out.

With this in mind, doctors are always looking for better ways to do things. Newer ways of using two smaller plates, instead of one larger, shaped plate, have shown promise. The idea is that these smaller plates might be less noticeable and cause less irritation, reducing the need for a second operation. This study is designed to be the first major trial to directly compare these two approaches. By carefully looking at how well the bones heal, how many people need another operation to remove the plates, and any other issues that come up, the researchers hope to find out if using two small plates is a better option for people with certain types of collarbone fractures.

Key takeaways

The study compares two surgical options for a broken collarbone.
It aims to find out which plate type causes fewer follow-up operations.
A broken collarbone can heal better with surgery for some people.
Participation involves surgery and regular check-ups.
You will be randomly assigned to one of the two plate types.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 65 years old. You must have a specific type of collarbone fracture (known as a midshaft fracture) where the bone pieces are clearly separated, and your doctor believes this break can be fixed well with a plate that uses at least three screws on each side of the break.

There are also some reasons why you might not be able to join. These include if your skin is broken over the fracture, if your bone broke due to a disease, or if more than 28 days have passed since your injury. You also wouldn't be able to join if you have certain other injuries like severe head trauma, significant damage to nerves or blood vessels near the break, or other serious health problems. It's also important that you can reliably attend all your follow-up appointments and are able to give your full consent to participate.

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 between 18 and 65 years old?
Do you have a broken collarbone where the bone pieces are completely separated?
Has it been less than 28 days since your collarbone injury?
Do you have any other serious health conditions or injuries that might prevent surgery?
Are you able to attend all planned follow-up appointments?
Do you understand what the study involves and are happy to give your permission to take part?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve having surgery to fix your broken collarbone. You would be randomly chosen to receive either one specially shaped plate or two smaller plates. After your surgery, you would have regular check-ups with the study team to monitor your healing and recovery. These check-ups would likely include physical examinations, X-rays to see how your bone is mending, and questionnaires about your pain and how well you can use your arm. The study team would track your progress for a certain period to see how well the bone heals and if you experience any irritation from the plate that might require another operation. The total duration of your participation would involve the surgery, recovery, and follow-up appointments over several months.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a surgical technique that could result in less irritation from the plate, potentially avoiding a second operation. However, as with any surgery, there are always risks, such as infection, bleeding, nerve damage, or problems with the bone healing. You might also experience discomfort from the plate, regardless of which type is used. The researchers will carefully monitor you for any problems. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'midshaft clavicle fracture'?

This is a break in the middle part of your collarbone (clavicle), which is the bone that runs horizontally across the top of your chest.

Why might I need surgery for a broken collarbone?

For some types of collarbone breaks, especially those where the bone pieces are significantly separated, surgery can help the bone heal better, reduce pain, and help you get back to your normal activities sooner.

What are the two types of plates used in this study?

One type is a 'single precontoured plate,' which is one plate shaped to fit the collarbone. The other is 'dual mini-fragment plating,' which uses two smaller plates.

Why are researchers looking at two smaller plates?

Sometimes, the larger plates used in surgery can cause irritation under the skin, leading to another operation to remove them. Researchers hope two smaller plates might cause less irritation.

Will I get to choose which plate I receive?

No, in this study, the choice between the two plate types is made randomly, like flipping a coin. This helps ensure fair comparison of the treatments.

How to find out more

Sara Aman, BSc

orthores@sunnybrook.ca 416-480-4285 Official trial record

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