BoneTape Feasibility Trial
This study is testing a new medical device called BoneTape. It's a special tape designed to fix broken bones in the middle part of the face, often caused by accidents. Currently, doctors use metal plates and screws, which can be tricky to put in and sometimes cause problems that need more surgery later. BoneTape is different because it's flexible and breaks down naturally in the body over time. It's also easier to apply during surgery without drilling new holes. The study wants to see if BoneTape is safe, works well to help bones heal, and is simple for doctors to use. If successful, it could make facial fracture surgery much easier for patients and improve their recovery.
At a glance
What is this study about?
Imagine you've had an accident and broken a bone in your cheek or around your eye. This is called a zygomaticomaxillary fracture. Usually, surgeons fix these breaks using small metal plates and screws. While this works, putting these plates in can take a bit longer, and sometimes they might cause pain or other issues that require another operation down the line to remove them.
This study is looking at an exciting new option called BoneTape. Think of it like a special, thin piece of flexible material that surgeons can cut to the exact size needed. Instead of having to drill holes for screws, this tape can be applied directly to the broken bone with a special tool that helps it stick firmly. The best part is that BoneTape is 'resorbable,' which means it gradually dissolves and disappears in your body as your bone heals, so there’s no need for a second surgery to take it out. This could make the surgery simpler, quicker, and potentially lead to fewer complications.
The main goal of this study is to see if BoneTape is safe, if it helps bones heal properly, and if it's easy for surgeons to use. Researchers will be paying close attention to how well patients recover, if they have any pain, and if there are any unexpected problems. If BoneTape proves to be successful, it could offer a much improved way to fix facial bone breaks, making recovery smoother for people who've had these kinds of injuries.
Key takeaways
- It's a new study looking at a special 'BoneTape' for facial bone fractures.
- BoneTape aims to be a simpler alternative to traditional metal plates and screws.
- The tape dissolves in your body, so no second surgery for removal is needed.
- The study will check if BoneTape is safe, effective, and easy for doctors to use.
- Participation involves surgery with BoneTape and follow-up checks for one year.
Who may be eligible?
To be part of this study, you would need to be an adult who has broken a bone in the middle of your face on one side only. This break should also not be in many small pieces. You'd also need to be old enough for your bones to have stopped growing, feel well enough to come back for follow-up appointments, and be happy to give your permission to join the study.
There are some reasons why you wouldn't be able to join. For example, if your bone break is very large, or if it also affects the bone beneath your eye and that needs surgery too. If you are pregnant, or if you have certain health conditions like brittle bones (osteoporosis) or a pacemaker, you also wouldn't be able to take part. Other reasons include if you smoke, have an ongoing infection, or if your general health or medicines might stop your bones from healing well.
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.
- I am an adult.
- I have a broken bone in the middle of my face, but only on one side and it's not shattered into tiny pieces.
- I am able and willing to come to all the follow-up appointments.
- I am not pregnant.
- I do not have certain medical conditions like brittle bones or an active infection.
What does participation involve?
If you decide to take part in this study, the process will involve a few steps. Before your surgery, you will have a thorough check-up, including an examination, special scans (CT scans), and you'll be asked to complete questionnaires about any pain you might be experiencing. During your surgery, the BoneTape will be used to fix your broken facial bone.
After your surgery, doctors will check on you within 24 hours. You'll then have follow-up visits with the study team at specific times: one week, six weeks, 24 weeks (about six months), and a final visit at 12 months (one year) after your surgery. These visits are important to see how well your bone is healing, to check on your pain levels, and to make sure you're recovering well without any problems. The total time you'll be involved in the study, from your initial checks to your last follow-up, will be about 12 months.
Potential risks and benefits
Locations (1)
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada· Recruiting
Common questions
What kind of broken bones is this study for?
This study is for breaks in the mid-face bones, like your cheekbone, that haven't shattered into many pieces and only affect one side of your face.
What is BoneTape made of?
BoneTape is made from a special material that gradually dissolves in your body as your bone heals over time.
Will I need to have BoneTape removed?
No, because BoneTape is designed to dissolve naturally, you won't need another surgery to take it out.
How long will I be followed in the study?
You will be followed and checked by the study team for about one year after your surgery.
Can I still have surgery if I don't join the study?
Yes, you can still have your facial fracture fixed using standard methods, regardless of whether you participate in this study.
How to find out more
Janaina F Bortolatto, DDS, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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