Induce XT™ Bone Graft in Foot and Ankle Fusion
This study is testing a special material called Induce XT™ that helps bones heal and join together. It's being used in patients who need foot or ankle surgery, especially those undergoing a 'fusion' procedure where bones are permanently joined. The goal is to see how well Induce XT works compared to older methods. Researchers will check if it helps bones fuse properly, how much pain patients have, and their overall recovery. Patients in the study will have check-ups, X-rays, and fill out questionnaires over 12 months to track their progress and see if Induce XT is a good and safe option for these types of surgeries.
At a glance
What is this study about?
When people have serious problems with their foot or ankle joints, such as arthritis or deformities, surgery can sometimes be needed. A common type of surgery in these cases is called a 'fusion,' where bones are permanently joined together to stop pain and improve stability. To help these bones fuse, surgeons often use a material called a 'bone graft' to fill any gaps and encourage new bone growth. For a long time, the best option was to take bone from another part of the patient's own body, like their hip. However, this extra step can lead to more pain, longer surgery, and other problems.
Because of these difficulties, doctors are always looking for better and safer materials to help bones fuse. This study is focused on a new material called Induce XT™. This material is made from specially prepared human bone fibers and tiny bone particles. The idea is that Induce XT™ will provide a framework and signals to help the body grow new, strong bone to fuse the joint, without needing to take bone from the patient's hip.
By carefully studying patients who receive Induce XT™ during their surgery, the researchers hope to understand how effective it is. They want to see if it helps patients heal faster, reduces their pain, and allows them to recover well. This research is important because finding better bone graft materials could make these types of surgeries easier and recovery smoother for many people.
Key takeaways
- This study is testing a new material called Induce XT™ to help bones fuse in foot and ankle surgery.
- It aims to find an alternative to taking bone from the patient's own hip.
- Participants will have check-ups, X-rays, and pain assessments for 12 months.
- The study focuses on adult patients needing specific foot or ankle fusion operations.
- It could lead to better healing and recovery for future patients.
Who may be eligible?
This study is looking for adults aged 18 or older who need a specific type of foot or ankle surgery called a 'fusion.' This means your surgeon plans to join together bones in your hindfoot or ankle using an open surgical approach, and you'll need extra material to help the bones fuse.
You would not be able to join the study if you are under 18. Also, if you have an active infection, have already had a fusion surgery in the same spot, or have problems understanding instructions or filling out forms, you wouldn't be able to take part. The doctors will check all these things carefully to make sure the study is right for you.
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 need surgery to fuse bones in your foot or ankle?
- Do you currently have a bone defect in your hindfoot or ankle?
- Are you able to attend follow-up appointments over 12 months?
- Do you feel comfortable completing questionnaires and providing consent?
What does participation involve?
If you join this study, it actually starts before your surgery with a screening visit to make sure you're suitable. On the day of your foot or ankle surgery, the Induce XT™ material will be used as planned by your surgeon. After your surgery, you'll have five follow-up visits over a year (12 months). These visits will involve taking X-rays to check how your bones are healing, asking you about any pain you might have, and filling out some questionnaires about your recovery and how you're feeling. There's no extra medication involved in this study; it's about evaluating the bone graft material used during your standard surgery.
Potential risks and benefits
Locations (1)
- Halifax InfirmaryVerified postcodeHalifax, Canada
Common questions
What is Induce XT™ exactly?
Induce XT™ is a special material made from human bone fibers and tiny bone pieces. It's designed to act as a scaffold and encourage new bone to grow, helping bones fuse together during surgery.
Why is this study being done?
The study aims to find out how well Induce XT™ works in people having foot and ankle fusion surgery. Doctors want to see if it's a safe and effective option to help bones heal.
What kind of surgery is this for?
This study is for specific "fusion" surgeries in the foot or ankle, where bones are joined together to fix problems like arthritis or deformities.
How long will I be in the study if I take part?
If you join, you'll be part of the study for about 12 months after your surgery, attending five follow-up visits during that time.
Will taking part in the study change my surgery?
The main difference is that Induce XT™ will be used during your surgery. Otherwise, your surgeon will perform the operation as they normally would, and you'll have extra follow-up appointments related to the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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