Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
This study is investigating a new type of implant called the Nexis® PECA Bunion device, used for correcting bunions (hallux valgus). Bunions are bumps that form on the joint at the base of your big toe. Surgeons use screws like these to help realign the toe bone during an operation. The main goal of this research is to see how effectively this device works in fixing bunions and improving how well people can use their feet after surgery. We'll be looking at patients' foot function six months after their operation. We'll also check how this surgery affects their quality of life, how much the bunion is straightened, how well the bones heal, and if any problems occur. It's for adults having their first bunion operation on one foot.
At a glance
What is this study about?
This study is about a new medical device called the Nexis® PECA Bunion device. This device is a type of screw used by surgeons to help correct bunions, which is a common problem where your big toe points towards your other toes, causing a bump on the side of your foot. The screws are designed to hold the bones in place after they're reshaped during surgery.
The main purpose of this study is to see how well this specific device works. We want to know if it successfully corrects the bunion and, more importantly, if it helps patients' feet feel and function better after the operation. We will be checking on people six months after their surgery to see how their foot is doing. We also want to understand if this surgery improves their overall quality of life, how straight their toe is after the operation, and how quickly their bones heal.
By carefully observing patients who receive this device, we can learn more about its safety and effectiveness. This information helps doctors understand if this new device is a good option for people needing bunion surgery. It's important to keep track of any problems that might occur, so we'll be monitoring patients closely throughout the study.
Key takeaways
- Tests a new screw (Nexis® PECA Bunion device) for bunion surgery.
- Aims to see if it improves foot function and quality of life after 6 months.
- Only for adults having their first bunion surgery on one foot.
- Looks at how well bones heal and if any problems occur.
- Participation is voluntary and involves follow-up appointments.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older and have a bunion problem on one foot that requires surgery. This should be your first operation for a bunion, and the doctors must plan to use the Nexis® PECA Bunion device as the main way to correct your toe. Your bunion should be the only issue being corrected in that foot during the surgery, without other procedures at the same time.
It's also important that you can understand what the study involves and are willing to sign a consent form, showing you agree to take part. You also need to be able to follow your surgeon's advice and recommendations throughout the study period.
However, you cannot take part if you have any medical reasons that prevent using this device, or if you're already involved in another medical study. People under legal protection, in prison, pregnant, or breastfeeding cannot participate either. The study is open to both men and women.
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 bunion on one foot that needs to be corrected by surgery?
- Is this your first time having bunion surgery on that foot?
- Can you understand information about the study and agree to take part?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
The study focuses on the results of your routine bunion surgery using the Nexis® PECA Bunion device. Taking part means that researchers will collect information about your foot's function and your quality of life at specific times after your operation, particularly at 6 months post-surgery. You won't be given any experimental medication, as the study is about the surgical device itself. There will be follow-up appointments where assessments like questionnaires will be used to gather information. The total duration of your active participation will primarily involve this 6-month follow-up period, though some data might be collected around your surgery.
Potential risks and benefits
Locations (4)
- New Clinic Bel AirVerified postcodeBordeaux, France
- Policlinic Bordeaux North AquitaineVerified postcodeBordeaux, France
- Saint-Charles ClinicVerified postcodeLyon, France
- Toulouse University HospitalVerified postcodeToulouse, France
Common questions
What is a bunion?
A bunion is a bony bump that forms on the joint at the base of your big toe, making the big toe point inwards towards your other toes.
What is the Nexis® PECA Bunion device?
It's a special type of screw used in surgery to help hold the bones in place after they've been realigned to correct a bunion.
Will I have different surgery if I join this study?
No, you will have standard bunion surgery on one foot, but the surgeons will use this specific Nexis® PECA Bunion device to fix your big toe.
How long will I be involved in the study?
Your main involvement will be around your surgery and then a follow-up assessment roughly 6 months afterwards.
Can I choose not to participate?
Yes, taking part is completely voluntary. You can choose not to join, or you can withdraw at any point without it affecting your medical treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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