Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
This study focuses on a modern, less invasive surgical technique, called the Lapidus procedure, used to correct bunions. We are comparing two ways to perform this surgery: one with a tiny camera to check the joint, and one without. Because this minimally invasive bunion surgery is relatively new, we want to understand how well the bones heal and, most importantly, how patients feel about their recovery and the overall results. We'll use special questionnaires for patients to share their experiences. Ultimately, this research aims to improve bunion treatment by finding the best way to do this surgery and ensure patients have the best possible outcomes.
At a glance
What is this study about?
This study is about a common foot problem called bunions, also known as hallux valgus. A bunion is a bony lump that forms on the joint at the base of your big toe, making the toe point inwards. They can be painful and make it hard to wear shoes.
Surgeons often fix bunions using an operation called the Lapidus procedure. This study is looking at a newer, less invasive way to do the Lapidus procedure, meaning smaller cuts are made. Because this 'minimally invasive' approach is quite new, we don't have a lot of information on how patients truly feel about their results after the surgery. Previous studies mainly focused on X-ray pictures of the bones, but this study will pay close attention to patients' experiences through questionnaires.
We also want to compare two slightly different ways of doing this minimally invasive Lapidus surgery. In one group, the surgeon will use a tiny camera (similar to a keyhole surgery) to look inside the joint during the operation. In the other group, they will just use a small window-like cut to check things visually. Patients will be randomly assigned to one of these two approaches. The main goals are to see how well the bones join together after surgery, how happy patients are with their recovery, and how these two methods compare.
Key takeaways
- This study evaluates a newer, less invasive bunion surgery.
- It compares two slight variations of the minimally invasive procedure.
- An important part is how patients feel about their results.
- Bones healing well after surgery is a key measure.
- You'll have follow-up appointments and fill out questionnaires.
- Participation helps improve bunion treatments for others.
Who may be eligible?
To be part of this study, you need to be at least 19 years old and have fully grown bones. You must have a bunion that needs a specific type of surgery called a 1st TMT fusion (Lapidus procedure). You also need to be able to come to all the follow-up appointments and understand what's involved in the study and agree to take part.
There are some reasons why you wouldn't be able to join. For example, if you have severe arthritis in the affected joint, very weak bones (severe osteoporosis), nerve or muscle problems that affect your foot, or an infection in the joint. You also can't join if you've had surgery on the same foot joint before, or if you're having other major foot surgeries at the same time. If you have poorly controlled diabetes, smoke, have certain bone problems, or specific cancers, you might also not be able to participate. The medical team will check all these details carefully with 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 19 years old or older?
- Do you have a bunion that your doctor thinks needs a Lapidus procedure?
- Can you attend several follow-up appointments after surgery?
- Do you have severe arthritis, very weak bones, or an infection in your foot joint?
- Have you had previous surgery on the same foot joint?
- Do you have poorly controlled diabetes or are currently a smoker?
What does participation involve?
If you decide to take part, you will have the minimally invasive Lapidus procedure for your bunion. You will be randomly assigned to one of two groups: one where the surgeon uses a small camera during the operation, and one where they don't. After your surgery, you will have several follow-up appointments, including check-ups at 12 weeks. At these visits, you'll answer questionnaires about how your foot feels and how you're recovering. Doctors will also take X-rays or special CT scans to see how well your bones are healing and how much your bunion has been corrected. The total duration of your participation will involve these appointments over several months after your surgery.
Potential risks and benefits
Locations (1)
- St. Paul's HospitalVerified postcodeVancouver, Canada
Common questions
What is a bunion?
A bunion is a bony bump at the base of your big toe that causes the toe to point outwards, often causing pain and difficulty with footwear.
What does 'minimally invasive' mean?
It means the surgery is done through very small cuts, which can lead to less pain and a quicker recovery compared to traditional open surgery.
Will I know which surgery I'm getting?
You will be told whether your surgery involves a small camera (arthroscopy) or not, but the decision will be made randomly by the study team.
Why are patient questionnaires important?
Your answers help us understand how you feel about your recovery, pain, and overall satisfaction, which is crucial for evaluating the surgery's success from a patient's perspective.
What if I change my mind about participating?
You are free to withdraw from the study at any point without it affecting your ongoing medical care.
How to find out more
Biraj Bora
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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