The Purpose of This Pilot Study is to Determine Feasibility of a Randomized Controlled Trial Comparing Labral Repair Versus Reconstruction in Patients Over 40 Years of Age Undergoing Hip Arthroscopy for FAIS.
This small study is looking into a common hip condition called Femoral Acetabular Impingement Syndrome (FAIS), which causes hip pain. When surgery is needed, doctors either repair a damaged part of the hip called the labrum or rebuild it. This study specifically focuses on people over the age of 40 who need this surgery. The main goal of this initial study is to figure out if it's possible to do a larger study in the future. We want to understand how many people would be willing to join, how to best measure results, and how much effort it takes for patients to complete questionnaires. This helps us design the main study so it runs smoothly and gives us clear answers about the best treatment.
At a glance
What is this study about?
This study is about a hip problem called Femoral Acetabular Impingement Syndrome, or FAIS for short. This condition is becoming more common and causes hip pain, often because a part of your hip called the labrum gets damaged. If not treated, it can sometimes lead to arthritis in the hip.
While some people get better with treatments like physical therapy, surgery is often considered, and many studies show it can help people feel much better and might even lower the chance of getting arthritis in the future. During this surgery, called hip arthroscopy, doctors either fix (repair) the damaged labrum or rebuild it (reconstruction) if it's too damaged to repair. This study is specifically looking at what happens in people over 40 years old.
Doctors want to understand which surgery works best for this age group because there's been some debate. Some studies suggest that the labrum in older patients might not heal as well, so rebuilding it might be a better option. However, other studies show that both repair and reconstruction can give good results. This initial study is a crucial first step in finding out which approach is better. It's a 'pilot' study, meaning it's a practice run to help us plan a larger, more definitive study down the road.
Key takeaways
- This study is for adults over 40 with hip pain from FAIS.
- It compares two surgical options: labral repair vs. reconstruction.
- This is a small 'pilot' study to prepare for a larger one.
- Participation involves surgery and completing questionnaires for two years.
- The goal is to find the best surgical treatment for this age group.
Who may be eligible?
To be considered for this study, you would need to be at least 40 years old and have hip impingement (FAIS) that hasn't improved with other treatments like physical therapy.
There are several reasons why you might not be able to join. For example, if you have advanced arthritis in your hip, if you've had hip surgery before, or if you have certain serious medical conditions or infections, this study might not be suitable for you. Also, if you smoke or have a condition that would make it hard for you to understand the study or follow its instructions, you wouldn't be able to participate. You also need to be willing to be followed by the study team for two years.
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 40 years old or older?
- Do you have hip pain from FAIS that hasn't improved with other treatments?
- Have you NOT had hip surgery before?
- Do you NOT have advanced arthritis in your hip?
- Are you willing to complete questionnaires for two years?
What does participation involve?
If you choose to take part in this study, you would undergo either a labral repair or a labral reconstruction surgery for your hip. Before and after your surgery, you would be asked to complete some questionnaires about your hip pain and how well you can move and do daily activities. This helps doctors understand how well each treatment works.
These questionnaires would need to be completed at different times over a two-year period following your surgery. There are no extra trips to the hospital beyond your usual surgical appointments and follow-up care. The total duration of your active involvement in the study, which mainly involves completing these questionnaires, would be two years.
Potential risks and benefits
Locations (1)
- Fowler Kennedy Sport Medicine ClinicVerified postcodeLondon, Canada
Common questions
What is FAIS?
FAIS stands for Femoral Acetabular Impingement Syndrome, a hip condition where the bones of the hip joint rub together, causing pain and damage.
What is a labrum?
The labrum is a ring of cartilage around the socket of your hip joint that helps keep the joint stable and moving smoothly.
What's the difference between repair and reconstruction?
Repair means fixing the damaged labrum, while reconstruction means rebuilding it, often when the damage is too severe for a simple repair.
Why is this study only for people over 40?
Doctors want to understand if these surgeries work differently in older patients, as there's been some debate about the best approach for this age group.
Will I know which surgery I get?
This study includes a 'randomized' part, meaning the choice between repair or reconstruction would be made by chance, like flipping a coin, to ensure fair comparison.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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