RecruitingPHASE1INTERVENTIONAL

AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

This study is testing two different surgical approaches to repair cartilage damage in the hip joint. One method is called Autologous Matrix-Induced Chondrogenesis (AMIC), and the other is Microfracture. Both are performed during a keyhole (arthroscopy) hip operation. Researchers want to see which method works best for improving hip movement, reducing pain, and enhancing a person's overall quality of life. They will also look at how well the new cartilage grows back and if there are any problems with either treatment. Forty patients aged 18-55 will take part, and their progress will be checked regularly for two years after their surgery. This research aims to find better ways to help people with specific hip cartilage problems.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

McMaster University

Enrolment target

Start

13 Mar 2023

Estimated completion

01 Jan 2027

Hip Arthroscopy Articular Cartilage Defect Microfractures

What is this study about?

When you have a problem with the smooth lining (cartilage) in your hip joint, it can cause pain and make it hard to move. This study is looking at two ways doctors try to fix this. Think of your hip joint like a smooth ball and socket. Cartilage is the slippery coating that helps the joint move easily. Sometimes, this coating gets damaged, leading to rough spots.

The two operations being compared are called AMIC and Microfracture. In a Microfracture, the surgeon makes tiny holes in the bone beneath the damaged cartilage. This encourages new cartilage-like tissue to grow. With AMIC, after preparing the area, a special spongy material (almost like a scaffold) is added to help the new cartilage grow and mature properly. Both procedures aim to repair the damaged area and improve how the hip works.

The main idea behind this study is to see which of these two procedures works better in the long run. Researchers want to know if one method leads to less pain, better hip function, and a higher quality of life for patients. They will carefully follow people who have one of these operations to compare the results, hoping to learn more about the most effective treatment for hip cartilage damage.

Key takeaways

This study compares two surgical methods (AMIC vs Microfracture) for hip cartilage damage.
It aims to find out which treatment leads to better hip function, less pain, and improved quality of life.
Participation involves hip surgery and following a specific recovery plan.
You'll have follow-up appointments for two years after your operation.
Researchers are looking for people aged 18-55 with specific hip cartilage defects.
You can stop participating in the study at any time.

Who may be eligible?

This study is looking for volunteers between 18 and 55 years old who have had ongoing hip pain for at least six months that hasn't gotten better with other treatments. You would need to have specific cartilage damage in your hip, which doctors would confirm with scans (MRI) and during the keyhole surgery itself. The damaged area should be of a certain size.

There are also some reasons why you might not be able to join. For example, if you have cartilage damage in a different part of the hip (the 'ball' part), or if you've had surgery on that hip before. You also couldn't take part if you have severe arthritis, another type of inflammatory joint disease, certain other health conditions like uncontrolled diabetes, or if you're pregnant or breastfeeding. If you're currently involved in legal or workplace claims related to your hip, you also wouldn't be eligible.

Crucially, you must be able to understand and speak English, and be willing to follow a specific recovery plan after surgery and attend all the follow-up appointments. The doctors would also need to be sure you would be able to complete the study properly.

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 between 18 and 55 years old?
Have you had hip pain for at least six months that hasn't gotten better with other treatments?
Do you have confirmed cartilage damage in the 'socket' of your hip joint?
Are you able to follow a special exercise programme after surgery and attend regular appointments for two years?
Have you *not* had previous surgery on this hip?
Do you *not* have severe arthritis or other major health conditions like uncontrolled diabetes?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a hip keyhole (arthroscopy) operation. During this surgery, the doctor will either perform the AMIC procedure or the Microfracture procedure, which will be decided by chance, like flipping a coin. After your surgery, you will follow a specific rehabilitation (recovery) plan designed for the study.

You will have several follow-up appointments over two years: at 6 weeks, 6 months, 12 months, 18 months, and finally at 24 months (two years) after your operation. During these visits, doctors will check your hip function, how much pain you have, your general health and quality of life, and look at how your cartilage is healing. This means answering questions and potentially having scans or other assessments. The total duration of your participation in the study would be two years.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving one of the advanced surgical treatments for hip cartilage damage and close medical monitoring of your recovery over two years. However, as with any surgery, there are potential risks, including infection, pain, bleeding, or problems with the new cartilage. The procedures themselves carry their own specific risks, and you would be fully informed of these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

McMaster University
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What kind of hip damage is this study for?

This study is specifically for damage to the smooth lining (cartilage) in the 'socket' part of your hip joint (called the acetabulum), which is confirmed by scans and during surgery.

What are AMIC and Microfracture?

They are both surgical techniques used to repair damaged hip cartilage. AMIC uses a special 'scaffold' to help new cartilage grow, while Microfracture involves making tiny holes in the bone to stimulate healing.

Will I know which treatment I'm getting?

No, the treatment you receive (AMIC or Microfracture) will be decided by chance, like drawing a name from a hat. This helps doctors fairly compare the two methods.

How long will I be involved in the study?

You'll be involved for two years after your hip surgery, with regular check-ups at 6 weeks, 6 months, 12 months, 18 months, and 24 months.

What if I decide I don't want to continue in the study?

You can leave the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

Nicole Simunovic, MSc

simunon@mcmaster.ca 2892373224 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.