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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized control trial comparison between intra-articular infiltrations of PRP, MFAT, and PRP-MFAT in the treatment of symptomatic knee osteoarthritis.

This research study is about finding better treatments for knee osteoarthritis, a common condition causing pain and stiffness. Doctors are comparing three types of injections directly into the knee joint: PRP (Platelet-Rich Plasma), MFAT (Microfragmented Adipose Tissue, or refined fat), and a combination of PRP and MFAT. The goal is to see which of these treatments is most effective at reducing pain and helping people move their knees more easily. This is a large study that aims to confirm if these treatments really work and could become part of standard care for knee osteoarthritis.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Assistance Publique Hopitaux De Marseille
Enrolment target
180
Start
29 May 2024

What is this study about?

This study is a research project designed to help people who have knee osteoarthritis. Osteoarthritis is a common condition where the cartilage cushioning your knee joint wears down over time, leading to pain, stiffness, and difficulty moving. The purpose of this study is to compare different new treatments that use natural substances from your own body to try and repair the joint or reduce inflammation.

The researchers are focusing on three main treatments, all given as injections into the knee. The first is Platelet-Rich Plasma (PRP), which involves taking a small sample of your blood, spinning it to concentrate the platelets (which are full of growth factors), and then injecting this back into your knee. The second is Microfragmented Adipose Tissue (MFAT), which uses a small amount of your own fat tissue, processed to create tiny fragments, and then injected. The third treatment is a combination of both PRP and MFAT. The aim is to understand if one of these injections is better than the others at reducing pain and improving how your knee works.

This is an important study because it could lead to new, effective treatment options for knee osteoarthritis that are less invasive than surgery and use your body's natural healing abilities. By carefully comparing these treatments in a large group of people, scientists hope to find clear answers about which approach offers the most benefit to patients.

Key takeaways

  • Exploring new injection treatments for knee osteoarthritis.
  • Compares PRP, MFAT, and a combination of both.
  • Aims to reduce pain and improve knee movement.
  • Uses natural substances from your own body.
  • Participants are randomly assigned to one treatment.
  • Could lead to new options for knee pain relief.

Who may be eligible?

This study is looking for adults aged 18 years and older who have knee osteoarthritis. Both men and women can take part.

To be considered for this study, you would need to have been diagnosed with knee osteoarthritis by a doctor and be experiencing ongoing symptoms like pain or stiffness in your knee.

There might be further detailed health checks the study team will do to make sure the treatment is safe for you and that you fit all the requirements for taking part.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with knee osteoarthritis?
  3. Do you currently have pain or stiffness in your knee due to osteoarthritis?
  4. Are you able to attend regular clinic appointments for checks?
  5. Are you willing to receive one of the study injections (PRP, MFAT, or combination)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the three types of knee injections mentioned (PRP, MFAT, or a combination). You won't get to choose which one you receive, as this is decided randomly, much like flipping a coin, to ensure a fair comparison.

You will have several appointments at the study clinic where doctors and nurses will assess your knee pain and movement, and ask you about how you are feeling. These appointments will involve check-ups, questionnaires, and possibly some simple tests. You will also have follow-up visits over a certain period to monitor your progress and how well the treatment is working. The exact number and timing of visits, and the total length of your participation, will be clearly explained by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer you a new treatment for your knee osteoarthritis that might reduce your pain and improve your knee function. However, as with any medical procedure, there are potential risks, such as pain or bruising at the injection site, or a very small chance of infection. You might also find that the treatment doesn't work for you. It's really important to know that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is PRP?

PRP stands for Platelet-Rich Plasma. It's made by taking a small amount of your own blood, processing it to get a concentrated liquid of plasma rich in platelets, and then injecting it back into your knee.

What is MFAT?

MFAT stands for Microfragmented Adipose Tissue. This involves taking a very small amount of your own fat, usually from your tummy or thigh, processing it into tiny pieces, and then injecting it into your knee.

Will I know which treatment I get?

No, you won't know which injection you receive (PRP, MFAT, or the combination). This is done to make sure the study results are fair and unbiased.

How long will the study last?

The total length of time you'll be involved in the study, including all your visits and follow-ups, will be clearly explained by the study team before you decide to join.

Do I have to pay to join the study?

No, you will not have to pay for any of the study-related treatments or appointments.

How to find out more

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

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