RecruitingNAINTERVENTIONAL

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

This study is investigating if injections of Platelet-Rich Plasma (PRP) can effectively reduce knee pain for individuals with moderate knee osteoarthritis. Currently, scientific societies don't recommend PRP for knee osteoarthritis because past studies haven't been strong enough. This new trial aims to provide clearer answers. Participants will receive either PRP or a 'dummy' (placebo) injection into their knee over three weeks. Researchers will then track their pain levels and how their knee feels for several months to find out if PRP offers a real benefit. We want to understand if this treatment could be a helpful new option for people struggling with knee pain.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

210

Start

15 Jan 2025

Estimated completion

15 Feb 2028

Knee Osteoarthritis

What is this study about?

Many people suffer from knee osteoarthritis, which can cause ongoing pain and stiffness. Platelet-Rich Plasma (PRP) is a treatment that uses a patient's own blood platelets, which are thought to help with healing. While PRP has been used for various muscle and joint problems, it's not currently recommended for knee osteoarthritis by major medical groups in the UK and elsewhere. This is because previous studies often had small numbers of patients or different ways of giving the treatment, making it hard to draw firm conclusions.

This new study aims to change that. Researchers want to conduct a very careful and well-designed trial to see if PRP truly helps reduce pain in people with moderate knee osteoarthritis. They will compare PRP directly with a 'dummy' injection, known as a placebo. This is important to ensure that any improvements seen are actually due to the PRP and not just the natural course of the condition or the expectation of feeling better.

The main goal is to measure how much knee pain decreases 14 weeks after the injections. They'll also look at pain levels at other times, how well people can move their knee, and how much pain medication they use. The hope is to gather strong, clear evidence to help doctors and patients understand if PRP is a safe and effective treatment option for knee osteoarthritis.

Key takeaways

This study compares PRP injections to a 'dummy' (placebo) injection for moderate knee osteoarthritis.
Major medical groups currently don't recommend PRP for knee osteoarthritis due to limited strong evidence.
The study aims to provide clear, scientific evidence on whether PRP injections truly help reduce knee pain.
Participants will receive 3 injections over 3 weeks and be followed for 26 weeks.
You won't know if you're receiving PRP or the placebo during the study.
Participation involves questionnaires and follow-up visits to track your pain and knee function.

Who may be eligible?

To join this study, you would generally need to be between 40 and 79 years old and have been diagnosed with knee osteoarthritis for at least three months. Your knee pain should be mainly in the main part of your knee joint, and X-rays should show a moderate level of osteoarthritis. You'll also need to be experiencing a certain level of pain, even if you're taking your usual pain relief.

There are also some reasons why you might not be able to join. For example, if you have other painful conditions in your legs or hips that might affect how we measure your knee pain. You also couldn't join if your osteoarthritis is very mild or very severe, if you've had surgery on that knee with metal implants, or if you have certain other serious health problems like inflammatory arthritis, uncontrolled diabetes, or a history of specific blood disorders. You also couldn't have had certain injections in your knee recently, like PRP or steroids.

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 40 and 79 years old?
Have you had knee osteoarthritis pain for more than 3 months?
Is your knee pain mainly in the main part of the joint, not just the kneecap?
Do you have moderate osteoarthritis on x-rays (not too mild or too severe)?
Are you able to fill out questionnaires and attend study visits?
Have you recently had (within 3 months) PRP, HA, or steroid injections in your knee?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. If you are, the study will involve receiving three injections over three weeks (once a week for three weeks). You won't know if you're getting the PRP or the placebo. After the injections, you'll have several follow-up appointments to check on your pain and how your knee is feeling. These will happen at weeks 8, 14, and 26 after your first injection. You'll be asked to fill out questionnaires about your pain and daily activities, and blood samples might be taken. The total duration of your active involvement in the study, from your first injection to your last follow-up, will be around 26 weeks (about 6 months).

Potential risks and benefits

Participating in research always carries potential benefits and risks. For benefits, you might experience a reduction in your knee pain if you receive the active PRP treatment, or even from the placebo effect or extra care you receive. However, there's no guarantee of improvement. Potential risks are generally mild and related to the injections, such as temporary pain, bruising, or swelling at the injection site. Serious complications, like infection, are very rare. Remember, you can also decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Henri Mondor
Verified postcode
Créteil, France· Recruiting
Florent Eymard
Verified postcode
Créteil, France· Not yet recruiting

Common questions

What is PRP?

PRP stands for Platelet-Rich Plasma. It's a treatment made from your own blood, which is processed to concentrate platelets, tiny cells thought to help with healing.

What is a placebo injection?

A placebo injection is a 'dummy' injection, usually just sterile salt water. It looks exactly like the real treatment but has no active medication. This helps researchers see if the real treatment works better than just believing you're getting treated.

Will I know if I'm getting PRP or the placebo?

No, during the study, neither you nor your doctor will know if you are receiving the PRP or the placebo. This is to ensure fair results.

How long will the study last for me?

From your first injection to your final check-up, your involvement in the study will last about 26 weeks, which is roughly six months.

Can I stop taking part in the study?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Florent Eymard, MD, PhD

florent.eymard@aphp.fr 01 49 81 27 02 Official trial record

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