Active not recruitingNAINTERVENTIONAL

Episealer® Knee System IDE Clinical Study

This research study is looking at a new treatment called the Episealer Knee System for people who have pain and problems with their knee movement because of damage to the cartilage in their knee. This is a type of tissue that cushions your joints. The study aims to find out if the Episealer system is better or as good as a more common operation called microfracture. Microfracture involves making small holes in the bone to encourage new cartilage growth. Participants will have either the Episealer implant or the microfracture surgery. Doctors will then check how well the treatment works for reducing pain and improving how the knee moves. They will also look for any issues with the implant, like it moving out of place. The study focuses on people generally aged between 30 and 70 with specific types of cartilage damage in their knee. It's designed to compare these two surgical options carefully.

At a glance

Status

Active not recruiting

Phase

Sponsor

Episurf Medical Inc.

Enrolment target

Start

18 Jun 2020

Estimated completion

01 Jun 2028

Degenerative Lesion of Articular Cartilage of Knee

What is this study about?

This study is about finding the best way to treat knee pain caused by damaged cartilage. Cartilage is the smooth, slippery tissue that covers the ends of your bones in a joint, helping them glide past each other easily. When this cartilage gets damaged, it can lead to pain, stiffness, and difficulty moving your knee.

The study is comparing two different surgical treatments: the Episealer Knee System and a procedure called microfracture. The Episealer uses a custom-made metal implant to cover the damaged area of cartilage. Microfracture is a more traditional surgery where small holes are made in the bone to encourage the body to grow new cartilage. The doctors want to find out which of these treatments is safer and more effective at reducing pain and helping people move their knee better.

To do this, some patients will receive the Episealer, and others will receive microfracture. Over time, the medical team will carefully check how well each treatment works by asking patients about their pain and how well they can use their knee. They will also do examinations and scans to ensure the treatments are working as expected and to check for any problems.

Key takeaways

This study compares a new knee implant (Episealer) to a standard surgery (microfracture).
It's for people aged 30-70 with specific knee cartilage damage and ongoing pain.
The goal is to see which treatment is safer and more effective for pain and movement.
Participation involves surgery, rehabilitation, and regular follow-up appointments.
You won't choose your treatment; it will be decided randomly.
All medical procedures have risks, but you can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to be between 30 and 70 years old. You should have knee pain and problems moving your knee due to cartilage damage in specific areas of the knee, such as the medial or lateral sides, or the kneecap area. The damaged area needs to be a certain size, not too small and not too big (between 1.5 and 7 square centimetres). Your pain level needs to be quite noticeable, and standard treatments like physiotherapy or braces should have been tried for at least four weeks without completely fixing the problem.

There are also some reasons why you might not be able to join. For example, if you have severe obesity (a BMI over 37), or certain other medical conditions. If you're a woman who could become pregnant, you'll need a negative pregnancy test and shouldn't plan to get pregnant for the next two years. Basically, the doctors need to make sure the study is right for you and that you're healthy enough for the surgery and follow-up care.

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 30 and 70 years old?
Do you have ongoing knee pain from cartilage damage that hasn't improved much with other treatments?
Has your pain lasted at least 4 weeks, with non-surgical treatments tried?
Are you willing and able to attend all planned hospital visits and follow a recovery plan?
If you are a woman who could become pregnant, are you able to avoid pregnancy for the next 24 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you meet all the requirements. If you're eligible, you'll be randomly assigned to receive either the Episealer implant or the microfracture surgery. This means you won't get to choose which one you receive.

After your surgery, you will have regular clinic visits and assessments. These visits will involve answering questions about your pain and how well your knee is working, and possibly having X-rays or other scans. You'll also need to follow a specific rehabilitation (recovery) plan to help your knee heal. The study will continue for a period of time after your surgery to track your progress, with follow-up appointments scheduled over several years. You'll need to be committed to attending all scheduled appointments and following the treatment and recovery instructions.

Potential risks and benefits

Taking part in this study could offer you the benefit of receiving one of two advanced treatments for knee cartilage damage, which might improve your pain and knee function. However, like any surgery, there are potential risks, including infection, pain, bleeding, or problems with the implant or healing process specific to the surgery you receive. You'll be closely monitored throughout the study for any issues. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (13)

Physicians Research Group
Verified postcode
Tempe, United States
Horizon Clinical Research
Verified postcode
La Mesa, United States
Ochsner Sports Medicine Institute
Verified postcode
New Orleans, United States
Hackensack University Medical Center
Verified postcode
Hackensack, United States
Plancher Orthopaedics & Sports Medicine
Verified postcode
New York, United States
Ohio State University
Verified postcode
Columbus, United States
Helios Clinical Research
Verified postcode
Jackson, United States
North Texas Medical Research Institute
Verified postcode
Dallas, United States
QEII Health Sciences Center
Verified postcode
Halifax, Canada
Universitatsmedizin Berlin Charite
Verified postcode
Berlin, Germany
Orthocentrum Hamburg
Verified postcode
Hamburg, Germany
University Hospital Coventry and Warwickshire NHS Trust
Verified postcode
Coventry, United Kingdom

Common questions

What is cartilage and why is it important?

Cartilage is a smooth, rubbery tissue that covers the ends of bones in your joints, like the knee. It allows your bones to glide over each other easily, acting like a cushion. When it gets damaged, it can cause pain and make movement difficult.

What is the Episealer Knee System?

The Episealer Knee System is a new type of treatment. It involves implanting a small, custom-made metal cap into the damaged area of your knee cartilage to restore a smooth surface.

What is microfracture surgery?

Microfracture is a common knee surgery to treat cartilage damage. Small holes are made in the bone underneath the damaged cartilage to encourage your body to grow new repair tissue.

Will I get to choose which treatment I receive?

No, in this study, you will be randomly assigned to receive either the Episealer or microfracture. This is done to make the comparison between the two treatments fair and scientific.

How long will I need to be involved in the study?

The study involves surgery, a recovery plan, and several follow-up appointments over a number of years to track your progress and assess the long-term effects of the treatment.