RecruitingNAINTERVENTIONAL

JuggerStitch Post Market Clinical Follow-up Study

This study is looking at the JuggerStitch device, which is used to fix tears in the meniscus (the cartilage in your knee). It's a 'post-market follow-up' study, meaning the device is already in use, but doctors want to keep a close eye on how well it works and if it's safe for patients. The main goal is to confirm that the JuggerStitch device helps people with meniscus tears recover without needing another operation on their knee. They'll also check its overall performance and safety to make sure it meets all necessary standards. This helps provide reassurance about the device for current and future patients.

At a glance

Status

Recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

104

Start

25 Sep 2020

Estimated completion

30 Apr 2026

Meniscus Tear, Tibial Meniscus Lesion

What is this study about?

Imagine your knee has a cushion of cartilage, called the meniscus. If you tear this cartilage, it can be quite painful and make it hard to move your knee. Doctors can sometimes repair this tear using different methods. One such method involves a device called JuggerStitch.

This study is a bit different from typical drug trials. It’s not testing a new medicine, but rather observing how a medical device, the JuggerStitch, performs in real-world use. Think of it like buying a new car; while it's been tested in the factory, the company still wants to see how it performs over time once people start driving it every day. This study is doing something similar for the JuggerStitch device.

The main purpose is to make sure the JuggerStitch device is safe and works effectively for people who've had their meniscus tear repaired using it. The doctors will be especially looking to see if patients who've had the JuggerStitch device implanted avoid needing another operation on the same knee because of the meniscus tear. They aim for a high success rate, meaning most people won't need further surgery. This careful monitoring helps ensure that medical devices continue to meet strict safety and performance standards for everyone.

Key takeaways

This study is checking the safety and performance of the JuggerStitch device for knee cartilage repair.
It's a follow-up study for a device already in use, not a brand-new treatment.
The main goal is to confirm whether the device helps patients avoid repeat surgery.
Participation involves having the surgery and attending follow-up checks.
You must be over 18 and have a suitable meniscus tear to join.
Your involvement helps gather important information for patient care.

Who may be eligible?

To be able to join this study, you would generally need to have a meniscus tear that your doctor believes can be repaired with the JuggerStitch device. You must be over 18 years old and mature in your bone development. It's also important that you are willing and able to follow all the study instructions and attend any necessary follow-up appointments.

There are certain reasons why you might not be able to join. For example, if your meniscus tear is in a part of the knee that doesn't get much blood flow (avascular zone), or if the tear is too complicated or damaged (like a degenerative or complex tear), then this repair might not be suitable for you. You also cannot participate if you have an active infection, are pregnant, or would find it difficult to understand or follow the study's requirements. This includes situations where someone may be vulnerable or unable to give proper consent.

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.

Do you have a meniscus tear that your doctor thinks can be repaired?
Are you 18 years old or older?
Are you able to understand and follow instructions for medical appointments?
Are you not pregnant and do not have an active infection?
Are you willing and able to give your consent to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will involve having your meniscus tear repaired using the JuggerStitch device. After your operation, the study team will ask you to come for follow-up appointments. During these visits, they will check how your knee is healing and how you are recovering from the surgery. The main thing they will be looking for is whether you need another operation on your knee because of the meniscus tear within one year of your first surgery. The study involves collecting information over time to understand how well the device is working for you and others.

Potential risks and benefits

The potential benefit of participating is receiving treatment for your meniscus tear, and by being part of the study, you're also helping doctors understand more about how well the JuggerStitch device works, which can benefit future patients. As with any surgery, there are always potential risks, including those related to the procedure itself or complications from the device. However, this study is about checking a device that is already in use, meaning it has met initial safety standards. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

OrthoCarolina
Verified postcode
Charlotte, United States· Active not recruiting
OrthoVirginia, Inc.
Verified postcode
Richmond, United States· Active not recruiting
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Verified postcode
Lyon, France· Recruiting
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Verified postcode
Magdeburg, Germany· Recruiting
Ichihara Hospital
Verified postcode
Tsukuba, Japan· Recruiting
Tokyo Medical and Dental University Hospital of Medicine
Verified postcode
Tokyo, Japan· Recruiting

Common questions

What is a meniscus tear?

A meniscus tear is a common injury to the cartilage in your knee that acts like a shock absorber. It can cause pain, swelling, and difficulty moving your knee.

What is the JuggerStitch device?

The JuggerStitch is a medical device designed to help surgeons repair torn meniscus cartilage in the knee.

Is this a new treatment?

No, this study is observing a device that is already in use. It's called a 'post-market' study, following up on devices after they've been approved.

What will doctors be looking for?

Doctors will mainly check if patients who received the JuggerStitch device avoid needing another surgery on their knee due to the meniscus tear within a year.

Will I have more doctor appointments than usual?

Yes, you might have specific follow-up appointments scheduled as part of the study to monitor your recovery and the device's performance.

How to find out more

Nesma Bayrich, DDS

nesma.bayrich@zimmerbiomet.com +41 793001484 Official trial record

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