Active not recruitingOBSERVATIONAL

Comprehensive Nano - Post Market Clinical Follow-Up Study

This study is checking how well a specific type of shoulder replacement, called Comprehensive Nano, works after it's been used in surgery. It's for people with shoulder problems caused by conditions like osteoarthritis, rheumatoid arthritis, or when a previous shoulder surgery hasn't worked well. Doctors will follow 150 patients who have had either a full or partial shoulder replacement, and 44 who had a 'reverse' shoulder replacement. They want to see how patients get on, how the new shoulder helps them with their daily lives, and if there are any problems. This information helps engineers and marketing teams, and it also meets important safety requirements set by health regulators.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

194

Start

30 Oct 2013

Estimated completion

31 Jul 2030

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Revision Correction of Functional Deformity

What is this study about?

This study is all about a specific type of shoulder replacement called the Comprehensive Nano Shoulder System. This system is used in surgery to replace parts of the shoulder joint that are worn out or damaged. Sometimes, only the ball part of the shoulder joint is replaced (this is called a Hemi-arthroplasty), and other times, both the ball and the socket parts are replaced (this is called a Total shoulder arthroplasty). The aim of this study is to gather information on how well patients recover and get on with their lives after having this particular shoulder replacement.

The experts running this study want to understand the real-world results of this surgery. They will be looking at how people feel, how much movement they get back in their shoulder, and if the new joint helps reduce their pain. This kind of information is really important because it helps improve future treatments and makes sure that medical devices like shoulder replacements are safe and effective for everyone who needs them.

They're planning to watch 150 patients who have had either a full or partial shoulder replacement, and another 44 patients who had a 'reverse' shoulder replacement – this is a special type of surgery for certain shoulder problems. These patients will be from up to ten different hospitals or clinics. By collecting all this information, they can learn a lot about how the Comprehensive Nano system performs over time.

Key takeaways

This study evaluates a specific shoulder replacement system called Comprehensive Nano.
It aims to understand how well patients recover after this surgery.
Data from your routine check-ups will be used for research.
Eligible patients have shoulder conditions like arthritis or previous failed treatments.
Your participation helps improve future shoulder replacement treatments.
You can stop being part of the study at any time.

Who may be eligible?

This study is designed for adults aged 18 and over who are having shoulder replacement surgery. Generally, you might be suitable if you have painful shoulder problems due to conditions like osteoarthritis or rheumatoid arthritis, which are types of arthritis that cause joint damage.

It also includes people who need another shoulder operation because a previous treatment or surgery didn't work as well as hoped, or if you have a shoulder deformity that needs fixing. Basically, if other treatment options haven't been suitable or enough to help your severe shoulder problems, this study might be for you.

However, you cannot take part if you currently have an infection in your body, a severe blood infection (sepsis), or a bone infection (osteomyelitis). Your doctor will discuss all of these points with you to see if this study is an option.

Quick self-check

Are you 18 years old or older?
Do you have shoulder pain from conditions like osteoarthritis or rheumatoid arthritis?
Are you considering or having a shoulder replacement?
Do you need surgery because a previous treatment didn't work or for a deformity?
Do you NOT have an active infection in your body (like sepsis or bone infection)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it means that information about your recovery and the success of your shoulder replacement will be collected. This information will come from your regular follow-up appointments after your surgery. There are no extra visits or special assessments just for the study; it will use the information gathered during your usual care.

Before you join, you will be asked to read and sign a consent form. This form explains everything about the study in detail, and it ensures you understand what's involved and agree to your information being used for research purposes. You won't be given any special medication as part of the study; it simply observes how well the Comprehensive Nano shoulder replacement works in real patients.

Potential risks and benefits

Taking part in this study means your medical details, specifically about your shoulder replacement and recovery, will be used to help improve medical care. The main benefit is that your information helps create a better understanding of how this specific shoulder replacement works, which can lead to better outcomes for future patients. There are no additional risks beyond those usually associated with having shoulder replacement surgery. You are always free to decide to withdraw your participation at any time without giving a reason, and this will not affect your medical care.

Locations (5)

Privatklinik Leech
Graz, Austria
Kingston General Hospital
Kingston, Canada
Chonnam National University Hospital
Gwangju, South Korea
Samsung Medical Centre
Seoul, South Korea
University of Liverpool
Liverpool, United Kingdom

Common questions

What is the Comprehensive Nano Shoulder System?

It's a specific type of artificial shoulder joint used in surgery to replace damaged parts of your shoulder.

Why is this study being done?

It helps doctors and manufacturers understand how well the Comprehensive Nano shoulder replacement works in real patients after surgery, and it meets important safety guidelines.

Will I get any special treatment if I join?

No, you will receive the standard surgical care and follow-up. This study simply collects information about your recovery and the success of the operation.

Who can take part in this study?

Adults aged 18 and over who are having the Comprehensive Nano shoulder replacement for suitable shoulder conditions, and who don't have certain infections.

What if I change my mind about participating?

You can withdraw from the study at any time without affecting your medical treatment or care.