Active not recruitingOBSERVATIONAL

Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

This research is investigating a shoulder replacement system called the Trabecular Metal Reverse Shoulder System. It’s for people who need a shoulder replacement either for the first time or to replace an older one. The study wants to understand how long this new system lasts and how well it helps people with conditions like severe arthritis or very damaged rotator cuffs. Researchers will track pain levels, how well people can move their shoulder, and how their general health changes. They'll also look at X-rays and any health problems that might come up. This helps ensure the new shoulder system is a good option for improving patients' quality of life.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

200

Start

01 Jan 2011

Estimated completion

01 Dec 2026

Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Ununited Humeral Head Fracture Irreducible 3-and 4-part Proximal Humeral Fractures Avascular Necrosis Gross Rotator Cuff Deficiency Revision Total Shoulder Arthroplasty

What is this study about?

This study is all about a specific type of shoulder replacement surgery using something called the Trabecular Metal Reverse Shoulder System. You might be considering this surgery if you have severe shoulder pain and limited movement due to conditions like osteoarthritis, rheumatoid arthritis, an old injury that didn't heal right, or a badly damaged rotator cuff. Sometimes, this system is also used if a previous shoulder replacement needs updating.

Think of this study like a careful review. Researchers want to collect information on how well this particular shoulder replacement works in real life. They are especially interested in several key things: how long the new joint lasts inside the body (its 'survival'), whether it reduces pain, and if it helps people move their arm and shoulder better. They'll also keep an eye on your general health and comfort after the surgery.

To do this, they'll use various tools, including special questionnaires about your pain and arm function, looking at X-rays to check the joint's position, and recording any health issues that might occur. By gathering all this information, they can assess if the Trabecular Metal Reverse Shoulder System is performing as expected and if it's a good option for people needing shoulder surgery.

Key takeaways

This study evaluates a specific new shoulder replacement called the Trabecular Metal Reverse Shoulder System.
It aims to see how long the replacement lasts and how well it helps with pain and movement.
You might be eligible if you have severe shoulder arthritis or extensive rotator cuff damage.
Participation involves surgery, physiotherapy, and follow-up appointments.
There are potential benefits of pain relief and improved function, but also surgical risks.
Your decision to join is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 years old and your bones must have finished growing. You'd be eligible if you're a candidate for a new shoulder replacement or need to replace an existing one, specifically for problems like severe arthritis (osteoarthritis or rheumatoid), a shoulder broken in a bad way, or serious damage to your rotator cuff.

There are also some important things that would mean you couldn't join. For example, if you're pregnant, have a serious infection, are a heavy drinker or drug user, or can't understand what the study involves, you wouldn't be able to participate. Also, if you have nerve damage in your arm that would make the surgery pointless, or if you're allergic to the materials used in the replacement, you wouldn't be suitable.

Quick self-check

Are you over 18 years old?
Do you have severe shoulder arthritis or a badly damaged shoulder that might need replacing?
Are you able and willing to attend follow-up appointments and do physiotherapy?
Are you not pregnant and do not have a current infection?
Do you understand what taking part in a study involves?

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, you'll first have a detailed discussion about the study and sign a consent form. You'll then undergo the shoulder replacement surgery with the Trabecular Metal Reverse Shoulder System. After the operation, you'll need to follow a specific physiotherapy programme. You'll also be asked to attend scheduled follow-up appointments, which will involve filling out questionnaires about your pain and how well your shoulder is working, and having X-rays taken. Any health issues or changes will also be recorded. The total duration of your participation will depend on the study's follow-up schedule.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of a new shoulder replacement aimed at reducing pain and improving function. However, as with any surgery, there are risks, including infection, pain, and other complications. The new joint might not perform as expected, or it might need to be removed in the future. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

University of California, San Francisco
San Francisco, United States
Norton Orthopaedic & Sports Medicine
Louisville, United States
The Rothman Institute
Egg Harbor, United States
The Rothman Institute
Philadelphia, United States
Royal Blackburn Hospital
Blackburn, United Kingdom

Common questions

What is a 'reverse' shoulder replacement?

In a reverse shoulder replacement, the ball and socket parts of your shoulder are switched around. This design works better for people with very damaged rotator cuff muscles.

What does 'Trabecular Metal' mean?

Trabecular Metal is the special material the shoulder replacement is made from. It's designed to be strong and allow your bone to grow into it, helping the replacement stay firmly in place.

Will I have to pay to be in this study?

Clinical trials are generally free for participants in the UK, but you should always check with the study team about any potential costs or travel expenses.

How often will I need to visit the hospital?

You will have regular follow-up appointments after surgery. The exact number and timing of these visits will be explained in detail by the study team.

What happens if this new shoulder replacement doesn't work for me?

The study team will monitor your progress closely. If the replacement isn't working or causes problems, they will discuss your options and further treatment with you.