RecruitingNAINTERVENTIONAL

Clinical Outcomes Study of the Nexel Total Elbow

This study is investigating a specific type of artificial elbow joint called the Zimmer Nexel Total Elbow. The main goal is to understand if it's both safe and effective for people who need either their first elbow replacement or a replacement for an existing one that isn't working well. This elbow replacement might be considered if you have severe elbow problems like arthritis, joint damage from an injury, or very stiff joints that make daily activities difficult. Doctors will be carefully monitoring how patients recover, checking things like pain levels, how well they can move their arm, and how long the new joint lasts. They will also look for any side effects.

At a glance

Status

Recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

134

Start

01 Jun 2015

Estimated completion

01 Dec 2036

Elbow Joint Destruction Post-traumatic Lesions Ankylosed Joints Advanced Rheumatoid Arthritis Joint Instability or Loss of Motion Acute Comminuted Articular Fracture of Elbow Joint Surfaces Bone Loss Contributing to Elbow Instability Bilateral Ankylosis From Causes Other Than Active Sepsis Post-traumatic Arthritis Degenerative Arthritis

What is this study about?

This study is all about a new type of artificial elbow joint called the Zimmer Nexel Total Elbow. When your elbow joint is severely damaged, perhaps from arthritis, a bad injury, or stiffness that makes it hard to use your arm, an elbow replacement operation might be an option to help relieve pain and improve movement. This study aims to find out how well this particular joint works in people who have had it implanted and if there are any problems with it.

Researchers want to make sure that this new elbow joint is both safe and helps people. They'll be looking carefully at how patients feel after the operation – for example, if their pain has improved and if they can move their arm better. They will also use X-rays to see how the joint settles in and check for any unexpected issues.

By gathering this information, doctors can better understand whether the Zimmer Nexel Total Elbow is a good and reliable option for people needing an elbow replacement. This is important for ensuring that patients get the best possible treatment for their elbow problems.

Key takeaways

This study evaluates a specific elbow replacement called the Zimmer Nexel Total Elbow.
It aims to confirm the safety and performance of the device.
Suitable for adults (18+) needing elbow replacement for severe conditions.
Requires follow-up visits to monitor joint function and overall health.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. You would also need to be a candidate for an elbow replacement operation, either for the first time or if you're having an old one replaced. This usually means you have severe elbow problems that make everyday tasks hard, such as bad pain from arthritis, joint damage from an injury, or very stiff joints.

There are also some reasons why you might not be able to join. For example, if you have an active infection in your body or around the elbow, or if you have severe scarring that might cause problems with the surgery. If your hand on the same side as the problem elbow has severe difficulties, or if you have certain nerve problems affecting your elbow, you might not be eligible.

Quick self-check

Are you 18 years old or older?
Are you needing an elbow replacement, either for the first time or as a replacement for an old one?
Do you have severe elbow pain, stiffness, or damage that affects daily life?
Do you have any active infections or severe scarring near your elbow?
Have you been told you have bad hand function or nerve problems on the same side as your problem elbow?

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, you'll first have an elbow replacement operation with the Zimmer Nexel Total Elbow. After your surgery, doctors will regularly check your progress. This will involve appointments where they will ask you about your pain and how well you can use your arm. They'll also take X-rays to see how the new joint is doing. You'll need to be willing to attend these follow-up appointments as scheduled by the study team. The total duration of your participation will depend on the study plan, but it will involve continued monitoring of your new joint and your health.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be receiving a new elbow joint designed to improve your pain and movement. However, like any surgery, elbow replacement carries risks such as infection, problems with healing, or issues with the implant itself. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Panorama Orthopedics and Spine Center
Golden, United States· Recruiting
OrthoCarolina Research Institute
Charlotte, United States· Recruiting
Rothman Institute
Philadelphia, United States· Recruiting
Campbell Clinic
Germantown, United States· Recruiting
Sydney Shoulder & Elbow, NSW
Sydney, Australia· Terminated
Coxa Hospital
Tampere, Finland· Recruiting
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse, France· Terminated
Arcus Sportklinik
Pforzheim, Germany· Terminated
AO Mauriziano
Torino, Italy· Recruiting
Amphia Ziekenhuis Breda
Breda, Netherlands· Active not recruiting
Wrightington
Wigan, United Kingdom· Recruiting

Common questions

What is the purpose of this study?

The study aims to check how safe and effective the Nexel Total Elbow replacement is for people needing elbow surgery.

Who can join this study?

Adults aged 18 or over who need an elbow replacement due to severe elbow problems like arthritis, injury, or stiffness, and who meet other specific medical criteria.

What kind of elbow problems does this study address?

It's for severe problems like advanced arthritis, elbows damaged by injury, stiff joints, or where bones are missing or broken leading to instability.

Will I have to take any special medication?

No, this study is about the elbow joint itself, not a specific medication. You'll have the standard care for an elbow replacement.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and it won't affect your ongoing medical care.

How to find out more

Richard Marek

richard.marek@zimmerbiomet.com 574-453-7567 Official trial record

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