Active not recruitingOBSERVATIONAL

Post Market Clinical Follow-Up TOUCH® CMC 1

This study is focused on a new type of artificial thumb joint, called the Touch® CMC 1. Many people experience severe pain and weakness in their thumb due to arthritis, which can make everyday tasks difficult. When other treatments don't work, surgery to replace the joint in the thumb base is a common solution. The Touch® CMC 1 is designed to fit without cement and has a special movable part. The main goal of this study is to check how well this new joint replacement works and how safe it is for people who have it fitted. We'll be looking at its performance and safety over a long period to make sure it functions as intended.

At a glance

Status

Active not recruiting

Sponsor

Keri Medical SA

Enrolment target

216

Start

22 Nov 2019

Estimated completion

01 Dec 2031

Osteoarthritis Thumb

What is this study about?

If you have arthritis in the base of your thumb, you might know how painful it can be and how it can make simple tasks like gripping or pinching very difficult. This part of the thumb is a common area for arthritis to become so severe that surgery is considered. The current study is observing a new type of artificial joint replacement called the Touch® CMC 1, which is designed to replace the worn-out joint at the base of the thumb.

The Touch® CMC 1 is a special kind of joint replacement that doesn't use cement to fix it in place. It's made up of a few different parts that work together to mimic your natural joint movement. The hospital wants to understand how well this new joint works in real-life situations and if it's safe for people who receive it. This means they'll be tracking people over time to see if their pain improves, if they can use their hand better, and if there are any unexpected problems.

The main goal is to make sure this new thumb joint replacement performs as it should and continues to be a safe option for patients in the long run. By studying it carefully, doctors can learn more about its benefits and any potential drawbacks, which helps ensure the best care for people with thumb arthritis.

Key takeaways

The study is about a new thumb joint replacement called Touch® CMC 1.
It aims to check the safety and performance of the implant for people with thumb arthritis.
The study involves long-term follow-up after the surgery.
Participants must have significant thumb arthritis pain and be scheduled for the implant.
It's an observational study, meaning no new treatments or medications are given.

Who may be eligible?

This study is looking for adults aged 18 or older who have arthritis at the base of their thumb, specifically cases that range from mild to severe (Dell classification I-IV). You should also be experiencing significant pain, scoring more than 3 on a pain scale, and be scheduled to have the Touch® CMC 1 prosthesis fitted to replace your thumb joint.

However, there are certain situations where you wouldn't be able to join the study. For example, if you are pregnant, or if your general health means you can't have surgery. If you have certain ongoing infections, severe muscle, nerve, or blood vessel problems affecting your thumb joint, or if your bones are too weak or damaged for the implant to be properly fixed, you would not be able to participate. Also, if the size of your bones isn't right for the implant, or if you have specific allergies to materials like chromium, cobalt, or nickel, you wouldn't be eligible.

Other reasons for not being able to join include having certain related conditions like specific arthritis in nearby wrist bones, needing to have a previously fitted thumb joint replacement redone, or if you've had a steroid injection in your thumb joint within three months of the planned surgery. If you have a condition that makes it hard to follow doctor's instructions, you would also not be able to take part.

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 18 years old or older?
Do you have arthritis at the base of your thumb causing pain?
Are you scheduled to have the Touch® CMC 1 joint replacement surgery?
Are you generally healthy enough to have surgery?
Do you not have any severe infections or bone problems in your hand?

Answer every question to see your result.

What does participation involve?

This study involves observing patients who are already having the Touch® CMC 1 joint replacement surgery for their thumb arthritis. After your surgery, doctors will regularly monitor your progress over many years. This will involve appointments where they will check how your thumb is feeling and working, assess your pain levels, and ensure the new joint is performing safely. There won't be any extra medication involved, as the study is simply observing the standard use of the new joint replacement. The total duration of your participation will cover both the short-term recovery and the long-term performance and safety of the Touch® prosthesis, aligning with its expected lifespan.

Potential risks and benefits

Taking part in this study means you'll be among the first to have your experience with the new Touch® CMC 1 joint replacement closely monitored, potentially contributing to better care for others with thumb arthritis in the future. The potential benefits for you include relief from severe pain and improved ability to use your hand, as expected from the surgery. However, as with any surgery, there are potential risks, such as those related to the operation itself, or the chance that the implant might not work as planned or could cause problems over time. You have the right to withdraw from the study at any point without affecting your medical care.

Locations (6)

Centre de la main du Pays d'Aix
Verified postcode
Aix-en-Provence, France
Clinic of Chataigneraie
Verified postcode
Beaumont, France
Orthopaedics and Trauma Surgery Practice
Verified postcode
Bezannes, France
Médipôle De Savoie
Verified postcode
Challes-les-Eaux, France
Medical Office of Dr TCHURUKDICHIAN
Verified postcode
Dijon, France
Medical Office Archimed
Verified postcode
Lesquin, France

Common questions

What is the Touch® CMC 1?

It's a new artificial joint designed to replace the worn-out joint at the base of your thumb if you have arthritis.

Why is this study happening?

The study wants to check how well and safely the new Touch® CMC 1 joint works for people with thumb arthritis over time.

Will I have to take any extra medicines for the study?

No, this study is about observing the joint replacement itself, not about new medications.

Who can take part in this study?

Adults aged 18 or over with moderate to severe thumb arthritis pain who are having the Touch® CMC 1 joint replacement.

How long will I be followed up?

You will be followed up for a long time, both short-term after surgery and over many years, to see how the joint performs.