Active not recruitingOBSERVATIONAL

Anatomical Shoulder Domelock System Study

This study is focused on a new shoulder replacement system called the Anatomical Shoulder Domelock. The main goal is to see if this system is safe and performs effectively when used for shoulder replacement surgery, either a full (total) or partial (hemi) replacement. This surgery is typically for people experiencing severe shoulder pain and difficulty moving their arm due to conditions like arthritis, damage from previous operations, or a problem called avascular necrosis. Researchers will monitor patients through special scoring systems, X-rays, and by recording any problems that might occur. They want to make sure the new system helps improve patients' comfort and movement the way it should, allowing them to get back to their daily lives with less pain.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

Start

28 Sep 2017

Estimated completion

09 Dec 2032

Avascular Necrosis Revision Surgery Conditions Consequent to Earlier Operations Arthritis, Rheumatoid Arthritis, Degenerative Arthritis;Traumatic

What is this study about?

Imagine your shoulder joint is like a ball and socket, allowing you to move your arm in many directions. For various reasons, such as arthritis (wear and tear), previous injuries, or a condition called avascular necrosis where the bone tissue dies, this joint can become very painful and difficult to move. When other treatments like medicine or physical therapy haven't helped, a shoulder replacement might be an option. This is where surgeons replace parts of the damaged joint with artificial ones.

This particular study is looking into a new design for shoulder replacements called the Anatomical Shoulder Domelock System. The team behind this research wants to make sure this new system is both safe for patients and does a good job of restoring movement and reducing pain. They're gathering information from patients who have already had this system implanted (retrospective) and from new patients receiving it now (prospective).

Doctors participating in the study are experts in shoulder surgery. They will carefully check how patients are doing after their operation using special assessment scores, X-rays to look at the joint, and by keeping records of any side effects or problems. The aim is to confirm that the Anatomical Shoulder Domelock System is a reliable and effective option for people needing shoulder replacement surgery, helping them to live more comfortably with better use of their arm.

Key takeaways

This study evaluates a new shoulder replacement system.
It aims to confirm the system's safety and effectiveness for shoulder pain.
You must have severe shoulder pain not helped by other treatments.
Monitoring involves check-ups, X-rays, and pain assessments.
Participation includes surgery and follow-up, but you can withdraw anytime.

Who may be eligible?

To be part of this study, you generally need to be between 18 and 80 years old and have stopped growing. You should be experiencing severe shoulder pain and have trouble using your arm, and your doctor must believe you need a shoulder replacement (either a partial or full replacement) because other treatments haven't worked. This pain might be due to conditions like severe arthritis, problems from a previous operation, or a condition called avascular necrosis.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you would not be able to participate. Also, if there are concerns that your bone might not be strong enough to support the new joint, or if you have specific physical disabilities or other health problems that the doctors feel would make the study unsafe or unsuccessful for you, you wouldn't be eligible. It's also vital that you are able and willing to attend follow-up appointments and understand what is involved in the study.

Quick self-check

Are you between 18 and 80 years old?
Do you have severe shoulder pain and trouble using your arm?
Have regular treatments (like pain medicine or physical therapy) not worked for your shoulder pain?
Are you able and willing to attend follow-up appointments?
Are you not pregnant or breastfeeding?

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

What does participation involve?

If you join this study, your doctor will replace part or all of your shoulder joint with the new Anatomical Shoulder Domelock System, just as they would with a standard shoulder replacement. After your surgery, you'll have regular check-ups with your medical team. These appointments will involve your doctor asking you questions about your pain and how well you can use your arm. They'll also use special scoring systems to measure your progress and take X-rays to see how the new joint is doing inside your body. Any problems or side effects will be carefully recorded. The total duration of your participation will depend on the study's follow-up schedule, but it's mainly about monitoring your recovery and the performance of your new shoulder over time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit of this study is that you would receive a new shoulder replacement system which researchers hope will effectively relieve your pain and improve your shoulder movement. However, as with any surgery, there are risks, such as infection, problems with healing, or issues with the new joint. The research team will explain all the known risks associated with the surgery and the device. You have the right to withdraw from the study at any time, even after you've started, without it affecting your medical care.

Locations (6)

Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Krankenhaus Maria Hilf
Daun, Germany
HELIOS ENDO-Klinik Hamburg
Hamburg, Germany
Univeritätklinik Bagrist
Zurich, Switzerland
Universitätsspital Basel
Basel, Switzerland
Royal Derby Hospital
Derby, United Kingdom

Common questions

What is avascular necrosis?

Avascular necrosis is a condition where bone tissue dies because it doesn't get enough blood. This can lead to tiny breaks in the bone and cause the bone to collapse, often affecting joints like the shoulder.

What's the difference between hemi and total shoulder replacement?

A hemi shoulder replacement replaces only the 'ball' part of the shoulder joint, while a total shoulder replacement replaces both the 'ball' and the 'socket' parts of the joint.

Will I know if I'm getting the new system?

Yes, if you participate in this study, the Anatomical Shoulder Domelock System will be used for your shoulder replacement surgery.

Is this system still being tested?

This study is gathering more information on the safety and performance of the Anatomical Shoulder Domelock System in real-world use.

What if I change my mind about being in the study?

You can decide to leave the study at any time, for any reason, without it affecting your ongoing medical care.