Active not recruitingOBSERVATIONAL

Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

This study is gathering information on a type of shoulder replacement called the Sidus Stem-Free Shoulder. It's for people in the UK experiencing severe shoulder pain and disability due to conditions like osteoarthritis or rheumatoid arthritis, who need a shoulder replacement. Doctors want to check how safe and effective this new shoulder implant is after it's been used in patients. They will look at whether it helps relieve pain, improves shoulder movement, and how long the implant lasts. They'll also check for any problems that might come up. This isn't a new experimental treatment; it's about carefully following patients who receive this already available implant in routine surgery.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

152

Start

01 Oct 2012

Estimated completion

01 Mar 2026

Non-inflammatory Degenerative Joint Disease (NIDJD)Avascular Necrosis Osteoarthritis Inflammatory Joint Disease (IJD)Rheumatoid Arthritis

What is this study about?

Imagine your shoulder joint is causing you a lot of pain and making it hard to move your arm, perhaps due to conditions like arthritis where the joint surfaces wear away. When other treatments haven't helped, a doctor might suggest a shoulder replacement. This study is focused on a specific type of shoulder replacement called the Sidus Stem-Free Shoulder.

The main goal of this study is to carefully watch how well the Sidus Stem-Free Shoulder works after it has been used in patients. This isn't a trial of a completely new, experimental device; instead, it's about collecting more information on its long-term safety and performance in real-world use. Doctors want to confirm that it's safe, helps reduce pain, improves how you can use your arm, and lasts a long time.

They will be looking at various aspects, such as how often any problems occur, how long the implant stays in place and functions properly, how much pain relief patients experience, and how well they can move their shoulder. They will also assess the patient's general quality of life. This information helps assure everyone that the implant is a good option for people needing shoulder replacement surgery for conditions like severe osteoarthritis or other degenerative joint problems.

Key takeaways

This study is collecting long-term data on the Sidus Stem-Free Shoulder replacement.
It aims to confirm the safety and effectiveness of the implant for shoulder conditions like arthritis.
Participation involves routine shoulder replacement surgery and follow-up appointments for up to 10 years.
The study evaluates pain relief, shoulder movement, and overall quality of life.
You must be between 18 and 80 years old with severe shoulder pain to be considered.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 80 years old with fully grown bones. You should be experiencing severe shoulder pain and disability that requires shoulder replacement surgery, and other treatments you've tried haven't worked.

The specific reasons for your shoulder problems might include certain types of arthritis, like osteoarthritis or rheumatoid arthritis (as long as it hasn't caused significant bone defects in your arm), or a condition where the bone tissue in your arm dies (avascular necrosis).

There are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if your bones are too soft or weak to hold the implant securely. Certain other shoulder problems, like severe nerve damage to the joint, an active infection, or significant damage to the shoulder's tendons, would also mean you couldn't take part. You also need to be willing and able to attend all the scheduled follow-up appointments.

Quick self-check

Are you between 18 and 80 years old?
Do you have severe shoulder pain and difficulty moving your arm?
Have other treatments for your shoulder pain not worked?
Are you able and willing to attend follow-up appointments for up to 10 years?
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, you will undergo standard shoulder replacement surgery using the Sidus Stem-Free Shoulder. Before your operation, doctors will take measurements, and conduct physical exams and X-rays, and you'll be asked to complete questionnaires about your quality of life. After your surgery, you'll have similar assessments immediately after the operation and then at regular intervals over a long period.

These follow-up appointments are scheduled at 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, and 10 years after your surgery. These visits will involve physical examinations, X-rays to check the implant, and you'll complete questionnaires to assess your pain, shoulder function, and overall quality of life. The study aims to follow you for up to 10 years to gather comprehensive long-term information.

Potential risks and benefits

Participating in this study means you will receive a shoulder replacement which aims to relieve your pain and improve your shoulder movement. The primary benefit of the study is helping doctors gather more information on the long-term effectiveness and safety of this implant, which can benefit future patients. As with any surgery, there are potential risks, including those associated with anaesthesia, infection, bleeding, and complications related to the implant itself, such as loosening or wear. You will be fully informed of all potential risks of the surgery by your medical team. You are free to withdraw from the study at any time without affecting your medical care.

Locations (8)

AKH Linz
Linz, Austria
Groupe Chirurgical Thiers
Grenoble, France
Centre Hospitalier Universitaire Toulouse
Toulouse, France
Charité
Berlin, Germany
Orthopaedische Chirurgie Muenchen
Munich, Germany
Gemeinschaftspraxis am Wall
Rinteln, Germany
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
New Royal Infirmary of Edinburgh
Edinburgh, United Kingdom

Common questions

What is a 'stem-free' shoulder replacement?

It's a type of shoulder replacement where the part that goes into your upper arm bone doesn't have a long 'stem' like some traditional implants. It usually fits more closely to the end of the bone.

Is this a new, experimental surgery?

No, the Sidus Stem-Free Shoulder is already in use. This study is collecting more long-term information on how well it works and its safety in patients who receive it.

How long will I need to be in the study?

You will have follow-up appointments for up to 10 years after your surgery to monitor the implant's performance and your recovery.

What kind of conditions is this treatment for?

It's for severe shoulder pain and disability caused by conditions like osteoarthritis, rheumatoid arthritis, or avascular necrosis, when other treatments haven't helped.

Do I have to take part if my doctor offers it?

No, participating is completely voluntary. You will be given full information to help you decide, and your decision won't affect your medical care.