RecruitingOBSERVATIONAL

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

This study is a long-term review of shoulder replacement operations using devices made by FX Shoulder Solutions. It will follow patients for up to 10 years after their surgery to see how well these devices work in a real-world setting. Doctors want to understand if patients need further surgery, how much their shoulder can move, and how much pain they experience over time. They will also look at scan results, check for any problems, and gather feedback from surgeons. This information helps ensure these shoulder replacements are safe and effective for people suffering from conditions like osteoarthritis, broken shoulder bones, or other issues affecting the shoulder joint.

At a glance

Status

Recruiting

Sponsor

FX Solutions

Enrolment target

1,004

Start

01 Jun 2020

Estimated completion

01 Jun 2037

Humeral Fracture, Proximal Glenohumeral Osteoarthritis Avascular Necrosis of the Head of Humerus Rotator Cuff Tear Rotator Cuff Arthropathy Inflammatory Arthritis Revision of a Shoulder Prosthesis

What is this study about?

This study is like a long-term check-up for shoulder replacements. When a new medical device, like a shoulder implant, is widely used, it's important to keep track of how well it performs over many years. This particular study is looking at shoulder implants made by a company called FX Shoulder Solutions.

The main goal is to see how many people might need another operation on their shoulder after having one of these implants, up to 10 years later. This is called a 'revision rate'. But they're also interested in many other things, like how much movement people get back in their shoulder, how their pain changes, and if there are any other problems or complications.

Researchers will also look at X-rays or scans to see how the implant sits in the shoulder joint and ask surgeons what they think about the tools used during the operation. All this information helps doctors and manufacturers understand how these shoulder replacement systems perform in everyday use, ensuring they continue to be a good option for patients with shoulder problems.

Key takeaways

Study follows shoulder replacement patients for 10 years.
Mainly looks at long-term success and need for further surgery.
Data collected on pain, movement, and complications.
Helps understand real-world performance of existing implants.
You must be 18+ and need a specific shoulder replacement.

Who may be eligible?

To be able to join this study, you would need to be 18 years old or older. You must also have a specific shoulder problem, like a severe break in your upper arm bone, arthritis in your shoulder, or other long-term shoulder issues, that your doctor has decided requires a shoulder replacement using one of the FX Shoulder Solutions implants.

It's important that you have health insurance that covers you, and you must understand what the study involves and agree to take part. This means signing a consent form after a doctor explains everything.

There are also some reasons why you might not be able to join. For example, if you have a nerve condition that affects your shoulder's stability, or if you have severe obesity, or if your shoulder muscles are too weak, you might not be suitable for this particular study.

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?
Has your doctor recommended a shoulder replacement with an FX Shoulder Solutions implant?
Do you have health insurance / social security coverage?
Are you prepared to attend follow-up appointments for up to 10 years?
Do you not have nerve problems, severe obesity, or very weak shoulder muscles?

Answer every question to see your result.

What does participation involve?

If you join this study, it means that your medical information related to your shoulder replacement will be collected and followed for up to 10 years. This includes details from your surgery and regular check-ups.

You would have follow-up appointments at specific times after your operation: at 6 weeks, then 3 or 6 months, and then every year for the first three years. After that, you'd have appointments at 5, 7, and 10 years. At these visits, doctors will check how well your shoulder is moving, ask about your pain, and you might fill out some questionnaires about your shoulder function (like the Quick Dash or Constant scores). They will also look at X-rays to see how your implant is positioned and check for any problems. You won't be given any new medications specifically for the study; it's mostly about observing how you recover and how the shoulder replacement performs over time.

Potential risks and benefits

Taking part in this study means your medical information will contribute to a better understanding of how shoulder replacements work over time, which could help future patients. You will also receive regular follow-up care for your shoulder. As with any medical procedure, there are always potential risks linked to the surgery itself, which your surgeon will discuss with you. There are no additional medical risks from just being part of the study, as it mainly involves collecting information from your standard care. You are free to withdraw from the study at any time without affecting your medical treatment.

Locations (22)

CHU Amiens Picardie
Verified postcode
Amiens, France· Recruiting
CHU d' Angers
Verified postcode
Angers, France· Recruiting
Hôpital Jean Minjoz
Verified postcode
Besançon, France· Recruiting
Clinique Aguiléra
Verified postcode
Biarritz, France· Recruiting
Hôpital privé Saint-Martin
Verified postcode
Caen, France· Recruiting
Infirmerie Protestante
Verified postcode
Caluire-et-Cuire, France· Recruiting
CHMS Chambéry
Verified postcode
Chambéry, France· Recruiting
HÔPITAUX CIVILS de Colmar
Verified postcode
Colmar, France· Recruiting
Hôpital privé Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting
Clinique Saint Charles
Verified postcode
La Roche-sur-Yon, France· Recruiting
Clinique chirurgicale Porte Océane
Verified postcode
Les Sables-d'Olonne, France· Recruiting
Clinique Saint Charles
Verified postcode
Lyon, France· Recruiting

Common questions

What kind of shoulder problems does this study look at?

It looks at conditions like broken upper arm bones, severe arthritis, bone dying in the shoulder, and problems with the rotator cuff that need a shoulder replacement.

How long will I be followed if I join?

You'll be followed for up to 10 years after your shoulder replacement operation.

Will I have extra tests because of the study?

The study mostly collects information from your routine follow-up appointments, including movement checks, pain scores, and X-rays.

Can I leave the study if I change my mind?

Yes, you can decide to stop being part of the study at any time, and it won't affect your medical care.

Is this a new type of shoulder implant?

This study is reviewing shoulder implants that are already available and used by doctors, rather than testing a brand-new device.

How to find out more

Kathy TRIER, PhD

ktrier@fxshouldersolutions.com 800-280-0775 Official trial record

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