Perform Humeral System Study
This study is checking how safe and effective a new type of shoulder implant, called the PERFORM™ Humeral System, is for people who have shoulder problems like arthritis or rotator cuff tears. It’s an international study that follows patients for up to 10 years after their surgery. Researchers will collect information on their pain levels, how well they can move their shoulder, and their overall quality of life. This helps ensure the implant is working well in the long term, and the information gathered can be used to improve future treatments and share with other doctors. It's a way to keep an eye on implants after they've been approved for use.
At a glance
What is this study about?
Imagine you're having trouble with your shoulder, perhaps from arthritis, a serious injury, or a severe tear in your rotator cuff muscles. Sometimes, these problems can be so bad that a doctor might suggest a shoulder replacement. This study is focused on a specific type of shoulder replacement called the PERFORM™ Humeral System.
The main goal of this study is to see how well this particular shoulder replacement works and if it's safe for patients over a long period. Researchers want to understand if it reduces pain, helps people move their arm better, and improves their general quality of life after surgery. They'll also be looking for any problems or side effects.
This isn't a study where a new, untested treatment is being tried out. Instead, it's a 'post-market' study, meaning the PERFORM™ Humeral System is already available, and this research helps gather more information on its long-term performance in real-world patients. The information collected will help doctors and manufacturers ensure the device continues to meet high standards and might even help improve shoulder replacement options in the future.
Key takeaways
- Checks how a specific shoulder replacement (PERFORM™ Humeral System) works long-term.
- Aims to understand safety, pain relief, and arm function after surgery.
- Involves regular check-ups for up to 10 years after the operation.
- Is for adults aged 18 and over with certain shoulder problems.
- Helps improve knowledge about shoulder replacements for future patients.
Who may be eligible?
To join this study, people generally need to be 18 years or older and be willing to give their clear permission to take part. You also need to be someone who your doctor thinks would benefit from a shoulder replacement using the PERFORM™ Humeral System and be able to keep up with the study appointments and tasks.
There are certain reasons why someone might not be able to join. For example, if you have an active infection, very weak bones that might not support the implant, or certain nerve or muscle problems around the shoulder. People who are pregnant or planning for a very specific type of two-stage surgery also wouldn't be able to participate. The study also needs to make sure that everyone joining can understand what's involved and is making their own decision to participate, without feeling pressured.
- Are you 18 years old or older?
- Are you able to agree to take part and follow study appointments?
- Do you have shoulder arthritis, avascular necrosis, an old shoulder injury, or a severe rotator cuff tear?
- Are you considered a good candidate for a shoulder replacement by your doctor?
- Do you *not* have an active infection, very weak bones around the shoulder, or specific nerve/muscle conditions in your arm?
- Are you *not* pregnant?
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 have check-ups at the time of your shoulder surgery using the PERFORM™ Humeral System. After that, you'll have appointments or checks once a year for up to 10 years. During these visits, doctors and nurses will ask you questions about your pain, how well you can use your arm, and your general feelings about your quality of life. They might also take X-rays to see how the implant is holding up. The overall commitment is to attend these annual follow-up appointments for up to 10 years after your surgery.
Potential risks and benefits
Locations (10)
- Baptist HealthcareLexington, United States· Recruiting
- Summit OrthopedicsEagan, United States· Recruiting
- Mayo ClinicRochester, United States· Terminated
- Washington UniversitySt Louis, United States· Active not recruiting
- Orthopedic InstituteSioux Falls, United States· Recruiting
- University of UtahSalt Lake City, United States· Recruiting
- Roth McFarlane Hand and Upper Limb CentreLondon, Canada· Active not recruiting
- Orthopedic Center SantyLyon, France· Active not recruiting
- Schulthess KlinikZurich, Switzerland· Active not recruiting
- Wrightington HospitalWigan, United Kingdom· Active not recruiting
Common questions
What kind of shoulder problems is this study looking at?
It's for people with shoulder issues like arthritis, problems with blood supply to the bone (avascular necrosis), shoulder damage from old injuries, or severe rotator cuff tears.
Is the shoulder replacement new or already used?
The PERFORM™ Humeral System is already available for use. This study is to follow up on how it works for patients over a long period.
How long will I be followed in the study?
You'll be followed for up to 10 years after your shoulder surgery, with annual check-ups.
Will I have more doctor visits than usual if I join?
Yes, you'll have yearly check-ups for up to 10 years specifically for the study, which might be more frequent than typical post-surgery follow-ups.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, and it won't affect the medical care you receive.
How to find out more
Meredith Schreier
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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