Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
This study is looking at the long-term safety and performance of a medical device called the Infinity-Lock Button System. This system is already available and is used to treat shoulder dislocations, which happen when the collarbone separates from the shoulder blade. The device uses a strong tape and a small button to help stabilise the joint. Researchers will follow patients who have this device to see how they get on over several years. They want to make sure it continues to work well and is safe for people who have had their shoulder stabilised using this method. The study will involve observing patients over 4.5 years, including follow-up visits after their surgery.
At a glance
What is this study about?
This is a study designed to check on a medical device called the Infinity-Lock Button System. This system helps to stabilise your shoulder if you have a condition called acromioclavicular (AC) joint dislocation. This is where your collarbone separates from your shoulder blade, which can happen suddenly (acute) or over time (chronic). The Infinity-Lock Button System is already used in hospitals – it's made up of a strong, flexible tape and a small titanium button. The tape helps to hold the joint in place, and the button secures the tape.
The main goal of this study is to see how well this system performs over a long period, and to make sure it remains safe when used in real-world situations, just as the manufacturer intended. Researchers will be collecting information from patients who have already had this device fitted as part of their treatment at several different hospitals.
By following these patients for a few years, the study aims to gather important information about the device's lasting safety and effectiveness. This helps doctors and patients understand more about how devices work outside of controlled initial testing.
Key takeaways
- Checks a shoulder stabilisation device already in use.
- Focuses on long-term safety and how well it works.
- Involves follow-up appointments for 3 years.
- Suitable for adults aged 16 and over with specific shoulder dislocations.
- Participation requires willingness to attend follow-ups.
Who may be eligible?
To join this study, you need to be at least 16 years old. You must have been diagnosed with an AC joint dislocation, which is when your collarbone separates from your shoulder blade, whether it happened recently or a while ago. It's really important that you are willing to take part, understand what the study involves, and agree to attend the follow-up checks. You'll also need to give your written consent, which confirms you're happy to participate.
You wouldn't be able to join if you know you're allergic to any materials used in the implant. Also, if you have an infection or any other bone or soft tissue problems that might stop you from healing properly, or if you can't stick to the doctor's advice about limiting your activities or following a rehab plan during your recovery. If you're still growing, this device wouldn't be suitable as it could interfere with your growth.
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 16 years old or older?
- Have you been diagnosed with a shoulder dislocation involving your collarbone and shoulder blade?
- Are you able to attend follow-up appointments over 3 years?
- Do you have any known allergies to materials used in medical implants?
- Are you able to follow doctor's advice on recovery and rehabilitation?
What does participation involve?
If you join this study, you will already have received the Infinity-Lock Button System as part of your shoulder treatment. There isn’t a comparison group; everyone in the study will have the device. You will be asked to attend follow-up appointments at certain times after your procedure: at 3 months, 6 months, 1 year, 2 years, and 3 years. These appointments are designed to check on your recovery and how the device is performing. The study expects to follow each patient for 3 years after their surgery. The total length of the study from the first person joining until the last person finishes their follow-up is about 4.5 years.
Potential risks and benefits
Locations (4)
- East Kent Hospitals University NHS Foundation Trust,Verified postcodeCanterbury, United Kingdom· Recruiting
- Barts Health NHS TrustVerified postcodeLondon, United Kingdom· Recruiting
- Nottingham University HospitalsVerified postcodeNottingham, United Kingdom· Recruiting
- Royal Berkshire NHS Foundation TrustVerified postcodeReading, United Kingdom· Active not recruiting
Common questions
What is an AC joint dislocation?
It's when the collarbone (clavicle) separates from the shoulder blade (acromion), causing pain and sometimes a bump on top of the shoulder.
Is the Infinity-Lock Button System new?
No, it's a device that is already available and used in surgical procedures for shoulder dislocations. This study is checking its long-term performance.
How long will I be followed in the study?
If you join, you will be followed for 3 years after your surgery, with check-ups at specific times.
Do I have to take any special medication?
No, this study is about a surgical device, not a new medicine. You would just follow your usual post-surgery recovery plan.
Will I get the Infinity-Lock Button System if I join?
Yes, if you meet the criteria and choose to participate, you will receive the Infinity-Lock Button System as part of your treatment.
How to find out more
Lisa Cook
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.