Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
This study is checking a medical device called Poly-Tape, used for people whose kneecap repeatedly slips out of place. This happens when a key ligament in the knee, called the Medial Patellofemoral Ligament (MPFL), isn't working properly. The Poly-Tape devices are designed to help reconstruct this ligament. Researchers want to see if these devices are safe and effective over many years. They will follow 59 patients who have had this surgery, checking their progress over five years. The aim is to understand how well the Poly-Tape devices help patients in the long term, ensuring they perform as expected for this important knee repair.
At a glance
What is this study about?
If your kneecap (patella) keeps slipping out of place, doctors call this Medial Patellofemoral Dislocation. It can be quite painful and make it hard to move your knee properly. Often, this happens because a strong band of tissue that holds your kneecap in place, called the Medial Patellofemoral Ligament (MPFL), has become stretched or damaged. When this ligament doesn't work well, your kneecap can move too far to the side.
To help fix this problem, surgeons sometimes use a medical tape to reconstruct or repair the MPFL. This study is looking at two specific types of these tapes, called 10mm Poly-Tape and 5mm Infinity-Lock Tape. These tapes are already approved for use, and this research is a 'Post-Market Clinical Follow-up' study. This means the tapes are already in use, and now doctors want to gather more information about how well they perform and how safe they are over a longer period, specifically five years after surgery.
By carefully following patients who receive these tapes, the study aims to confirm that they continue to work safely and effectively over many years for people recovering from kneecap dislocations. This information helps doctors understand the best ways to treat this condition and ensures patients are getting the best care possible.
Key takeaways
- This study is for people whose kneecap keeps slipping.
- It checks how well special medical tapes work long-term to fix a knee ligament.
- Participants will be followed for five years after their surgery.
- It helps doctors understand the best way to treat kneecap dislocations.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be part of this study, you need to be at least 13 years old and have been recommended for surgery to fix your MPFL ligament because your kneecap keeps dislocating. You must also be willing to take part, understand what the study involves, and agree to attend all the follow-up appointments.
There are some reasons why you might not be able to join. For example, if you are very young and still growing, these devices might not be suitable because they don't stretch as you grow. Also, if you know you're allergic to metals like titanium or materials like polyester, or if you have an infection or a bone condition that could affect healing, you wouldn't be able to participate.
It's also important that you're able and willing to follow your doctor's advice about limiting your activities and doing rehabilitation exercises after your surgery. The tapes are meant to be a permanent part of your body once implanted and integrate with your own tissues, so if you needed a temporary fix, this wouldn't be the right choice.
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 13 years old or older?
- Has your doctor recommended MPFL reconstruction surgery?
- Are you able to attend follow-up appointments for five years?
- Are you willing and able to follow rehabilitation instructions?
- Do you have any known allergies to titanium or polyester?
What does participation involve?
If you decide to join this study, you will be one of about 59 patients having surgery to reconstruct your MPFL using either the 10mm Poly-Tape or 5mm Infinity-Lock Tape. After your surgery, you'll have several follow-up appointments. These will happen at 6 weeks, 6 months, 1 year, 2 years, and 5 years after your operation. During these appointments, doctors will check your knee, and you'll complete questionnaires about how you're feeling and how your knee is working. The study is planned to last for a total of seven years, but your direct involvement with follow-up appointments will be for five years after your surgery.
Potential risks and benefits
Locations (5)
- James Paget University Hospitals NHS Foundation TrustVerified postcodeGreat Yarmouth, United Kingdom
- Tameside and Glossop Integrated Care NHS Foundation TrustVerified postcodeManchester, United Kingdom
- University of North Midlands NHS TrustVerified postcodeStoke-on-Trent, United Kingdom
- Hampshire Hospitals NHS Foundation TrustVerified postcodeWinchester, United Kingdom
- Somerset NHS Foundation TrustVerified postcodeYeovil, United Kingdom
Common questions
What is an MPFL reconstruction?
It's a surgery to rebuild a torn or damaged ligament in your knee (the Medial Patellofemoral Ligament) that helps keep your kneecap in place.
What are Poly-Tape devices?
They are special medical tapes used by surgeons to help recreate or strengthen ligaments and tendons, in this case, the MPFL in your knee.
Will I get paid to be in the study?
The study information doesn't mention payment for participation. You should discuss this with the study team if it's a concern.
How long will I be followed in the study?
You will have follow-up appointments for five years after your surgery.
Can I leave the study if I change my mind?
Yes, you have the right to withdraw from the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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