OrthoPureXT Multiligament PMCF Study
This study is checking a special type of tissue called OrthoPure XT, which is used for repairing serious knee ligament injuries. It's made from pig tissue that has been specially treated to be safe and suitable for implanting into a person's knee. The main goal is to carefully watch how well patients recover and if there are any unexpected problems after surgery. This is a follow-up study rather than a brand new treatment trial. By monitoring patients over time, researchers want to make sure the OrthoPure XT device continues to be safe and works as expected when used to fix different knee ligaments like the ACL or PCL.
At a glance
What is this study about?
Imagine your knee has been badly hurt, and several important ropes (ligaments) inside it are damaged. This study is about a special 'patch' called OrthoPure XT that surgeons can use to help repair these serious knee ligament injuries. This patch isn't a new medicine, but rather a specially prepared tissue from pigs. It's been treated so that it's safe to be put into your body and helps your own tissues heal and grow around it.
The main idea behind this study is to carefully watch people who have had this OrthoPure XT patch used in their knee surgery. Doctors want to make sure it continues to be safe and works well over time in different situations. They'll be looking out for any problems or unexpected issues that might come up after surgery to make sure it's a reliably good treatment for serious knee injuries.
Twenty-eight patients who need surgery for multiple knee ligament injuries will take part. They will be split into smaller groups, depending on which specific ligaments in their knee need repairing – for example, the main front ligament (ACL), the main back ligament (PCL), or ligaments on the sides (MCL and LCL). This helps doctors understand how OrthoPure XT performs for each type of injury.
Key takeaways
- This study is checking the safety and performance of OrthoPure XT for serious knee ligament injuries.
- OrthoPure XT is a specially treated pig tissue used as a 'patch' during surgery.
- The study focuses on monitoring patients after their surgery to ensure long-term effectiveness.
- It covers repairs for different knee ligaments, including the ACL, PCL, and side ligaments.
- You must be an adult with multiple knee ligament injuries and able to follow rehabilitation to join.
Who may be eligible?
To join this study, you need to be at least 18 years old, male or female, and have multiple knee ligament injuries. You should be able to understand and communicate with the study team, give your permission in writing to take part, and be willing to follow all the study steps, including a rehabilitation plan.
There are some reasons why you might not be able to join. For example, if you can't give your consent, have other serious injuries like open wounds, nerve damage, or a life-threatening condition. If an investigator thinks your other injuries or existing medical conditions would make it difficult to collect accurate information for the study, you might not be eligible.
Also, if you're pregnant or planning to get pregnant in the next year, you can't join. You also can't participate if you have an infection before surgery, are allergic to pig materials, or aren't able or willing to follow the post-surgery care and rehabilitation plan.
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?
- Do you have more than one damaged ligament in your knee?
- Can you clearly communicate and understand information about the study?
- Are you able and willing to follow a rehabilitation plan after surgery?
- Are you not currently pregnant or planning to become so in the next 12 months?
- Do you have no known allergy to pig materials?
What does participation involve?
This study is essentially a follow-up of your progress after surgery using the OrthoPure XT. While the document doesn't detail specific visit schedules, you would typically have several follow-up appointments with the study team and your surgeon. These appointments would involve checking your knee's healing, pain levels, and how well you can move and use your leg. You'll also need to commit to a rehabilitation program to help your knee recover fully. The total duration of your participation would likely span several months to a year or more, depending on the typical recovery time for your specific knee injury and the follow-up schedule designed to monitor long-term outcomes.
Potential risks and benefits
Locations (1)
- Royal Stoke University HospitalVerified postcodeStoke-on-Trent, United Kingdom· Recruiting
Common questions
What is OrthoPure XT?
It's a special type of 'patch' made from treated pig tissue, used by surgeons to help repair serious knee ligaments. It's designed to be safe and help your body heal.
Why is this study happening?
Doctors want to carefully watch how well patients recover after having OrthoPure XT used in their knee surgery. This helps ensure it's safe and effective over time.
Will I get different treatment if I join?
The study focuses on monitoring patients who are already having OrthoPure XT used in their surgery. It's about observing its performance, not testing a new kind of surgery.
Who can take part?
Adults aged 18 or over with multiple knee ligament injuries who can understand and follow the study instructions, and are not pregnant, can join.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without it affecting the medical care you receive for your knee injury.
How to find out more
Anna Kaniewska
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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