Bone Substitutes Outcomes - Post Market Follow-up
This study, called 'Bone Substitutes Outcomes - Post Market Follow-up,' is looking into how effective and safe TEKNIMED bone substitutes are. These products, like CERAFORM and TRIHA+, are used to fill gaps in bones that might come from surgery or injuries, or to help spine fusions. They've been used for many years, and previous studies have shown they work well and are safe. This new study aims to confirm these good results by looking at how they're used in everyday hospital settings across the world. It will involve looking back at patient records and following current patients to see how the bone substitutes perform over time as part of their standard care.
At a glance
What is this study about?
Imagine you have a gap in one of your bones, perhaps from an injury or surgery. Sometimes, surgeons need to fill these gaps to help your bone heal properly. They can use different materials for this, including synthetic bone substitutes – these are man-made materials designed to be like your own bone.
TEKNIMED makes several of these bone substitutes, which have names like CERAFORM, TRIHA+, and NANOGEL. They've been used for a long time, some for over 20 years, and previous information shows they are generally safe and work well. These materials are 'bioresorbable,' meaning your body gradually replaces them with new, healthy bone over time. They're also used in spine surgery, for example, to help with 'spine fusion,' where two or more bones in the spine are joined together.
This study is called a 'Post-Market Follow-Up' study. This just means it's happening after the products have been available to patients for some time. The main goal is to carefully check up on how these TEKNIMED bone substitutes are performing in real-life hospital situations. The study will gather information from patients who have already had these products, as well as those who will receive them in the future as part of their regular treatment. This helps make sure the products continue to be safe and effective.
Key takeaways
- This study reviews the safety and effectiveness of existing TEKNIMED bone substitutes.
- It collects 'real-world' data from patients receiving standard medical care.
- No changes to your treatment or extra appointments are involved.
- The goal is to confirm the good performance of these products for future patients.
- Participation helps improve understanding of bone substitute use.
Who may be eligible?
To be part of this study, you need to be 18 years old or older. If you're having an operation where one of these TEKNIMED bone substitutes is planned to be used, or if you've already had such an operation since January 2015, you might be included.
Before you're included, you'll either be asked to sign a consent form, or, if you're in France, you'll be informed about the study and have the chance to say if you don't want your information used.
However, some people cannot join this study. This includes those who are pregnant or breastfeeding, or if the product's instructions say it's not suitable for your specific procedure or if you're allergic to any of its ingredients. Also, those with certain severe bone problems that would impact the stability of the bone without other reinforcements (like plates or screws) might not be included for some of the products.
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?
- Are you having surgery where a TEKNIMED bone substitute is being used, or have you had one since January 2015?
- Are you NOT currently pregnant or breastfeeding?
- Do you NOT have an allergy to any part of the bone substitute product that will be used?
- Is your procedure compatible with the bone substitute product's instructions for use?
What does participation involve?
If you're already receiving standard medical care that involves a TEKNIMED bone substitute, your information might be included in this study. You won't have any extra appointments or assessments specifically for the study. Doctors will simply collect details about your treatment and recovery from your medical records, as part of your usual care. There are no additional medications or procedures involved just for being in this study. The follow-up will simply be as long as your regular medical care continues.
Potential risks and benefits
Locations (6)
- Pôle Rachis Hôpital Privé d'Eure et LoirVerified postcodeMainvilliers, France· Recruiting
- Hôpital Joseph DucuingVerified postcodeToulouse, France· Recruiting
- Clinique Médipole GaronneVerified postcodeToulouse, France· Recruiting
- CHRU BraboisVerified postcodeNancy, France· Recruiting
- Clinique du PréVerified postcodeLe Mans, France· Recruiting
- OCM Klinik GmbHVerified postcodeMünchen, Germany· Recruiting
Common questions
What are bone substitutes?
They are materials, often man-made, that surgeons use to fill gaps in bones or help with bone healing, for example in spine operations.
What does 'Post-Market Follow-Up' mean?
It means the study is checking how well a product works and its safety after it's already available for patients to use.
Will I have extra appointments or tests for this study?
No, you won't have any extra appointments, tests, or treatments. Doctors will just use information from your regular medical care.
Is this a new medicine or treatment?
No, this study is looking at existing bone substitute products that have been used for many years. It's not testing a new treatment.
Will my personal data be kept private?
Yes, all your medical information collected for the study will be handled carefully to protect your privacy.
How to find out more
Solange VAN DE MOORTELE, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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