Bone Substitutes Outcomes - Post Market Follow-up

Launched by TEKNIMED · Apr 16, 2024

Keywords

ClinConnect Summary

The Bone Substitutes Outcomes study is looking at the safety and effectiveness of TEKNIMED’s bone substitute products, which are used to help with bone resorption, or the loss of bone. This study is important because these products have been used for over 20 years, and the researchers want to gather more information about how well they work in real-life medical situations. Participants will either be those who are about to have surgery needing a bone substitute or those who have already had such a surgery since January 2015.

To be part of this study, you need to be at least 18 years old and willing to share your medical information. The study is open to everyone, regardless of gender, and is currently recruiting participants. If you join, you’ll be followed up by your local healthcare provider to ensure everything goes smoothly. However, individuals who are pregnant, breastfeeding, or have certain allergies won’t be eligible. This study aims to provide more evidence about the use of these bone substitutes, helping to ensure they are safe and effective for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be 18 years or older.
• • Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and
• o For prospective inclusion:
• • Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.
• o For retrospective inclusion:
• • Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 and the date of the site initiation visit
• • Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.
• Exclusion Criteria:
• Patients presenting one of the following conditions will not be included:
• • Under trusteeship or guardianship
• • Pregnancy or breast-feeding women
• According to contraindications per IFU:
• • Procedures other than those stated in the INDICATIONS section
• • Patients susceptible to allergic reactions to the product components.
• CERAFORM®, TRIHA+®:
• • - Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))
• NANOGEL®:
• • Use in vertebroplasty procedures
• • Subcutaneous use