Study on Safety and Performance of AdvanCore Bone Void Filler

Launched by ARTUR SALGADO SA · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on studying the safety and effectiveness of a new product called AdvanCore, which is used as a bone graft to help heal bone fractures, defects, or loss. The study will follow participants for 12 months to see how well the AdvanCore implant works in real-life situations. It is important to note that this trial is not yet recruiting participants, and it aims to meet certain regulations required for use in Europe.

To be eligible for this study, participants must be adults aged 18 or older who need a bone grafting procedure due to a bone issue that their body cannot heal on its own. They should also be willing to provide informed consent and participate in all required tests. However, some individuals may not qualify if they have certain medical conditions, allergies to the product, or are pregnant or breastfeeding. If you decide to participate, you can expect regular follow-ups and testing to monitor your progress with the AdvanCore implant over the one-year period.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult subjects ≥ 18 years old, male or female.
• • Subjects who are eligible for a bone grafting/bone void filler procedure.
• • Subjects with bone lesions beyond the limits of the bone's self-healing ability.
• • Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
• • Subjects with only one fracture susceptible to treatment with an AdvanCore implant.
• Exclusion Criteria:
• • Subjects with any AdvanCore contraindication for implantation or use.
• • Subjects with hypersensitivity to any of the AdvanCore components.
• • Subjects with infections or soft/granulation tissue in the area to place bone graft.
• • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
• • Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).