Study on Safety and Performance of AdvanCore Bone Void Filler

Study on Safety and Performance of AdvanCore Bone Void Filler

The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

AdvanCore is a porous beta-tricalcium phosphate CE-marked medical device. It is intended to be used to aid in the bone regeneration process in situations where bone is damaged beyond the limits of its self-healing ability. The target population is constituted by adult subjects in need of bone grafting of mechanically unaffected, pathologic, or traumatic bone defects caused by surgery or trauma.

AdvanCore is produced in the shape of blocks, wedges, or granules in different sizes and is surgically placed into spaces between or around broken bone (fractures) or in holes (defects). The site to be augmented must be free from infection and free from soft or granulation tissue. AdvanCore must contact cancelous bone and may be pressed into the defect area by hand or shaped more accurately to fit the area. It can be used as is, impregnated with subjects' blood/ bone marrow and/ or mixed with medicinal substances under the responsibility of the qualified professionals.

AdvanCore acts as a temporary scaffold and is not intended to provide mechanical support during the healing process. Additional therapy for load-bearing (such as osteosynthesis) is indicated if the bone does not comply with the required biomechanical function.

The study on safety and performance of AdvanCore bone void filler will be conducted in European sites and include up to 190 subjects requiring bone implant surgery, which will be divided in 3 different groups:

• Group 1- This group is formed by those subjects with long-bone injuries. The treatment of this type of lesion may be performed using blocks, wedges, or granules.
• Group 2- Subjects included in this group suffer from spine injuries, which can be treated using granules.
• Group 3- Those subjects with maxillofacial injuries are included in this group. In this case, granules are used to treat the lesion.

The primary safety endpoint of this study is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of Adverse Events or Serious Adverse Events [(S)AEs] related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.

The primary performance endpoint will analyze the AdvanCore osteointegration after 6 months of surgery, studying the percentage of subjects with successful osteointegration at the defined time point. AdvanCore will be considered successfully osteointegrated when no presence of fibrotic tissue surrounding the implant is detected.

Secondary endpoints planned for this clinical investigation are listed below:

• Evaluation of (S)AEs related to the procedure;
• Evaluation of (S)AEs related to the device;
• Freedom of reintervention due to AdvanCore usage;
• AdvanCore osteointegration;
• AdvanCore resorption rate, assessed as the percentage of subjects with successful bone graft resorption.

The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk as possible for subjects.

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).