Study on Safety and Performance of AdvanCore Bone Void Filler
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 7
- 主要终点
- Freedom of bone reintervention (safety)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Freedom of bone reintervention (safety)
时间窗: 6 months post-surgery
The primary safety endpoint is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of (S)AEs related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
Successful osteointegration (performance)
时间窗: 6 months post-surgery
The primary performance endpoint will analyze the AdvanCore integration at 6 months of surgery. This process is defined as osteointegration, which refers to the direct structural and functional connection of the living bone with the surface of the implant. The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. In this regard, the primary performance endpoint will be analyzed by considering the percentage of subjects with successful osteointegration at the defined timeline. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
次要结局
- Evaluation of Adverse Events or Serious Adverse Events [(S)AEs] related to the procedure (safety)(30-days post-surgery)
- Evaluation of (S)AEs related to the procedure (safety)(12 months post-surgery)
- Evaluation of (S)AEs related to the device (safety)(12 months post-surgery)
- Freedom of reintervention (safety)(12 months post-surgery)
- Successful osteointegration (performance)(12 months post-surgery)
- Successful resorption (performance)(12 months post-surgery)