Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biomatlante
- 入组人数
- 3
- 试验地点
- 8
- 主要终点
- Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery)
研究概览
简要总结
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.
详细描述
A lot of osseous substitution products were already used to fill osseous defects in order to prevent losses of osseous that are envisaged and so prejudicial.
Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their osteoconduction potential in human at different sites. But it is difficult to put these granules in very little place.
The injectable form of calcium phosphate granules "ready to use" is easier to be used and allow a diminution of the risk of infection during surgery, and permit homogeneity of the biomaterial.
Injectable form of calcium phosphate granules did already has shown his biocompatibility and biofunctionality in animals.
The purpose of this study is to study the biocompatibility and biofunctionality of this biomaterial in his injectable form in fillings of little losses of osseous substance from various origins were no charge will act to the biomaterial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medium osseous defects (inferior to 20 cc) without articular communication
- •Patients without a personal medical history of bone infection, cancer, diabetes, tuberculosis, and in general, any pathology which could interfere with the results of the study or expose the patient to additional risk
- •Patients without drepanocytosis, or congenital or acquired immunizing deficit
- •Patients who have the benefit of a social security system, a previous medical exam and who were informed and gave free consent about this study
排除标准
- •Proven nicotinism and alcoholism
- •Pregnant or nursing women
- •Patients who received another study drug or another study device in the past 3 months or patients who will be included in another clinical study
- •If postoperative follow-up for a patient is considered to be random by the investigator, he/she should not be included
结局指标
主要结局
Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery)
时间窗: 3, 6 and 12 months
次要结局
- An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.(3, 6 and 12 months)