Clinical Study of Bioceramic Materials in Bone Defect Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quality of life (SF-36)
研究概览
简要总结
The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
详细描述
The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily take the test and sign the informed consent form;
- •Patients aged 18-65 years old with no history of allergies;
- •Patients able to communicate well with the investigator and follow the requirements of the entire trial.
排除标准
- •Patients who refuse to sign the informed consent form to participate in the trial;
- •Patients who are not in the age range of 18 to 65 years;
- •Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
- •Patients in the acute phase of local or systemic bacterial infections;
- •Patients who cannot cooperate with the operation and evaluate the effect;
- •Other conditions that are considered inappropriate by the investigator to participate in the study.
结局指标
主要结局
Quality of life (SF-36)
时间窗: 12 months
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Level of bone healing
时间窗: 12 months
X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.
次要结局
未报告次要终点