NCT04645186终止不适用
CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery
Bioceramed1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Radiological healing
研究概览
简要总结
This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.
- •Give written informed consent to participate in the study and be willing to comply with the protocol requirements.
- •Able to verbalize and differentiate regarding the location and intensity of pain.
- •Physical and mental availability to meet the clinical and radiographic follow-up schedule.
排除标准
- •Serious infection within two months before surgery.
- •Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases.
- •Primary bone tumors and contraindications in performing an X-ray or CTscan.
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
- •The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
结局指标
主要结局
Radiological healing
时间窗: 24 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
次要结局
- Number and description of any adverse event during the follow-up(24 months)
研究者
研究点 (1)
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