In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bone voids repairing
研究概览
简要总结
Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.
详细描述
The products were prepared from medical grade Thai rice starch mixed with high purity (>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient who requires treatment by surgery and product implant in bone.
- •Not indicate sex type
- •18-65 years
- •Patients accepted participate in the study.
- •Type of surgery will be treat for only bone.
排除标准
- •Refused to join the study.
- •Patients have an allergic history of carbohydrates and bovine bone.
结局指标
主要结局
Bone voids repairing
时间窗: 6 months
The primary outcome will be assessed from satisfactory grading by operative nurses and surgeons. Add a convenient storage, package removal, contamination risk, unused material disposal, size appropriateness, tolerability by hand, ease to cut, stability when wet, weight, and disturbance to operative field.
次要结局
- Bone voids repairing(6 months)
研究者
Sittiporn Punyanitya
Principal Investigator
Chiang Mai University