A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations.
研究概览
简要总结
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Skeletally mature, male and female subjects who are at least 18 years old.
- •Closed diaphyseal tibial fracture.
- •Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury.
排除标准
- •Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing.
- •Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
- •Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.
研究组 & 干预措施
A
1.0 mg/mL rhBMP-2/CPM + surgical fixation
干预措施: rhBMP-2/CPM (Drug)
B
2.0 mg/mL rhBMP-2/CPM + surgical fixation
干预措施: rhBMP-2/CPM (Drug)
C
Buffer/CPM + surgical fixation Intervention
干预措施: rhBMP-2/CPM (Drug)
D
Standard of Care: Surgical fixation intervention
干预措施: rhBMP-2/CPM (Drug)
结局指标
主要结局
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations.
时间窗: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra
次要结局
- Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months(12 months)