NCT00384358已完成2 期
A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
研究概览
简要总结
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 or older.
- •Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
- •Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.
排除标准
- •Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
- •Previous arthroplasty of contralateral (unaffected) hip.
- •Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.
研究组 & 干预措施
A
Experimental
1.0 mg/mL rhBMP-2/CPM + surgical fixation
干预措施: rhBMP-2/CPM (Drug)
B
Experimental
2.0 mg/mL rhBMP-2/CPM + surgical fixation
干预措施: rhBMP-2/CPM (Drug)
C
Other
Control: Surgical fixation
干预措施: surgical intervention alone (Other)
结局指标
主要结局
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
时间窗: upon completion 6 months of follow-up
次要结局
- To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.(6 months follow-up)
- To estimate the success and failure rates associated with key fracture outcomes.(6 months follow-up)
研究者
研究点 (1)
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