NCT00409799已完成2 期
A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 45
- 主要终点
- Radiographic Images
研究概览
简要总结
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.
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
- None
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
- •Radiological evidence of a tibial plateau fracture requiring grafting
- •Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).
排除标准
- •Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
- •Active or past history of malignant tumor.
- •Evidence of systemic or localized infection at time of surgery.
- •Pregnant or lactating females.
研究组 & 干预措施
1
Experimental
Experimental - high dose
干预措施: I-0401 (a new bone graft substitute) (Drug)
2
Experimental
Experimental - low dose
干预措施: I-0401 (a new bone graft substitute) (Drug)
3
Active Comparator
Autograft
干预措施: I-0401 (a new bone graft substitute) (Drug)
结局指标
主要结局
Radiographic Images
时间窗: All Follow-Up Visits
次要结局
- Clinical assessments of the fracture site(All Follow-Up Visits)
- Blood parameters(All Follow-Up Visits)
- Vital signs(At several Follow-Up visits)
- Questionnaires of Life(All Follow-Up Visits)
- Pharmacoeconomic evaluation(All Follow-Up Visits)
研究者
研究点 (45)
Loading locations...
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