NCT01828905已完成不适用
A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
Johannes Gutenberg University Mainz32 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2013年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 32
- 主要终点
- SF-12 Physical Component Summary (PCS) at week 26
研究概览
简要总结
The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENT™|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 & B3)
- •solitary trauma
- •candidate for bone grafting
- •patients between the age of 18 and 65 years
- •written informed consent obtained before any study-related activities
- •patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program
排除标准
- •patients with multiple injuries
- •polytrauma patients
- •compartment syndrome
- •previous iliac crest bone graft harvesting
- •local infection at the site of implantation
- •chronic pain disease
- •malignancy
- •rheumatoid arthritis
- •chronic cortisone intake
- •X-ray diagnostics not available, fracture cannot be classified
- •clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
- •a pre-existing calcium metabolism disorder (e.g. hypercalcemia)
- •known hyperthyroidism or autonomous thyroid adenoma
- •history of serious reaction to iodine based radio contrast agents
- •women who are pregnant or breastfeeding
- •irreversible coagulopathy or bleeding disorder
- •history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications
- •history of hypersensitivity to the investigational device or any of its ingredients
- •participation in other clinical trials during the present clinical trial or within the last 1 month
研究组 & 干预措施
Cerament
Experimental
CERAMENT™|BONE VOID FILLER as bone graft substitute
干预措施: CERAMENT™|BONE VOID FILLER (Device)
Bone graft
Active Comparator
Autologous cancellous bone graft (iliac crest)
干预措施: Autologous cancellous bone graft (Procedure)
结局指标
主要结局
SF-12 Physical Component Summary (PCS) at week 26
时间窗: 26 weeks
Global pain VAS score at week 26
时间窗: 26 weeks
次要结局
- SF-12 PCS and MCS at visit 5(6 weeks)
- Utilisation of costs of care related resources(26 weeks)
- SF-12 PCS and MCS at visit 4(1 week)
- Bone healing(1, 6, 12 and 26 weeks)
- SF-12 PCS and MCS at visit 6(12 weeks)
- SF-12 PCS and MCS at visit 7(26 weeks)
研究者
Univ.-Prof. Pol M. Rommens
Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery
Johannes Gutenberg University Mainz
研究点 (32)
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