NCT00206037终止4 期
Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing
AO Clinical Investigation and Publishing Documentation6 个研究点 分布在 2 个国家目标入组 49 人开始时间: 2005年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 6
- 主要终点
- Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively
研究概览
简要总结
The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.
详细描述
The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.
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
- •Adult and active patient
- •Varus malalignment of the leg
- •Intact lateral joint compartment
- •Physiological age-appropriate ROM in hip, knee and ankle of affected leg
排除标准
- •Drug or alcohol abuse
- •Known equine protein allergy or immunological anormalities
- •Immunosuppressive treatment
- •Systemic or severe local inflammation or infections
- •History of active malignancy or systemic disease
- •Impossible to obtain informed consent
- •Legal incompetence
- •Pregnant and nursing women
- •Patients before, during or one year after radio- or chemotherapy
- •Patients with metal or metal implants near vulnerable structures
- •Patients with pacemakers or other implanted devices
结局指标
主要结局
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively
时间窗: 6 weeks
次要结局
- Bone union
- Complication rate
- Pain asset on the VAS
- Deviation planing angle
- Immuno reaction on equine proteins
- Range of motion
- Ligament stability
- Time to pain free walking
- WOMAC osteoarthritis index
- SF36 Index
研究者
研究点 (6)
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