Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Visible radiological signs of healing after 6 months.
研究概览
简要总结
Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor.
5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and improve clinical results when autologous bone graft is reduced or removed.
The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace autologous bone graft in order to stimulating ossification during transplantation of osseous tissue.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalised for autologous bone graft based on Ilizarow treatment.
- •Age between 20 and 70 years.
排除标准
- •Rheumatoid osteoarthritis
- •Malignant disease
- •Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)
- •Pregnancy
- •Abuse of drugs and alcohol
- •Need of long-term NSAID treatment
- •Breastfeeding women
研究组 & 干预措施
Bone Morphogenetic Protein 2
Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
干预措施: Bone Morphogenetic Protein 2 (Drug)
Bone Morphogenetic Protein 2
Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
干预措施: Autologous bone graft (Procedure)
Autologous bone graft
Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.
干预措施: Bone Morphogenetic Protein 2 (Drug)
Autologous bone graft
Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.
干预措施: Autologous bone graft (Procedure)
结局指标
主要结局
Visible radiological signs of healing after 6 months.
时间窗: An expected average of 6 months
Radiological signs of healing is a criteria for a successful result. Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in: * Dynamic measurement af immobilization * Ultrasound stimulation * Re-surgery with application of bone graft or bone replacement
次要结局
- Change in serologic bone markers(An expected average of 6 months)