CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: A 2 Year Prospective Randomised Study on Distal Radius Osteotomies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- volar angulation distal radius, x-ray
研究概览
简要总结
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
详细描述
Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft.
Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland & Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •distal radius malunion with dorsal deformity, disability and pain.
排除标准
- •age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.
结局指标
主要结局
volar angulation distal radius, x-ray
时间窗: 24 months
次要结局
未报告次要终点
研究者
Mona Winge
Consultant, Orthopaedic Surgeon, Principal Investigator
Oslo University Hospital