NCT02388438Unknown4 期
Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- days to union from applied demineralized bone matrix
研究概览
简要总结
This study evaluates the demineralized bone matrix in "Hallux valgus".
详细描述
Demineralized bone matrix use for filling in the space removed bone in open wedge osteotomy and correction. The purpose this study is to test therapeutic benefits of demineralized bone matrix.
Investigator will recruit thirty patients. Total evaluation period will be 12 months. In this period, investigator will examine correction rate, fusion rate, functional test, adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) The patient ranging in age from 20 to 75 years
- •(2) Has to be operated over 5mm osteotomy for correcting hallux valgus.
- •(3) The patients who were able to comply with the research protocol.
排除标准
- •(1) Bursitis in metatarsal bones has affected surgery.
- •(2) Has rheumatism
- •(3) The patient who has clinical sign of infection on the operated site at pre-screening
- •(4) Patient who has failure of peripheral blood circulation caused by chronic disease and neurological symptoms
- •(5) In the opinion of investigator, the patient is not suitable to participate in this study
研究组 & 干预措施
Demineralized bone matrix
Experimental
Applied demineralized bone matrix when investigator conduct hallux valgus surgery.
干预措施: Bongener (Device)
结局指标
主要结局
days to union from applied demineralized bone matrix
时间窗: up to 12months
Examine the days from applied medical device to union.
次要结局
- Complete fusion rate after applied medical device.(up to 12months)
- Complete correction rate after applied medical device.(up to 12months)
- Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months.(change form baseline at 12months)
研究者
Woojin Choi
Orthopedic part
Severance Hospital
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