NCT00586170终止不适用
A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Percentage of Successful 5th Metatarsal Unions Achieved.
研究概览
简要总结
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
详细描述
The investigators hypothesize:
- That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
- PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with a 5th metatarsal delayed or non-union.
- •Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
- •Male or female between ages of 18 and 75 years old, inclusive
排除标准
- •Subject has synovial pseudarthrosis.
- •Subject has a fracture gap of larger than 5mm as measured on CT Scan.
- •Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
- •If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
- •Subject has an implanted unipolar pacemaker.
- •Subjects who have previous malignant or connective tissue disorder.
- •Subjects who use medication such as steroids or anticoagulants.
- •Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
结局指标
主要结局
Percentage of Successful 5th Metatarsal Unions Achieved.
时间窗: 24 Weeks
Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.
次要结局
- Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)(24 Weeks)
研究者
研究点 (4)
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