Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Pain free weight bearing
研究概览
简要总结
The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Zone 3 fracture
排除标准
- •Neuropathy
- •Open fractures
- •High energy injuries
- •Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
- •Pressure ulcer(s)
- •Lack of consent competence
- •Fracture radiologically confirmed more than six months ago
- •No possibility of follow-up at one of the study centers
- •Established pseudarthrosis
- •Medical condition that contraindicates surgery
- •Non-compliance
结局指标
主要结局
Pain free weight bearing
时间窗: 2 years
Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".
次要结局
- Delayed union(2 years)
- Palpatory pain(2 years)
- Nonunions(2 years)
- Level of activity(2 years)
- Radiological healing(2 years)
- Work status(2 years)
- Refracture(2 years)