Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Isala
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Numerical rating scale-11 score for pain 3 months
研究概览
简要总结
Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment
详细描述
Objective
The main objective is to determine experienced pain, as measured by NRS-11 score, 3 months after intervention and compare this between the intervention and control group. Secondary objectives are functional outcome as measured by AOFAS Lesser Toe Scale, FAAM score, progress of NRS-11 score through time and PROMIS Mobility/pain interference. Furthermore, quality and duration of fracture healing will be compared between groups. The impact on daily life will be compared as measured by duration of return to work and normal footwear.
Study design: Randomised controlled clinical intervention trial
Study population: Humans with an acute shaft fracture of the fifth metatarsal bone, 18 years or older.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at the time of study entry
- •Informed consent
- •Competent to participate in follow up and fill out questionnaires
- •Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C
排除标准
- •Open fracture
- •Proximal fifth metatarsal fracture, Jones fracture
- •Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg
- •Former surgery or history of development disorder of the contralateral fifth metatarsal
- •Multiple fractured metatarsals in the affected foot
- •Medical history of Rheumatoid Arthritis
- •Unable to undergo surgical procedure
结局指标
主要结局
Numerical rating scale-11 score for pain 3 months
时间窗: 3 months after intervention
Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome
次要结局
- Return to normal footwear(0-12 months)
- Numerical rating scale-11 score for pain through time(0-12 months after intervention)
- American Orthopedic Foot &Ankle Society Lesser Toe Scale(3 months after intervention)
- Foot and Ankle Ability Measure(6 weeks, 3,6 and 12 months after intervention)
- Patient Reported Outcome Measure Information System - Mobility(6 weeks, 3,6 and 12 months after intervention)
- Patient Reported Outcome Measure Information System - Pain Interference(6 weeks, 3,6 and 12 months after intervention)
- Return to work(0-12 months)
- Malunion(6 weeks after intervention)
- Non union(0-6 months)