Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Re-Displacement
研究概览
简要总结
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are:
Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels?
Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
- •Distal Third (<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)
- •Insolated Radial Shaft Fracture (diaphyseal)
- •Radial and Ulna Shaft Fracture (diaphyseal)
排除标准
- •Initial presentation >7 days from the time of injury
- •Pathologic fracture
- •Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
- •Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
- •If operative treatment is required at initial presentation
结局指标
主要结局
Re-Displacement
时间窗: From Cast Placement to Cast Removal, aproximately 6-8 weeks.
Re-displacement will be defined as a change in angulation of greater than 10 degrees.
次要结局
- Complications(From casting to cast removal, approximately 6-8 weeks.)
- Activity Level as measured by patient-completed validated activity surveys (PAQ)(Time of clinic presentation to cast removal, approximately 6-8 weeks.)
- Activity Level as measured by patient-worn activity trackers(Time of clinic presentation to cast removal, approximately 6-8 weeks)
研究者
Nathaniel Lempert
Assistant Professor of Pediatric Orthopaedics
Vanderbilt University Medical Center