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
- 1
- 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
研究组 & 干预措施
Restricted Activity Group
This group of patients will be given restricted activity recommendations. They will be told: "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner"
干预措施: Restricted Activity Reccomendations (Behavioral)
Activity (Limited) Group
This group of patients will be given limited activity recommendations. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety."
干预措施: Full Activity/Limited Activity Reccomendations (Behavioral)
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