Prevention of the Os Fibulare After an Acute Lateral Ankle Avulsion Fracture in Pediatric Patients: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bony Union
研究概览
简要总结
This is a randomized control trial of pediatric patients with acute lateral ankle avulsion fractures. Patients will be randomized into two groups: Standard of care treatment which includes booting with early range of motion and gradual weening from the boot and a Test treatment which includes a 6 week short-let cast. The purpose of the study is to test whether prolonged immobilization (casting) can help prevent the formation of a subfibular ossicle. The study consists of two patient visits.
详细描述
This is a randomized control trial for pediatric patients who present to Scottish Rite for an acute lateral ankle avulsion fracture. Patients will be randomized into standard of care treatment or prolonged immobilization (test treatment). Standard of care treatment is booting with early range of motion or test treatment and gradually weaning from the boot. Test treatment (prolonged immobilization) is 6 weeks of immobilization in the form of a short-leg cast. The purpose is to see if prolonged immobilization will promote healing of the avulsion fracture and prevent the formation of a subfibular ossicle which occurs 100% of the time in standard of care treatment based upon our previous study. Patients will follow-up for a single visit between 6- and 12-months post enrollment for repeat imaging to assess for the formation/prevention of a subfibular ossicle. These visits will include an ultrasound and radiographs. Secondary outcomes include evaluation of function based upon PROs and biomechanical testing in the movement science lab at the follow-up visit. Enrolled patients may also be contacted for injury surveillance and PROs for up to 5 years following RTP.
Treatment Groups:
A) Standard of Care Treatment: Patients will receive brief immobilization (boot) as needed, followed by early range of motion exercises. Physical therapy and a return-to-activity plan will be implemented as symptoms allow.
B) Prolonged Immobilization (Casting): Patients will be treated with a non-weightbearing short leg cast for 6 weeks to promote avulsion fracture healing. This will be followed physical therapy, and a gradual return to activity.
Visits:
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 5-12 at time of enrollment
- •Diagnosis of first-time lateral ankle injury and an avulsion fracture visible on imaging who can be enrolled within 14 days of injury
- •Patient and parent/legal guardian must speak English or Spanish
排除标准
- •Previous ipsilateral ankle surgery
- •Pre-existing musculoskeletal disease
- •If patient has been casted prior to confirmation of avulsion fracture on imaging
- •Developmental delay
- •Does not meet inclusion criteria
研究组 & 干预措施
Standard of Care Treatment
干预措施: Standard of Care (SOC) (Procedure)
Prolonged Immobilization (Casting)
干预措施: Prolonged Immobilization (Casting) (Procedure)
结局指标
主要结局
Bony Union
时间窗: 6-12 months
Ultrasound and radiographic images will be used to assess bony union. The images will be reviewed by a physician with expertise in assessing ultrasound to visualize the presence of bony bridging across the fracture site. This will be visualized as a hyperechoic line connecting the fracture piece to the donor bone.
次要结局
- Hospital for Special Surgery Pediatric Functional Activity Bried Scale (HSS Pedi-FABS)(6-12 months)
- PROMIS Physical Activity(6-12 months)
- PROMIS Mobility(6-12 months)
- PROMIS Anxiety(6-12 months)
- Oxford Ankle Foot Questionnaire for Children(6-12 months)