A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
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
- Number of Weeks Need to Obtain Correction
研究概览
简要总结
The purpose of this study is to assess if the application of Mastisol, a liquid adhesive, improves outcomes during bilateral clubfoot casting and reduces complications and development of complex clubfoot for the duration of their casting and up to 5 years follow-up.
详细描述
Study Objectives include:
- Determine if application of Mastisol is associated with improved clubfoot outcomes including length of treatment, recurrence of clubfoot, and reconstruction of clubfoot.
- Assess if the application of Mastisol prior to cast placement is associated with reduced cast slippage and other complications such as severe skin irritation, sores, and development of complex clubfoot.
The investigators hypothesize that Mastisol application will be associated with improved outcomes by helping to maintain a well-fitting cast, which can be key to reducing complications, optimizing correction (i.e. minimizing treatment time). Proper correction can ultimately be associated with decreased incidence of clubfoot recurrence and need for reconstruction.
Participants' participation will last roughly 8-12 weeks but may be shorter or longer depending on their response to manipulation and casting. This is a standard expectation with the Ponseti method of clubfoot casting.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral clubfeet
- •Starting standard of care treatment with the Ponseti method between 0-12 weeks of age
- •For patients born pre-maturely their eligibility age will be based on a corrected gestational age
- •Patients for whom at least one parent/guardian is able to converse, read, and write in English
排除标准
- •Patients who do not have bilateral clubfoot
- •Patients who are starting treatment for clubfoot after 12 weeks of age
- •Patients whose parents/guardians are unable to converse, read, and write in English
- •Patients whose parents/guardian do not provide or are not able to provide informed consent
研究组 & 干预措施
Leg with Mastisol
干预措施: Mastisol (Device)
Control Leg
结局指标
主要结局
Number of Weeks Need to Obtain Correction
时间窗: up to 12 weeks
Incidence of recurrent casting or tenotomy
时间窗: follow up to 5 years from medical records
Incidence of recurrent casting or tenotomy
时间窗: follow up to 5 years from medical records
Incidence of reconstructive surgery
时间窗: follow up to 5 years from medical records
Incidence of reconstructive surgery
时间窗: follow up to 5 years from medical records
次要结局
- Number of Casts to Correction(up to 12 weeks)
- Number of Casts to Correction(up to 12 weeks)
- Number of times that each leg has unplanned re-casting in between visits(up to 12 weeks)
- Tibio-calcaneal angle measured from radiograph at tenotomy time point(up to 12 weeks)
- Incidence of Adverse Events(up to 12 weeks)
- Incidence of Severe Adverse Events(up to 12 weeks)
- Incidence of formation of complex clubfoot(up to 12 weeks)
- Number of times that each leg has unplanned re-casting in between visits(up to 12 weeks)
- Tibio-calcaneal angle measured from radiograph at tenotomy time point(up to 12 weeks)
- Dorsiflexion angle measure from radiograph at tenotomy time point(up to 12 weeks)
- Incidence of Adverse Events(up to 12 weeks)
- Incidence of Severe Adverse Events(up to 12 weeks)
- Incidence of formation of complex clubfoot(up to 12 weeks)