Waterproof Casting for Pediatric Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of Participants Without Fracture Displacement at 8 Weeks Post Injury
研究概览
简要总结
Distal radius fractures are one of the most commonly seen fractures in children. Traditionally, minimally angulated or non-displaced distal radius fractures are treated with short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast gets wet, it must be removed and replaced. In general, waterproof casting has been shown to improve patient comfort and overall satisfaction.
We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the treatment of minimally angulated distal radius fractures in children using a randomized, controlled, cross-over study design. We will include patients between 4 and 14 years of age with minimally angulated distal radius fractures (<15 degrees of angulation on sagittal or coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility within 7 days of injury. As determined by a power analysis, a total of 26 patients will be enrolled in the study.
Patients eligible for the study will be randomized into one of two equally sized (n=13) groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh material and patients in Group 2 will receive a regular fiberglass cast. Both groups will follow-up at two weeks for clinical and radiological evaluation, after which they will be transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast (Group 2) for an additional two weeks. This crossover will allow both groups to experience each type of cast. After four weeks of immobilization, patients in both groups will discontinue casting and be advised to avoid contact sports or strenuous activities until week 8.
Patients in both groups will follow up 8 weeks after initial treatment for clinical and radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical function will be evaluated at weeks 1, 2, and 4 using the Activities Scale for Kids - Performance, a validated, highly reliable, self-reported measure that assesses physical function in children between 5 and 15 years. Pain will be evaluated using the Faces Pain Scale, a validated, highly reliable scale commonly used in the pediatric population. Patient satisfaction will be measured at Weeks 1, 2, and 4, and the radiographs at Week 8 will be compared with initial radiographs to assess fracture displacement and angulation. Skin changes will be assessed at week 2 and week 4 by an independent observer blinded to the type of cast that has been removed and digital photographs will be obtained and analyzed using ImageJ Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast. Itching will be assessed at weeks 1, 2, and 4 using a visual analogue scale in which a horizontal line of 100 mm will be presented to the patient with "no itching" at the left end of the scale and "strongest itching" at the right end.
We hope to determine whether the new, waterproof cast can result in similar clinical outcomes and patient satisfaction for distal radius fractures as compared with the traditional fiberglass cast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 4 and 14 years of age (open physis)
- •Patients seen at Orthopedic Institute for Children within 7 days of the original injury
- •Patients with a closed, buckle, or minimally displaced and angulated fracture (< 15 degrees of angulation on sagittal or coronal planes) of the distal radius, with or without associated distal ulnar fracture.
排除标准
- •Skeletally mature patients (closed physis), or patients younger than 4 or older than 14 years of age.
- •Patients with displaced distal radius fractures (at least 15 degrees of angulation on sagittal or coronal planes or bayoneted apposition)
- •Any association generalized condition that affects the forearm or wrist range of motion.
- •Patients with history of a previous injury or surgery to the contralateral forearm or wrist.
- •Patients who received previous treatment for a forearm fracture
- •Open fractures
研究组 & 干预措施
Traditional cast first
Patients in this group will first receive a traditional fiberglass cast for two weeks, after which this cast will be removed and a waterproof cast applied.
干预措施: Waterproof Cast (Device)
Traditional cast first
Patients in this group will first receive a traditional fiberglass cast for two weeks, after which this cast will be removed and a waterproof cast applied.
干预措施: Traditional cast (Device)
Waterproof cast first
Patients in this group will receive a waterproof cast for 2 weeks, after which the waterproof cast will be removed and a traditional fiberglass cast will be applied for an additional two weeks.
干预措施: Traditional cast (Device)
Waterproof cast first
Patients in this group will receive a waterproof cast for 2 weeks, after which the waterproof cast will be removed and a traditional fiberglass cast will be applied for an additional two weeks.
干预措施: Waterproof Cast (Device)
结局指标
主要结局
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury
时间窗: 8 weeks post injury
The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.
次要结局
- Number of Participants Without Skin Irritation at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type)(4 weeks post-injury)
研究者
Mauricio Silva
Medical Director, Orthopaedic Institute for Children
University of California, Los Angeles
