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临床试验/NCT03724773
NCT03724773撤回不适用

Outcomes of Long-Arm Casting Versus Sugar-Tong Splinting of Displaced Forearm Shaft Fractures

Washington University School of Medicine2 个研究点 分布在 1 个国家开始时间: 2019年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Radiographic measurements

研究概览

简要总结

The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Consented participants will be randomly assigned to be treated with either a sugar-tong splint or a long-arm cast (both standard of care treatments) in REDCap. Each participant will have a 50/50 chance of being assign to either treatment.

详细描述

Forearm fractures are very common in the pediatric population and can often be treated with closed reduction and immobilization. Immobilization techniques include long-arm casting, short-arm casting and sugar-tong splinting. At the time of injury casts are usually split into two using a cast saw, known as bivalving, to allow for swelling and are overwrapped at a later time. By design sugar-tong splints allow for swelling and are overwrapped or converted to a cast at a later time. Traditionally long-arm casts have been used as the standard mode of immobilization for forearm fractures. Recent evidence demonstrates that long-arm casting is equivalent to better tolerated short-arm casting as an immobilization choice for distal third forearm fractures.1 Further work has shown that sugar-tong splints are also appropriate for treatment of distal third forearm fractures. No study has compared the efficacy of using a long-arm cast versus a sugar-tong splint for treatment of forearm shaft fractures.

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
Double (Participant, Investigator)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Single or both bone forearm shaft fractures, follow-up at the St. Louis Children's Hospital and affiliated branches

排除标准

  • Children below 4 or above 12 years of age
  • Distal radius/ulna fracture(s)
  • Distal radius/ulna third shaft fracture(s)
  • Proximal radius/ulna third shaft fracture(s)
  • Radius/ulna fracture(s) not requiring reduction
  • Open radius/ulna fracture(s)
  • Radius/ulna fracture(s) requiring open reduction in the operating room
  • Patient with metabolic defects
  • Pathologic radius/ulna fracture(s)
  • Previous fractures in the same location (radius/ulna)

研究组 & 干预措施

Long-Arm Cast

Active Comparator

Reduction and long-arm cast application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques.

干预措施: Long-Arm Cast (Device)

Sugar-Tong Splint

Active Comparator

Reduction and sugar-tong splint application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques.

干预措施: Sugar-Tong Splint (Device)

结局指标

主要结局

Radiographic measurements

时间窗: 6 weeks

Measure sagittal angulation

次要结局

  • Clinical follow-up(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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