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临床试验/NCT02614690
NCT02614690已完成不适用

Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?

Connecticut Children's Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Complication Rate of the Cast Type

研究概览

简要总结

This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.

详细描述

Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling.

However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.

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
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures.
  • •Forearm fractures that require closed reduction (with or without conscious sedation)
  • •Patients between the ages of 3 and 12 years old

排除标准

  • •Specific exclusions
  • •Age less than 3 or greater than 12
  • •Patients presenting with an associated neurological or vascular injury caused by the fracture
  • •Patients presenting with an open fracture
  • •Patients requiring operative treatment following the initial fracture evaluation
  • •Ipsilateral upper extremity fracture
  • •Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort
  • •Generic exclusion: "Subjects not meeting all inclusion criteria."

研究组 & 干预措施

No split Cast of forearm fractures

Active Comparator

Patient will have a "No split cast" long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.

干预措施: No Split Cast of forearm fractures (Procedure)

Univalve Split Cast of forearm fractures

Active Comparator

Patients will have a "Univalve Split Cast" long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm

干预措施: Univalve Split Cast of forearm fractures (Procedure)

Bivalve Split Cast of forearm fractures

Active Comparator

Patients will have a "Bivalve Split Cast" long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.

干预措施: Bivalve Split Cast of forearm fractures (Procedure)

结局指标

主要结局

Complication Rate of the Cast Type

时间窗: <60 days corresponding to total study time and consistent with outcome 6

This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Lee, MD

Assistant Professor of Orthopaedic Surgery

Connecticut Children's Medical Center

研究点 (1)

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