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临床试验/NCT01238523
NCT01238523已完成不适用

Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2007年5月最近更新:
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
81
试验地点
2
主要终点
The Activities Scale for Kids - Performance (ASK-P)

研究概览

简要总结

Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5).

The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study

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
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients between 4 and 14 years of age (open physis)
  • Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury
  • All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern

排除标准

  • Fractures with greater than 2 cm of initial shortening
  • Open fractures
  • Patients that have other orthopaedic medical issues such as hemophilia

研究组 & 干预措施

Long leg cast in full extension

Experimental

Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity

干预措施: Long leg cast in full extension (Procedure)

Long leg cast with 45 degrees of flexion

Experimental

Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity

干预措施: Long leg cast with 45 degrees of flexion (Procedure)

结局指标

主要结局

The Activities Scale for Kids - Performance (ASK-P)

时间窗: May 2007 - May 2010

The Activities Scale for Kids (ASK) is a 30 item child self-report musculoskeletal outcome measure that focuses on the child's physical disability, and is scored with a summary score with no sub-scales. The performance format ASK-P will be used in this study. The scoring system is from 0-100 with 100 being the best possible score.

次要结局

  • Time to Healing(May 2007 - May 2010)

研究者

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

Mauricio Silva

Principal Investigator

University of California, Los Angeles

研究点 (2)

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