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临床试验/NCT01010347
NCT01010347已完成2 期

A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年12月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
2
主要终点
The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function.

研究概览

简要总结

Background: distal radial buckle fractures are common injuries in children. the ideal immobilization technique is controversial. Few, retrospective studies have been conducted to evaluate bone healing after casting versus splinting. However, the impact of the immobilization technique on daily function and comfort has not been evaluated.

Objective: To compare the impact on daily function, comfort and satisfaction of casting versus splinting in children with distal radial buckle fractures.

Primary Hypothesis: Children with short arm casts to immobilize a distal radial buckle fracture will have a greater reduction in daily activities compared to those immobilized with a volar splint.

Secondary Hypothesis: Children who are immobilized in a short arm cast will have less pain, less patient/parental satisfaction, more adverse effects, fewer follow-up visits, longer emergency department (ED) treatment time. Furthermore, we hypothesize that all fractures will have acceptable alignment/healing at the follow-up orthopaedic clinic evaluation.

详细描述

Methods: A randomized controlled trial will be conducted in children 2 to 17 years old with a radio graphically confirmed distal radial buckle fracture. Exclusion criteria will include skeletal maturity, previous distal radius fracture, concurrent other fracture(s), osteogenesis imperfecta or other metabolic bone disease. Enrolled subjects will be randomized to receive either a short arm cast or a volar wrist splint. The pediatric emergency department attending physician will be responsible for applying or directly supervising the immobilization technique. All subjects' radiographs will be reviewed by a pediatric orthopaedic surgeon with 1 day to confirm diagnosis and measure fracture angulation. Those subjects with unacceptable angulation will be called and asked to return to the ED or orthopaedic clinic for re-evaluation.

Outcomes Measures: The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function. This will be assessed at baseline in the ED, by phone at 1 day, 3 days and 1 week after the ED visit, and at the orthopaedic clinic follow-up visit 3 weeks after the ED visit. Secondary outcome measures will include questionnaires assessing demographic data (baseline), pain, satisfaction, adverse effects (baseline, immediately after immobilization applied, 1 day, 3days and 1 week after ED visit by phone, and at the 3 week orthopaedic clinic follow-up visit), and ED treatment time (in ED prior to discharge). At the 3 week orthopaedic surgery clinic follow-up visit, an assessment of the integrity of the immobilization technique will be conducted by a cast technician and fracture alignment/healing and range of motion of affected arm will be conducted by the pediatric orthopaedic surgeon who will be blinded to treatment group.

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
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 2 - 17 years
  • radiographically confirmed distal radial buckle fracture

排除标准

  • skeletal maturity
  • previous distal radius fracture
  • concurrent other fracture
  • osteogenesis imperfecta or other metabolic bone disease

研究组 & 干预措施

Splint

Active Comparator

Preformed velcro volar splints are compared to traditional circumferential casting.

干预措施: Volar Splint (Procedure)

Cast

Placebo Comparator

The circumferential cast is the standard of treatment against which the splint is compared.

干预措施: Cast (Procedure)

结局指标

主要结局

The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function.

时间窗: Patients are followed for 3 weeks after the initial emergency encounter. They complete the PedsQL and answer questions by telephone.

次要结局

  • Pain and satisfaction.(Patients and parents are queried via telephone at days 1, 3, and 7 after the initial emergency visit. They are questioned about pain scores and satisfaction with the immobilization device.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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