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临床试验/NCT00205972
NCT00205972已完成4 期

Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

AO Clinical Investigation and Publishing Documentation2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2000年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
- Comparison of functional outcome

研究概览

简要总结

The aim of the study is to radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

详细描述

Radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over age 16
  • fracture according to AO classifications 12A2, 12A3, 12B2
  • have to be available for the FU's

排除标准

  • open fractures
  • polytraumatized patients
  • multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
  • pseudoarthrosis
  • pathological and refractures

结局指标

主要结局

- Comparison of functional outcome

时间窗: 3 months to 12 months post OP

Comparison of functional outcome

- Radiological comparison of fracture healing between the conservative versus operative treatment

时间窗: 3 months to 12 months post OP

Radiological comparison of fracture healing between the conservative versus operative treatment

次要结局

  • - Subject satisfaction(3 months to 12 months post OP)
  • - Collection of possible complication of the treatment(3 months to 12 months post OP)
  • - Financial impact of the compared treatments(3 months to 12 months post OP)

研究者

发起方
AO Clinical Investigation and Publishing Documentation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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