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临床试验/NCT03816436
NCT03816436已完成不适用

The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Clavicula shortening (cm)

研究概览

简要总结

Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft and lateral non- unions on restoration of clavicular length and bony healing and its association with functional outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
  • minimal follow- up of two years after surgery
  • written informed consent

排除标准

  • legal incompetence
  • non- union of pathologic fractures
  • current pregnancy
  • German language barrier to complete questionnaires

结局指标

主要结局

Clavicula shortening (cm)

时间窗: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting

Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).

次要结局

  • Constant Murley score (CS)(one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting)
  • Subjective shoulder pain (NRS)(one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting)
  • Simple shoulder test (SST)(one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting)
  • Quality of Life (QoL)(one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting)
  • Subjective shoulder value (SSV)(one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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