跳至主要内容
临床试验/NCT04041258
NCT04041258终止不适用

"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
range of motion ROM

研究概览

简要总结

This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle

详细描述

The aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the Rizzoli Orthopedic Institute, in order to evaluate the clinical and radiographic results of the treatment. This is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the Rizzoli Orthopedic Institute

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of pseudarthrosis intervention
  • Males and Females
  • Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute

排除标准

  • Floating shoulder
  • subjects who present contraindications to radiographic examination at the time of telephone contact

结局指标

主要结局

range of motion ROM

时间窗: at least 1 year of follow up

improvement of range of motion measure (in grade)

presence of dyskinesias

时间窗: at least 1 year of follow up

objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)

alteration of the clavicle length

时间窗: at least 1 year of follow up

measure (mm) obtained from radiographic evaluation

次要结局

  • evaluate shoulder function(at least 1 year of follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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