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临床试验/NCT06354894
NCT06354894招募中不适用

Riduzione e Sintesi Delle Fratture Del Terzo Prossimale d'Omero: Confronto Prospettico Tra Placca e Viti e Pinning Percutaneo

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Quick Disabilities of the arm, shoulder and hand (DASH) score

研究概览

简要总结

The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.

研究设计

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

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

  • > 18 year old
  • proximal humeral fracture
  • both X-rays and CT scan available

排除标准

  • psychiatric disease

结局指标

主要结局

Quick Disabilities of the arm, shoulder and hand (DASH) score

时间窗: 1 year

The questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms ranging from 0 (no disability) to 100 (most severe disability)

Radiographic outcomes

时间窗: 1 year

Shoulder x-rays will be reviewed by a panel of experts in shoulder traumatology who will be asked to define the result as: * normal * nonunion * malunion * avascular necrosis * infection

Oxford Shoulder Score (OSS)

时间窗: 1 year

Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)

Subjective Shoulder Value (SSV)

时间窗: 1 year

The subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder during ADLs (from 0% to 100%, with the higher score being the better)

次要结局

未报告次要终点

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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