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临床试验/NCT00835562
NCT00835562Unknown3 期

Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2009年4月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
162
试验地点
1
主要终点
Constant Disability Scale

研究概览

简要总结

Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.

The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.

The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Displaced four-part fracture of the proximal humerus
  • •Mentally alert
  • •Physically fit for surgery and rehabilitation (ASA-group 1-3)
  • •Informed written consent
  • •Operation can be conducted within 2 weeks of injury

排除标准

  • •Fracture-dislocations
  • •Head-splitting fractures
  • •Previous shoulder surgery on injured side
  • •Chronic shoulder pain
  • •Abuse problems
  • •Patients unable to understand instructions in Danish

研究组 & 干预措施

Hemiarthroplasty

Experimental

干预措施: Hemiarthroplasty (Procedure)

Osteosynthesis

Experimental

干预措施: Osteosynthesis (Procedure)

Non-surgical

Experimental

干预措施: Non-surgical management (Procedure)

结局指标

主要结局

Constant Disability Scale

时间窗: 3 years

次要结局

  • Oxford Shoulder Score, Short Form-36(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stig Brorson

MD PhD

Herlev Hospital

研究点 (1)

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