跳至主要内容
临床试验/NCT03383991
NCT03383991已完成不适用

Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial

Karolinska Institutet0 个研究点开始时间: 2013年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
主要终点
Constant-Murley Score

研究概览

简要总结

Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

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

入选标准

  • •Displaced 3- or 4-part fracture of the proximal humerus
  • •Age over 70 years
  • •Independent living
  • •Low energy trauma

排除标准

  • •Pre-existing shoulder disease
  • •Severe cognitive dysfunction
  • •More than 14 days from injury to surgery
  • •Comorbidity that affects shoulder rehabilitation considerably
  • •Concurrent injury that affect shoulder rehabilitation considerably

研究组 & 干预措施

Reverse Total Shoulder Arthroplasty

Experimental

干预措施: Reverse Total Shoulder Arthroplasty (Procedure)

Hemiarthroplasty

Active Comparator

干预措施: Hemiarthroplasty (Procedure)

结局指标

主要结局

Constant-Murley Score

时间窗: 24 months

The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function.

WOOS (Western Ontario Osteoarthritis of the Shoulder) Index

时间窗: 24 months

次要结局

未报告次要终点

研究者

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

Per Olerud

MD, PhD, Senior Consulting Orthopedic Surgeon

Karolinska Institutet

相似试验

Reverse Total Shoulder Arthroplasty Versus... | 临床试验