跳至主要内容
临床试验/NCT03596736
NCT03596736已完成不适用

Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial

Linkoeping University3 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2011年1月19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
42
试验地点
3
主要终点
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

研究概览

简要总结

Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. In elderly patients, poor bone quality (osteopenia) and fragmentation of the articular surface can make rigid internal fixation non-reliable or even impossible. Total elbow arthroplasty has been shown to be of value in this type of situation. Elbow hemiarthroplasty has been proposed as an alternative to total elbow arthroplasty. The theoretical advantages as opposed to total elbow arthroplasty are: no restriction in the weight allowed to be lifted, complications related to polyethylene wear debris are avoided as there is no polyethylene liner and there is no ulna component that can loosen. Wear of the native ulna and instability are potential complications of elbow hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that elbow hemiarthroplasty gives better elbow function than total elbow arthroplasty for irreparable distal 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
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Intra-articular distal humeral fracture with two or more displaced joint surface fragments devoid of soft tissue attachment
  • Osteopenia
  • Fracture deemed unsuitable for internal fixation
  • Low-energy trauma
  • Closed fracture
  • Independent living

排除标准

  • Comorbidity that affects elbow rehabilitation considerably
  • Severe pre-existing elbow disease
  • Concurrent injury that affects elbow rehabilitation considerably
  • Pathologic fracture
  • Vascular injury
  • Inability to participate in follow-up

结局指标

主要结局

Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

时间窗: 24 months

The DASH questionnaire aims to assess symptoms and functional status of the upper extremities. It is a patient reported outcome measure that contains 30 core items. The score ranges from 0 to 100 points with higher scores indicating greater impairment.

次要结局

未报告次要终点

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lars Adolfsson

Prof, MD, PhD

Linkoeping University

研究点 (3)

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