跳至主要内容
临床试验/NCT02197819
NCT02197819终止不适用

A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Re-dislocation of shoulder

研究概览

简要总结

Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2% in the general population. In young patients, recurrence after a primary dislocation is also common (~60%) and multiple recurrent episodes can cause significant disability over time. Following initial reduction of the joint, the traditional treatment for primary shoulder dislocations has been immobilization in a sling, with the arm in a position of adduction and internal rotation. The length of the immobilization period is controversial, however most authors would recommend between three to six weeks in a sling followed by several months of rehabilitation to include range of motion and strengthening exercises. The clinical course of patients after this approach has been extensively investigated. Of particular interest is the relatively high rate of recurrent instability in young patients, reported to be between 17 and 96%.

A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of age) following reduction of a first-time traumatic anterior shoulder dislocation, does EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external rotation reduce the rate of recurrent instability experienced within 12 months versus emergent immobilization in a traditional internal rotation sling? Eligible patients will be randomly allocated to the sling or ER brace. The results of this study will provide the best evidence for choosing emergent immobilization for shoulder dislocations.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Skeletally mature patients between 18 - 35 years of age inclusive
  • Patient is seen within 24 hours from time of injury.
  • Sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by;
  • Mechanism of abduction, external rotation
  • Sudden pain in the shoulder
  • Manipulative reduction required or
  • Radiograph documenting a dislocated joint
  • Willing to participate in follow-up for at least 24 months.

排除标准

  • Incompetent or unwilling to consent
  • Inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments.
  • Previous instability of the affected shoulder
  • Significant associated fracture (Exception Hill Sachs or bankart lesions)
  • Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
  • Neurovascular compromise of the affected limb
  • A medical condition making the patient unable to wear a brace or sling
  • Patient is seen within 24 hours from time of injury

研究组 & 干预措施

External Rotation Brace

Experimental

Shoulder placed in an external rotation brace for 4 weeks

干预措施: External Rotation Brace (Device)

Traditional Sling

Active Comparator

Patient placed in traditional sling

干预措施: Sling (Device)

结局指标

主要结局

Re-dislocation of shoulder

时间窗: within 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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