跳至主要内容
临床试验/NCT05279261
NCT05279261Unknown不适用

Clinical Effect of the Axillary Approach to Acute Anterior Glenoid Fractures

Peking University Third Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年6月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
fracture union

研究概览

简要总结

Glenoid fractures result in glenohumeral post-trauma arthritis and instability. Operative treatment is indicated for severe fractures. The traditional deltopectoral approach, which requires detachment of the subscapularis, has many drawbacks, including loss of external rotation and suboptimal fixation. Arthroscopic techniques also cannot allow anatomic reduction and biomechanical stability for large fractures. We describe an alternative approach that enters from the axilla through the interval between the rotator cuff and the inferior glenoid, neck and lateral border of the scapula without detachment of the rotator cuff.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Traumatic and closed fractures
  • Fracture type conforms to Ideberg Ia classification or AO/OTA F1.1 classification
  • Fracture displacement ≥4mm, the area of involvement ≥20%.

排除标准

  • Severe multiple trauma
  • Pathological fracture
  • Unable to tolerate surgical treatment
  • The interval between injury and operation was > 2 weeks

结局指标

主要结局

fracture union

时间窗: 6 months

X-rays and CT scans are used to evaluate the bone union

the Constant and Murley scores

时间窗: 2 years

The questionaire evaluates shoulder function in terms of pain (15 points), daily activities (20 points), range of motion (40 points) and muscle strength (25 points) on a scale of 100, with the higher the score, the better the function.

the DASH(disabilities of the arm,shoulder and hand) scores

时间窗: 2 years

Shoulder function was evaluated by patients' subjective feelings about pain, activity, daily life, work and entertainment of the affected limb in the past 1 week. A total of 30 items were evaluated, and the score of each item was 1-5, DASH= (total score-30) /1.2, with the maximum score of 100, the lower the score, the better the function

次要结局

  • Complications(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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