跳至主要内容
临床试验/NCT04532216
NCT04532216Unknown不适用

The Clinical and Biomechanical Research of the New Arthroscopic Technique for the Treatment of High-grade Dislocation of the Acromioclavicular Joint

Beijing Jishuitan Hospital0 个研究点目标入组 54 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
54
主要终点
ASES score

研究概览

简要总结

Acromioclavicular joint dislocation is a common disease in shoulder surgery, which mostly occurs in young and middle-aged patients. Severe acromioclavicular joint dislocations of Rockwood type IV, V, and VI require surgical treatment. Among them, the common clinical type IV and type V severe acromioclavicular joint dislocations are often treated with autologous/allogenous tendon transplantation and coracoclavicular ligament reconstruction under shoulder arthroscopy. Although this minimally invasive surgical method has certain advantages over incision surgery, due to factors such as poor healing after tendon transplantation and failure of coracoclavicular fixation, the recurrence rate of postoperative dislocation is still as high as 30%, which seriously affects the prognosis of patients. Therefore, we proposed a new surgical technique of minimally invasive shoulder arthroscopic coracoclavicular suspension fixation and coracoclavicular ligament residual reconstruction, which aims to strengthen the fixation strength of the coracoclavicular space, promote the healing of the coracoclavicular ligament, and reduce the recurrence rate of postoperative dislocation. To improve postoperative shoulder joint function of patients. This project intends to use non-randomized controlled clinical research and biomechanical research to compare traditional surgical techniques with new microscopic techniques in terms of surgical efficacy, postoperative complications, and internal plant fixation strength to establish the therapeutic advantages of the new technology. Its application and promotion provide important clinical evidence to improve the treatment of severe acromioclavicular joint dislocation in the field of shoulder surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Consecutive cases of coracoclavicular ligament reconstruction surgery usingTightRope Device With Allograft Augmentation and shoulder arthroscopic reconstruction of coracoclavicular ligament with autologous/allogeneic tendon transplantation.
  • Injury type Rockwood type IV and V type severe acromioclavicular joint dislocation
  • The time from injury to operation is less than 3 weeks

排除标准

  • Combined with neurovascular injury
  • Previous history of ipsilateral shoulder surgery
  • The patient refused to sign the informed consent and participate in the trial

结局指标

主要结局

ASES score

时间窗: 1 year postoperatively

The ASES score is a 10-item measure of shoulder pain and function

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

Chunyan Jiang

Director of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

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