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临床试验/NCT07399834
NCT07399834Enrolling By Invitation不适用

Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries, A Randomized Controlled Trial

Queen Savang Vadhana Memorial Hospital, Thailand1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年4月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
74
试验地点
1
主要终点
ACJI score

研究概览

简要总结

The study conducted to compare both clinical and radiological outcomes comparing two techniques of Coracoclavicular-stabilization; single and double tunnel technique

详细描述

There are now over 150 techniques of operative treatment for Acromioclavicular joint injury. Despite no techniques used nowadays is recommended as gold standard treatment, most surgeons prefer Coracoclavicular-stabilization technique. Coracoclavicular-stabilization, providing favorable outcomes in many studies, regularly conducted with two surgical techniques which are single tunnel technique and double technique. Although, both techniques result in good biomechanic, patients underwent double tunnel technique report better clinical outcome. However, double tunnel technique compared to single tunnel technique is more challenging in surgical steps and risk intraoperative complications. This trial aims to compare both clinical and radiological outcomes of the two mentioned Coracoclavicular-stabilization techniques, in order to provide data to support treatment decision in patient with acute Acromioclavicular joint injury.

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

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with acute Acromioclavicular joint injury classified as Rockwood classification type III and above who willing to undergo CC-stabilization operative treatment
  • Patients aged 18-45 years

排除标准

  • Patients who had experienced shoulder surgery at the same injured shoulder side
  • Patients with shoulder pathology at the same injured shoulder side
  • Patients with onset of Acromioclavicular joint injury for more than 3 weeks
  • Patients who decided to discontinue participating the study

研究组 & 干预措施

Single tunnel group

Other

Patients undergo single tunnel technique Coracoclavicular stabilization

干预措施: Coracoclavicular stabilization (Procedure)

Double tunnel group

Other

Patients undergo double tunnel technique Coracoclavicular stabilization

干预措施: Coracoclavicular stabilization (Procedure)

结局指标

主要结局

ACJI score

时间窗: ACJI score at preop, postop 3 months, 6 months and 1 year

次要结局

  • CC-distance difference(Measured at preop, postop 1 month, 3 months, 6 months and 1 year)

研究者

发起方
Queen Savang Vadhana Memorial Hospital, Thailand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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