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临床试验/NCT06019260
NCT06019260尚未招募不适用

Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device

Assiut University0 个研究点目标入组 54 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
主要终点
Radiological evaluation using the true anteroposterior view of the shoulder

研究概览

简要总结

Compare the clinical and radiological outcome between the arthroscopic and open surgical repair using suture button device method in cases with acute AC joint disruption

详细描述

Acromioclavicular (AC) joint dislocation is a common shoulder injury, especially among athletes and has an estimated incidence of 17% of all shoulder injuries and30%-50% of athletic shoulder injuries ,In most cases, these are caused by a direct fall on the ipsilateral shoulder tip. The indirect mechanism of injury with an extended arm is rare, The Rockwood classification system is currently used and based on the degree and direction of the disrupted anatomy of the AC joint.

Despite the high prevalence of this injury, there is no consensus about its optimal treatment. A variety of surgical procedures are described in the literature, such as an augmented suture with absorbable materials, stabilization with Kirschner (K)-wires in combination with or without additional wire loops, hook plates, or the Bosworth screw, but none can be considered the gold standard of operative AC joint stabilization, another treatment option was offered by the Tight Rope system, This technique was developed as a minimally invasive procedure in the management of AC dislocations. Because of its minimally invasive approach, it reduces soft tissue damage and yields better cosmetic results.9 Also, there is no need for reoperation to remove the hardware that might screws, or plates. Moreover, the complications of hardware failure, like breakage, dislocations, or bone fractures, are minimized

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 16 to 60 years
  • Definite radiographic diagnosis of isolated Rockwood type IIIb(unstable), IV and type v acromioclavicular joint dislocation
  • Time from injury to operation < 3 weeks
  • Patient with complete at least 12-month follow-up assessments

排除标准

  • . Age outside the range
  • Open injury, old injury (≥ 3 weeks since injury)
  • Injury caused by other diseases (tendinitis, metabolic, et al.), concurrent shoulder osteoarthritis, arthropathy or any fracture
  • Any previous operation of the injured limb
  • Incomplete data or follow-up < 12 months

结局指标

主要结局

Radiological evaluation using the true anteroposterior view of the shoulder

时间窗: preoperative, three month postoperative and six month postoperative

Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)

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

Mohamed Adel Abdelmajeed

resident doctor

Assiut University

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