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临床试验/NCT07024056
NCT07024056尚未招募不适用

Acute Acromioclavicular Joint Dislocation Rockwood Type (III&VI): Coracoclavicular Ligaments Reconstruction Associated With Acromioclavicular Ligament Reconstruction Versus Coracoclavicular Ligaments Reconstruction With Acromioclavicular Temporary k Wire Fixation

Benha University0 个研究点目标入组 20 人开始时间: 2025年7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
尚未招募
入组人数
20
主要终点
complications

研究概览

简要总结

The aim of this study is to compare the clinical and radiographical outcome of patients treated by coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction versus coracoclavicular ligaments reconstruction acromioclavicular temporary k wire fixation in management of Acute AC dislocation Rockwood type (III&VI).

  • Number of patients (20)
  • Type of disease (AC dislocation Rockwood type (III&VI)
  • follow up period (6 months)
  • type of study: this is a clinical research study

详细描述

Acromioclavicular joint dislocation (ACD) is one of the most common shoulder injuries and is usually sports related. Acromioclavicular (AC) joint injuries account for about 12% of all shoulder injuries in clinical practice, a rate that increases to almost 40% in athletes participating in contact sports.

Epidemiological studies showed that most AC joint injuries occur in the third decade of life, and the gender distribution is 5:1 in favor of men. Acromioclavicular joint (ACJ) injuries have been reported to especially occur in 20- to 30-year-old male patients engaging in high-contact sports.

The mechanism of injury leading to AC joint dislocation can be direct or indirect. A direct force on the superior aspect of the acromion process, it happen due to fall onto the outer aspect of the shoulder, is the most common scenario. The acromioclavicular capsule-ligamentous structures fail with consecutive loading of the coraco-clavicular (CC) ligaments.

The Four components of the acromioclavicular (AC) capsular ligaments and the two components of the coracoclavicular (CC) ligaments contribute to AC joint stability depending upon the direction and magnitude of the force applied. The trapezoid ligament provides the major support against compressive loads applied along the axis of the clavicle and acts as a secondary restraint to superior translation. On the other hand, the conoid ligament contributes to both superior and anterior stability. Among the 4 AC capsular ligaments, the superior and posterior capsular ligaments, reinforced by the deltoid and trapezius muscle, are important due to their primary role in prevention of posterior translation. Despite the different contribution of each ligament on the stability of the AC joint, most current surgical techniques for complete AC joint dislocation focus on CC interval fixation to restore the CC ligaments.

Nonsurgical management is the mainstay of treatment for type I and II injuries, whereas surgery is usually recommended for type IV to VI injuries. The treatment for type III remains instead controversial as no clear treatment algorithm has been established.

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

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age at least 18 years old.
  • •Acute AC dislocation Rockwood type VI.
  • •Acute AC dislocation Rockwood type III patients with pre-injury high level of activity (work or athletic activity).
  • •Patient is fit for surgery.
  • •Patient is willing to participate.

排除标准

  • •Chronic AC dislocation.
  • •AC dislocation Rockwood type (I, II, IV and VI).
  • •Previous surgery to the same shoulder, degenerative changes of the glenohumeral joint, shoulder infections, and concomitant neurologic diseases.
  • •Associated neurological disorders in the affected limb.

研究组 & 干预措施

coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction

Active Comparator

The Gracilis or SemiT graft will be harvested from the ipsilateral knee. The acromioclavicular joint will be exposed by the deltopectoral approach. A strap incision will be started from the acromioclavicular joint and extended distally towards the tip of coracoid process. 2 drill holes will be prepared on the superior cortex of the clavicle at the footprint of the original 2 ligaments, using a 4.5-mm drill bit. The 2 holes will be around 1.5 cm apart and the lateral hole was around 2 to 2.5 cm proximal to the distal end of the clavicle. Another 4.5 mm drill bit hole was created in the acromion. The graft exiting laterally around the coracoid is then passed through the conoid tunnel from inferior to superior and then passed through the acromial tunnel from superior to inferior to augment/reconstruct the AC joint capsule. The graft exiting the acromion tunnel is passed through the trapezoid tunnel from superior to inferior. The two free ends of the hamstring graft are tied together.

干预措施: coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction (Procedure)

coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation

Active Comparator

Two 2.4-mm tunnels corresponding to the origins of the conoid and trapezoid ligaments will be created through the distal clavicle, approximately 1.5cm apart from each other. The distal tunnel will be 2.5cm away from the AC joint. After harvesting the Gracilis or Semitendinosus from the ipsilateral leg, the graft was prepared with no. 2 Ethibond sutures and passed beneath the coracoid. Both ends of the graft will be passed inside out through the tunnels after enlarging the tunnels by 4.5 drill bit making a figure of 8 sling. The AC joint will be provisionally reduced with two 1.5/1.8-mm smooth K-wires while keeping the graft ends under adequate manual tension. The ends of the graft will be sutured onto themselves and the surrounding soft tissues.

干预措施: coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation (Procedure)

结局指标

主要结局

complications

时间窗: 12 months after surgery.

Redislocations. Other local complications, eg. infection.

次要结局

  • Constant-Murley Score(12 months after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Ahmed ElSherif

Resident

Shebin El-Kom Teaching Hospital

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