Acute ACJ Dislocation Type (III&VI): CC Ligaments Reconst... | NCT07024056

NCT07024056

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Detailed Description

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.

Because of the distinct functional anatomy of the AC and CC ligaments, several studies provided good results focusing on anatomical surgical techniques that recreate those structures, rather than non-anatomical procedures that aim to improve function and stability regardless of restoration of anatomy of the torn ligaments. Although several anatomic reconstruction techniques are available, most of them showed promising results after conducting underpowered studies at short-term follow-up. Moreover, no gold standard has been identified yet.

Several surgical techniques have been described in the literature. Rockwood classified the early surgical treatments for AC joint instability into 4 groups: (1) AC ligament repairs, (2) CC ligaments repairs, (3) excision of the distal clavicle, and (4) dynamic muscle transfer. In addition, K-wires, screws, and plates have been used for temporary fixation of the AC joint. A better understanding of the anatomy and biomechanics of the AC joint and the coracoclavicular (CC) ligaments has led to advances in surgical techniques. Anatomic reconstructions using free grafts have become popular in recent years. In addition, arthroscopically assisted procedures using cortical fixation devices have become more popular.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Procedure: coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction
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.	Procedure: coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction	Procedure	The Gracilis or SemiT graft will be harvested from the ipsilateral knee. An oblique skin incision will be made starting from the ACJ 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 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 will be then passed through the conoid tunnel from inferior to superior and then passed through the acromial tunnel from superior to inferior. The graft exiting the acromion tunnel will be passed through the trapezoid tunnel from superior to inferior. The two free ends of the hamstring graft will be tied to one another with Ethibond No.2 sutures

Measure	Description	Time Frame
complications	Redislocations. Other local complications, eg. infection.	12 months after surgery.

Measure	Description	Time Frame
Constant-Murley Score	Constant-Murley Score (range: 0-100). Higher scores indicate better shoulder function. Scores above 80 generally reflect excellent shoulder performance.	12 months after surgery.

Eligibility Module

PubMed Identifier	Type	Citation	Retractions
32778383	Background	Frantz T, Ramkumar PN, Frangiamore S, Jones G, Soloff L, Kvit A, Curriero FC, Schickendantz M. Epidemiology of acromioclavicular joint injuries in professional baseball: analysis from the Major League Baseball Health and Injury Tracking System. J Shoulder Elbow Surg. 2021 Jan;30(1):127-133. doi: 10.1016/j.jse.2020.04.029. Epub 2020 Jun 9.
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