Acute ACJ Dislocation Type (III&VI): CC Ligaments Reconstruction With AC Ligament Reconstruction vs. CC Ligaments Reconstruction With AC Temporary k Wire Fixation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBenha University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction

    Procedure/Surgery

    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

  • coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation

    Procedure/Surgery

    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. The wound will be closed in layers.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstructionActive comparator 1 intervention
Group B: coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complications

Redislocations. Other local complications, eg. infection.

Time frame
12 months after surgery.

Secondary outcomes

1

Constant-Murley Score

Constant-Murley Score (range: 0-100). Higher scores indicate better shoulder function. Scores above 80 generally reflect excellent shoulder performance.

Time frame
12 months after surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Shebin El-Kom Teaching Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: