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

NCT07024056 | Not Yet Recruiting

• 1 other identifier: ACJ disruption management
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acromioclavicular Joint; Acromioclavicular Joint Dislocation

Outcome Measures

Primary Outcomes (1)

• complications

  Redislocations. Other local complications, eg. infection.

  12 months after surgery.

Secondary Outcomes (1)

• Constant-Murley Score

  12 months after surgery.

Study Arms (2)

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

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

coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction

coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation PROCEDURE

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.

coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Related Publications (10)

• 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.

  PMID: 32778383 BACKGROUND

• Saccomanno MF, Fodale M, Capasso L, Cazzato G, Milano G. Reconstruction of the coracoclavicular and acromioclavicular ligaments with semitendinosus tendon graft: a pilot study. Joints. 2014 May 8;2(1):6-14. eCollection 2014 Jan-Mar.

  PMID: 25606535 BACKGROUND

• Pallis M, Cameron KL, Svoboda SJ, Owens BD. Epidemiology of acromioclavicular joint injury in young athletes. Am J Sports Med. 2012 Sep;40(9):2072-7. doi: 10.1177/0363546512450162. Epub 2012 Jun 15.

  PMID: 22707749 BACKGROUND

• Sirin E, Aydin N, Mert Topkar O. Acromioclavicular joint injuries: diagnosis, classification and ligamentoplasty procedures. EFORT Open Rev. 2018 Jul 17;3(7):426-433. doi: 10.1302/2058-5241.3.170027. eCollection 2018 Jul.

  PMID: 30233818 BACKGROUND

• Nolte PC, Lacheta L, Dekker TJ, Elrick BP, Millett PJ. Optimal Management of Acromioclavicular Dislocation: Current Perspectives. Orthop Res Rev. 2020 Mar 5;12:27-44. doi: 10.2147/ORR.S218991. eCollection 2020.

  PMID: 32184680 BACKGROUND

• Shin SJ, Campbell S, Scott J, McGarry MH, Lee TQ. Simultaneous anatomic reconstruction of the acromioclavicular and coracoclavicular ligaments using a single tendon graft. Knee Surg Sports Traumatol Arthrosc. 2014 Sep;22(9):2216-22. doi: 10.1007/s00167-013-2569-x. Epub 2013 Jul 11.

  PMID: 23842800 BACKGROUND

• Frank RM, Cotter EJ, Leroux TS, Romeo AA. Acromioclavicular Joint Injuries: Evidence-based Treatment. J Am Acad Orthop Surg. 2019 Sep 1;27(17):e775-e788. doi: 10.5435/JAAOS-D-17-00105.

  PMID: 31008872 BACKGROUND

• Xara-Leite F, Andrade R, Moreira PS, Coutinho L, Ayeni OR, Sevivas N, Espregueira-Mendes J. Anatomic and non-anatomic reconstruction improves post-operative outcomes in chronic acromio-clavicular instability: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2019 Dec;27(12):3779-3796. doi: 10.1007/s00167-019-05408-3. Epub 2019 Feb 26.

  PMID: 30806755 BACKGROUND

• Moatshe G, Kruckeberg BM, Chahla J, Godin JA, Cinque ME, Provencher MT, LaPrade RF. Acromioclavicular and Coracoclavicular Ligament Reconstruction for Acromioclavicular Joint Instability: A Systematic Review of Clinical and Radiographic Outcomes. Arthroscopy. 2018 Jun;34(6):1979-1995.e8. doi: 10.1016/j.arthro.2018.01.016. Epub 2018 Mar 21.

  PMID: 29573931 BACKGROUND

• Garofalo R, Ceccarelli E, Castagna A, Calvisi V, Flanagin B, Conti M, Krishnan SG. Open capsular and ligament reconstruction with semitendinosus hamstring autograft successfully controls superior and posterior translation for type V acromioclavicular joint dislocation. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):1989-1994. doi: 10.1007/s00167-017-4509-7. Epub 2017 Apr 22.

  PMID: 28434037 BACKGROUND

Central Study Contacts

Sherif Eltraigy, Ass. Prof.

CONTACT

+201221754037; shareefaltraigy@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06