Comparison of Coracoclavicular Fixation With Versus Without Acromioclavicular Stabilization for Repair of Acute Acromioclavicular Joint Dislocations: A Randomized Controlled Clinical Trial

NCT05501509 | Unknown DMC

• 1 other identifier: 101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The entire upper extremity is attached to the axial skeleton, specifically through the clavicle and the acromioclavicular articulation (AC). The stability of the AC articulation is provided by coracoclavicular ligaments in the vertical plane and acromioclavicular ligaments in the horizontal plane. The AC luxation is a frequent pathology in youth and athletes that practice contact sports, it has incidence 9,2 per 1000 inhabitants per year, which represents between 30% to 50% of shoulder injuries in young athletes, which is more frequent in men than in women with a ratio of 8:1. Its main injury mechanism is direct trauma while the shoulder is adducted and its less frequent secondary indirect mechanism following is of a fall of the extended arm. In 1984 the Rockwood team published the most used and accepted classification system till this day, which is divided into 6 types according to the grade of instability types. The treatment is usually conservative in patients with Rockwood type I and II lesions and surgical in types IV, V and VI. There is controversy in the surgical indication of type III lesions, highlighting the importance of medial stability associated with the characteristics and expectations of each patient. Although there are more than 160 described surgical techniques, the percentage of complications is considerable, with a 14% of intra-operative complications, 21% reduction loss and a 10% end up in a revision surgery . To minimize the complications and obtain better functional results, the idea of this randomized controlled clinical trial was born.

Conditions

Acromioclavicular Joint Dislocation

Keywords

Shoulder surgery; Sports trauma; Acromioclavicular joint; Coracoclavicular

Outcome Measures

Primary Outcomes (2)

• User satisfaction rate

  The clinical impact of the daily strength, proprioception, range of movement and decrease of pain (functional Score: ASES Score, CONSTANT Score, Nottingham clavicle score)

  Up to 12 month

• Complication rates

  Number of participants with fail of the implant, loss of the reduction, clavicular or coracoid fracture, pain associated with the implant and infections

  Up to 12 month

Secondary Outcomes (4)

• Number of participants who returned to normal adduction force after surgery

  Up to 12 month

• Number of participants who ned of postoperative analgesic

  Up to 12 month

• Rate of coracoclavicular reduction

  Up to 12 month

• Rate of revision surgery

  Up to 12 month

Study Arms (2)

Restoring Vertical and horizontal stability of the acromioclavicular joint

ACTIVE COMPARATOR

Procedure: Coracoclavicular fixation with acromioclavicular stabilization for the management of an unstable acromiclavicular luxation

Restoring Vertical stability of the acromioclavicular joint

EXPERIMENTAL

Procedure: Coracoclavicular fixation for the management of an unstable acromiclavicular luxation

Interventions

Coracoclavicular fixation with acromioclavicular stabilization for the management of an unstable acromiclavicular luxation PROCEDURE

Using a 3-hole third plate and high resistance sutures across the acromioclavicular joint to achieve horizontal and vertical stability of the joint

Restoring Vertical and horizontal stability of the acromioclavicular joint

Coracoclavicular fixation for the management of an unstable acromiclavicular luxation PROCEDURE

Isolated coracoclavicular repair using a 3 hole third plate.

Restoring Vertical stability of the acromioclavicular joint

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Rockwood IIIB, V, and VI acromioclavicular luxation
• Less than 14 días of progression time since the lesion
• Patient over the age of 15
• Possibility of clinical monitoring
• Informed and validated consent by the ethics committee

You may not qualify if:

• Surgery previously done on the clavicle and/or ipsilateral acromioclavicular, contralateral and/or bilateral articulation.
• Neuropathy of motor or mixed upper extremities.
• Exposure of an acromioclavicular injury.
• Fractures associated with clavicles, scapula and/or ipsilateral humerus.
• Function alterations concerning the previously mentioned extremity.
• Functional alterations of the contralateral extremity.
• Disease that can evolve with neuropathy during the study period (Multiple Sclerosis, Vasculitis, badly controlled Diabetes with progressed damage, etc.)

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Hernán Henríquez Aravena Hospital

Temuco, 4781151, Chile

RECRUITING

Related Publications (17)

• Gorbaty JD, Hsu JE, Gee AO. Classifications in Brief: Rockwood Classification of Acromioclavicular Joint Separations. Clin Orthop Relat Res. 2017 Jan;475(1):283-287. doi: 10.1007/s11999-016-5079-6. Epub 2016 Sep 16. No abstract available.

  PMID: 27637619 BACKGROUND

• Lafosse T, Fortane T, Lafosse L. All-Endoscopic Treatment of Acromioclavicular Joint Dislocation: Coracoclavicular Ligament Suture and Acromioclavicular Ligament Desincarceration. Arthrosc Tech. 2020 Sep 25;9(10):e1485-e1494. doi: 10.1016/j.eats.2020.06.011. eCollection 2020 Oct.

  PMID: 33134050 RESULT

• 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 RESULT

• Stucken C, Cohen SB. Management of acromioclavicular joint injuries. Orthop Clin North Am. 2015 Jan;46(1):57-66. doi: 10.1016/j.ocl.2014.09.003. Epub 2014 Oct 11.

  PMID: 25435035 RESULT

• Gowd AK, Liu JN, Cabarcas BC, Cvetanovich GL, Garcia GH, Manderle BJ, Verma NN. Current Concepts in the Operative Management of Acromioclavicular Dislocations: A Systematic Review and Meta-analysis of Operative Techniques. Am J Sports Med. 2019 Sep;47(11):2745-2758. doi: 10.1177/0363546518795147. Epub 2018 Oct 1.

  PMID: 30272997 RESULT

• Tossy JD, Mead NC, Sigmond HM. Acromioclavicular separations: useful and practical classification for treatment. Clin Orthop Relat Res. 1963;28:111-9. No abstract available.

  PMID: 5889033 RESULT

• Beris A, Lykissas M, Kostas-Agnantis I, Vekris M, Mitsionis G, Korompilias A. Management of acute acromioclavicular joint dislocation with a double-button fixation system. Injury. 2013 Mar;44(3):288-92. doi: 10.1016/j.injury.2013.01.002. Epub 2013 Jan 24.

  PMID: 23352675 RESULT

• Beitzel K, Mazzocca AD, Bak K, Itoi E, Kibler WB, Mirzayan R, Imhoff AB, Calvo E, Arce G, Shea K; Upper Extremity Committee of ISAKOS. ISAKOS upper extremity committee consensus statement on the need for diversification of the Rockwood classification for acromioclavicular joint injuries. Arthroscopy. 2014 Feb;30(2):271-8. doi: 10.1016/j.arthro.2013.11.005.

  PMID: 24485119 RESULT

• Barnes CJ, Higgins LD, Major NM, Basamania CJ. Magnetic resonance imaging of the coracoclavicular ligaments: its role in defining pathoanatomy at the acromioclavicular joint. J Surg Orthop Adv. 2004 Summer;13(2):69-75.

  PMID: 15281402 RESULT

• Zumstein MA, Schiessl P, Ambuehl B, Bolliger L, Weihs J, Maurer MH, Moor BK, Schaer M, Raniga S. New quantitative radiographic parameters for vertical and horizontal instability in acromioclavicular joint dislocations. Knee Surg Sports Traumatol Arthrosc. 2018 Jan;26(1):125-135. doi: 10.1007/s00167-017-4579-6. Epub 2017 May 25.

  PMID: 28547587 RESULT

• 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 RESULT

• Nakazawa M, Nimura A, Mochizuki T, Koizumi M, Sato T, Akita K. The Orientation and Variation of the Acromioclavicular Ligament: An Anatomic Study. Am J Sports Med. 2016 Oct;44(10):2690-2695. doi: 10.1177/0363546516651440. Epub 2016 Jun 17.

  PMID: 27315820 RESULT

• Beitzel K, Obopilwe E, Apostolakos J, Cote MP, Russell RP, Charette R, Singh H, Arciero RA, Imhoff AB, Mazzocca AD. Rotational and translational stability of different methods for direct acromioclavicular ligament repair in anatomic acromioclavicular joint reconstruction. Am J Sports Med. 2014 Sep;42(9):2141-8. doi: 10.1177/0363546514538947. Epub 2014 Jul 2.

  PMID: 24989491 RESULT

• Saier T, Venjakob AJ, Minzlaff P, Fohr P, Lindell F, Imhoff AB, Vogt S, Braun S. Value of additional acromioclavicular cerclage for horizontal stability in complete acromioclavicular separation: a biomechanical study. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1498-1505. doi: 10.1007/s00167-014-2895-7. Epub 2014 Feb 21.

  PMID: 24554242 RESULT

• Barth J, Duparc F, Andrieu K, Duport M, Toussaint B, Bertiaux S, Clavert P, Gastaud O, Brassart N, Beaudouin E, De Mourgues P, Berne D, Bahurel J, Najihi N, Boyer P, Faivre B, Meyer A, Nourissat G, Poulain S, Bruchou F, Menard JF; French Society of Arthroscopy. Is coracoclavicular stabilisation alone sufficient for the endoscopic treatment of severe acromioclavicular joint dislocation (Rockwood types III, IV, and V)? Orthop Traumatol Surg Res. 2015 Dec;101(8 Suppl):S297-303. doi: 10.1016/j.otsr.2015.09.003. Epub 2015 Oct 27.

  PMID: 26514849 RESULT

• Scheibel M, Droschel S, Gerhardt C, Kraus N. Arthroscopically assisted stabilization of acute high-grade acromioclavicular joint separations. Am J Sports Med. 2011 Jul;39(7):1507-16. doi: 10.1177/0363546511399379. Epub 2011 Mar 24.

  PMID: 21436458 RESULT

• Sobhy MH. Midterm results of combined acromioclavicular and coracoclavicular reconstruction using nylon tape. Arthroscopy. 2012 Aug;28(8):1050-7. doi: 10.1016/j.arthro.2012.02.001. Epub 2012 Apr 21.

  PMID: 22521916 RESULT

Central Study Contacts

Felipe Gómez, Resident Traumatology

CONTACT

+56978228414; gomezlagosf@gmail.com

Martin Zecher, Traumatologist

CONTACT

+56998268185; mzecher@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: July 31, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)