NCT05501509

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

Status unknown NA Last updated 23 August 2022

What this trial tests

NA trial testing Coracoclavicular fixation with acromioclavicular stabilization for the management of an unstable acromiclavicular luxation in Acromioclavicular Joint Dislocation in 240 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
30 November 2022

31 July 2023

Quick facts

Lead sponsor	Universidad de La Frontera
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	1 January 2022
Primary completion	30 November 2022
Estimated completion	31 July 2023
Sites	1 location across Chile

Drugs / interventions tested

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

Conditions studied

• Acromioclavicular Joint Dislocation — all drugs for Acromioclavicular Joint Dislocation →

Sponsor

Universidad de La Frontera — full company profile →

Who can join

Adults 15 to 65, any sex, with Acromioclavicular Joint Dislocation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comprehensive review of acromioclavicular joint dislocation: anatomy, mechanism, imaging, treatment and rehabilitation-narrative review.
   He X, Kong D, Lu X, Qian D, et al · · 2026 · PMID 41761265 · DOI 10.1186/s13018-026-06753-z