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

NCT05501509 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-08-23

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

PROCEDURE

Coracoclavicular fixation for the management of an unstable acromiclavicular luxation

Isolated coracoclavicular repair using a 3 hole third plate.

Sponsors & Collaborators

  • Universidad de La Frontera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-11-30
Completion
2023-07-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501509 on ClinicalTrials.gov