Acromioclavicular Joint Dislocation Clinical Trial
Official title:
Comparison of Coracoclavicular Fixation With Versus Without Acromioclavicular Stabilization for Repair of Acute Acromioclavicular Joint Dislocations: A Randomized Controlled Clinical Trial, Double-blind Test
NCT number | NCT05501509 |
Other study ID # | 101 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | July 31, 2023 |
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | July 31, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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.) |
Country | Name | City | State |
---|---|---|---|
Chile | Hernán Henríquez Aravena Hospital | Temuco |
Lead Sponsor | Collaborator |
---|---|
Universidad de La Frontera |
Chile,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of participants who returned to normal adduction force after surgery | Up to 12 month | ||
Secondary | Number of participants who ned of postoperative analgesic | Up to 12 month | ||
Secondary | Rate of coracoclavicular reduction | Up to 12 month | ||
Secondary | Rate of revision surgery | Up to 12 month |
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