Acromioclavicular Joint Dislocation
Conditions
Keywords
conservative, treatment, surgical, Acromioclavicular, Joint, dislocation
Brief summary
The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment. For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.
Detailed description
Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries. There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6. For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them. During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient. The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular dislocations.
Interventions
PROCEDUREopen reduction internal fixation
MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.
OTHERsling rest and early functional recovery
Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.
Sponsors
Hospital General Universitario Gregorio Marañon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 50 years. * Grade III acromioclavicular dislocation. * Signed informed consent.
Exclusion criteria
* Any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease…). * Previous acromioclavicular osteoarthritis. * Previous acromioclavicular lesions. * Concomitant lesions in the ipsilateral limb or in the contralateral shoulder. * Polytraumatized patients. * Any disease or condition the investigator finds decisive for exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 12 months | Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| X-ray evaluation | 12 months | X-ray evaluation of the patients who underwent open reduction and internal fixation treatment, comparing the results with the contralateral shoulder and with the preoperative images: 1. Width of the acromioclavicular joint in millimetres, before and after surgery. 2. Coracoclavicular distance, in millimetres, of the injured joint (the closest distance between these two structures) before and after surgery. 3. Vertical displacement distance of the clavicle, in millimetres, to the tangent line along the inferior edge of the acromioclavicular joint, before and after surgery. |
Countries
Spain
Outcome results
None listed