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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open reduction internal fixation | Experimental | open reduction internal fixation |
|
| non operative treatment | Active Comparator | 'sling rest and early functional recovery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open reduction internal fixation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| X-ray evaluation | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikel Aburto, MD | Hospital Heneral Universitario Gregorio Maranon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon | Madrid | 28007 | Spain |
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| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| sling rest and early functional recovery | Other | Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed. |
|
| 12 months |