Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations
This trial has been suspended.
|Condition||acromioclavicular joint dislocation|
|Treatments||open reduction internal fixation, sling rest and early functional recovery|
|Sponsor||Hospital General Universitario Gregorio Marañon|
|Start date||June 2014|
|End date||December 2017|
|Trial size||32 participants|
|Trial identifier||NCT02195219, ACLUX-3|
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.
|Intervention model||parallel assignment|
time frame: 12 months
time frame: 12 months
All participants from 18 years up to 50 years old.
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.
|Official title||Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations|
|Principal investigator||Mikel Aburto, MD|
|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.|
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