This trial is active, not recruiting.

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 2016
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
open reduction internal fixation
open 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.
(Active Comparator)
'sling rest and early functional recovery
sling rest and early functional recovery
Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.

Primary Outcomes

time frame: 12 months

Secondary Outcomes

X-ray evaluation
time frame: 12 months

Eligibility Criteria

Male or female 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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hospital General Universitario Gregorio Marañon.