Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

Hospital General Universitario Gregorio Marañon

Status

Withdrawn

Conditions

Acromioclavicular Joint Dislocation

Treatments

Procedure: open reduction internal fixation

Other: sling rest and early functional recovery

Study type

Interventional

Funder types

Other

Identifiers

NCT02195219

ACLUX-3

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.