Clinical Trial: Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations

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 Summary:

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.


Sponsor: Hospital General Universitario Gregorio Marañon

Current Primary Outcome: Efficacy [ Time Frame: 12 months ]

Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.


Original Primary Outcome: Same as current

Current Secondary Outcome: X-ray evaluation [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Hospital General Universitario Gregorio Marañon

Dates:
Date Received: July 10, 2014
Date Started: June 2014
Date Completion: December 2017
Last Updated: March 2, 2017
Last Verified: March 2017