Clinical Trial: Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study

Brief Summary:

Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. The nature of the treatment is decided according to the severity of the lesion.

The purpose of this study is to determine whether the surgical treatment is required or not for type III AC joint dislocations.


Detailed Summary:
Sponsor: Hopital de l'Enfant-Jesus

Current Primary Outcome: Functional results of injured shoulder on Constant score [ Time Frame: 3 months after surgery ]

Based on the patient's subjective and objective answers to the Constant and Murley questionnaire, data are collected and calculated over a 100 points to measure the functional score of the injured shoulder.

Also, to measure shoulder strength, the Isoforce system from MDS® is used.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Return to professional activities [ Time Frame: 3 months after surgery ]
    Evaluation of the patient's capacity to return to work and evaluating if those treated surgically return to work faster than the patients with a conservative treatment.
  • Rate of secondary surgery [ Time Frame: up to 12 months after surgery ]
    The difference on the reoperation rate between the two groups will be analyzed.
  • Social impact on SF-36 scale [ Time Frame: 3 months after surgery ]
    The social impact of both treatments will be measured with the SF-36 score.
  • Functional difference [ Time Frame: 6 months after surgery ]
    Using the Constant score, the functional difference between the two groups at 6 months will be measured.
  • Social impact on SF-36 scale [ Time Frame: 6 months after surgery ]
    The social impact of both treatments will be measured with the SF-36 score.
  • Social impact on SF-36 scale [ Time Frame: 12 months after surgery ]
    The social impact of both treatments will be measured with the SF-36 score.
  • Radiologic assessment on the Zanca and axillary views [ Time Frame: 6 weeks after surgery ]

    Zanca view allows control of the superior displacement. It will be expressed in percentage of the CC distance compared to the non-injured side.

    Axillary view allows control of the posterior displacement. It will be expressed in percentage of the AC distance compared to the non-injured side.

    Both views will assess degenerative changes, subacromial osteolysis, distal clavicle osteolysis (all expressed in percentage of patients per group).

  • Rate of complications [ Time Frame: up to 12 months after surgery ]
    The rate of complications both general and orthopaedic will be described in the in percentage of the number of patients per group.
  • Pain on Visual analog scale (VAS) [ Time Frame: 6 weeks after surgery ]
    Pain is described with the VAS, which range from 1 to 10.
  • Pain on VAS [ Time Frame: 3 months after surgery ]
    Pain is described with the VAS, which range from 1 to 10.
  • Pain on VAS [ Time Frame: 6 months after surgery ]
    Pain is described with the VAS, which range from 1 to 10.
  • Pain on VAS [ Time Frame: 12 months after surgery ]
    Pain is described with the VAS, which range from 1 to 10.


Original Secondary Outcome:

  • Return to professional activities [ Time Frame: 3 months after surgery ]
    Evaluation of the patient's capacity to return to work and evaluating if those treated surgically return to work faster than the patients with a conservative treatment.
  • Rate of secondary surgery [ Time Frame: up to 12 months after surgery ]
    The difference on the reoperation rate between the two groups will be analyzed.
  • Social impact [ Time Frame: 3 months after surgery ]
    The social impact of both treatments will be measured with the SF-36 score.
  • Functional difference [ Time Frame: 6 months after surgery ]
    Using the Constant score, the functional difference between the two groups at 6 months will be measured.
  • Social impact [ Time Frame: 6 months after surgery ]
    The social impact of both treatments will be measured with the SF-36 score.
  • Social impact [ Time Frame: 12 months after surgery ]
    The social impact of both treatments will be measured with the SF-36 score.


Information By: Hopital de l'Enfant-Jesus

Dates:
Date Received: April 21, 2010
Date Started: May 2007
Date Completion: February 2015
Last Updated: December 19, 2012
Last Verified: December 2012