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Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation — ACJoint  

Shoulder Dislocation Clinical Trial

Official title:
A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

Clinical Trial Summary

The purpose of this study is to compare non-operative treatment versus operative treatment in patients who suffer a complete, acute acromioclavicular (AC) joint dislocation. This study will show if one method is superior to the other and will also show advantages and disadvantages associated with each treatment method.

Clinical Trial Description

All patients presenting to the hospital with a Type III, IV or V acute acromioclavicular (AC) joint dislocation and meeting the eligibility criteria will be approached and asked to enter this prospective, randomized clinical trial. After obtaining consent, the subject will be managed in accordance with one of the two randomized treatment strategies. The first treatment strategy will involve conservative (nonoperative) management of the AC joint dislocation. The second treatment strategy will involve operative fixation (i.e. ORIF) of the dislocation with a hook plate and screws.

The subjects in both treatment groups will receive post-operative care according to the same standards and protocol. The surgeon and research staff will be responsible for study follow-up (clinical and radiological assessment) of the patient on admission (baseline), on discharge from the hospital and at post-operative intervals of six weeks, three months, six months, one year and two years. Primary and secondary outcomes will be monitored at these post-operative intervals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00594841
Study type Interventional
Source St. Michael's Hospital, Toronto
Contact
Status Completed
Phase N/A
Start date January 2008
Completion date November 2012
View Details
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