Clinical Trial: Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH). [ Time Frame: 2 years ]

2 years for recruitment plus 2 years for follow-up. Total study duration = 4 years


Original Primary Outcome: The primary outcome measure will be a patient-oriented, limb-specific functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH). [ Time Frame: 2 years ]

Current Secondary Outcome: Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes. [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: January 7, 2008
Date Started: January 2008
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016