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Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

2014-07-24 14:19:13 | BioPortfolio

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.

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Shoulder Dislocation

Intervention

Open Reduction Internal Fixation of AC joint dislocation, Non operative treatment of AC joint dislocation (sling)

Location

St. Michael's Hospital
Toronto
Ontario
Canada

Status

Recruiting

Source

St. Michael's Hospital, Toronto

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:13-0400

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