Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation (ACJoint)
|ClinicalTrials.gov Identifier: NCT00594841|
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : December 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Dislocation||Procedure: Open Reduction Internal Fixation of AC joint dislocation Other: Non operative treatment of AC joint dislocation (sling)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Active Comparator: 1
Conservative (nonoperative) management of the AC joint dislocation.
Other: Non operative treatment of AC joint dislocation (sling)
Standard protocol for conservative treatment will consist of the implementation of a sling, for shoulder support and patient comfort, for four weeks followed by physiotherapy. Pendulum exercises may be implemented at any time as dictated by the attending surgeon.
Operative fixation (i.e., ORIF) of the dislocation with a hook plate and screws.
Procedure: Open Reduction Internal Fixation of AC joint dislocation
Definitive surgical treatment (i.e., ORIF) will be performed within 28 days of the injury. In all cases the procedure will be performed by an orthopedic staff surgeon with the assistance of a fellow/resident(s). The operating surgeon will determine the positioning of the patient for surgery. ORIF of the AC joint dislocation will be carried out as follows:
- 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
- Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594841
|St. Michael's Hospital|
|Toronto, Ontario, Canada|
|Principal Investigator:||Michael D McKee, MD, FRCSC||St. Michael's Hospital, Toronto|