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| ID | Type | Description | Link |
|---|---|---|---|
| MMES 2008 |
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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Osteosynthesis & Trauma Care | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Conservative (nonoperative) management of the AC joint dislocation. |
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| 2 | Experimental | Operative fixation (i.e., ORIF) of the dislocation with a hook plate and screws. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction Internal Fixation of AC joint dislocation | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH). | 2 years for recruitment plus 2 years for follow-up. Total study duration = 4 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D McKee, MD, FRCSC | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26489055 | Result | Canadian Orthopaedic Trauma Society. Multicenter Randomized Clinical Trial of Nonoperative Versus Operative Treatment of Acute Acromio-Clavicular Joint Dislocation. J Orthop Trauma. 2015 Nov;29(11):479-87. doi: 10.1097/BOT.0000000000000437. |
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| ID | Term |
|---|---|
| D012783 | Shoulder Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| Non operative treatment of AC joint dislocation (sling) | Other | 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. |
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| D000070599 |
| Shoulder Injuries |