Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Procedure: Open Reduction Internal Fixation of AC joint dislocation
* Other: Non operative treatment of AC joint dislocation (sling)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 16 to 65 years of age Grade III (3), IV (4) or V (5) dislocation of the acromioclavicular (AC) joint (evidenced by no contact between the distal clavicle and the acromion as seen in standardized radiographs) Closed injury AC joint dislocations within 28 days post injury Provision of informed consent Exclusion Criteria: Grade I(1), II (2), or VI (6) subluxation/dislocation of the AC joint Open AC joint separation Scapulothoracic dissociation Presence of vascular injury Dislocations over 28 days post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery (including pregnancy) Inability to comply with rehabilitation or form completion Inability to provide informed consent Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, patients not mentally competent to give consent, etc.)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Conservative (nonoperative) management of the AC joint dislocation. | Other: Non operative treatment of AC joint dislocation (sling)<br>* 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.<br>|
| Experimental: 2<br>Operative fixation (i.e., ORIF) of the dislocation with a hook plate and screws. | Procedure: Open Reduction Internal Fixation of AC joint dislocation<br>* 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: Anatomic reduction of the AC joint Definitive fixation with a hook plate and screws<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromioclavicular Joint, Shoulder dislocation, AC dislocation