Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation (ACJoint)

Unity Health Toronto

Status

Completed

Conditions

Shoulder Dislocation

Treatments

Procedure: Open Reduction Internal Fixation of AC joint dislocation

Other: Non operative treatment of AC joint dislocation (sling)

Study type

Interventional

Funder types

Other

Identifiers

NCT00594841

AC 02-Nov-07

MMES 2008

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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.)