Clinical trial NCT00594841: Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Official title: A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Acromioclavicular Joint
Shoulder dislocation
AC dislocation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Osteosynthesis & Trauma Care
First posted: 2008-01-16
Enrollment: 83
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH).
timeFrame: 2 years
Secondary outcomes:
measure: Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Michael D McKee, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.