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

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Other: Non operative treatment of AC joint dislocation (sling); Procedure: Open Reduction Internal Fixation of AC joint dislocation

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: 2; 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: Anatomic reduction of the AC joint; Definitive fixation with a hook plate and screws

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Orthopaedic Trauma Association; Osteosynthesis & Trauma Care
• Investigators: Principal Investigator: Michael D McKee, MD, FRCSC, Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Shoulder dislocation; Acromioclavicular Joint; AC dislocation
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: AC 02-Nov-07; MMES 2008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO