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

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00594841

Collaborator

Orthopaedic Trauma Association (Other), Osteosynthesis & Trauma Care (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Procedure: Open Reduction Internal Fixation of AC joint dislocation Other: Non operative treatment of AC joint dislocation (sling)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]
2 years for recruitment plus 2 years for follow-up. Total study duration = 4 years

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada

Sponsors and Collaborators

Unity Health Toronto
Orthopaedic Trauma Association
Osteosynthesis & Trauma Care

Investigators

Principal Investigator: Michael D McKee, MD, FRCSC, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unity Health Toronto

ClinicalTrials.gov Identifier:

NCT00594841

Other Study ID Numbers:

AC 02-Nov-07
MMES 2008

First Posted:

Jan 16, 2008

Last Update Posted:

Apr 24, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Unity Health Toronto

Acromioclavicular Joint

Shoulder dislocation

AC dislocation

Additional relevant MeSH terms:

Joint Dislocations

Shoulder Dislocation

Study Results

No Results Posted as of Apr 24, 2020