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

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Open Reduction Internal Fixation of AC joint dislocation
Non operative treatment of AC joint dislocation (sling)
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Acromioclavicular Joint, Shoulder dislocation, AC dislocation

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Conservative (nonoperative) management of the AC joint dislocation.

Operative fixation (i.e., ORIF) of the dislocation with a hook plate and screws.

Outcomes

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 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.

Full Information

First Posted
January 7, 2008
Last Updated
April 23, 2020
Sponsor
Unity Health Toronto
Collaborators
Orthopaedic Trauma Association, Osteosynthesis & Trauma Care
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1. Study Identification

Unique Protocol Identification Number
NCT00594841
Brief Title
Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Acronym
ACJoint
Official Title
A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Orthopaedic Trauma Association, Osteosynthesis & Trauma Care

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Acromioclavicular Joint, Shoulder dislocation, AC dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Conservative (nonoperative) management of the AC joint dislocation.
Arm Title
2
Arm Type
Experimental
Arm Description
Operative fixation (i.e., ORIF) of the dislocation with a hook plate and screws.
Intervention Type
Procedure
Intervention Name(s)
Open Reduction Internal Fixation of AC joint dislocation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non operative treatment of AC joint dislocation (sling)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH).
Description
2 years for recruitment plus 2 years for follow-up. Total study duration = 4 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D McKee, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26489055
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.
Results Reference
result

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Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

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