Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

NCT ID: NCT00594841

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-11-30

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.

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Conservative (nonoperative) management of the AC joint dislocation.

Group Type: ACTIVE_COMPARATOR

Non operative treatment of AC joint dislocation (sling)

Intervention Type: OTHER

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.

2

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

Group Type: EXPERIMENTAL

Open Reduction Internal Fixation of AC joint dislocation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Trauma Association

OTHER

Sponsor Role: collaborator

Osteosynthesis & Trauma Care

UNKNOWN

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D McKee, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 26489055 (View on PubMed)

Other Identifiers

MMES 2008

Identifier Type: -

Identifier Source: secondary_id

AC 02-Nov-07

Identifier Type: -

Identifier Source: org_study_id