Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

NCT00594841 | Completed

• 2 other identifiers: AC 02-Nov-07MMES 2008
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Keywords

Acromioclavicular Joint; Shoulder dislocation; AC dislocation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes.

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Conservative (nonoperative) management of the AC joint dislocation.

Other: Non operative treatment of AC joint dislocation (sling)

2

EXPERIMENTAL

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

Procedure: Open Reduction Internal Fixation of AC joint dislocation

Interventions

Open Reduction Internal Fixation of AC joint dislocation 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

2

Non operative treatment of AC joint dislocation (sling) 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.

1

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Unity Health Toronto: lead
• Orthopaedic Trauma Association: collaborator
• Osteosynthesis & Trauma Care: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 26489055 RESULT

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Michael D McKee, MD, FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)