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Completed

NCT Number: NCT00594841

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

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.

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).

    Time frame: 2 years

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

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Orthopaedic Trauma Association
  • Osteosynthesis & Trauma Care

Registry information

Official study title

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

Acronym: ACJoint

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2008
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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