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

This study has been completed.
Sponsor:
Collaborators:
Orthopaedic Trauma Association
Osteosynthesis & Trauma Care
Information provided by (Responsible Party):
Michael McKee, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00594841
First received: January 7, 2008
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention
Shoulder Dislocation
Procedure: Open Reduction Internal Fixation of AC joint dislocation
Other: Non operative treatment of AC joint dislocation (sling)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

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). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: January 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594841

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Orthopaedic Trauma Association
Osteosynthesis & Trauma Care
Investigators
Principal Investigator: Michael D McKee, MD, FRCSC St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Michael McKee, MD, FRCS(C), St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00594841     History of Changes
Other Study ID Numbers: AC 02-Nov-07, MMES 2008
Study First Received: January 7, 2008
Last Updated: March 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Acromioclavicular Joint
Shoulder dislocation
AC dislocation

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 21, 2014