Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation (ACJoint)
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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 |
- 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 measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 122 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (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:
|
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 |
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| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada | |
| 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: | February 28, 2013 |
| 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 June 17, 2013