Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation (NCT00594841) | Clinical Trial Compass
CompletedNot Applicable
Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Canada83 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH).