Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Dist… (NCT00872105) | Clinical Trial Compass
CompletedNot Applicable
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Canada59 participantsStarted 2009-03
Plain-language summary
This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.
Who can participate
Age range
16 Years – 60 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 60 years of age
* Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
* Fractures within 28 days post injury
* Provision of informed consent
Exclusion Criteria:
* Pathological fractures
* Non-displaced (cortical contact) distal clavicle fractures
* Open clavicle fractures
* Presence of vascular injury
* Fractures more than 28 days post-injury
* Limited life expectancy due to significant medical co-morbidity
* Medical contraindication to surgery
* Inability to comply with rehabilitation or form completion
* 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 measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.