Treatment of Displaced, Midshaft Clavicle Fractures. Sling or Plate? (NCT01483482) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Displaced, Midshaft Clavicle Fractures. Sling or Plate?
Denmark120 participantsStarted 2011-04
Plain-language summary
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics.
There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle fractures. Conservative treatment has, traditionally, been the preferred treatment but recent studies have shown higher incidences of non-union and symptomatic malunion associated with conservative treatment. Primary surgery has in several studies been associated with high success rates and few complications but there is no compelling evidence towards superior results after primary surgery.
The objective of this randomized study is to compare conservative treatment (sling) with primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.
Who can participate
Age range
18 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:
* Age 18-65 years
* The patient can not have any medical untreated illness : only ASA 1-2
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.
* The patient is expected to be able to follow the postoperative controls.
Exclusion Criteria:
* Multitrauma patient
* Other simultaneous fractures
* Former surgery of the shoulder or clavicular.
* Former chronic illness of the shoulder
* Pathological or open fractures
* Associated nerve or vessel damage of the affected arm.
* Fractures older than 3 weeks (21 days)
* Patients with drug(alcohol abuse where it is not expected that the patient i able to complete the follow-up.
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.