Clavicle Fracture Clinical Trial
Official title:
Operative Versus Non-Operative Treatment For Clavicle Fracture in the PolyTrauma Patient With Associated Chest Injury. A Prospective, Randomized Clinical Trial
About 90% of chest injuries in America are due to blunt forces, mostly as a result of motor
vehicle collisions and falls. Severity varies from minor bruising to severe chest injuries.
For several years, clavicle ("collarbone") fractures have been treated without surgery
(non-operatively), even when the fracture is out of place (displaced). Over the last few
years, however, treatment has changed more towards surgical fixation (operative), because of
the sometimes difficult healing in clavicle fractures that are displaced. Several research
studies have shown that cases in which the clavicle fracture never heals completely
(non-union) are more frequent after nonoperative treatment, compared to operative fixation.
In those cases, surgery is still required, only later (secondary surgery). Further, clavicle
malunion, in which the fracture heals but is still out of place) has been shown to be high
after nonoperative treatment. Recent published research studies have shown better function,
higher patient satisfaction, earlier return to activity (use of the arm) and decreased
nonunion and malunion following surgery, also called open reduction/internal fixation.
Despite recent published research, there is still a lack of agreement on when surgical
fixation should be performed for clavicle fractures.
Patients with chest injuries often have clavicle fractures. Chest injuries can restrict
patients' ability to breathe, cough, stand, walk and leave the hospital. Although it is
unusual that chest injuries can be improved with surgery, patients with clavicle fractures
and chest injuries might recover faster if the clavicle fractures were repaired.
Patients are being asked to take part in the study they have sustained a clavicle fracture
associated with a chest injury with or without any other injury to the abdomen, or arms or
legs. The aim of this study is to determine the difference in the hospital length of stay,
intensive care unit length of stay, respiratory rehabilitation (recovery of good respiratory
function), functional outcome, ability to become mobile again, complications and risk of
dying in trauma patients with chest injury and clavicle fracture treated operatively versus
non-operatively.
n/a
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