Operative Versus Non-Operative Treatment of Clavicle Fracture in PolyTrauma
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|ClinicalTrials.gov Identifier: NCT01133769|
Recruitment Status : Withdrawn (Institutional issues Institution issues)
First Posted : May 31, 2010
Last Update Posted : January 20, 2017
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.
|Condition or disease|
|Clavicle Fracture Chest Injury|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Operative Versus Non-Operative Treatment For Clavicle Fracture in the PolyTrauma Patient With Associated Chest Injury. A Prospective, Randomized Clinical Trial|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2013|
Surgical vs Non surgical
This is an open, prospective, randomized, dual arm, parallel group clinical study of open reduction and internal fixation (ORIF) or intramedullary nail (IMN) versus non operative treatment for clavicle fracture in polytrauma patients with associated chest injury, with or without additional injuries to the head, abdomen, pelvis and extremities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133769
|United States, Colorado|
|St. Anthony's Hospitals Centura Health|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Edmund Rowland, M.D.||St. Anthony's Hospitals/Panorama Orthopedics and Spine Center|