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Sponsored by: |
MetroHealth Medical Center |
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Information provided by: | MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT00888160 |
Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates. However, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood. The practice of "early total care," early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response. The alternative extreme of "damage control orthopedics (DCO)" has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation. It is speculated that DCO will diminish the potential for systemic compromise. However, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial. The investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome. The investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.
Condition |
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Unstable Pelvic Ring Fracture Unstable Acetabulum Fracture Femur Fracture |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Timing of Orthopaedic Surgery in the Multiply-Injured Patient: Development of a Protocol for Early Appropriate Care |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries: unstable pelvic ring fracture, unstable acetabulum fracture, or femur fracture.
Inclusion Criteria:
All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries:
Exclusion Criteria:
Responsible Party: | MetroHealth Medical Center ( Heather Vallier, M.D. ) |
Study ID Numbers: | IRB06-00089 |
Study First Received: | April 24, 2009 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00888160 History of Changes |
Health Authority: | United States: Institutional Review Board |
Femoral Fractures Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries |
Femoral Fractures Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries |