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Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Heather A. Vallier, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00888160
First received: April 24, 2009
Last updated: March 15, 2016
Last verified: March 2016

April 24, 2009
March 15, 2016
September 2010
September 2030   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00888160 on ClinicalTrials.gov Archive Site
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Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
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.
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Observational
Time Perspective: Prospective
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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.
  • Unstable Pelvic Ring Fracture
  • Unstable Acetabulum Fracture
  • Femur Fracture
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
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September 2030   (final data collection date for primary outcome measure)

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:

    • unstable pelvic ring fracture
    • unstable acetabulum fracture, or
    • femur fracture
  • Patients will be included regardless of race or gender. Isolated fractures will be included

Exclusion Criteria:

  • Low-energy pelvis and hip fractures will be excluded
  • Patients younger than 16 years of age will be excluded
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00888160
IRB06-00089
No
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Heather A. Vallier, MetroHealth Medical Center
MetroHealth Medical Center
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MetroHealth Medical Center
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP