Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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
Unstable Pelvic Ring Fracture
Unstable Acetabulum Fracture
Femur Fracture

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care

Further study details as provided by MetroHealth Medical Center:

Estimated Enrollment: 500
Study Start Date: September 2010
Estimated Primary Completion Date: September 2030 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888160

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
  More Information

Responsible Party: Heather A. Vallier, Professor of Orthopaedic Surgery, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00888160     History of Changes
Other Study ID Numbers: IRB06-00089 
Study First Received: April 24, 2009
Last Updated: March 15, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on December 08, 2016