Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Greenville Hospital System University Medical Center |
---|---|
Information provided by: | Greenville Hospital System University Medical Center |
ClinicalTrials.gov Identifier: | NCT00534326 |
Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.
Condition | Intervention |
---|---|
Femoral Fractures |
Procedure: Standard Reaming Procedure: Reaming/Irrigating/Aspirating |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures |
Estimated Enrollment: | 550 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Standard Reaming
|
Procedure: Standard Reaming
Femoral reaming using standard reaming techniques of multiple reamers
|
2: Active Comparator
Reamer/Irrigator/Aspirator
|
Procedure: Reaming/Irrigating/Aspirating
Reaming using the Reamer/Irrigator/Aspirator
|
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
University of Missouri- Columbia | |
Columbia, Missouri, United States, 65212 | |
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28203 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, South Carolina | |
Greenville Hospital System Univeristy Medical Center | |
Greenville, South Carolina, United States, 29605 | |
Palmetto Health | |
Columbia, South Carolina, United States, 29203 | |
United States, Tennessee | |
University of Tennessee-Chattanooga Unit | |
Chattanooga, Tennessee, United States, 37403 | |
United States, Virginia | |
Carilion Medical Center | |
Roanoke, Virginia, United States, 24033 |
Principal Investigator: | Kyle J Jeray, MD | Greenville Hospital System University Medical Center |
Responsible Party: | Greenville Hospital System University Medical Center ( Kyle J. Jeray, MD ) |
Study ID Numbers: | Ort-07-06-06 |
Study First Received: | September 20, 2007 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00534326 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 |