Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Completed · Not applicable
Conditions studied: Femoral Fractures
In brief
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.
Key facts
- Study ID
- NCT00534326
- Run by
- Prisma Health-Upstate
- People needed
- 158
- Starts
- 2006-12-01
- Expected to finish
- 2018-12-30
- Last updated by the study team
- 2020-03-10
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women between the ages of 18 years and 85 years;
- Acute fractures of the femoral shaft
You may not qualify if…
- Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
- Pathological fractures;
- Open fractures;
- Patients with additional injuries to the ipsilateral femur;
- Surgical delay of greater than 7 days from the time of injury;
- Retained hardware in the affected limb;
- Previous infection in fractured limb;
- Likely problems in the judgment of the investigators with maintaining follow-up;
- Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires;
- Hopeless diagnosis;
- Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic;
- Fractures requiring cephalomedullary nails
Where it is running
- Indiana University — Indianapolis, Indiana, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- University of Missouri- Columbia — Columbia, Missouri, United States
- Carolinas Medical Center — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Palmetto Health — Columbia, South Carolina, United States
- Greenville Hospital System Univeristy Medical Center — Greenville, South Carolina, United States
- University of Tennessee-Chattanooga Unit — Chattanooga, Tennessee, United States
- Carilion Medical Center — Roanoke, Virginia, United States
Full record on ClinicalTrials.gov
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