The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.
Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
San Francisco General Hospital
San Francisco, California, United States
University of Florida - Jacksonville
Jacksonville, Florida, United States
Necessity for additional operation
Time frame: Months 6, 9, and 12
Return to work, functional status, and health-related quality of life
Time frame: Months 6, 9, and 12
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Deaconess Hospital
Evansville, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
University of Buffalo
Buffalo, New York, United States
Jamaica Hospital
Jamaica, New York, United States
Wake Medical Center
Raleigh, North Carolina, United States
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