SPRINT - Randomized Trial of Tibial Fracture Fixation
- Conditions
- Tibial Fracture
- Registration Number
- NCT00038129
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- Fractured tibia requiring fixation using an intramedullary nail
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Necessity for additional operation Months 6, 9, and 12
- Secondary Outcome Measures
Name Time Method Return to work, functional status, and health-related quality of life Months 6, 9, and 12
Trial Locations
- Locations (16)
San Francisco General Hospital
🇺🇸San Francisco, California, United States
University of Florida - Jacksonville
🇺🇸Jacksonville, Florida, United States
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
Scroll for more (6 remaining)San Francisco General Hospital🇺🇸San Francisco, California, United States