SPRINT - Randomized Trial of Tibial Fracture Fixation
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
- Fractured tibia requiring fixation using an intramedullary nail
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,200 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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