Tibial Fracture
Conditions
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.
Interventions
PROCEDUREIntramedullary nail implant
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fractured tibia requiring fixation using an intramedullary nail
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Necessity for additional operation | Months 6, 9, and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Return to work, functional status, and health-related quality of life | Months 6, 9, and 12 |
Countries
United States
Outcome results
None listed