(Taken from the application):Tibial fractures are the most common long bone fractures. Surgeons agree that intramedullary nails are the implant of choice when surgery is indicated. However, the decision to, ream or enlargen the intirarnedullary canal prior to nail insertion remains controversial. Proponents believe that reaming increases cortical bow blood flow increases the stability of the fracture fixation, and provides autogenous bone graft at the fracture site. Opponents believe that reaming damages the endosteal blood supply and threatens fracture healing. We, therefore, propose a randomized trial of reamed vs nonreamed intramedulary insertion in 900 patients with dosed or open tibial shaft fractures. Eligible patients receive 1) reaming of the intramedullary canal prior to insertion of an intramedullary nail or 2) insertion of an intramedullary nail without prior reaming of the intramedullary canal. Surgeons will follow a strict protocol in managing patients in both groups. The protocol will include proscription to re-operation prior to six rnonths. The rate of re-operations aimed at improving fracture healing (bone grafting, nail exchange or removal, soft tissue coverage procedures) will be determined at 6 months, 9 months and one year. Secondary outcomes will Include return to work, functional status and health-related quality of life. The large size of the trial will reveal a more reliable and precise estimate of the true effect of both treatments. The results from this trial will be useful in guiding clinical practice.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
3R01AR048529-03S1
Application #
7169352
Study Section
Special Emphasis Panel (ZAR1)
Program Officer
Panagis, James S
Project Start
2002-05-28
Project End
2008-03-31
Budget Start
2004-04-01
Budget End
2008-03-31
Support Year
3
Fiscal Year
2006
Total Cost
$73,539
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Orthopedics
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Obremskey, William; Agel, Julie; Archer, Kristin et al. (2016) Character, Incidence, and Predictors of Knee Pain and Activity After Infrapatellar Intramedullary Nailing of an Isolated Tibia Fracture. J Orthop Trauma 30:135-41
Lin, Carol A; Swiontkowski, Marc; Bhandari, Mohit et al. (2016) Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial. J Orthop Trauma 30:142-8
Lin, Carol Alice; Bhandari, Mohit; Guyatt, Gordon et al. (2016) Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. J Orthop Trauma 30:156-61
Sanders, David W; Bhandari, Mohit; Guyatt, Gordon et al. (2014) Critical-sized defect in the tibia: is it critical? Results from the SPRINT trial. J Orthop Trauma 28:632-5
Busse, Jason W; Bhandari, Mohit; Guyatt, Gordon H et al. (2012) Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. J Orthop Trauma 26:370-8
Bhandari, Mohit; Tornetta 3rd, Paul; Rampersad, Shelly-Ann et al. (2012) (Sample) Size Matters! An Examination of Sample Size from the SPRINT Trial. J Orthop Trauma :
Schemitsch, Emil H; Bhandari, Mohit; Guyatt, Gordon et al. (2012) Prognostic factors for predicting outcomes after intramedullary nailing of the tibia. J Bone Joint Surg Am 94:1786-93
Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Fractures (SPRINT) Investigators; Sun, Xin; Heels-Ansdell, Diane et al. (2011) Is a subgroup claim believable? A user's guide to subgroup analyses in the surgical literature. J Bone Joint Surg Am 93:e8
SPRINT Investigators; Briel, Matthias; Sprague, Sheila et al. (2011) Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT). Value Health 14:450-7
SPRINT Investigators; Simunovic, Nicole; Walter, Stephen et al. (2011) Outcomes assessment in the SPRINT multicenter tibial fracture trial: Adjudication committee size has trivial effect on trial results. J Clin Epidemiol 64:1023-33

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