A critical appraisal of the SPRINT trial.
The Study to Prospectively evaluate Reamed Intramedullary Nails in Tibial fractures (SPRINT) was a randomized controlled trial to evaluate rates of reoperation and complications resulting from reamed versus unreamed intramedullary nailing for the treatment of tibial shaft fractures. The trial found a possible benefit for reamed intramedullary nailing in patients with closed tibial fractures, but no difference was found between the 2 approaches in patients with open fractures. This article is a review and critique of the methodology used in the SPRINT trial. Numerous aspects of the trial's design served to greatly reduce the potential bias, producing sound and reliable results. Overall, the SPRINT trial should provide recommendations for change in clinical practice and also set a benchmark for the conduct of randomized controlled trials in orthopedic surgery.
Helfet
David L
DL
Weill Cornell Medical College, New York, NY, USA. helfetd@hss.edu
Suk
Michael
M
Hanson
Beate
B
D005594:Fracture Fixation, Intramedullary / Q000009:adverse effects / Q000379:methods*; D017102:Fracture Healing; D005597:Fractures, Open / Q000601:surgery; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology; D011379:Prognosis; D012086:Reoperation / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012107:Research Design; D013978:Tibial Fractures / Q000601:surgery*; D016896:Treatment Outcome