Journal of Bone & Joint Surgery - American Volume:
Letters to the editor
Corresponding author: Mohit Bhandari, MD, MSc, FRCSC, Department of Clinical Epidemiology and Biostatistics, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 2X2, Canada, e-mail: email@example.com
M. Bhandari, P. Tornetta III, M. Swiontkowski, E. Schemitsch, D. Sanders, S. Walter, and G. Guyatt reply:
We read with interest the letter from Drs. Sarmiento and Latta in response to our recently published multinational SPRINT trial comparing reamed and unreamed tibial nail insertion in patients with closed and open tibial shaft fractures. They raised concerns about omissions in our publication, including (1) the lack of information on infection rates for all patients, (2) the lack of radiographic assessments of fracture-healing times, radiographic shortening, and malunions, and (3) the lack of reporting of knee pain.
The SPRINT primary outcome, reoperation at twelve months, was a composite that included bone-grafting procedures, implant exchanges, and dynamizations performed after intramedullary nail insertion as well as operations for the treatment of infection and fasciotomies (the latter two irrespective of the fracture gap). The rates of infections in patients with both closed and open fractures were presented in Tables III and IV of the publication. We focused on only infections that required operative treatment.
While radiographic assessments of shortening and malunion and time to healing are traditionally important, they are less important to patients than are reoperations, function, and pain. Our article focused on what we believe to be the most important issue related to tibial fracture treatment: the need for a reoperation. Tables III and IV provided details about the types of reoperations in response to nonunions.
Drs. Sarmiento and Latta raised the greatest concern with regard to our omission of information on knee pain and related functional issues; these issues are indeed important. SPRINT evaluated patient function at regular intervals up to twelve months after surgery with use of the Short Form-36 (SF-36), the Short Musculoskeletal Functional Assessment (SMFA), the Health Utilities Index (HUI), and a focused Knee Pain Questionnaire. We will provide functional and knee pain outcomes in a separate publication. As we stated in our report, we presented the findings on only our primary outcome (i.e., the reoperation rate). We further referred readers to our trial registration and our previously published SPRINT protocol paper1 in the first paragraph of the Materials and Methods section.
These letters originally appeared, in slightly different form, on jbjs.org. They are still available on the web site in conjunction with the article to which they refer.
1. SPRINT Investigators, Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008;9:91.