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SPRINT trial finds little difference in reoperation rates between groups

Long-awaited tibial nailing study heralded as model for future orthopaedic trauma trials.

Issue: Issue 6 2007

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BOSTON — The long awaited results of the multi-million dollar Study to Prospectively evaluate Reamed Intramedullary Nails in Tibial fractures, or SPRINT trial, shows a lower revision rate than previously reported for this form of fracture fixation, one of the primary investigators reported here.

The SPRINT trial was started 10 years ago after a number of smaller randomized, controlled trials suggested that reamed intramedullary nails significantly reduced the risk of nonunion compared to nonreamed intramedullary nails, said Mohit Bhandari, MD, at the 23rd Annual Meeting of the Orthopaedic Trauma Association.

Multicenter trial

The multicenter trial collected data from 205 surgeons at 29 clinical sites. Investigators enrolled 1,339 patients, of whom 1,226 were available for 1-year follow-up. The patients were randomly assigned to receive either reamed or nonreamed intramedullary nails. Specifically, the reamed group included 622 patients with 416 closed fractures and 206 open fractures. The nonreamed group included 604 patients with 410 closed fractures and 194 open fractures.

Overall, there were 55 crossovers, mostly from the reamed to the nonreamed groups, but this had no effect on the results, Bhandari said. Also, there were no differences between the groups for all parameters investigated, he noted.

“If you look at the pooled groups, there were no major differences in terms of reoperation,” he said.

Differences between groups

However, there was a difference between the open and closed fracture groups. The closed fracture group included 826 fractures with 113 total events, for a 14% overall event rate. “There was a 33% reduction in the risk of having a reoperation with reaming,” Bhandari said.

The open fracture group included 400 fractures with 106 total events, for a 27% overall event rate, “which was just shy of reaching statistical significance,” he said.

Bhandari said the key findings of the SPRINT trial are that the event rate, or reoperation, was substantially lower than that shown in previous randomized trials and, excluding dynamizations, there was no difference between the reamed and nonreamed nails.

In introducing the study to the OTA audience, William T. Obremsky, MD, called the study “maybe one of the future models for multicentered trials for orthopaedic trauma.”

For more information:

• Bhandari M. A randomized trial of reamed versus non-reamed intramedullary nail insertion on rates of reoperation in patients with fractures of the tibia. Paper #21. Presented at the 23rd Annual Meeting of the Orthopaedic Trauma Association. Oct. 18-20, 2007. Boston.