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Reamed vs. unreamed nailing: Differences may be overblown
Preliminary findings of a large trial fail to produce the dramatic results of smaller studies.
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Several small studies over the years found that reamed nailing significantly decreased reoperations for tibial fractures. But emerging findings from a large study indicate that these results may have been overestimated.
Mohit Bhandari, MD, the project manager of the new trial, told Orthopaedics Today, “Based on the aggregate event rates, we are finding nowhere near that sort of magnitude of effect,” he said about the ongoing study.
Bhandari and his colleagues from the Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Fractures (SPRINT) trial have been analyzing one-year follow-up data from nearly 1000 patients randomized into reamed and unreamed groups. The investigators are blinded to group allocation, but say they are not seeing projected differences between cohorts. “ ... it will be highly unlikely that we’ll identify such a large difference between the groups,” Bhandari said. The researchers expect to collect data on 1325 patients and present the results in fall 2006.
Smaller study
The investigators estimated a greater gap between the groups and based their hypothesis on a meta-analysis performed five years ago. They pooled data from nine randomized studies (totaling 600 patients) comparing reamed and unreamed nailing. The investigators discovered that reoperation rates dropped 60% one year after reaming the canal, Bhandari said.
The discrepancy between the results of the new trial and previous studies illustrates the superiority of large sample sizes, he said. Conflicting parameters and differing research protocol in small studies create bias when researchers pool data.
According to Bhandari, the $4 million SPRINT trial constitutes one of the first large-scale, multicenter studies in trauma. The trial, funded by the National Institutes of Health and the Canadian Institutes of Health Research, tracks patients from 25 centers in North America and the Netherlands.
Investigators included nearly all forms of open and closed fractures. except type 3C injuries that had a neurovascular deficiency in the leg, Bhandari said. To ensure that patients could be randomized to either group, researchers also excluded patients with small canals that required reaming.
Given the size of the trial, the researchers developed several quality control measures to guarantee patient follow-up and standardization. Previous research on intramedullary nailing had a 70% patient follow-up, but so far the SPRINT trial has 95% follow-up, Bhandari said. Each center receives a weekly report tracking patient progress and indicating follow-up dates.
The participating centers fax patient information to a main computer, which flags questionable data and sends a query back to the individual center coordinators within 24 hours. Two full-time research coordinators also re-check the incoming data, Bhandari said. When a significant event is recorded, the center coordinators electronically send all OR notes and cropped X-rays to a panel of nine adjudicators. They then determine the need for reoperation based on preset trial guidelines.
The need for large trials
When all results are collected, Bhandari hopes that trial will end the reamed vs. unreamed nailing debate and call attention to the importance of large, randomized trials. Randomized trials compose less than 10% of the articles in some research journals, he said.