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01.12.2018 | Research article | Ausgabe 1/2018 Open Access

BMC Musculoskeletal Disorders 1/2018

Are large clinical trials in orthopaedic trauma justified?

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2018
Autoren:
Sheila Sprague, Paul Tornetta III, Gerard P. Slobogean, Nathan N. O’Hara, Paula McKay, Brad Petrisor, Kyle J. Jeray, Emil H. Schemitsch, David Sanders, Mohit Bhandari, on behalf of the FLOW Investigators

Abstract

Background

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data.

Methods

The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study.

Results

The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57).

Conclusions

Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds.

Trial registration

NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.
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