Are large clinical trials in orthopaedic trauma justified?

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; FLOW Investigators

doi:10.1186/s12891-018-2029-3

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Are large clinical trials in orthopaedic trauma justified?

Journal article

Open access

Peer reviewed

Are large clinical trials in orthopaedic trauma justified?

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, …

BMC musculoskeletal disorders, Vol.19(1), pp.124-124

04/20/2018

DOI: 10.1186/s12891-018-2029-3

PMCID: PMC5909275

PMID: 29678204

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Abstract

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. 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. 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). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

Humans

Multicenter Studies as Topic - methods

Multicenter Studies as Topic - standards

Orthopedic Procedures - methods

Orthopedic Procedures - standards

Pilot Projects

Randomized Controlled Trials as Topic - methods

Randomized Controlled Trials as Topic - standards

Reoperation - methods

Reoperation - standards

Therapeutic Irrigation - methods

Therapeutic Irrigation - standards

Details

Title: Subtitle: Are large clinical trials in orthopaedic trauma justified?
Creators: Sheila Sprague - McMaster University
Paul Tornetta III - Department of Orthopaedic Surgery, Boston University School of Medicine, Boston, MA, USA
Gerard P Slobogean - University of Maryland, Baltimore
Nathan N O'Hara - Department of Orthopaedics, University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
Paula McKay - McMaster University
Brad Petrisor - McMaster University
Kyle J Jeray - Prisma Health
Emil H Schemitsch - Western University
David Sanders - Western University
Mohit Bhandari - McMaster University
FLOW Investigators
Contributors: Matthew Karam (Contributor) - University of Iowa, Orthopedics and Rehabilitation
Resource Type: Journal article
Publication Details: BMC musculoskeletal disorders, Vol.19(1), pp.124-124
DOI: 10.1186/s12891-018-2029-3
PMID: 29678204
PMCID: PMC5909275
NLM abbreviation: BMC Musculoskelet Disord
ISSN: 1471-2474
eISSN: 1471-2474
Grant note: MCT-93173 / Canadian Institutes of Health Research W81XWH-12-1-0530 / Peer Reviewed Orthopaedic Research Program W81XWH-08-1-0473 / Orthopaedic Trauma Research Program
Language: English
Date published: 04/20/2018
Academic Unit: Orthopedics and Rehabilitation
Record Identifier: 9984304708902771

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