• Login
    View Item 
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2018
    • View Item
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2018
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    Are large clinical trials in orthopaedic trauma justified?

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Author
    Sprague, S.
    Tornetta, P. III
    Slobogean, G.P.
    Date
    2018
    Journal
    BMC Musculoskeletal Disorders
    Publisher
    BioMed Central Ltd.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://dx.doi.org/10.1186/s12891-018-2029-3
    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. Copyright 2018 The Author(s).
    Sponsors
    The FLOW trial was supported by Research Grants from the Canadian Institutes of Health Research # MCT-93173, United States Army Institute of Surgical Research, Orthopaedic Trauma Research Program (OTRP) and Peer Reviewed Orthopaedic Research Program (PRORP), and Association Internationale pour l’Ostéosynthèse Dynamique (AIOD). The FLOW trial was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Orthopaedic Trauma Research Program under Award No. W81XWH-08-1-0473 and the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH-12-1-0530.
    Keyword
    FLOW trial
    Large trials
    Orthopaedic trial
    Sample size
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85045936005&doi=10.1186%2fs12891-018-2029-3&partnerID=40&md5=a5221a4995fdc50c3779e45fbd1df6d0; http://hdl.handle.net/10713/9808
    ae974a485f413a2113503eed53cd6c53
    10.1186/s12891-018-2029-3
    Scopus Count
    Collections
    UMB Open Access Articles 2018

    entitlement

    Related articles

    • Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures.
    • Authors: Flow Investigators.
    • Issue date: 2010 May 6
    • Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures.
    • Authors: FLOW Investigators., Petrisor B, Sun X, Bhandari M, Guyatt G, Jeray KJ, Sprague S, Tanner S, Schemitsch E, Sancheti P, Anglen J, Tornetta P, Bosse M, Liew S, Walter S
    • Issue date: 2011 Sep
    • A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.
    • Authors: FLOW Investigators., Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH
    • Issue date: 2015 Dec 31
    • Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review.
    • Authors: Desai B, Desai V, Shah S, Srinath A, Saleh A, Simunovic N, Duong A, Sprague S, Bhandari M
    • Issue date: 2018 Nov 24
    • Intramedullary nailing for tibial shaft fractures in adults.
    • Authors: Duan X, Al-Qwbani M, Zeng Y, Zhang W, Xiang Z
    • Issue date: 2012 Jan 18
    DSpace software (copyright © 2002 - 2021)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.