Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

Authors

Carol Alice Lin, Hennepin County Medical Center
Mohit Bhandari, McMaster University, Faculty of Health Sciences
Gordon Guyatt, McMaster University, Faculty of Health Sciences
Stephen D. Walter, McMaster University, Faculty of Health Sciences
Emil H. Schemitsch, Saint Michael's Hospital University of Toronto
Marc Swiontkowski
David Sanders, London Health Sciences Centre
Paul Tornetta, Boston University School of Medicine
David W. Sanders, Western University
Sheila Sprague, McMaster University, Faculty of Health Sciences
Diane Heels-Ansdell, McMaster University, Faculty of Health Sciences
Lisa Buckingham, McMaster University, Faculty of Health Sciences
Pamela Leece, McMaster University, Faculty of Health Sciences
Helena Viveiros, McMaster University, Faculty of Health Sciences
Tashay Mignott, McMaster University, Faculty of Health Sciences
Natalie Ansell, McMaster University, Faculty of Health Sciences
Natalie Sidorkewicz, McMaster University, Faculty of Health Sciences
Julie Agel, University of Minnesota Twin Cities
Claire Bombardier
Jesse A. Berlin
Michael Bosse
Bruce Browner
Brenda Gillespie
Alan Jones
Peter O'Brien
Rudolf Poolman
Mark D. Macleod, Western University
Timothy Carey, Western University
Kellie Leitch, Western University
Stuart Bailey, Western University
Kevin Gurr, Western University
Ken Konito, Western University
Charlene Bartha, Western University

Document Type

Conference Proceeding

Publication Date

3-1-2016

Journal

Journal of Orthopaedic Trauma

Volume

30

Issue

3

First Page

156

Last Page

161

URL with Digital Object Identifier

10.1097/BOT.0000000000000533

Abstract

© Copyright 2016 Wolters Kluwer Health, Inc. All rights reserved. Objectives: To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients. Design: Retrospective review of prospectively collected data from a large clinical trial. Setting: Six level-1 international trauma centers. Methods: We compared rates and timing of reoperation in a subset of patients enrolled in the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) to concurrent patients who were eligible but not enrolled. This was a retrospective review of prospectively collected trial data. The records of 6 of the original SPRINT centers were searched for non-SPRINT patients who underwent intramedullary nailing of a closed tibial fracture. The rate and timing of reoperation were compared. A P < 0.05 was considered significant. Results: One hundred fourteen non-SPRINT patients were compared with 328 patients enrolled in SPRINT from those same sites. There were 7 reoperations (6.1%) in non-SPRINT patients versus 18 (5.2%) in SPRINT patients [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.41 to 3.13; P 0.811]. There was no difference in the time to reoperation between the SPRINT and non-SPRINT patients (6.2 vs. 6.8 months, 95% CI of the difference -3.8 to 2.6; P 0.685) or in the proportion of patients who underwent reoperation before 6 months (29% vs. 43%; OR 1.75; 95% CI 0.18 to 15.41; P 0.647). Conclusions: Patients not enrolled in SPRINT had similarly low rates of reoperation for nonunion, and the average time to reoperation for both groups was longer than 6 months. A 6-month waiting period may have allowed slow-to-heal fractures adequate time to heal, thereby reducing the rate of diagnosis of nonunion. As such, this waiting period could contribute to lower-than-expected reoperation rates for nonunion. It is possible that clinical trials may beneficially influence the care of nonenrolled patients.