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European Journal of Trauma and Emergency Surgery
Published in: European Journal of Trauma and Emergency Surgery 6/2018

01-12-2018 | Original Article

Are large fracture trials really possible? What we have learned from the randomized controlled damage control study?

Authors: Eva Steinhausen, Bertil Bouillon, Dieter Rixen, Members of the damage control study group

Published in: European Journal of Trauma and Emergency Surgery | Issue 6/2018

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Abstract

Purpose

Although they are considered the ‘gold standard’ of evidence-based medicine, randomized controlled trials are still a rarity in orthopedic surgery. In the management of patients with multiple trauma, there is a current trend toward ‘damage control orthopedics’, but to date, there is no proof of the superiority of this concept in terms of evidence-based medicine. The purpose of this article is to present unexpected difficulties we encountered in successfully completing our randomized controlled trial and to discuss the problematic differences between theoretically planning a trial and real-life practical experience of implementing the plan, with attention to published strategies.

Methods

The multicenter randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients (DCO study) was designed to determine whether ‘risk adapted damage control orthopedics’ of femoral shaft fractures is advantageous when treating multiple trauma patients. We compared our methods of study planning and realization point by point with published methods for conducting such trials.

Results

The study was methodically planned. We met the most prerequisites for successfully completing a large fracture trial, but experienced unexpected difficulties. After 2.5 years, the Deutsche Forschungsgemeinschaft suspended the financing because of low recruitment. The reasons were multifactorial.

Conclusions

We believe it is much more difficult to perform a large fracture trial in reality than to plan it in theory. Even the theoretically best designed trial can prove unsuccessful in its implementation. The question remains: are large fracture trials even possible? Hopefully YES!

Trial registration

Current Controlled Trials ISRCTN10321620. Date assigned: 09/02/2007.

Level of evidence

Level I.
Appendix
Available only for authorised users
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Metadata
Title
Are large fracture trials really possible? What we have learned from the randomized controlled damage control study?
Authors
Eva Steinhausen
Bertil Bouillon
Dieter Rixen
Members of the damage control study group
Publication date
01-12-2018
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Trauma and Emergency Surgery / Issue 6/2018
Print ISSN: 1863-9933
Electronic ISSN: 1863-9941
DOI
https://doi.org/10.1007/s00068-017-0891-6

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