Evidence map›Paper›PMID 29285613›Full record

ArticleEuropean journal of trauma and emergency surgery : official publication of the European Trauma Society2018

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

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

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In one paragraph

Article in European journal of trauma and emergency surgery : official publication of the European Trauma Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Non-operative vs. operative treatment for multiple rib fractures after blunt thoracic trauma: a multicenter prospective cohort study.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023
    Observational
  2. Translational research: what is the value of experimental studies in comparison with clinical studies to help understand clinical problems?European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Eva SteinhausenDepartment of Orthopedic and Trauma Surgery, BG Klinikum Duisburg, Großenbaumer Allee 250, 47249, Duisburg, Germany. EvaSimone.Steinhausen@bg-klinikum-duisburg.de.
Bertil BouillonFaculty of Health, University of Witten/Herdecke, Witten, Germany.
Dieter RixenFaculty of Health, University of Witten/Herdecke, Witten, Germany.
Members of the damage control study group

Funding

Deutsche Forschungsgemeinschaft RI 929/3-1
6 · The paper itself

Abstract

purposeAlthough 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.

methodsThe 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.

resultsThe 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.

conclusionsWe 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 registrationCurrent Controlled Trials ISRCTN10321620. Date assigned: 09/02/2007. LEVEL OF EVIDENCE: Level I.

Indexed as

Femoral FracturesMultiple TraumaOrthopedicsEvidence-Based MedicineFracture FixationHumansInjury Severity ScoreRandomized Controlled Trials as TopicResearch DesignClinical trialDamage controlFemoral fractureMultiple traumaRandomized trial

Identifiers

PMID29285613

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.