Trial reportTrials2016
Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Initial surgical management of injuries to the lower extremities in patients with multiple and/or severe injuries - A systematic review and clinical practice guideline update.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024Guideline
- Developments in the understanding of staging a "major fracture" in polytrauma: results from an initiative by the polytrauma section of ESTES.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024Pooled it
- Damage control orthopaedics is associated with impaired fracture healing and delayed recovery in a rodent model of severe multiple trauma.Bone & joint research · 2025Article
- Translating Biomarker Research into Clinical Practice in Orthopaedic Trauma: A Systematic Review.Journal of clinical medicine · 2025Review
- A Case of Symmetrical Bilateral Bifocal Femur Fracture with Bilateral Patella Fracture - A Case Report!Journal of orthopaedic case reports · 2023Article
- Early total care or damage control orthopaedics for major fractures ? Results of propensity score matching for early definitive versus early temporary fixation based on data from the trauma registry of the German Trauma Society (TraumaRegister DGUEuropean journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023Article
- Surgical treatment results in patients with defects of the integumentary tissues of the trunk and limbs of mechanical origin.Journal of medicine and life · 2022Article
- Strategies for the treatment of femoral fractures in severely injured patients: trends in over two decades from the TraumaRegister DGUEuropean journal of trauma and emergency surgery : official publication of the European Trauma Society · 2022Article
- Are large fracture trials really possible? What we have learned from the randomized controlled damage control study?European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2018Article
- [The TraumaRegister DGU® dataset, its development over 25 years and advances in the care of severely injured patients].Der Unfallchirurg · 2018Review
- The use of extracorporeal membrane oxygenation in trauma patients: A national case-control study.Medicine · 2018Article
- Innate immune responses to trauma.Nature immunology · 2018Review
- Two-stage treatment in patients with patients with high-energy femoral fractures does not lead to an increase in deep infectious complications: a propensity score analysis.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2018Article
- Complex pelvic ring injuries associated with floating knee in a poly-trauma patient: A case report.Medicine · 2017Article
- [Treatment strategies for mass casualty incidents and terrorist attacks in trauma and vascular surgery : Presentation of a treatment concept].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2017Review
- Treatment of femoral shaft fractures with monoaxial external fixation in polytrauma patients.F1000Research · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLong bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of "damage control orthopedics" (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). METHODS/
designThe study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score.
resultsThirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment.
conclusionsThus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains.
trial registrationCurrent Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.
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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.