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

Steinhausen, Eva; Bouillon, Bertil; Rixen, Dieter

doi:10.1007/s00068-017-0891-6

Cited by 4 publications

(2 citation statements)

References 34 publications

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“…However, the recent study on rib fractures by Pieracci et al illustrates the challenges that may occur in randomized studies in trauma surgery 80% of the eligible subjects declined randomization [ 7 ]. The feasibility of large orthopedic trials has been questioned previously [ 37 ]. Observational studies often do not suffer from these hardships and may better represent daily clinical practice [ 38 ].…”

Section: Discussionmentioning

confidence: 99%

Non-operative vs. operative treatment for multiple rib fractures after blunt thoracic trauma: a multicenter prospective cohort study

Hoepelman

Beeres

Beks

et al. 2022

Eur J Trauma Emerg Surg

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Background Patients with multiple rib fractures without a clinical flail chest are increasingly being treated with rib fixation; however, high-quality evidence to support this development is lacking. Methods We conducted a prospective multicenter observational study comparing rib fixation to non-operative treatment in all patients aged 18 years and older with computed tomography confirmed multiple rib fractures without a clinical flail chest. Three centers performed rib fixation as standard of care. For adequate comparison, the other three centers performed only non-operative treatment. As such clinical equipoise formed the basis for the comparison in this study. Patients were matched using propensity score matching. Results In total 927 patients with multiple rib fractures were included. In the three hospitals that performed rib fixation, 80 (14%) out of 591 patients underwent rib fixation. From the nonoperative centers, on average 71 patients were adequately matched to 71 rib fixation patients after propensity score matching. Rib fixation was associated with an increase in hospital length of stay (HLOS) of 4.9 days (95%CI 0.8–9.1, p = 0.02) and a decrease in quality of life (QoL) measured by the EQ5D questionnaire at 1 year of 0.1 (95% CI − 0.2–0.0, p = 0.035) compared to non-operative treatment. A subgroup analysis of patients who received operative care within 72 h showed a similar decrease in QoL. Up to 22 patients (28%) who underwent surgery experienced implant-related irritation. Conclusions We found no benefits and only detrimental effects associated with rib fixation. Based on these results, we do not recommend rib fixation as the standard of care for patients with multiple rib fractures. Trial registration Registered in the Netherlands Trial Register NTR6833 on 13/11/2017.

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Section: Discussionmentioning

confidence: 99%

Non-operative vs. operative treatment for multiple rib fractures after blunt thoracic trauma: a multicenter prospective cohort study

Hoepelman

Beeres

Beks

et al. 2022

Eur J Trauma Emerg Surg

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“…Clinical studies alone may be difficult to obtain [1,2] and patient numbers may represent an issue [3]. This may get to a point where research organizations stop providing the financial support if the patient numbers are not met on time [4]. Other publications provide subsets of data studies that may suffer from type II errors and lack of long-term impact [5,6] (Table 1).…”

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confidence: 99%