Yannic Lecoutre (Lucerne / CH), Bryan van de Wall (Lucerne / CH), Frank Beeres (Lucerne / CH)
Abstract text (incl. references and figure legends)
Introduction
Clavicle fractures account for 2% to 5% of all fractures in adults. Single plate osteosynthesis is most commonly used for surgical stabilization. Structural low profile double plating technique might form a possible solution for the high removal rates associated with single plating. Although randomized controlled trials (RCTs) are considered the gold standard for testing the efficacy of such new interventions, its design sets highly artificial condition on surgical practice. A natural experiment (NE) design offers a possible solution. NEs are observational studies in which patients are exposed to either the experimental or the control condition and treatment allocation is determined by factors outside the control of the investigators. The present study encompasses a natural experiment comparing low profile double plating to single plating in midshaft clavicle fractures.
Material & Methods
Adult patients (≥18 years) with a primary midshaft clavicula fractures (Robinson Type II or AO 15.2) that are eligible for operative treatment will be included (Figure 1). Treatment allocation will be determined by geographical location. Five hospitals will participate in this study. In three centers, single plating is the treatment of choice and in two low profile double plating currently is the standard treatment. For the double plating group, one superiorly positioned VariAx 2.0mm plate and one anterior VariAx 2.4mm or 2.7mm plate will be used. For the single plating group, the standard local available implant will be used. The primary and secondary objectives are shown in Table 1.
Discussion
This study will help us understand if double plating has significant clinical and cost-effective benefits over a single plating technique in midshaft clavicle fractures as suggested in a previous meta-analysis by our study group. It will also provide insight on how the NE design functions in a research field where it has rarely been used.
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This investigator-driven study has been provided with a grant from Stryker Osteonics SA to cover the logistical costs (salary study coordinator, data management, costs related to congresses and publications fees).
No conflicts of interest have been reported by research management. The manuscript shall be published in a peer reviewed journal.
Contact details: Stryker Osteonics SA, Niederlassung Biberist, Burgunderstraße 13, CH-4562 Biberist / SO.