A natural experiment study: Low-profile double plating versus single plating techniques in midshaft clavicle fractures-Study protocol.

Autor: Lecoultre Y; Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.; Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland., van de Wall BJM; Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.; Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland.; Department of Surgery, Obwalden Cantonal Hospital, Sarnen, Switzerland., Diwersi N; Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.; Department of Surgery, Obwalden Cantonal Hospital, Sarnen, Switzerland., Pfarr SW; Department of Surgery, Schwyz Hospital, Schwyz, Switzerland., Galliker B; Department of Surgery, Sursee Hospital, Sursee, Switzerland., Babst R; Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.; Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland., Link BC; Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland., Beeres FJP; Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Sep 08; Vol. 18 (9), pp. e0291238. Date of Electronic Publication: 2023 Sep 08 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0291238
Abstrakt: Background: Single plate osteosynthesis is commonly employed when performing surgical stabilization of midshaft clavicle fractures. In recent years, a smaller structural low-profile double plating technique has been described as a possible solution for the high removal rates associated with single plating. A previous meta-analysis has demonstrated that low-profile double plating attains the same healing rates as single plating without a higher chance of fracture-related infections. This meta-analysis, however, was based on relatively small studies. Therefore, a multicentre prospective natural experiment was designed using natural variation in treatment regimens and geographical location of the trauma as treatment allocation mechanism to compare both treatments on a larger scale. This manuscript describes its protocol.
Material & Methods: Patients (≥16 years) with primary midshaft clavicle fractures that are eligible for operative treatment will be included. Treatment allocation will be determined by the geographical location of the accident and local hospital providing treatment. In two centres, single plating is the treatment of choice for these patients. In two others, low-profile double plating has become the standard treatment. For the low-profile double plating group, one superiorly positioned VariAx 2.0mm and one anterior VariAx 2.4mm or 2.7mm plate will be used. For the single plating group, the standard locally available implant will be used. A total of 336 patients will be included. The primary outcome of interest is re-intervention. Secondary outcomes include complications, operative time, length of incision, functional scores (DASH, EQ-5D-DL, VAS-Pain/Satisfaction) and cost-effectiveness.
Discussion: This study will determine whether low-profile double plating has significant clinical and cost-effective benefits over single plating techniques in midshaft clavicle fractures. The study will also give insight in the performance of a natural experiment study design for orthopedic trauma research.
Trial Registration: This study has been registered on ClincialTrials.gov, identifier NCT05579873.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2023 Lecoultre et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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