Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial

SA Stegeman, M Jong, CFM Sier, PAJ Krijnen, JW Duijff, TPH Van Thiel, PAR de Rijcke, NMR Soesman, Tjebbe Hagenaars, FD Boekhoudt, MR de Vries, GR Roukema, AFK Tanka, J van den Bremer, HGWM Van der Meulen, Maarten Bronkhorst, BA van Dijkman, SWAM van Zutphen, DI Vos, Niels SchepMG Eversdijk, GDJ van Olden, JGH Van den Brand, RJ Hillen, JPM Frolke, IB Schipper

Research output: Contribution to journalArticleAcademicpeer-review

20 Citations (Scopus)
1 Downloads (Pure)

Abstract

Background: The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries. Aim: A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. Methods/design: A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Discussion: This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures.
Original languageUndefined/Unknown
JournalBMC Musculoskeletal Disorders
Volume12
DOIs
Publication statusPublished - 2011

Cite this