title: Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial.
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majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures.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.
  
  
  OBJECTIVE
  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
  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 Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands National Trial Register NTR2399.
authors.affiliation: Department of Surgery-Traumatology, Leiden University Medical Centre, 2300 RC Leiden, the Netherlands. S.A.Stegeman@lumc.nl
authors.forename: Sylvia A
authors.initials: SA
authors.lastname: Stegeman
authors.forename: Mireille
authors.initials: M
authors.lastname: de Jong
authors.forename: Cornelis F M
authors.initials: CF
authors.lastname: Sier
authors.forename: Pieta
authors.initials: P
authors.lastname: Krijnen
authors.forename: Jan W
authors.initials: JW
authors.lastname: Duijff
authors.forename: Tom P H
authors.initials: TP
authors.lastname: van Thiel
authors.forename: Piet A R
authors.initials: PA
authors.lastname: de Rijcke
authors.forename: Nicolaj M R
authors.initials: NM
authors.lastname: Soesman
authors.forename: Tjebbe
authors.initials: T
authors.lastname: Hagenaars
authors.forename: Freek D
authors.initials: FD
authors.lastname: Boekhoudt
authors.forename: Mark R
authors.initials: MR
authors.lastname: de Vries
authors.forename: Gert R
authors.initials: GR
authors.lastname: Roukema
authors.forename: Andras F K
authors.initials: AF
authors.lastname: Tanka
authors.forename: Jephta
authors.initials: J
authors.lastname: van den Bremer
authors.forename: Hub G W M
authors.initials: HG
authors.lastname: van der Meulen
authors.forename: Maarten W G A
authors.initials: MW
authors.lastname: Bronkhorst
authors.forename: Bart A
authors.initials: BA
authors.lastname: van Dijkman
authors.forename: Stephan W A M
authors.initials: SW
authors.lastname: van Zutphen
authors.forename: Dagmar I
authors.initials: DI
authors.lastname: Vos
authors.forename: Niels W L
authors.initials: NW
authors.lastname: Schep
authors.forename: Martin G
authors.initials: MG
authors.lastname: Eversdijk
authors.forename: Ger D J
authors.initials: GD
authors.lastname: van Olden
authors.forename: Johan G H
authors.initials: JG
authors.lastname: van den Brand
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: Hillen
authors.forename: Jan Paul M
authors.initials: JP
authors.lastname: Frölke
authors.forename: Inger B
authors.initials: IB
authors.lastname: Schipper
mesh_terms: D000293:Adolescent; D000328:Adult; D017760:Bone Malalignment / Q000628:therapy*; D001860:Bone Plates; D002968:Clavicle / Q000293:injuries*; D004185:Disability Evaluation; D005260:Female; D005593:Fracture Fixation, Internal / Q000379:methods*; D017102:Fracture Healing; D050723:Fractures, Bone / Q000628:therapy*; D005599:Fractures, Ununited; D006801:Humans; D008297:Male; D008875:Middle Aged; D009989:Orthotic Devices; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D016896:Treatment Outcome; D055815:Young Adult