title: A hinged external fixator for complex elbow dislocations: a multicenter prospective cohort study.
abstract: BACKGROUND
  Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation.
  
  
  METHODS
  The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36).
  
  
  CONCLUSIONS
  The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator.
  
  
  BACKGROUND
  The trial is registered at the Netherlands Trial Register (NTR1996).
authors.affiliation: Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, P,O, Box 2040, 3000 CA Rotterdam, The Netherlands.
authors.forename: Niels W L
authors.initials: NW
authors.lastname: Schep
authors.forename: Jeroen
authors.initials: J
authors.lastname: De Haan
authors.forename: Gijs I T
authors.initials: GI
authors.lastname: Iordens
authors.forename: Wim E
authors.initials: WE
authors.lastname: Tuinebreijer
authors.forename: Maarten W G A
authors.initials: MW
authors.lastname: Bronkhorst
authors.forename: Mark R
authors.initials: MR
authors.lastname: De Vries
authors.forename: J Carel
authors.initials: JC
authors.lastname: Goslings
authors.forename: S John
authors.initials: SJ
authors.lastname: Ham
authors.forename: Steven
authors.initials: S
authors.lastname: Rhemrev
authors.forename: Gert R
authors.initials: GR
authors.lastname: Roukema
authors.forename: Inger B
authors.initials: IB
authors.lastname: Schipper
authors.forename: Jan Bernard
authors.initials: JB
authors.lastname: Sintenie
authors.forename: Hub G W M
authors.initials: HG
authors.lastname: Van der Meulen
authors.forename: Tom P H
authors.initials: TP
authors.lastname: Van Thiel
authors.forename: Arie B
authors.initials: AB
authors.lastname: Van Vugt
authors.forename: Egbert J M M
authors.initials: EJ
authors.lastname: Verleisdonk
authors.forename: Jos P A M
authors.initials: JP
authors.lastname: Vroemen
authors.forename: Philippe
authors.initials: P
authors.lastname: Wittich
authors.forename: Peter
authors.initials: P
authors.lastname: Patka
authors.forename: Esther M M
authors.initials: EM
authors.lastname: Van Lieshout
authors.forename: Dennis
authors.initials: D
authors.lastname: Den Hartog
mesh_terms: D001178:Arthroplasty; D004185:Disability Evaluation; D004551:Elbow Joint / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D016267:External Fixators; D005592:Fracture Fixation / Q000295:instrumentation*; D050723:Fractures, Bone / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D004204:Joint Dislocations / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D007593:Joint Instability / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D009426:Netherlands; D010147:Pain Measurement; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D011859:Radiography; D016059:Range of Motion, Articular; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome