title: A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: the RAMBO trial.
abstract: BACKGROUND
  The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits.
  
  
  METHODS
  The RAMBO trial (Radial Head - Amsterdam - Amphia - Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the 'Disabilities of Arm, Shoulder and Hand (DASH) score' twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the 'Numeric Rating Scale', range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year.
  
  
  CONCLUSIONS
  The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head.
  
  
  BACKGROUND
  The trial is registered at the Dutch Trial Register: NTR3413.
authors.affiliation: Trauma Unit, Department of Surgery, Academic Medical Center, Meibergdreef 9, 1100 DD Amsterdam, The Netherlands. w.e.bruinsma@amc.nl.
authors.forename: Wendy
authors.initials: W
authors.lastname: Bruinsma
authors.forename: Izaäk
authors.initials: I
authors.lastname: Kodde
authors.forename: Robert-Jan O
authors.initials: RJ
authors.lastname: de Muinck Keizer
authors.forename: Peter
authors.initials: P
authors.lastname: Kloen
authors.forename: Anneluuk L C
authors.initials: AL
authors.lastname: Lindenhovius
authors.forename: Jos P A M
authors.initials: JP
authors.lastname: Vroemen
authors.forename: Robert
authors.initials: R
authors.lastname: Haverlag
authors.forename: Michel P J
authors.initials: MP
authors.lastname: van den Bekerom
authors.forename: Hugo W
authors.initials: HW
authors.lastname: Bolhuis
authors.forename: Pieter H J
authors.initials: PH
authors.lastname: Bullens
authors.forename: Sven A G
authors.initials: SA
authors.lastname: Meylaerts
authors.forename: Peer
authors.initials: P
authors.lastname: van der Zwaal
authors.forename: Philip E
authors.initials: PE
authors.lastname: Steller
authors.forename: Michiel
authors.initials: M
authors.lastname: Hageman
authors.forename: David C
authors.initials: DC
authors.lastname: Ring
authors.forename: Dennis
authors.initials: D
authors.lastname: den Hartog
authors.forename: Eric R
authors.initials: ER
authors.lastname: Hammacher
authors.forename: Graham J W
authors.initials: GJ
authors.lastname: King
authors.forename: George S
authors.initials: GS
authors.lastname: Athwal
authors.forename: Ken J
authors.initials: KJ
authors.lastname: Faber
authors.forename: Darren
authors.initials: D
authors.lastname: Drosdowech
authors.forename: Ruby
authors.initials: R
authors.lastname: Grewal
authors.forename: J Carel
authors.initials: JC
authors.lastname: Goslings
authors.forename: Niels W L
authors.initials: NW
authors.lastname: Schep
authors.forename: Denise
authors.initials: D
authors.lastname: Eygendaal
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D016268:Internal Fixators / Q000706:statistics & numerical data; D008023:Ligaments, Articular / Q000000981:diagnostic imaging* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D011885:Radius Fractures / Q000000981:diagnostic imaging* / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult